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CLINICAL EVALUATION REPORT
FOR
BioCon-700
Document Number: CE-BioCon-700
Revision: 9
Name Date Signature

Written By: HR Choi 2020.
07.20
/подпись/.
Reviewed By: CH Kim 2020.
07.20
/подпись/.
Approved By: MC Heo 2020.
07.20
/подпись/.
Mcube Clinical Evaluation Report Doc. No. CE BioCon-700
Technology
Bladder Volume Measurement System Rev. No. 9
CUBEScan TM
BioCon-700 Rev. Date 2020.07.20
Revision History
Date Revision Description Author
2010-01-10 0 Initially prepared Heo, Munchang
2011-02-07 1 Renewal of PMS data Heo, Munchang
2012-03-05 2 Renewal of Appraisal Criteria for Suitability Kim Changhyun
2013-02-14 3 6.2 Safety (PMS) Kim Changhyun
2017-02-07 4 MEDDEV 2.7.1 rev.4 Choi HyeRi
2018-01-30 5 Change the probe Choi HyeRi
2018-04-23 6 Biocompatibility study(HP1) Kim Changhyun
2019-08-07 7 Add the equivalent device( BioCon-900s), Choi HyeRi
Update the literature data
Update the summary and appraisal of clinical data
Update the qualification of the responsible
evaluators
2020-01-07 8 2.Scope of the clinical evaluation, 8) Choi HyeRi
4.6.2 Requirement on safety (MDD ER1)
8.2 Evidence of Evaluator Qualification
2020-07-20 9 The literature search results were corrected. Choi HyeRi
Mcube Technology Co., Ltd. 2 / 55

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CUBEScanTM BioCon-700 Rev. Date 2020.07.20
TABLE OF CONTENTS
1. Summary .......................................................................................................................................................................4
2. Scope of the clinical evaluation 4
3. Clinical background, current knowledge, state of the art ........................................................................................9
4. Device under evaluation ............................................................................................................................................... 12
4.1 Type of evaluation ............................................................................................................................................ 12
4.2 Demonstration of equivalence (only when equivalence is claimed).............................................................. 12
4.3 Clinical data generated and held by the manufacturer ................................................................................ 17
4.4 Clinical data from literature ........................................................................................................................... 17
4.5 Summary and appraisal of clinical data ........................................................................................................ 17
4.5.1 Clinical data appraisal method with grade ......................................................................................... 17
4.5.2 Clinical data appraisal .......................................................................................................................... 19
4.6 Analysis of the clinical data .............................................................................................................................26
4.6.1 Use sound methods ................................................................................................................................27
4.6.2 Essential Requirement Section 1 27
4.6.3 Essential Requirement Section 3 .........................................................................................................30
4.6.4 Essential Requirement Section 6 .........................................................................................................31
4.6.5 Determine if additional clinical investigations or other measures are necessary ............................32
4.6.6 Determine PMCF needs ........................................................................................................................33
4.6.7 Clinical Hazards of the Risk Management Report ............................................................................34
5. Conclusions ....................................................................................................................................................................34
6. Date of the next clinical evaluation 35
8. Qualification of the responsible evaluators 38
8.1 Requirements ....................................................................................................................................................38
8.1.1 General knowledge for clinical evaluation ..........................................................................................38
8.1.2 Knowledge on device under evaluation ...............................................................................................38
8.1.3 Pertinent experience .............................................................................................................................38
8.2 Evidence of Evaluator Qualification ..............................................................................................................39
8.3 Declaration of Interests 45
9. References ......................................................................................................................................................................46
Annex 1 THE LITERATURE SEARCH REPORT .........................................................................................................47

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1. Summary
The BioCon-700 must be designed and manufactured in such a way that, when used under the conditions and for the
intended purpose, they will not compromise the clinical condition or the safety of patients, or the safety and health of
users or, where applicable, other persons, provided that any risks which may be associated with their use constitute
acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection
of health and safety.
2. Scope of the clinical evaluation.

1) Identification of device covered by this clinical evaluation report
a) Model name: BioCon-700

b) Component
No Parts Quantity Description

.
1 Console 1 Main body
2 Probe (Transducer) 1 2.6MHz
3 AC cord 1 The type of power cord depends on your
country.
4 Adapter (Power supply) 1 Model No. MES30A
5 Thermal paper 1 Pack For built-in printer (57mm width)
6 Operator Manual 1 Operator Manual
7 SD card 1 SanDisk
8 Battery Pack Module 1 Li18S(X) (Installed in the console)
9 CD 1 PC Software (CubePro-700)
10 USB Cable 1 USB: A-mini B (5 pins) cable
11 SD Card Reader 1 USB 2.0
12 Rolling Cart Optional Rolling Cart with BioCon-700 mounted
13 Cradle Optional For storage
14 Carrying Bag Optional For carrying or storage
c) Size
- Console: 66(L) X 260(W) X 130(H) mm

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- Probe: 181(L) X 60(W), R25

d) Manufacturer: Mcube Technology Co., Ltd.
e) Manufacturer Address: #803, 123, Bongwhasan-ro, Jungnang-gu, Seoul, Korea
2) This clinical evaluation is submitted to the MDD as amended by directive 2007/47/EC.

3) Concise device description
BioCon-700 is a portable ultrasound system intended to measure the volume of urine in a patient’s bladder.
BioCon-700 transmits ultrasound signals into the abdomen of a patient and receives the echoed signals. Using
the echoed signals, the system determines the bladder’s outline and calculates the volume of the bladder based
on the outline.
BioCon-700 has a Pre-Scan function, which shows a live ultrasound image of a horizontal planar crosssection
of the bladder found by using the echoed signals. The Pre-Scan function helps in locating the bladder and
improving accuracy. A user can print the results using a built-in thermal printer immediately after
measurements are taken.
4) Technologies use, whether the device is based on a new technology, a new clinical application of
an existing technology, or the result of incremental change of an existing technology.
The ultrasound image device has been used for a long time, and no apparent side effects have been reported.
Bladder volume measurement system has been used for many years in the fields and there is no

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new technology used in this device. So clinical experience data will be used for the evaluation of the safety and
effectiveness rather than literature search.
a) Statement on Mammalian Biological Effects of Ultrasound In Vivo ( Approved 3/25/2015)

(http://www.aium.org/officialStatements/9)(http ://www. aium. org/ofFicialStatements/9)
InfoE01
ation from experiments using laboratory mammals has contributed significantly to our understanding of ultrasonically
induced biological effects and the mechanisms that are most likely responsible. Adverse biological effects have been
observed in some animal studies under conditions that may be achieved by using diagnostic scanners (see associated
specific statements). The following statement summarizes observations relative to minimal diagnostic ultrasound
parameters and indices.
In the low-megahertz frequency range, there have been no independently confirmed adverse biological effects in
mammalian tissues exposed in vivo under experimental ultrasound conditions, as follows:
b) Thermal Mechanisms
a. No effects have been observed for an unfocused beam having free-field spatial-peak temporal-average (SPTA)
intensities* below 100 mW/cm²,mW/cm, a focused** beam having intensities below 1 W/cm²,W/cm2, or temperature
increases of less than 1.5°C.
b. For fetal exposures, no effects have been reported for a temperature increase above the normal physiologic
temperature, ΔT, when ΔT < 4.5 – (log10 t)/0.6, where t is exposure time ranging from 1 to 250 minutes, including off
time for pulsed exposure.
c. For postnatal exposures producing temperature increases of 6°C or less, no effects have been reported when ΔT <
6 – (log10 t)/0.6, including off time for pulsed exposure. For example, for temperature increases of 6.0°C and 2.0°C,
the corresponding limits for the exposure durations t are 1 and 250 minutes.
d. For postnatal exposures producing temperature increases of 6°C or higher, no effects have been reported when ΔT
< 6 – (log10 t)/0.3, including off time for pulsed exposure. For example, for a temperature increase of 9.6°C, the
corresponding limit for the exposure duration is 5 seconds (=0.083 minutes) (see AIUM “Statement on Mammalian
Biological Effects of Heat”).
c) Nonthermal Mechanisms
a. For diagnostic ultrasound exposure by actual medical devices or laboratory equipment, no adverse effects have
been observed in tissues containing naturally occurring gas bodies for in situ peak rarefactional pressures below
approximately 0.4 MPa (estimated mechanical index [MI] values less than ≈0.4)-0.4) (see AIUM “Statement
Regarding Mammalian Biological Effects in Tissues With Naturally Occurring Gas Bodies”).
b. For contrast-enhanced diagnostic ultrasound, no adverse effects in mammalian tissue in vivo have been reported
and independently confirmed for an MI below about 0.4 (see AIUM “Statement on Mammalian

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Biological Effects in Tissues With Gas Body Contrast Agents”).
c. In tissues that do not contain well-defined gas bodies, no adverse nonthermal bioeffects have been observed for MI values
below 1.9: the upper limit for diagnostic ultrasound (see AIUM “Statement on Mammalian Biological Effects in Tissues
Without Gas Bodies”).
*Free-field SPTA intensity for continuous wave and pulsed exposures.
**Quarter-power (–6-dB) beam width smaller than 4 wavelengths or 4 mm, whichever is less at the exposure frequency.
5) Device group to which the device belongs

Bladder Volume Measurement System
6) Exact description of the device.

a) Indications for Use
BioCon-700 is a B-mode pulsed-echo ultrasound device. The BioCon-700 projects ultrasonic energy through
the abdomen of the patient to obtain images of the bladder. From the images of the bladder the device
calculates the urine volume non-invasively. And then the calculated volume and images are displayed on the
embedded LCD screen. The BioCon-700 is intended to be used only by qualified medical professionals.
Contraindications for the BioCon-700 are fetal use and use on pregnant patients.
b) Intended application
Item Comment
Patient populations Male, Female, and Pediatric patients
Anatomical Site Bladder
Intended user Qualified medical professional
Single use / reusable Reusable
Invasive / non-invasive Non-invasive
Implantable N/A
Duration of use or contact time < 10 minutes
Device Lifetime 7 years: Based on service period of the device
c) Contraindications
Do not use the BioCon-700 on following cases:
- Fetal or pregnant patient
- Patients with ascites
- Patients with open or damaged skin

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- Wounds in the suprapubic region
d) Precautions
The BioCon-700 Operator’s Manual covers precautions needed to use this device. See BioCon-700
Operator Manual(MUM-BioCon-700)
e) Materials
No Item Applicable
A Is there any contact with a patient? A
What’s the contact type? Skin contact
(abdominal)
What is the material of contact part? Polycarbonate
B Does the device incorporate a medicinal substance? N/A
C Does it include human or animal components? N/A
D Does it include any blood product? N/A
f) Sterile / non-sterile: Non-sterile Device
7) Claims on clinical performance and clinical safety

Specific safety and performance
-MI : Lower than 0.3 MPa acoustic pressure or MI is lower than 0.3
-Electrical Safety : IEC60601-1,
-EMC : IEC60601-1-2
-Minor effects (spontaneous cares less than a week) to patients has found in the clinical data
-Malfunction might not lead to a misdiagnosis in the customer compliant log
8) The BioCon-500, BioCon-700, BioCon-900, and BioCon-900S is already CE-marked.

