August 10, 2023

Sibel Health Inc.

Sarah Coughlin
Senior Regulatory Affairs and Quality Assurance Engineer
6650 W Touhy Ave.
Niles, Illinois 60714

Re: K223711
Trade/Device Name: ANNE One
Regulation Number: 21 CFR 870.2910
Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver
Regulatory Class: Class II
Product Code: DRG, MWI, FLL, DQA, MWJ, KMI
Dated: July 6, 2023
Received: July 10, 2023

Dear Sarah Coughlin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.03
Silver Spring, MD 20993
www.fda.gov
K223711 - Sarah Coughlin Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer W. Shih -S
Jennifer Shih Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K223711

Device Name
ANNE One

Indications for Use (Describe)

ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms,
heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, activity, body position,
fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare
settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse
rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on
ambulatory patients. The device is not intended to monitor or measure respiratory rate, SpO2, pulse rate, or noninvasive
blood pressure while the patient undergoes significant motion or is active.

ANNE One continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients.
The system provides visual notification when the patient’s position has not changed from a preset threshold of time.

The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to
provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are
transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 510(K) Summary

I. Submitter:

Sibel Health Inc.

2017 N Mendell St. Suite 2SE Chicago, IL 60614
Tel: (224) 251-8859

Official Correspondent:
Sarah Coughlin, Regulatory Affairs Manager
2017 N Mendell St. Suite 2SE Chicago, IL 60614
Tel: (224) 251-8859

Date Prepared: 08/10/2023

II. Device Information

Name of Device: ANNE One

510K Number: K223711
Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver
Regulation: 21 CFR §870.2910
Regulatory Class: Class II
Product Classification Code: DRG, MWI, FLL, DQA, MWJ, KMI

III. Predicate Device

Trade Name: ANNE One

510(k): K211305
Device Manufacturer: Sibel Health Inc.

IV. Reference Devices

Trade Name: ANNE Sleep

510(k): K220095
Device Manufacturer: Sibel Health Inc.

Trade Name: BioSticker System

510(k): K191614
Device Manufacturer: BioIntelliSense Inc.

Trade Name: Leaf Patient Monitoring System

510(k): K141877
Device Manufacturer: Leaf Healthcare Incorporated

510(k) Summary Page 1 of 15

K223711
 Trade Name: Eclipse Mini
510(k): K212317
Device Manufacturer: Spacelabs

V. Device Description

ANNE One is a wireless monitoring platform that streams and stores real-time biosignals
including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and
temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin
temperature, and body temperature. The ECG signal is not intended for automated arrhythmia
detection or classification; rather it is intended for manual interpretation, and the automated
computation of heart rate through QRS identification using the well-known Pan-Tompkins beat
detection algorithm. The displayed waveform is only intended for display as a check for normal
ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or
cardiac conditions. The system features two skin-mounted, bio-integrated sensors that pair with
the ANNE View software application for the continuous display, storage, and analysis of vital
sign measurements and physiological waveforms. The system is also compatible with optional
FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature
measurements.

VI. Indications for Use

ANNE One is a wireless monitoring platform indicated for the measurement of

electrocardiography (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation
of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature,
and body temperature by qualified healthcare professionals in home and healthcare settings.
ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure,
SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring
ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or
measure respiratory rate, SpO2, pulse rate, or noninvasive blood pressure while the patient
undergoes significant motion or is active.

ANNE One continuously monitors the orientation of patients to aid in the prevention of pressure
ulcers for at-risk patients. The system provides visual notification when the patient’s position has
not changed from a preset threshold of time.

The device is intended for use on general care patients who are 12 years of age or older as a
general patient monitor to provide continuous physiological information as an aid to diagnosis
and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and
analysis. The device is not intended for use on critical care patients.

510(k) Summary Page 2 of 15

K223711
VII. Performance Data

The following consensus standards and bench testing were used to evaluate the substantial
equivalence of ANNE One:
● Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI
ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards. Electrical safety testing in
the home healthcare environment per IEC 60601-1-11:2015.
● Safety and performance testing of pulse oximeter per ISO 80601-2-61:2017.
● Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-5:2009, and ISO
10993-10:2010 for patient contacting materials.
● Wireless coexistence testing according to ANSI IEEE C63.27-2017.
● Software verification and validation testing according to IEC 62304:2015 and the FDA
guidance document, Content of Premarket Submissions for Software Contained in
Medical Devices.
● Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC
60601-2-47:2012.
● Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012
● Shelf life testing of the adhesive to demonstrate safe and effective performance over the
intended device life cycle.
● Bench testing to demonstrate the mechanical durability of the sensors.
● Usability testing in accordance with the FDA guidance document, Applying Human
Factors and Usability Engineering to Medical Devices.
● Performance testing of heart rate, respiratory rate, pulse rate, skin temperature, body
temperature, activity, and posture.
● Cybersecurity evaluation according to the requirements of the FDA draft guidance
document, Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices.
● Assessment of Software of Unknown Provenance per the FDA guidance document,
Off-The-Shelf Software Use in Medical Devices.