There are no modifications affected safety and performance of the device.
Number of CUBEScan devices on the market in Europe and in other countries.
Year Asia Europe America Africa Australia & Total
New Zealand
Malaysia, U.K, Italy, USA, Canada, S.Africa, Saudi
Hong Kong, Germany, Paraguay, Arabia, Egypt,
China, Japan, France, Guatemala, Arab,
India, Iran, Belgium, Chile Emirates,
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Philippines, Netherland, Algeria, Israel,
Singapore, Norway, Turkey,
Taiwan, Denmark, Kuwait
Thailand, Finland,
South Korea Sweden,
Russia
2017 109 601 1783 73 57 2623

2018 269 648 1442 63 55 2477
2019 588 1007 1589 53 22 3189
Tota 966 2256 4814 189 134 8289
l
9) Changes since the last report

There are no changes, modifications, new intended purposes, new claims, new events related to the
device with an impact on clinical evaluation since the last report
3. Clinical background, current knowledge, state of the art

1) Identification of medical fields concerned/ relevant medical conditions
Bladder volume measurement system measure bladder volume and they provide accurate data to aid in the
diagnosis of common urological condition, to assess urinary retention, to help unnecessary catheterization, and
to reduce rates of catheter-associated urinary tract infection.
The benefits are as below;
BioCon-700 assists in: a. Assess urinary retention b. Evaluate post-up urinary retention (POUR) c. Reduce
unnecessary catheterization d. Reduce catheter-associated urinary tract infections(CAUTIs) e. Identify a
blocked Foley catheter f. Evaluate need to catheterize after Foley catheter removal g. Evaluate need to
catheterize during intermittent catheterization h. Assist in bladder retraining i. Verify empty bladder
2) Brief summary and justification of the literature search strategy applied for retrieval of
information on current knowledge/ the state of the art
A method for documenting the screening and selection of literature within a literature search report

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Literature excluded, with reasons
Literature excluded
from clinical evaluation, with reasons
3) Applicable standards and guidance documents

a) European Legislation:
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
b) Guidance Document
- MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System
- MEDDEV 2.12/212/2 rev. 2 Post Market Clinical Follow-up studies
- MEDDEV 2.7/1 rev.4 Clinical Evaluation: Guide for manufacturers and notified bodies
- FDA guidance - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
c) Relevant Standards
- EN ISO 13485:2016
- EN ISO 14971:2012
- IEC 60601-1:2005/A1:2012
- IEC 60601-2-37:2015
- IEC 60601-1-2:2014
- IEC 60601-1-6:2013
- IEC 62366:2014
- IEC 62304:2015
- ISO10993-1:2009
- ISO 15223-1:2016
- ISTA 2015 Integrity Test Procedure 2A

4) Description, natural course and consequences of the medical conditions concerned.
Normally Patients with Urinary retention may have difficulty initiating a stream of urine, may urinate
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frequently feel an urgent need to urinate but void only small amounts, and may feel that they still have to go
after they’ve finished urinating. Urine that remains in the bladder after voiding is referred to as Post Void
Residual. In patients experiencing acute or chronic urinary retention, diagnosis and treatment is aided by the
use of BioCon-700 non-invasive portable ultrasound device to measure the amount urine that remains in the
bladder after voiding.
5) Outline the development context for BioCon-700

BioCon-700 assists in:
a. Measuring post-void residual bladder volume
b. Assessing urinary retention
c. Diagnosing such as Bladder outlet obstruction, LUTS, OAB and so on
d. Monitoring postoperative recovery
BioCon-700 is the device that measures the volume of bladder and the residual urine using echo effect of
ultrasound. BioCon-700 Ultrasound System is a portable, battery powered ultrasound system used to acquire
and display bladder images. The device is used to non-invasively monitor residual bladder volume. This device
is composed of the main unit which is processing data acquired from ultrasound transducer and the ultrasound
transducer. The ultrasound transducer is a mechanical sector probe. Inside the ultrasound there is a 2.6MHz
ultrasound transducer. This transducer operates in B-mode only to monitor bladder volume. During 1-scan the
device gets the 12-plane images. Also this device helps users locate bladder position via pre-scan function
which displays a plane image continuously. Users can locate easily bladder position using this pre-scan
function.
6) Hazards due to substances and technologies that could be relevant to the device
The ultrasonic energy is projected to the abdomen and the energy has a thermal and mechanical effect to the
human body, so there is a global maximum index value by FDA guideline (MI>1.9) and BioCon-700 meets the
requirement.
Use ISPTA.3(mW/cm2) ISPPA.3(W/cm2) MI
Peripheral Vessel 720 190 1.9
Cardiac 430 190 1.9
Fetal Imaging & Other* 94 190 1.9
Ophthalmic 17 28 0.23
GMP MI≤MI< 0.662

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7) Type of users
RX only
4. Device under evaluation

4.1 Type of evaluation
Type: Literature search
Justification: There have been published articles of clinical investigations and adverse event reports for the device in
questions or for equivalent devices, because the devices (in questions or equivalent) with the same or equivalent
intended use/indications for use/clinical safety and performance features have already marketed. So the data source
of data to be used in the clinical evaluation is available from scientific literature. Literature searching is used to
identify data not held by the manufacturer that are needed for the clinical evaluation.
4.2 Demonstration of equivalence (only when equivalence is claimed)

1) Identification of the equivalent devices and its manufacturer.
The table below is a list of equivalent devices and their intended use is to measure the bladder volume with
ultrasonic energy.
Identification table of equivalent devices

Model Manufacturer Ultrasound PC Accessories Relationship Regulatory
Name Frequency( Software to the Status
MHz) evaluation
device
BioCon-900S Mcube 2/3.4 MHz CubePro Power cord, Successor CE-marked

Technology (Ver 2) Mobile cart Refer to
certificate:
KR19/8182
6331
BioCon-900 Mcube 2/3.4 MHz CubePro Power cord, Successor CE-marked

Technology (Ver 2) Mobile cart Refer to
certificate:
KR19/8182
6331
BioCon-700 Mcube 2.6 MHz CubePro- Power cord, Device under CE-marked
Technology 700 Adapter, Mobile evaluation Refer to
(Ver2) cart certificate:

Technology Bladder Volume Measurement System Rev. No. 9
KR19/8182
6331
BioCon-500 Mcube 2.8 MHz CubeScan Power cord, Successor CE-marked

Technology PC (Ver1) Mobile cart Refer to
certificate:
KR19/8182
6331
BVI-3000 Verahon 2MHz Adapter Successor CE-marked

Refer to the
BladderSca
n BVI-3000
IFU
2) Comparison of clinical, biological and technical characteristics.

Clinical, technical and biological characteristics is taken into consideration for the demonstration of
equivalence.
- The device under evaluation: BioCon-700
- The equivalent device: BioCon-900, BioCon-500
a) Clinical:
- Used for the same clinical condition (including when applicable similar severity and stage of disease,
same medical indication), and
- used for the same intended purpose, and
- used at the same site in the body, and
- used in a similar population (this may relate to age, gender, anatomy, physiology, possibly other
aspects), and
- not foreseen to deliver significantly different performances (in the relevant critical performances
such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).
b) Technical:
- be of similar design, and
- used under the same conditions of use, and
- have similar specifications and properties (e.g. physicochemical properties such as type and intensity
of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity,
particle size, nanotechnology, specific mass, atomic inclusions such as nitrocarburising, oxidability),
and

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- use similar deployment methods (if relevant), and

- have similar principles of operation and critical performance requirements.
c) Biological: Use the same materials or substances in contact with the same human tissues or body fluids.
3) Identification of literature
The lists below are the infromationinformation that may impact on the use of the device and its literature. The information is
intended to directly demonstrate adequate clinical performance and clinical safety of the device.
Informations for use Literature
Indications for use User Guide (MUM-BioCon-700)
Contraindications
Other cautions and warning using the device
Bladder volume accuracy on a phantom
4) Comparative tabulations for the device under evaluation versus the equivalent device.
Characteristics BioCon-900 BioCon-700 BioCon-500
Clinical
Clinical condition Bladder volume measurement Bladder volume Bladder volume measurement
system measure bladder measurement system system measure bladder volume
volume and they provide and they provide accurate data
measure bladder volume and
accurate data to aid in the to aid in the diagnosis of
they provide accurate data to
diagnosis of common common urological condition,
aid in the diagnosis of
urological condition, to assess to assess urinary retention, to
common urological
urinary retention, to help help unnecessary
condition, to assess urinary
unnecessary catheterization, catheterization, and to reduce
retention, to help
and to reduce rates of catheter- rates of catheter-associated
unnecessary catheterization,
associated urinary tract urinary tract infection.
and to reduce rates of
infection.
catheter-associated urinary
tract infection.
Intended purpose Measure the bladder volume Measure the bladder volume Measure the bladder volume
Site in the body Abdomen (Bladder) Abdomen (Bladder) Abdomen (Bladder)
Population Male, Female, and Pediatric Male, Female, and Pediatric Male, Female, and Pediatric
patients patients patients
Technical

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Transducer 2.0 /3.4MHz 2.6MHz 2.8MHz

Resonant
Frequency
Energy Delivered ultrasound ultrasound ultrasound

Measurement 0 to 999ml: ±15% ±15ml 0 to 999ml: ±15% ±15ml 0 to 699ml: ±20% ±20ml
Accuracy 700 to 999ml: ±25% ±25ml
Modes of Operation B-mode B-mode B-mode
Transducer Type Mechanical Sector Probe Mechanical Sector Probe Mechanical Sector Probe
Transducer 14mm 10mm 14mm
Diameter
Sector Angle 120 degrees 120 degrees 120 degrees

Live Scan Image Yes (Pre-scan) Yes (Pre-scan) Yes (Pre-scan)
Biological
Patient Contact Po lybutylene terephthalate/ Plastic, Polycarbonate Plastic, Polycarbonate (Model:
Material Polycarbonate (Model: HP1) HP1)
(Model:
LUPOX HI1002F)
Part in contact with Probe head Probe head Transducer head
/логотип: расшифровка/ /логотип: расшифровка/ /логотип: расшифровка/
the body
Characteristics BioCon-900S BVI-3000 (Verathon)
Clinical
Clinical condition Bladder volume measurement system measure A portable 3D ultrasound device, the Verathon
bladder volume and they provide accurate data Bladder Scanner BVI 3000 quickly, accurately,
to aid in the diagnosis of common urological and noninvasively measures bladder volume. It
condition, to assess urinary retention, to help is battery-operated, easy to use, and quickly
unnecessary catheterization, and to reduce rates provides accurate results. In less than five
of catheter-associated urinary tract infection. minutes, you can use the BladderScan to obtain
a precise reading of a patient’s bladder volume.
The BladderScan supplies the information that
caregivers need to diagnose, treat and manage
urinary conditions.
Intended purpose Measure the bladder volume Measure the bladder volume

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Site in the body Abdomen (Bladder) Abdomen (Bladder)

Population Male, Female, and Pediatric patients All
Technical
Transducer 2.0 /3.4MHz 2MHz
Resonant
Frequency
Energy Delivered ultrasound ultrasound
Measurement 0-99ml±10ml, 0-699ml ±(20% + 20ml)

Accuracy 100-999ml ±10% 700-999ml±(25%+ 25ml)
Modes of B-mode B-mode

Operation
Transducer Type Mechanical Sector Probe Mechanical Sector Probe

Transducer 14mm Unknown
Diameter
Sector Angle 120 degrees 120 degrees
Live Scan Image Yes (Pre-scan) No
Biological
Patient Contact Pl astic, Polycarbonate (Model: HP1) Plastic(PC)
Material
Part in contact with /логотип: расшифровка/ Probe head Probe head

the body
5) Identification of differences
a) Transducer Resonant Frequency
Acoustic Output (Doc. AOR_BioCon-700)
The Acoustic output report shows that the difference of ultrasound frequency has no effect on safety and
effectiveness.
b) Patient Contacting Material
Biocompatibility test report (Report No. 382-001, 382-002. 383-003)
Biological Risk Assessment Report (Doc. BAR-HP1)
The biocompatibility testing of contact material was performed and it does not raise different questions on

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safety and effectiveness.
c) Transducer diameter
Acoustic Output (Doc. AOR_BioCon-700)
A large transducer diameter means a less diverging beam and being sensible, but no effect in safety and effectiveness has been
proven by the Acoustic output report.
6) Conclusion concerning equivalence.

The comparison carried out covers all products/ models/ sizes/ settings/ accessories and the entire intended
purpose of the device under evaluation.
7) Conclusion whether equivalence is demonstrated or not.

The clinical properties of the device do not be affected by differences between the intended purpose of the
device under evaluation and the equivalent device.
4.3 Clinical data generated and held by the manufacturer

Accuracy of Post-Void Residual Urine Volume Measurement Using a Portable Ultrasound Bladder Scanner With
Real-Time Pre-Scan Imaging - Yong Hyun Park, Ja Hyeon Ku, and Seung-June Oh* Department of Urology, Seoul
National University College of Medicine, Seoul, Korea
-> 4.5 (3) as referred. But it is only for research, not for registration.
4.4 Clinical data from literature

Literature searching is used to identify data not held by the manufacturer that are needed for the clinical evaluation.
Annex 1 A format for the literature search report
4.5 Summary and appraisal of clinical data

In order to determine the value of the data identified, the evaluators appraised each individual document in terms of its
contribution and relevance to the evaluation of the clinical performance and clinical safety of the device in the Table D1 and D2.
The method used to evaluate the clinical data was qualitative.
The criteria adopted for the appraisal reflected the nature, history and intended clinical use of the device. They were documented
and justified on the basis of current knowledge / the state of the art, applying accepted scientific standards.
4.5.1 Clinical data appraisal method with grade

In order to determine the value of the data identified in stage 1, the evaluators should appraise each individual
document in terms of its contribution to the evaluation of the clinical performance and clinical safety of the device.

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The clinical data appraised for Suitability and Data Contribution will be further assessed to evaluate its relative
contribution towards safety and performance.
A Weighting Level is assigned to data based on the equivalence criteria to evaluate its relative contribution to the
safety and performance assessment.
The criteria adopted for the appraisal should reflect the nature, history and intended clinical use of the device. They
should be documented and justified on the basis of current knowledge / the state of the art, applying accepted
scientific standards. The appraisal should be thorough and objective, i.e. it should identify and attribute adequate
weighting both to favorable and unfavorable contents of each document. The data appraisal score of BioCon-700 is
shown in Table 1 and 2
Table 1 Appraisal Criteria for suitability of a data set for the clinical evaluation
Suitability Description Grading System Score
Criteria
Appropriate To what extent are the data generated D1 Actual device 3

device representative of the device under evaluation? D2 Equivalent device 2
D3 Other device 1
Appropriate Are the data relevant to the intended purpose A1 representative of the entire intended 3
device of the device or to claims about the device? purpose with all patient populations and all
application claims foreseen for the device under
evaluation
A2 concerns specific models/ sizes/ settings, 2
or concerns specific aspects of the intended
purpose or of claims
A3 does not concern the intended purpose or 1
claims
Appropriate Where the data generated from a patient P1 Applicable 3
patient group group that is representative of the intended
treatment population e.g., age, sex, etc.) and P2 Limited 2
clinical condition (i.e., disease, including state P3 Different population 1
and severity)?
Acceptable Do the reports or collations of data contain R1 High quality 3
report/data sufficient information to be able to undertake R2 Minor deficiencies 2
collation a rational and objective assessment? R3Insufficient information 1

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Table 2 Appraisal Criteria for Data Contribution of each data set to the clinical evaluation
Data Contribution Criteria Description Grading System Score
Data source type Was the design of the study appropriate? T1 Yes 3
T2 No 2
Outcome measures Do the outcome measures reported reflect the intended O1 Yes 3
performance of the device? O2 No 2
Statistical significance Has a statistical analysis of the data been provided and S1 Yes 3
is it appropriate? S2 No 2
Acceptance criteria: Since the total score is 21, the acceptance score shall exceed 15. In addition, the score of each
suitability criteria is bigger than or equal to 2 as below;
Note: If the any criteria scores 1, the data is not acceptable, even if the appraisal score is bigger than 15.
Suitability Criteria Grading System Score
Appropriate device D1 Actual device 3
D2 Equivalent device 2
Appropriate device A1 representative of the entire intended purpose with all patient populations and all 3
application claims foreseen for the device under evaluation
A2 concerns specific models/ sizes/ settings, or concerns specific aspects of the 2
intended purpose or of claims
Appropriate patient P1 Applicable 3
group P2 Limited 2
Acceptable report/data R1 High quality 3
collation R2 Minor deficiencies 2
4.5.2 Clinical data appraisal

After scanning the literature search results, 3 articles were adopted for clinical evaluation.
Listed clinical data and theirs category/weighting (performance erformance or safety)

No. Clinical data Category Total Are all the criteria
Score acceptable in suitability?
1 Accuracy of post-void residual urine volume Performance 20 Yes

measurement using a portable ultrasound bladder
scanner with real-time pre-scan imaging.`
2 Accuracy of Post-Void Residual Urine Volume Performance 20 Yes
Measurement Using an Ultrasound Bladder

Technology
Scanner among Postoperative Radical

Hysterectomy Patients
4.5.2.1 Clinical Data - Literature 1

Accuracy of post-void residual urine volume measurement using a portable ultrasound bladder scanner with real time
pre-scan imaging.
- Park Yong Hyun ; Ku Ja Hyeon ; Oh Seung-June
- Neurourology and urodynamics 2010
AIMS: To evaluate whether the bladder scanner with real-time pre-scan imaging (RPI) is superior to the
conventional bladder scanner in measuring post-void residual urine (PVR) volume.
METHODS: Sixty-seven patients with voiding dysfunction were subjected to PVR volume measurements. The PVR
volume was measured three times by two experienced examiners using bladder scanners with (BioCon-500, Mcube
Technology, Seoul, Korea) or without (BVI-3000 BladderScan, Verathon, WA) RPI. Immediately after the
procedure, urethral catheterization was performed to obtain true volume. The accuracy and variability of
measurements were compared between the two devices and correlation coefficients were obtained.
RESULTS: The Pearson correlation coefficients between the PVR volume measured by each device and the true
volume were 0.932 for the bladder scanner without RPI and 0.950 for the bladder scanner with RPI. The bladder
scanner without RPI tended to overestimate the true volume in moderate volume ranges (>100 ml) by a mean
percentage of differences of volume (PDV) of 16.3%, while the bladder scanner with RPI underestimated the true
volume in the whole volume range by a mean PDV of -14.1% (P < 0.001). Repeated measures ANOVA showed no
significant interobserver variability (P = 0.977 for the bladder scanner without RPI and P = 0.853 for the bladder
scanner with RPI) or intraobserver variability (P = 0.660 for the bladder scanner without RPI and P = 0.271 for the
bladder scanner with RPI). CONCLUSIONS: Our results showed that exact pointing to the bladder prior to actual
measurement of bladder volume with RPI seems to reduce the variability of the measured values.
Appraisal for relevance of a data set for the clinical evaluation

Relevance Description Grading System Score
Criteria
Appropriate To what extent are the data <D2 Equivalent device> 2
device generated representative of the Manufacturer: Mcube Techonology / Model: BioCon-500
device under evaluation? Manufacturer: Verathon / Model: BVI-3000
Appropriate Are the data relevant to the <A1 representative of the entire intended purpose with 3
device intended purpose of the device all patient populations and all claims foreseen for the
application or to claims about the device? device under evaluation>

Technology
Appropriate Where the data generated <P1 applicable> 3

patient group from the patient group that A total of 67 patients (28 men and 39 women) were
is representative of the prospectively included in this study from September 2007
intended treatment to March 2008. All the patients attended an outpatient
population (e.g. age, sex, clinic for the evaluation of voiding dysfunction. Exclusion
etc.) and clinical condition criteria included a history of bladder surgery, age younger
(i.e. disease, including state than 18 years, or pregnancy.
and severity)?
Acceptable Do the reports or collations <R1 High quality> 3
report/data of data contain sufficient This report results showed that bladder volume measured
collation information to undertake a by portable ultrasound devices with or without RPI
rational and objective correlates very well with the actual volume.
assessment?
Appraisal for the contribution of each data set to the clinical evaluation
Data Description Grading System Score
Contribution
Criteria
Data source Was the <T1 Yes> 3
type design of The PVR volume was measured using both the portable 12 frame B-mode
the study sector-probe ultrasound bladder scanner with (BioCon-500) or without
appropriate? (BVI-3000) RPI. Several measurements were taken to ensure the maximum
accuracy until the largest volume was obtained according to the
manufacturer’s protocol.
Using each device, each measurement was done three times by two
experienced independent examiners (A and B) randomly, which meant a
total of 12 measurements was done in a single patient. The time taken to
complete measurement was recorded.
Immediately after the procedure, urethral catheterization was performed to
obtain the true volume of the bladder.
Outcome Do <O1 Yes> 3
measures The PVR volume was measured three times by two experienced
the
examiners using bladder scanners with (BioCon-500, Mcube Technology,
outcome
Seoul, Korea) or without (BVI-3000
measures
reported