VIII. Clinical Studies

SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas
analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to
Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions
[510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013.
Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker
skin pigmentation (Fitzpatrick 5). The average root mean square error (ARMS) was 2.31%,
meeting the requirements of the above-mentioned standard.

Respiratory Rate Accuracy: Sibel validated the accuracy of respiratory rate measurements
compared to etCO2 in n=40 healthy adult subjects over the output range of 8-30 breaths per

510(k) Summary Page 3 of 15

K223711
minute. The mean absolute error of respiratory rate measurements with ANNE One was within
±3bpm of the reference device, meeting the defined performance criteria.

IX. Conclusion

The results of the substantial equivalence assessment, taken together with safety and
performance testing data, demonstrate that ANNE One’s performance characteristics are
substantially equivalent to the predicate device in both technology and intended use.

510(k) Summary Page 4 of 15

K223711
 Subject device Predicate device Reference device Reference device Reference Reference Variances /
Sibel Health Inc. Sibel Health Inc. Sibel Health Inc. BioIntelliSense Device Device Equivalence
Inc. Leaf Healthcare, Spacelabs
Inc.

Trade ANNE One ANNE One ANNE Sleep BioSticker System Leaf Patient Eclipse Mini
Name Monitoring System

510(k) K223711 K211305 K220095 K191614 K141877 K212317

Number

Class II II II II I II Equivalent

Product DRG, MWI, FLL, DRG, MWI, FLL MNR DRG KMI MWJ Similar
Code DQA, MWJ, KMI The DQA product
code for the
oximeter is
supported by the
ANNE Sleep
reference device.
The MWJ product
code for
ambulatory ECG
monitoring without
analysis is
supported by safety
and performance
testing to
consensus
standards as well
as the K212317
reference. The KMI
product code for
bed-patient
monitoring is
supported by the
Leaf Patient
Monitoring System
reference device.

Regulati 870.2910 870.2910 868.2375 870.2910 880.2400 870.2800 Equivalent

510(k) Summary Page 5 of 15

K223711
on Transmitters and Transmitters and Breathing Transmitters and Bed-patient Medical magnetic
Number Receivers, Receivers, Frequency Monitor Receivers, Monitor tape recorder
and Physiological Physiological Physiological
Regulati Signal, Signal, Signal,
on Radiofrequency Radiofrequency Radiofrequency
Name

Indicatio ANNE One is a ANNE One is a ANNE Sleep is a The BioSticker The Leaf Patient The Eclipse MINI Similar
ns for wireless monitoring wireless vital wearable sensor System is a Monitoring System Model 98900 is a The subject device
Use platform indicated signs and system intended remote monitoring monitors the portable utilizes the same
physiological data for use in the system intended orientation and non-invasive sensors and
for the algorithms for the
monitoring collection, for use by activity of patients continuous
measurement of analysis, display, healthcare susceptible to ambulatory ECG calculation of SpO2
platform indicated
electrocardiograph and storage of professionals for pressure ulcers. It patch recorder and pulse rate as
for the
y (ECG) physiological continuous allows healthcare intended to record the reference
measurement of
device, ANNE
waveforms, heart heart rate, parameters to aid collection of providers to the patient’s
Sleep. The subject
rate, respiratory respiratory rate, in the evaluation physiological data implement electrocardiogram.
device is
rate, functional step count, fall of sleep-related in home and individualized turn The recorder is compatible with an
count, skin breathing healthcare management intended to be optional,
oxygen saturation
temperature, and disorders of adult settings while the plans and used by either FDA-cleared
of arterial patients patient is at rest. continuously paediatric or adult
body temperature third-party device
hemoglobin by qualified suspected of This can include monitor each patients for NIBP
(SpO2), pulse rate, healthcare sleep apnea. The heart rate, patient. The Leaf suspected of monitoring.
activity, body professionals in device is intended respiratory rate, Patient Monitoring cardiac Ambulatory ECG
position, fall healthcare for use in the and skin System provides arrhythmias in heart rate
settings. The clinical and home temperature. Data alerts when either a clinical monitoring is
detection, skin
device is intended setting under the are transmitted via patient orientation setting or at home. supported by
temperature, and performance
for use on general direction and wireless or activity deviates The recorder does
body temperature care patients who interpretation by a connection from from parameters no cardiac testing to
by qualified are 18 years of Healthcare the BioSticker for set by healthcare analysis and is consensus
healthcare Professional storage and providers. The used with standards as well
age or older as a
(HCP). analysis. device is intended Spacelabs as the K212317
professionals in general patient
reference device.
home and monitor to provide for use in medical, Ambulatory ECG
Monitoring of body
continuous The device is nursing, and Analysis Software.
healthcare position for turn
physiological intended for use long-term care management in
settings. ANNE on general care facilities, including
information as an patients susceptible
One is compatible aid to diagnosis patients who are independent to pressure ulcers
with third-party, and treatment. 21 years of age or living, with the subject
FDA-cleared The device is not older as a general assisted-living and device is supported
devices for intended for use patient monitor, to rehabilitation by the Leaf
noninvasive blood on critical care provide facilities. reference device.
patients. The physiological The differences do