Technology
reflect the BladderScan, Verathon, WA) RPI. Immediately after the procedure,
intended urethral catheterization was performed to obtain true volume.
performanc
e
of the
device?
Statistical Has <S1 Yes> 3
significance The accuracy of the two devices was evaluated by the percentage of
been a differences of volume (PDV) calculated by dividing the measured volume
statistical by the true volume.1 A paired t-testwas used to determine whether the
analysis of differences in the PVR volume measured by each device and the time taken
the data for each measurement were statistically significant. Repeated measures
been ANOVA was used to compare both the PVR volume measurement of the
provided two independent examiners and the PVR volume measurements of the same
and is it examiners. The Pearson correlation coefficients (r) were calculated to
appropriate? identify potential correlations among the true volume and the PVR volume
measured by each device. Fisher’s r-to-z transformation was used to test for
significant differences between r values of both groups. A value of P<0.05
was considered statistically significant.
Critical Evaluation (Review) of the literature 1

This study was performed by department of urology, Seoul National University College of Medicine. It contains a simple
specification on BioCon-500 and BVI 3000, which is equivalent to BioCon-700 (including its intended functions,
description of the intended purpose and application of use).
Device under assessment (BioCon-500 with RPI) and compare device covered by the literature (BVI 3000 without RPI) are
bladder scanner in measuring post-void residual urine. The PVR volume was measured using both the portable 12 frame B-
mode sector-probe ultrasound bladder scanner (BioCon-500 and BVI-3000). However, there is no a statement that
equivalence has been demonstrated.
The populations to be applied by device’s intended use from literature demonstrate the performance of device as a
clinically significance of effects. A total of 67 patients (28 men and 39 women) were prospectively included in this study
from September 2007 to March 2008. All the patients attended an outpatient clinic for the evaluation of voiding
dysfunction. Exclusion criteria included a history of bladder surgery, age younger than 18 years, or pregnancy.
There is no effect of safety factors on patient or various clinic personnel during the study. Undesirable side-effect also was
not been observed in this literature. The contents of the IFU are supported by these clinical evidence (description of the
intended purpose, handling instructions, undesirable side-effect) and are in line with the risk analysis and clinical
evaluation.

Technology
The accuracy of the measured volume might be affected by the bladder volume status, which leads to different bladder
configuration. Although the more recently developed devices represent significant improvements, there have been changes
in accuracy according to the bladder volume status. Ghani et al. reported that the bladder scanner without RPI may
overestimate the measured volume when faced with large bladder volumes; however, other investigators have produced
different results. According to other investigators, the reasons for underestimation or overestimation include irregular shape
of the bladder, continued bladder filling during the delay before catheterization, and failure of the scan to include all parts
of the bladder because of large bladder volume.
A good correlation does not necessarily indicate a good clinical agreement. Thus, investigators of the study evaluated the
interobserver and intraob-server variation, PDV and the gap between the highest and lowest measured values as well as
correlation coefficients for evaluating the accuracy and agreement of the measurements. The investigators performed PDV
analysis for evaluating the accuracy of the measurement because the relative value of error, rather than the absolute value
of error, may be important for a given actual blad-der volume. Bland-Altman analysis is a use-ful method to analyze the
agreement between two different systems. However, Bland-Altman approach also has some lim-itations when differences
are not constant over the measuring interval. In these cases the mean and 95% confidence intervals of the differences do
not appropriately describe the agreement or deviation between two systems.
The results showed that bladder volume measured by portable ultrasound devices with or without RPI correlates very well
with the actual volume. Exact pointing to the bladder prior to actual measurement of bladder volume using a pre-scan
function seems to reduce the variability of measured values in the bladder scanner with RPI.
The bladder scanner without RPI (BVI-3000 BladderScan) used in this study was already on the market for a decade. The
more recently developed bladder scanners commercially available already might represent significant improvements over
their predecessors.
The literature contain a reference list cross-referenced in the evaluation.
4.5.2.3 Clinical Data - Literature 2

Accuracy of Post-Void Residual Urine Volume Measurement Using an Ultrasound Bladder Scanner among
Postoperative Radical Hysterectomy Patients
- Kanate Thanagumtorn MD
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Rajavithi Hospital, College
of Medicine, Rangsit University, Bangkok, Thailand
Background: Postoperative urinary retention occurs in 17 to 42% of Radical hysterectomy (RH) cases. The gold
standard assessment of post-void residual urine volume (PVR) is bladder catheterization. The use of the 3D portable
ultrasound device (Verathon BladderScan BVI 9400) to evaluate PVR is quick, safe, non-invasive, painless, and
comfortable for patients as well as being easy to use.
Objective: To compare the accuracy of ultrasound bladder scanner with that of urethral catheterization in the

Technology
assessment of post-void residual urine volume (PVR).

Material and Method: This was a prospective study. After removal of Foley’ s catheter in postoperative radical
hysterectomy(RH) patients, the voiding care schedule consisted of voids after six hours or earlier if the patient had
the urge. Promptly after voiding, PVR was measured using the BladderScan (Scan volume). Immediately after the
procedure, urethral catheterization was performed to obtain the actual PVR (Catheter volume). The process was
repeated in subsequent voids, and correlations between scan volume and catheter volume were analyzed.
Results: Seventy patients (140 measurements) were included. A high correlation was found between the scan
volume and the catheter volume (r = 0.89, p100 ml was the cutoff for determining the need for re-catheterization, the
scan volume returned 90.0% accuracy. Repetition of ultrasound scan in patients who had a first scan volume of
≤100ml<100ml yielded a 97.2% specificity and 100% NPV in predicting catheter volume of ≤100ml.<100ml.
Conclusion: The Bladder Scan provides good correlation together with high rates of specificity and NPV, and it
could be an alternative modality to catheterization for the measurement of PVR in postoperative RH patients.
Appraisal for relevance of a data set for the clinical evaluation

Relevance Description Grading System Score
Criteria
Appropriate To what extent are the data <D2 Equivalent device> 2
device generated representative of the Manufacturer: Verathon
device under evaluation? Model: BVI-9400
Appropriate Are the data relevant to the <A1 representative of the entire intended purpose 3
device intended purpose of the device with all patient populations and all claims foreseen
application or to claims about the device? for the device under evaluation>
Appropriate Where the data generated <P1 applicable> 3
patient group from the patient group that Seventy postoperative RH patients (140
is representative of the measurements) were included in the study. The
intended treatment difference in measurements between the catheter
population (e.g. age, sex, and scan methods was not related to age, body mass
etc.) and clinical condition index, parity, co-existing illness, type of surgical
(i.e. disease, including state incision or duration of indwelling catheter.
and severity)?
Acceptable Do the reports or collations <R1 High quality> 3
report/data of data contain sufficient The process was repeated in subsequent voids, and
collation information to undertake a correlations between scan volume and catheter volume
rational and objective were objectively analyzed.
assessment?

Technology
Appraisal for the contribution of each data set to the clinical evaluation
Data Description Grading System Score
Contributio
n
Criteria
Data source Was the design of the study <T1 Yes> 3
type appropriate? This was a prospective study on in-patient basis,
and it was reviewed and approved by the Ethics
Committee of Rajavithi Hospital. Inclusion criteria
were all postoperative RH patients undergone the
operation under either laparoscopy or laparotomy.
Patients who had serious intra-operative or
postoperative complications or obvious surgical
wound infection were excluded. Patients’
demographic data were recorded.
PVR was measured using the 3D portable
ultrasound (Verathon BladderScan BVI 9400),
giving the scan volume. Immediately after the
procedure (within five minutes), urethral
catheterization was performed to obtain the actual
PVR (the catheter volume).
Outcome Do the outcome measures <O1 Yes> 3
measures reported reflect the PVR was measured using the 3D portable ultrasound
intended performance of (Verathon BladderScan BVI 9400), giving the scan
the device? volume. Immediately after the procedure (within five
minutes), urethral catheterization was performed to
obtain the actual PVR (the catheter volume).
Statistical Has a statistical analysis of <S1 Yes> 3
significance the data been provided and Pearson’s correlation was used to evaluate correlations
is it appropriate? between Scan volume and Catheter volume. Sensitivity,
specificity, positive predictive values, negative
predictive values, and accuracy were calculated using a
2x2 table of the collected data. A p-value of less than
0.05 was considered to be statistically significant.

Critical Evaluation(Review) of the literature 2

This literature was performed by Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Rajavithi
Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.
It contains a simple specification on BVI9400, which is equivalent to BioCon-700 (including its intended functions,
description of the intended purpose and application of use). Device under assessment (BioCon-700) and compare device
covered by the literature(BVI 9400) are bladder scanner in measuring post-void residual urine volume
The description of BVI9400 described in the literature confirms that BioCon-700 and BVI9400 have equivalent
characteristics. However, there is no a statement that equivalence has been demonstrated.
The populations to be applied by device’s intended use from literature demonstrate the performance of device as a
clinically significance of effects.
A limitation of the present study was interpersonal variation, although all staff nurses engaged in the study were well
trained. As the same limitation is found in real practical settings, an intensive and regular training program is necessary to
decrease interpersonal variation and improve the reliability of the measurements.
This was a prospective study. After removal of Foley’ s catheter in seventy postoperative radical hysterectomy(RH)
patients, the voiding care schedule consisted of voids after six hours or earlier if the patient had the urge. Promptly after
voiding, PVR was measured using the BladderScan (Scan volume). Immediately after the procedure, urethral
catheterization was performed to obtain the actual PVR (Catheter volume). The process was repeated in subsequent voids,
and correlations between scan volume and catheter volume were analyzed. The difference in measurements between the
catheter and scan methods was not related to age, body mass index, parity, co-existing illness, type of surgical incision or
duration of indwelling catheter.
In conclusion, 3D portable ultrasound devices provide good correlation and high rates of specificity and negative predictive
values, as well as acceptable accuracy in the assessment of PVR. Repetition of scan volume in subsequent voiding to
confirm consistency improves reliability. These devices could be used as an alternative modality to catheterization for the
measurement of PVR among postoperative radical hysterectomy patients.
There is no effect of safety factors on patient or various clinic personnel during the study. Undesirable side-effect also was
not been observed in this literature. The contents of the IFU are supported by these clinical evidence (description of the
intended purpose, handling instructions, undesirable side-effect) and are in line with the risk analysis and clinical
evaluation.
These bladder scan device was already on the market for decades. Several studies have investigated and confirmed the
accuracy of bladder scan devices developed earlier(BVI 2000, BVI 2500, BVI 3000 and BioCon-500), and this study
evaluated a 3D ultrasound device (Verathon BladderScan BVI 9400) among postoperative RH patients.
The literature contain a reference list cross-referenced in the evaluation.
4.6 Analysis of the clinical data

The goal of the analysis stage is to determine if the appraised data sets available for a medical device collectively
demonstrate compliance with each of the Essential Requirements pertaining to the clinical

performance and clinical safety of the device, when the device is used according to its intended purpose.
In order to demonstrate compliance, the evaluators should

- use sound methods;
- make a comprehensive analysis;
- determine if additional clinical investigations or other measures are necessary;
- determine PMCF needs.
4.6.1 Use sound methods

The methods available for analysis of clinical data are both quantitative and qualitative. These methods is
used to appraise and weight clinical data. For many well established devices and lower- risk devices,
qualitative data may be adequate to fulfil the requirements of the MDD. The criteria adopted for the
appraisal is justified by the evaluator.
A possible appraisal criteria is given Tables D1 and D2 (4.5 Summary and appraisal of clinical data). The
criteria is worked through in sequence and a weighting assigned for each dataset.
To assess the data contribution criteria of the suitable data, the evaluator sorted the data sets according to
source type and then systematically considered those aspects that are most likely to impact on the
interpretation of the results
4.6.2 Essential Requirement Section 1

The devices must be designed and manufactured in such a way that, when used under the conditions and
for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the
safety and health of users or, where applicable, other persons, provided that any risks which may be
associated with their intended use constitute acceptable risks when weighed against the benefits to the
patient and are compatible with a high level of protection of health and safety.
This shall include:
—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the
environment in which the device is intended to be used (design for patient safety), and
—consideration of the technical knowledge, experience, education and training and where applicable the
medical and physical conditions of intended users (design for lay, professional, disabled or other users).
(1) Requirement on safety
Technology

ad) Summary of safety
One of predicate device (BVI 3000) cleared 510(K) in 1991 and no adverse event has been reported. And
also ultrasound devices to diagnose the symtoms and diseases have been comprehensively and widely used
for a long time in the clinical field, as you can figure the adverse events out from Mcube Technology’s post
market surveillance(Doc.PMS_CUBEScan). And also Biocon-700 meet the requirement of safety as the
standards and Eseential requirement in MDD as below:
-Electrical Safety: Refer to the report (Report No. KBW-2019-SM-210-A1)
-EMC: Refer to the report (Report No. OT-185-RED-017)
-Biocompatibility test report (Report No. 09-1712-107)
-Integrity test report (Report No. CT15-117106)
-Acoustic Output (Doc. AOR BioCon-700)
-Biological Risk Assessment (Doc. BAR-HP1)
be) Essential requirements, any special design features that pose safety concerns were identified in the risk
management and that required assessment from a clinical perspective
Free from noise on a waveform or artefacts or distortion in an image or error of a displayed numerical value which
cannot be attributed to a physiological effect and which may alter the diagnosis.
- Free from noise on a waveform or artefacts or distortion in an image or error of a displayed
numerical value which cannot be attributed to a physiological effect and which may alter the diagnosis.
:
- Free from the display of incorrect numerical values associated with the diagnosis to be performed
- Free from the production of unintended or excessive ultrasound output.
- Free from the production of unintended or excessive transducer assembly surface temperature.
- Guidance For Ultrasound FDA / IPTA.3(mW/cm2) = 94, ISPPA.3(W/cm2) = 190
- Constant Acoustic intensity (Acoustic intensity(derated): Maximum Ispta.3 ≤< 5mW/Cm2 )
cf) The primary causions and contraindications which might cause the adverse events clinically are listed
below;
- Fetal use or pregnant patients
- Patients with ascites.
- Patients with open or damaged skin.
- Wounds in the suprapubic region

And also the applied part to the patients’ skin should be cleaned and disinfected on a regular basis. BioCon-
700 Operator Manual (MUM-BioCon-700) includes the information that may impact on the use of the
device.
Technology
dg) Specific comment on safety characteristics

Contraindications are provided in the operator’s manual. And it is recommened that the end-users read the
operator’s manual thoroughly not to be used for the populations who are not allowed.
eh) Consistency of clinical data

See the lists in 4.6.1 a) are the results of risk management, for example, the electrical hazards have been
covered by compliance to IEC60601-1 and applicable collateral standards. And biological hazards have
been covered by compliance to ISO10993. And under circumstances, residual risks regarding cleaning &
disinfection between uses are acceptable, and additional clinical data are not needed unless negative issues
are detected during PMS activities and no adverse events have been detected so far. There is consistency
and alignment between the clinical evaluation, the information materials supplied be the manufacturer, and
the risk management documentation for the device under evaluation.
The results of all the above were explored and just prove that the differences between the device under
evaluation and the device presumed to be equivalent are not expected to significantly affect the clinical
performance and clinical safety of the device under evaluation.
So it is proven that the current knowledge/the state of the art, the available date, IFU and the risk
management and PMS are consistent with the intended use/Indications for use and clinical effect using
BioCon-700.
(2) Requirement on acceptable benefit/risk profile

a) Table of data related to safety with predicate devices.
Below is listed from the well-archived website such as MHRA, FDA and you can see all the data in
PMS (Doc. PMS_CUBEScan)
Data Mcube Verathon Cubescan Bladder BioCon BVI Prime Bladder
Keyword scan scanner
source
Medical devcie No result

alert
FSN No result
Medwatch No result
Nothing related to the Bladder volume measurement system has been founded in PMS
b) Characterstics of patients exposed to the device, and benefits to the patients and clinical risks Patients to be
dianose as below :
Technology
CUBEScan TM
a. Measure post-void residual and verify an empty bladder

b. Differentiate urological problems more efficiently
c. Assess postoperative urinary retention

d. Identify blocked foley catheters
Patients to be managed and treated
a. Evaluate need to catheterize
b. Discontinue Foley catheter use
c. Establish voiding schedules and assist in bladder retaining
Patients to be prevented
a. Avoid unnecessary catheterization and reduce rates of CAUTI
b. Reduce incontinent episodes
Risks exposed to patients
a.cross-contamination, so the cleaning&disinfection between uses needs to be followed compliance to the
operator manual.

The devices must achieve the performances intended by the manufacturer and be designed,
manufactured and packaged in such a way that they are suitable for one or more of the functions
referred to in Article 1 (2) (a), as specified by the manufacturer.
with frequency, of BioCon-700.
(1) Requirement on performance

a) Table of data related to performance with predicate devices
The performance of ultrasound device for bladder volume is normally assessed with frequency, accuracy
and its intended use. BVI series and BioCon series are the predicate device of BioCon-700.
Model Manufacturer Ultrasound Material Accuracy Intended Population
Name Frequency to be use from clinical
(MHz) applied (application) data
BioCon- Mcube 2.6 MHz/ HP1 ±15%,±15ml Bladder dysfunction
700 Technology Polycarbo (0 to 999ml) Volume were subjected
nate to PVR volume
measurements
BioCon- Mcube 2/3.4 MHz HP1 ±15%,±15ml Bladder -
900 Technology Polycarbo (0 to 999ml) Volume
nate
BioCon- Mcube 2/3.4 MHz HP1 0-99ml±10ml , Bladder -

Technology
900S Technology 100- Volume

999ml±10%
BioCon- Mcube 2.8 MHz Plastic ±15%,±15ml Bladder 249 adult
500 Technology (PC) (0 to 999ml) Volume outpatients for
accuracy
BVI 3000 Verathon 2 MHz Plastic ±20%,±20ml Bladder reliability of

(PC) (0 to 699ml) Volume estimates of
±25%,±25ml bladder volume
(700 to 999ml) (BV) in children
249 adult
outpatients for
accuracy
BVI 9400 Verathon 3.0/1.74MHz LDPE ±15%,±15ml Bladder Seventy-one
(0 to 999ml) Volume postoperative
RH patients
were included in
the study, with
140
measurements.
Prime Verathon 2.95MHz HP1 Greater than Bladder -
Plus 100ml±7.5%, Volume
0-
100ml±7.5ml
(0 to 999ml)
As you see the table above, the predicate devices have the same intended use, although they have technical
differences such as frequency, material to be applied and accuracy. The populations to be applied by
device’s intended use from clinical papers demonstrate the performance of device as a clinically
significance of effects.

Any undesirable side-effect must constitute an acceptable risk when weighed against the performances
intended. Demonstration of conformity with the essential requirements must include a clinical evaluation in
accordance with Annex X.
(1) Requirement on acceptability of side-effects

Technology
a) The evaluation was carried out with data obtained from literature research and PMS activities leading to the
CE-marking and placing on the market of the device. Undesirable side-effect was not been observed in
literature research and PMS activities. (Document No. PMS-CUBEScan)
b) AIUM stated in 1992 that under the following conditions there was no report on the biological effects to a
mammal.
TI
Duration time Maximum TI which has no biological effects
1 minutes 6
10 minutes 4.3
100 minutes 2.7
MI: Lower than 0.3 MPa acoustic pressure or MI is lower than 0.3
c) The ultrasound imaging device has been used for a long time. Bladder volume measurement system has
been used for many years in the fields and there is no new technology used in this device. So clinical
experience data will be used for the evaluation of the safety and effectiveness rather than literature search.
4.6.5 Determine if additional clinical investigations or other measures are necessary

According to Annex A2(when should additional clinical investigations be carried out) in Meddev 2.7.1, The clinical
data derived from literature research have drawn conclusions as to conformity of BioCon-700 to the Essential
requirements, which the data need to be in line with current knowledge/ the state of the art, be scientifically sound,
cover all aspects of the intended purpose, and all products/ models/sizes/ settings foreseen by Mcube Technology.
The BioCon-700 is classifieds IIa device. And it is not intended to be implanted into the body and class III as
Annex X section 1.1a MDD and Annex 7 AIMDD.
Mcube paid attention to determine if the additional clinical investigations need to be carried out as follows;
Attentions BioCon-700
new design features, including new materials the same design features
new intended purposes, including new medical The same intended purpose, medical indications,
indications, new target populations (age, gender, target populations(age, gender, etc)
etc.),
new claims the manufacturer intends to use, The same claims
new types of users (e.g. lay persons) The same types of users
seriousness of direct and/or indirect risks The same serious of direct and/or indirect risks
Technology

contact with mucosal membranes or invasiveness The same contact (noninvasive)

increasing duration of use or numbers of re- The same duration of use
applications,
use of animal tissues (other than in contact with intact No animal tissue used.
skin)
issues raised when medical alternatives with lower No medical alternatives
risks or more extensive benefits to patients are
available or have become newly available
issues raised when new risks are recognised No risks are recognized
(including due to progress in medicine, science and
technology)
whether the data of concern are amenable to No data of concern are amenable to evaluation
evaluation through a clinical investigation through a clinical investigation
4.6.6 Determine PMCF needs

The clinical evaluator of Mcube Technology assessed the needs for PMCF studies as part of post market
surveillance based on the residual risks including those identified from the results of the clinical evaluation
and from the characteristics of the device under evaluation. Besides any residual risks, the evaluator taken
into account any uncertainties or unanswered questions such as medium- and long-term performance, or
safety under wide-spread use, to assess the needs for PMCF studies as part of post market surveillance.
a) The design of the device, the material, the principles of operation, the technology and the medical
indication.
: BioCon-700 is the device that measures the volume of bladder and the residual urine using echo effect of
ultrasound. The ultrasound imaging device has been used for a long time, and no apparent side effects has
been reported in the pre-market.
b) Well known risk of similar marketed devices.
: Similar marketed devices are diagnostic ultrasound systems which lead to misdiagnose the symptom.
c) Identification of an acceptable risk during pre-CE clinical evaluation, which should be monitored in a
longer term and/or through a larger population.
: Bladder volume measurement system has been used for many years in the fields and there is no new
technology used in this device. So clinical experience data will be used for the evaluation of the safety and
effectiveness rather than literature search.

Technology
d) Residual (newly emerged) risk in the post market

: Any residual risk was not found in our PMS studies.
The ultrasound imaging device has been used for a long time, and no apparent side effects has been reported.
Bladder volume measurement system has been used for many years in the fields and there is no new technology used
in this device. BioCon-700 is well operated in the market without misuse by operators and patients . Any residual
risk and uncertainties or unanswered questions (including on rare complications, long term performance, safety
under wide-spread use) were not found in our PMS studies.
Mcube Technology does not need to perform a post-market clinical follow-up (PMCF) studies as part of post market
surveillance.
4.6.7 Clinical Hazards of the Risk Management Report

The risk analysis contains the clinical hazards. Refer to Doc No.RA-BioCon-700
Hazards on clinical safety and Identification Identified Hazards Risk control Evaluation
clinical performance Number measures
Clinical The device does not RM700-R Lack of Labeling: Acceptable
Safety meet the claims on information about Provide
clinical safety related undesirable side information on
to intended the undesirable
effect
side effect in
use/indications for
IFU
use
Clinical The device does not RM700-S Incorrect Labeling: Acceptable
Performance meet the claims on measurement Provide
clinical Performance information on
intended caused by the intended
incorrect intended use/indications
use/indications for
for
use use/indications for
use/applications
use/applications in IFU
5. Conclusions
The design and principles of operation in the BioCon-700 is not a novelty. So Mcube Technology has selected the
clinical data from the clinical experiences. Post market surveillance via adverse events search

Technology
now show no events relating to the predicative devices. The reports on the electrical safety, EMC, biocompatibility
and special requirements for the ultrasound device are generated. For the volume measurement the tissue-mimicking
ultrasound phantom has been used to verify the volume accuracy.
BioCon-700 assists in:

a) Assess urinary retention
b) Evaluate post-up urinary retention (POUR)
c) Reduce unnecessary catheterization
d) Reduce catheter-associated urinary tract infections (CAUTIs)
e) Identify a blocked Foley catheter
f) Evaluate need to catheterize after Foley catheter removal
g) Evaluate need to catheterize during intermittent catheterization
h) Assist in bladder retraining
i) Verify empty bladder.
And also the IFU informs the residual risks derived from the risk analysis such as warnings, cautions,
desirable side effects and contraindications. So lastly the risks are well identified and managed in the risk
management. The design and principles of operation using ultrasound have well been established.
In conclusion, the data that is now available adequately demonstrates compliance with the relevant essential
requirements. There are no results such that the BioCon-700 cannot be on the market as a Class IIa medical device.
The risks associated with the use of BioCon-700 are acceptable when weighed against the benefits to the patients.
6. Date of the next clinical evaluation

The clinical evaluation is actively updated:
a) Every 2 years because the BioCon-700 is not expected to carry significant risks and is well established.
- There are no relevant changes in clinical sciences, materials sciences or other sciences related to the
device under evaluation.
-The current level of confidence in the evaluation of clinical performance and clinical safety of the device
is dependent on the expected reporting rates under the vigilance system (Doc No. PMS- CUBEScan).
-The design and principles of operation using ultrasound have well been established. The design and
principles of operation in the device are not a novelty. Therefore, Mcube Technology has
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selected the Post market surveillance data relating to the devices the similar type. There are no significant
risks. (Doc No. PMS-CUBEScan).
b) When the manufacturer receives new information from PMS that has the potential to change the current
evaluation;
When involvement of notified bodies is required, updates are usually coordinated with the notified body. They are
aligned with the timetable for surveillance audits and the renewal of the certificates.

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CUBEScan TM
7. Dates and signatures

As an authorized official of the manufacturer, having responsibility for clinical evaluation of the BioCon-700
regulated by Directive 93/42/EEC, I hereby agree that the contents of this Clinical Evaluation Report, which
reflect the conclusions and opinions of the evaluator The report includes references to literature-based data, with
cross-references to the location in the manufacturer’s technical documented.
Name of Authorized Official CH Kim
Title of Authorized Official Quality M anagement Representative
Signature of Senior Official

/подпись/
Name of President Junghoe Kim
Signature of President
/подпись/
Date: July 20, 2020

Date: July 20, 2020

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8. Qualification of the responsible evaluators
According to MEDDEV 2.7/1 revision 4, the clinical evaluation was conducted by a suitably qualified
individual or a team. This clause shows evidence of the selected evaluator’s qualifications.
8.1 Requirements
The following requirements for the evaluator are defined by the manufacturer.
8.1.1 General knowledge for clinical evaluation

The device is based on ultrasound technologies with well-established safety and performance characteristics. It
may be possible to draw on the clinical experience and literature reports of the safety and performance of an
equivalent device to establish the clinical evidence, thereby reducing the need for clinical data generated
through clinical investigation of the device under evaluation. Therefore, manufacturer recognized that evaluator
who has experience and training in clinical data appraisal have general knowledge for clinical evaluation, even
if the knowledge on medical writing is lack.
The evaluators should possess follow knowledge depending upon the needs of clinical data
1) research methodology
2) information management
3) regulatory work
4) medical writing.
8.1.2 Knowledge on device under evaluation

With respect to the particular device under evaluation, the evaluators should in addition have knowledge of:
1) the device technology and its application;
2) diagnosis and management of the conditions intended to be diagnosed or managed by the device,
knowledge of medical alternatives, standards and technology.
8.1.3 Pertinent experience

The evaluators should have at least the following training and experience in the relevant field:
1) a degree from higher education in the respective field and 5 years of documented professional
experience; or
2) 10 years of documented professional experience if a degree is not a prerequisite for a given task.
But class II clinical evaluation report rests heavily on data in the literature and post-market surveillance data,

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so a degree from higher education in the respective field and documented professional experience is less critical.
Therefore, evaluator who has knowledge on device under evaluation and general knowledge for clinical
evaluation, even if the pertinent experience is lack, is recognized as the evaluator.
8.2 Evidence of Evaluator Qualification
The clinical evaluation was conducted by a suitably qualified author and reviewer.
a) CV’s of evaluator
(1) Name: Hye-ri Choi
General knowledge for clinical evaluation (Scientific working Skills)

Requirements knowledge-able Lack of
knowledge
1) research methodology O
Justification The evaluator has experience of clinical evaluation according to Directive
for use 93/42/EEC Annex X and MEDDEV 2.7.1.
The evaluator was trained by notified body to write CER according to MEDDEV
2.7.1
The evaluator completed the clinical monitoring & report training by KMDIA.
The evaluator can screen and summarize literature for target device
The evaluator has experience literature review to elucidate the clinical problem and
current relevant techniques.
2) information management O
Justification The evaluator has over 4 years of experience with literature research databases.
for use
3) regulatory work O
Justification The evaluator has a thorough understanding of relevant harmonized standards and
for use guidance documents.
The evaluator has a thorough understanding of risk management and product
development process.
4) medical writing O
2.7.1

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Knowledge on device under evaluation

knowledge
1) Device technology & application O
Justification The evaluator has knowledge to provide support through all phases of the product
for use development life cycle.
The evaluator studies and reports device characteristics and instructions for use
The evaluator evaluates data for similar competitor devices
The evaluator has a thorough understanding of product development, including
manufacturing practices, regulation, and approval process.
The evaluator is regulatory affairs specialist with over four year’s experience
working in the ultrasound medical device industry.
2) Intended use O
Justification The evaluator has knowledge with devices used in the diagnostic ultrasound area
for use and often in the technology.
3) Medical alternatives & standard O
Justification The evaluator has knowledge of device legislation, including the general safety and
for use performance requirements set out in Meddev 2.7.1 Rev.4 Annex I
Pertinent experience
knowledge
1) a degree from higher education in the respective field O
and 5 years of documented professional experience
2) 10 years of documented professional experience if a O

degree is not a prerequisite for a given task
Justification Major: Bachelor of Biomedical Engineering.

for use Minor: Nuclear Applied Engineering
4 years of documented professional experience in a diagnostic ultrasound area (e.g.
biomedical research, medical/regulatory/technical writing, clinical evaluation
management), with some exposure to medical devices
Class II clinical evaluation report rests heavily on data in the literature and post-
market surveillance data, so clinical trial knowledge and degree is less critical.
Work Experience Rating of qualification

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2015 to Mcube Technology Co., Ltd. 4 years

present Regulatory Affair : Bladder volume measurement
system(BioCon-700, BioCon-900, BioCon-900S, BioCon-
1100, BioCon-800), Extracorporeal magnetic
stimulator( BioCon-2000W, BioCon-2000P, BioCon-
1000Pro), Uroflowmeter(CUBEFLOW, CUBEFlow_S),
Urodynamics(Ellipse, Helix) - CE Technical file
management, 510K clearance, MHLW clearance, HC
clearance, MFDS(Korea) etc.
Education Rating of qualification
2010 to Inje University 4 years
2014 Major: Bachelor of Biomedical Engineering.
Minor: Nuclear Applied Engineering
Short course / workshops Education Institution
2015.02 CE Technical Construction File KMDICA
2015.03 Medical Device Risk Management KMDICA
2015.10 ISO 13485 & MDD KMDICA
2015.09 Clinical Evaluation & PMCF SGS Korea
2015.11 Clinical Research Associate Monitor KMDIA
2017.02 Risk Management on ISO 13485: 2016 SGS Korea
2017.10 MDD ISO 14971 Risk Management SGS Korea
2017.11 Technical Documentation for CE MDR SGS Korea
2018.11 Clinical Evaluation on MEDDEV 2.7.1 rev.4 SGS Korea
2018.07 Design Control and Design Validation for Medical Device SGS Korea
(ISO 13485:2016)
2019.01 IEC62366-1&-2 Usability Process SGS Korea
b) CV’s reviewer
(1) Name:Changhyun Kim

knowledge

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2.7.1
The evaluator completed the clinical monitoring & report training by KMDIA.
for use
2.7.1

knowledge
The evaluator is QMR with over 14 year’s experience working in the ultrasound
medical device industry.
2) Intended use O
Justification The evaluator has knowledge with devices used in the diagnostic ultrasound area

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for use and often in the technology.

Skills knowledge-able Lack of
knowledge

Justification 14 years of documented professional experience in a diagnostic ultrasound area

for use (e.g. biomedical research, medical/regulatory/technical writing, clinical evaluation
2005 to present Mcube Technology Co., Ltd. 14 years
2016.01 to QMR in Quality Management 2 years

2009 to Regulatory Affair : Bladder volume measurement 10 years
system(BioCon-700, BioCon-900, BioCon-900S, BioCon-
1100), Extracorporeal magnetic stimulator( BioCon-
2000W, BioCon-2000P, BioCon-1000Pro),
Uroflowmeter(CUBEFLOW, CUBEFlow_S),
Urodynamics(Ellipse, Helix) - CE Technical file
management, 510K clearance, MHLW clearance, HC
clearance, MFDS(Korea) etc.
~ 2003 University : Ajou Economics 4 years
Short course / workshops Education Institution
2010.02 CE Technical Construction File KMDICA
2011.03 Medical Device Risk Management KMDICA
2011.09 ISO 13485 & MDD KMDICA
2011.10 Clinical Evaluation & PMCF SGS Korea
2015.11 Clinical Research Associate Monitor KMDIA

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2016 to Quality Management Representatives Once a year NIDS

c) CV’s of Review and approver
(1) Name: Moon-chang Heo

knowledge
for use 93/42/EEC
Annex X and MEDDEV 2.7.1.
for use

Requirements knowledge-able Not knowledge-
able

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The evaluator is associate research engineer with over 13 year’s experience working
in the ultrasound medical device industry.
2) Intended use O
Justification The evaluator has knowledge with devices used in the diagnostic ultrasound area and
for use often
in the technology.
Skills knowledge-able Not
knowledgeable


Justification 13years of documented professional experience in a diagnostic ultrasound area (e.g.

for use biomedical research, medical/regulatory/technical writing, clinical evaluation
2006 to present Mcube Technology Co., Ltd. 13 years
2017 to Chief Technology Officer 2 years
2013 to Principal Research Engineer in R&D Center 6 years
2003 -2005 Master of Biomedical Engineering, Konkuk University 2 years
1997-2003 Bachelor’s Biomedical Engineering, Konkuk 4 years
University.
8.3 Declaration of Interests
Declaration of Interests of each of the evaluators refer to document number “DOI-BioCon-700”“DOI-BioCon-

700

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9. References
a) European Legislation:
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
b) European Guidance Document

- MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System
- MEDDEV 2.12/2 rev. 2 Post Market Clinical Follow-up studies
- MEDDEC 2.7/1 rev.4 Clinical Evaluation: Guide for manufacturers and notified bodies
c) Cross-references
- Post Market Surveillance Report (PMS-CUBEScan)
- Risk Management Report(RA BioCon-700)

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Annex 1 THE LITERATURE SEARCH REPORT
1. Device name/model
CUBEScan CUBEScan™ BioCon-700
TM
2. Scope of the literature search [should be consistent with scope of clinical evaluation] The safety
and performance of ultrasound device to measure bladder volume
3. Methods
3.1 Date of search

- 2020.07.17~2020.07.20
3.2 Name of person(s) undertaking the literature search

(1) Name: Hye-ri Choi
(2) Barchelorer’s degree in 2014
(3) ~2020 RA assist manager at Mcube Technology
(4) The author completed the training sessions below:
No. Session Education
Institution
1 CE Technical Construction File KMDICA
2 Medical Device Risk Management KMDICA
3 FDA 510(k) Process KMDICA
4 ISO 13485 & MDD KMDICA
5 Clinical Evaluation & PMCF SGS Korea
6 Clinical Monitoring & Report KMDIA
7 Risk Management on ISO 13485: 2016 SGS Korea
8 MDD ISO 14971 Risk Management SGS Korea
9 Technical Documentation for CE MDR SGS Korea
10 Clinical Evaluation on MEDDEV 2.7.1 rev.4 SGS Korea
11 Design Control and Design Validation for Medical Device (ISO 13485:2016) SGS Korea
12 Medical Device Design and Development Process KMDICA
13 IEC62366-1&-2 Usability Process SGS Korea

3.3 Sources of research

Scientific literature databases
- PubMed : PubMed provided free access to MEDLINE and links to full test articles when possible.
Vigilance databases
Refer to Post Market Surveillance Report (Document No. PMS-CUBEScan) for information derived from
vigilance data.
- MHRA
- FDA MedWatch / MAUDE / Recall
- TGA
- CFDA
- PMDA Introduction
- HPRA
- BfArM
- FDA
- MFDS
- Health Canada
- MEDSAFE
- Swissmedic
- TFDA
3.4 Period covered by search

- From July 20, 2020, 2020 to current (20years)
3.5 Inclusion Criteria

1) Articles that reported data on the performance or safety; and
2) Study design and methods that were described clearly; and
3) Relevant populations; and
4) Predicate or subject devices
3.6 Exclusion Criteria

1) Duplicate publications (publications superseded by another publication by the same investigator group
with the same objective and data); or
2) Nonsystematic reviews, letters, and editorials; or
3) Animal and in-vitro studies; or
4) Case reports; or
5) Studies that did not examine the outcomes of interest; or
6) Subjects not within the population of interest (i.e., healthy volunteers) or studies that did not

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describe the population of interest

3.7 Database search details:
3.7.1 First Search
1) Scientific literature database: PubMed
2) search key words: bladder measurement, ultrasound, bladder capacity
The first search → the retrieved data:39
The second search, added keyword: urology → the retrieved data: 25
The third search, added keyword: voiding dysfunction → the retrieved data: 8
Article Articles Excluded reasons.

No.
1 Ultrasound detrusor wall thickness measurement in The literature was excluded because the aim of this
combination with bladder capacity can safely detect study is to search for noninvasive tests which can
detrusor underactivity in adult men. Rademakers KL, safely predict DU in adult men.
van Koeveringe GA, Oelke M; FORCE Research
Group, Maastricht and Hannover.
2 Lower radiation burden in state of the art fluoroscopic The literature was excluded because the focus of this
cystography compared to direct isotope cystography paper is to question the common belief that direct
in children. Haid B, Becker T, Koen M, Berger C, isotope cystography confers less radiation burden
Langsteger W, Gruy B, Putz E, Haid S, Oswald J. compared to state of the art fluoroscopic voiding
cystography.
3 Postoperative bladder catheterization based on The literature was excluded because the paper is
individual bladder capacity: a randomized trial. irrelevant to the equipment.
Brouwer TA, Rosier PF, Moons KG, Zuithoff NP, van
Roon EN, Kalkman CJ. Anesthesiology. 2005
Jan;122(1):46-54.
4 Transabdominal ultrasonography of detrusor wall The literature was excluded because the paper focuses
thickness in women with overactive bladder. Chung on the clinical usefulness of measuring detrusor wall
SD, Chiu B, Kuo HC, Chuang YC, Wang CC, Guan thickness as a noninvasive test in women with
Z, Chancellor MB. BJU Int. 2010 Mar;105(5):668-72. overactive bladder.
5 Lower urinary tract dysfunction in children with The literature was excluded because the focus of this
cerebral palsy. Silva JA, Alvares RA, Barboza AL, paper is to evaluate urodynamic findings and possible
Monteiro RT. Neurourol Urodyn. 2009;28(8):959-63. renal damage in children with cerebral palsy and
urinary symptoms.
6 Reliability of bladder volume measurement with Adapted Literature for clinical evaluation, but

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BladderScan in paediatric patients. De Gennaro M, excluded. We’ve not confirmed that the device used
Capitanucci ML, Di Ciommo V, Adorisio O, Mosiello is CE marked.
G, Orazi C, Tubaro A. Scand J Urol Nephrol.
2006;40(5):370-5.
7 The role of video-urodynamic studies in managing The literature was excluded because the focus of this
non-neurogenic voiding dysfunction in children. paper is to retrospectively evaluate the role of video-
SoygürSoygur T, Arikan N, Tokatli Z, Karaboga R. urodynamic in the diagnosis and management of
BJU Int. 2004 Apr;93(6):841-3. voiding dysfunction in children
8 The urodynamic profile of myelodysplasia in The literature was excluded because the paper
childhood with spinal closure during gestation. compares the results to those in the literature on
Holzbeierlein J, Pope JC IV, Adams MC, Bruner J, patients with myelomeningocele and without prenatal
Tulipan N, Brock JW 3rd. J Urol. 2000 intervention
Oct;164(4):1336-9.
9 The aging lower urinary tract: a comparative The literature was excluded because the focus of this
urodynamic study of men and women. paper is the fact that aging women report similar
Madersbacher S, Pycha A, Schatzl G, Mian C, voiding symptoms as age-matched men prompted us
Klingler CH, Marberger M. to compare age-related changes of urodynamic
parameters in both sexes.
1) Scientific literature database: PubMed

2) Search keyword: urine volume, ultrasound bladder scanner
The first search → the retrieved data: 54
The second search, added keyword: post-void residual urine → the retrieved data: 17
The third search, added keyword: bladder volume measurement → the retrieved data: 13
Article Articles Excluded reasons.

No.
1 Falsely Elevated Postvoid Residual Urine Volume in The literature was excluded because this paper is case
Uterine Myoma. study.
Kim TH, Kim HS, Park JW, Lim OK, Park KD, Lee
JK. Ann Rehabil Med. 2017 Apr;41(2):332-336. doi:
10.5535/arm.2017.41.2.332. Epub 2017 Apr 27.
2 Accuracy of post-void residual urine volume Adapted Literature for clinical evaluation.
measurement using a portable ultrasound bladder
scanner with real-time pre-scan imaging. Park YH,

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Ku JH, Oh SJ. Neurourol Urodyn. 2011 Mar;30(3)

3 Ultrasound estimated bladder weight in men attending The literature was excluded because the focus of this
the uroflowmetry clinic. paper is to determine if measurements of ultrasound
Bright E, Pearcy R, Abrams P. estimated bladder weight provide an additional
Neurourol Urodyn. 2011 Apr;30(4):583-6. doi: diagnostic tool when assessing men with lower
10.1002/nau.21049. Epub 2011 Feb 9. urinary tract symptoms in the uroflowmetry clinic.
4 Accuracy of Post-Void Residual Urine Volume Adapted Literature for clinical evaluation.
Measurement Using an Ultrasound Bladder
Scanner among Postoperative Radical
Hysterectomy Patients. Thanagumtorn K.
5 Reliability of an automatic ultrasound system for The literature was excluded because the focus of this
detecting postpartum urinary retention after vaginal paper is to assess the reliability of a commercially
birth. Lukasse M, Cederkvist HR, Rosseland LA. Acta available automatic bladder volume scanner in the
Obstet Gynecol Scand. 2007 Oct;86(10) puerperium, and to specifically identify women with
a post-void residual volume of 400 ml or more.
6 Accuracy and precision of a new portable ultrasound The literature was excluded because the paper is
scanner, the BME-150A, in residual urine volume irrelevant to the equipment.
measurement: a comparison with the BladderScan
BVI-3000. Choe JH, Lee JY, Lee KS. Int Urogynecol
J Pelvic Floor Dysfunct. 2007 Jun;18(6)
7 The use of an ultrasound bladder scanning device in The literature was excluded because the focus of this
women undergoing urogynaecologic surgery. paper is to compare the accuracy of using a bladder
Fedorkow DM, Dore S, Cotton A. J Obstet Gynaecol scanner to measurement post-voiding residual urine
Can. 2005 Oct;27(10) volume with measurement by intermittent
catheterization in a postoperative urogynaecology
population.
8 Elevated post-void residual volume in a geriatric post- The literature was excluded because the focus of this
hip fracture assessment in women-associated factors paper is to examine factors associated with and
and risk of mortality. prognostic significance of elevated PVR in a geriatric
Nuotio MS, Luukkaala T, Tammela T.Aging Clin Exp post-hip fracture assessment in a female population.
Res. 2019 Jan;31(1):75-83. doi: 10.1007/s40520-018-
0946-5. Epub 2018 Apr 9.
9 Feasibility of The literature was excluded because the focus of this
approximate measurement of bladder volume in male paper is to evaluate the correlation between bladder
patients using the Lilium α-200a-200 volumes periodically measured by the Lilium α-200a-

200

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portable ultrasound bladder scanner. and instilled volume during video-urodynamic

Kamei J, Watanabe D, Homma Y, Kume H, Igawa studies (V-UDS).
Y.Low Urin Tract Symptoms. 2019 May;11(3):169-
173. doi: 10.1111/luts.12258.10.1m/luts.12258. Epub
2019 Mar 10.
10 Application of portable ultrasound scanners in the The literature was excluded because the focus of this
measurement of post-void residual urine. Teng CH, paper is to investigate the impact of research subjects'
Huang YH, Kuo BJ, Bih LI.J Nurs Res. characteristics on the accuracy of the BladderScan
2005 Sep;13(3):216-24. doi: when the latter is used to measure post-void residual
10.1097/01.jnr.0000387543.68383.a0. urine volume, and to evaluate differences between
BladderScan and catheterization in terms of the
expenditure of time and of human and material
resources.
11 Repeatability of post-void residual urine ≥> 100 ml in The literature was excluded because the focus of this
urogynaecologic patients. paper is to assess the repeatability of the finding of
Saaby ML, Lose G.Int Urogynecol J. 2012 PVR ≥> 100 ml in urogynaecologic patients.
Feb;23(2):207-9. doi: 10.1007/s00192-011-1614-x.
Epub 2011 Dec 13.
12 Lower abdominal pressure versus The literature was excluded because the focus of this
external bladder stimulation to aid bladder emptying paper is to investigate the change in post-void
in multiple sclerosis: a randomized controlled study. residual bladder volumes (PVR) with 'abdominal
Prasad RS, Smith SJ, Wright H.Clin Rehabil. 2003 vibration' using a percutaneous bladder stimulator in
Feb;17(1):42-7. doi: 10.1191/0269215503cr583oa. multiple sclerosis (MS) patients compared with either
'no treatment' or 'abdominal pressure'.
13 Incidence, prognosis, and risk factors for bladder and The literature was excluded because the focus of this
bowel dysfunction due to incidental dural tears in paper is to analyze the incidence, prognosis, and risk
lumbar microendoscopic surgery. factors for BBD after lumbar microendoscopic
Oshina M, Segawa T, Manabe N, Oshima Y, Tanaka surgery with or without incidental dural tears.
S, Inanami H.Spine J. 2020 May;20(5):688-694. doi:
10.1016/j.spinee.2019.12.008. Epub 2019 Dec 19.
4. Outputs 4.1 Attach copy of literature citations retrieved from each database search
No. Document Title
1 CER Literature 1-Accuracy of post-void residual urine volume measurement using a portable

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ultrasound bladder scanner with real time pre- scan imaging

2 2
CER Literature 2-Accuracy2 Accuracy of post- void residual urine volume measurement using an ultrasound
bladder scanner among postoperative radical hysterectomy patients
Literature 1: Accuracy of post-void residual urine volume measurement using a portable ultrasound
bladder scanner with real-time pre-scan imaging.
AIMS: To evaluate whether the bladder scanner with real-time pre-scan imaging (RPI) is superior to the
conventional bladder scanner in measuring post-void residual urine (PVR) volume.
METHODS: Sixty-seven patients with voiding dysfunction were subjected to PVR volume measurements. The
PVR volume was measured three times by two experienced examiners using bladder scanners with (BioCon-500,
Mcube Technology, Seoul, Korea) or without (BVI-3000 BladderScan, Verathon, WA) RPI. Immediately after
the procedure, urethral catheterization was performed to obtain true volume. The accuracy and variability of
measurements were compared between the two devices and correlation coefficients were obtained.
RESULTS: The Pearson correlation coefficients between the PVR volume measured by each device and the true
volume were 0.932 for the bladder scanner without RPI and 0.950 for the bladder scanner with RPI. The bladder
scanner without RPI tended to overestimate the true volume in moderate volume ranges (>100 ml) by a mean
percentage of differences of volume (PDV) of 16.3%, while the bladder scanner with RPI underestimated the
true volume in the whole volume range by a mean PDV of -14.1% (P < 0.001). Repeated measures ANOVA
showed no significant interobserver variability (P = 0.977 for the bladder scanner without RPI and P = 0.853 for
the bladder scanner with RPI) or intraobserver variability (P = 0.660 for the bladder scanner without RPI and P =
0.271 for the bladder scanner with RPI).
CONCLUSIONS: Our results showed that exact pointing to the bladder prior to actual measurement of bladder
volume with RPI seems to reduce the variability of the measured values.
Literature 2: Accuracy of Post-Void Residual Urine Volume Measurement Using an Ultrasound Bladder
Scanner among Postoperative Radical Hysterectomy Patients
Background: Postoperative urinary retention occurs in 17 to 42% of Radical hysterectomy (RH) cases. The gold
standard assessment of post-void residual urine volume (PVR) is bladder catheterization. The use of the 3D
portable ultrasound device (VerathonBladderScan BVI 9400) to evaluate PVR is quick, safe, non-invasive,
painless, and comfortable for patients as well as being easy to use.
Objective: To compare the accuracy of ultrasound bladder scanner with that of urethral catheterization in the
assessment of post-void residual urine volume (PVR).

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Material and Method: This was a prospective study. After removal of Foley’ s catheter in postoperative radical
hysterectomy(RH) patients, the voiding care schedule consisted of voids after six hours or earlier if the patient
had the urge. Promptly after voiding, PVR was measured using the BladderScan (Scan volume). Immediately
after the procedure, urethral catheterization was performed to obtain the actual PVR (Catheter volume). The
process was repeated in subsequent voids, and correlations between scan volume and catheter volume were
analyzed.
Results: Seventy patients (140 measurements) were included. A high correlation was found between the scan
volume and the catheter volume (r = 0.89, p<0.001). A 91.0% specificity and 93.1% negative predictive
value(NPV) were obtained using the scan volume in predicting a catheter volume of ≤100<100 ml. The
difference in measurements between the two methods was not related to age, body mass index, parity, co-
existing illness, type of surgical incision or duration of indwelling catheter. When catheter volume >100ml was
the cutoff for determining the need for re-catheterization, the scan volume returned 90.0% accuracy. Repetition
of ultrasound scan in patients who had a first scan volume of ≤100ml<100ml yielded a 97.2% specificity and
100% NPV in predicting catheter volume of ≤100ml.<100ml.
Conclusion: The bladder Scan provides good correlation together with high rates of specificity and NPV, and in
could be an alternative modality to catheterization for the measurement of PVR in postoperative RH patients.
4.2 Data selection process

Attach flow chart and associated tables showing how all citations were assessed for suitability for inclusion in
the clinical evaluation.

Doc. CE BioCon-700
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What is the purpose of the clinical evaluation report?

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What devices are being evaluated in the report?

What devices are being evaluated in the report?

Отчет о сравнении

Исходный документ: C:\Users\User\Downloads\4.2 Clinical Evaluation Report(Rev.9).pdf

Document Number: CE-BioCon-700

Name Date Signature

Mcube Technology Co., Ltd. 2 / 55

Mcube Technology Co., Ltd. 3 / 55

2. Scope of the clinical evaluation.

a) Model name: BioCon-700

No Parts Quantity Description

Mcube Technology Co., Ltd. 4 / 55

- Probe: 181(L) X 60(W), R25

2) This clinical evaluation is submitted to the MDD as amended by directive 2007/47/EC.

Mcube Technology Co., Ltd. 5 / 55

a) Statement on Mammalian Biological Effects of Ultrasound In Vivo ( Approved 3/25/2015)

Mcube Technology Co., Ltd. 6 / 55

5) Device group to which the device belongs

6) Exact description of the device.

Mcube Technology Co., Ltd. 7 / 55

f) Sterile / non-sterile: Non-sterile Device

7) Claims on clinical performance and clinical safety

8) The BioCon-500, BioCon-700, BioCon-900, and BioCon-900S is already CE-marked.

Mcube Clinical Evaluation Report Doc. No. CE BioCon-700

Mcube Technology Co., Ltd. 8 / 55

2017 109 601 1783 73 57 2623

9) Changes since the last report

3. Clinical background, current knowledge, state of the art

Mcube Technology Co., Ltd. 9 / 55

Literature excluded, with reasons

from clinical evaluation, with reasons

3) Applicable standards and guidance documents

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Mcube Clinical Evaluation Report Doc. No. CE BioCon-700

5) Outline the development context for BioCon-700

Cardiac 430 190 1.9

Fetal Imaging & Other* 94 190 1.9

GMP MI≤MI< 0.662

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4. Device under evaluation

4.2 Demonstration of equivalence (only when equivalence is claimed)

Identification table of equivalent devices

BioCon-900S Mcube 2/3.4 MHz CubePro Power cord, Successor CE-marked

BioCon-900 Mcube 2/3.4 MHz CubePro Power cord, Successor CE-marked

Mcube Clinical Evaluation Report Doc. No. CE BioCon-700

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BioCon-500 Mcube 2.8 MHz CubeScan Power cord, Successor CE-marked

BVI-3000 Verahon 2MHz Adapter Successor CE-marked

2) Comparison of clinical, biological and technical characteristics.

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- use similar deployment methods (if relevant), and

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Transducer 2.0 /3.4MHz 2.6MHz 2.8MHz

Energy Delivered ultrasound ultrasound ultrasound

Sector Angle 120 degrees 120 degrees 120 degrees

Characteristics BioCon-900S BVI-3000 (Verathon)

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