510(k) Summary Page 6 of 15

K223711
 pressure, SpO2, device is not information. The not affect safety or
pulse rate, and intended to data from the effectiveness.
body temperature monitor or BioSticker System
measure are intended for
measurements.
respiratory rate or use by healthcare
The device is heart rate on professionals as
indicated for ambulatory an aid to
monitoring ECG patients. diagnosis and
waveforms and treatment.
heart rate on
ambulatory The device is not
intended to
patients. The
measure
device is not physiological
intended to monitor parameters while
or measure the patient
respiratory rate, undergoes
SpO2, pulse rate, significant motion
or noninvasive or is active. The
device is not
blood pressure
intended for use
while the patient on critical care
undergoes patients.
significant motion
or is active.

ANNE One
continuously
monitors the
orientation of
patients to aid in
the prevention of
pressure ulcers for
at-risk patients.
The system
provides visual
notification when
the patient’s
position has not

510(k) Summary Page 7 of 15

K223711
 changed from a
preset threshold of
time.

The device is
intended for use on
general care
patients who are
12 years of age or
older as a general
patient monitor to
provide continuous
physiological
information as an
aid to diagnosis
and treatment. The
data from ANNE
One are
transmitted
wirelessly for
display, storage,
and analysis. The
device is not
intended for use on
critical care
patients.

Target 12 years of age 18 years of age 22 years of age 21 years of age or 18 years of age Pediatric and adult Similar
Populati and older and older and older older and older The subject
on device’s target
population includes
adolescents aged
12 to 17. Safety
and effectiveness in
this population is
established through
literature. ECG
monitoring in the

510(k) Summary Page 8 of 15

K223711
 target population is
supported by the
Eclipse Mini
reference device.
Safety and
effectiveness of RR
monitoring in the
adolescent
subpopulation is
demonstrated
through the
extrapolation of
adult clinical data.

Use Home and Healthcare Recording in the Home and Medical, nursing, Clinical and home Equivalent
Environ healthcare settings settings home environment healthcare and long-term
ment with the report and settings care facilities
interpretation
performed in the
clinical setting.

Sensor Finger and Chest Finger and Chest Finger and Chest Chest Chest Chest Equivalent
Placeme
nt

Heart 30-300 bpm 30 - 270 bpm 30-300 bpm 40-125 bpm N/A N/A Equivalent
Rate (the greater of ± (the greater of ± (the greater of ± (<± 5 beats per
10% or ± 5 bpm) 10% or ± 5bpm) 10% or ± 5 bpm) minute)

Respirat Accelerometer-deri ECG-derived N/A Accelerometer-der N/A N/A Equivalent

ory Rate ved 8 - 35 bpm ived The range and
8 - 30 bpm (± 3 bpm RMSE) 10 - 30 bpm accuracy of RR is
(± 3 bpm MAE) (± 3 bpm MAE) supported by the
K211305 predicate
device and the
K191614
reference. The use
of
accelerometer-deri
ved RR is
supported by the
K191614 reference
device.

510(k) Summary Page 9 of 15

K223711
Skin 73.4°F - 109.4°F 73.4°F - 109.4°F N/A 86°F - 107.6°F N/A N/A Equivalent
Tempera (±0.54°F) (±0.54°F) (30°C - 42°C)
ture 23°C - 43°C 23°C - 43°C
(±0.3°C) (±0.3°C) < 96.4°F ± 0.5°F
(< 35.8°C ± 0.3°C)

96.4°F to 98°F ±
0.3°F (35.8°C to
37°C ± 0.2°C)

98°F to 102°F ±
0.2°F (37°C to
39°C ± 0.1 °C)

102°F to 106°F ±
0.3°F (39°C to
41ºC ± 0.2°C)

> 106°F ± 0.5°F

(> 41ºC ± 0.3°C)

Body ± 0.05 °C ( ± 0.1 93.2°F - 109.4°F N/A N/A N/A N/A Different
Tempera °F ) during (±0.54°F) The subject
ture 35.00 °C ~38.00°C 34°C - 43°C device may be
(95.00 °F (±0.3°C) used with a
~100.40°F) ± third-party,
0.1°C ( ± 0.2 °F ) FDA-cleared
during thermometer for
T<35.00°C spot-check body
(95.00°F) or temperature.
T>38.00°C
(100.40°F)

SpO2 ARMS ≤ 3% (range N/A ARMS ≤ 3% (range N/A N/A N/A Equivalent
70-100%) 70-100%)

Pulse 30-300 bpm N/A 30-300 bpm N/A N/A N/A Equivalent
Rate (the greater of ± (the greater of ±
10% or ± 5 bpm) 10% or ± 5 bpm)

Activity Accelerometer Accelerometer Accelerometer Accelerometer Accelerometer N/A Equivalent

510(k) Summary Page 10 of 15

K223711
Posture Body Position Fall Count Body Position Body Position Body Position N/A Equivalent
Fall Detection

Non-Inv 0 - 300 mmHg N/A N/A N/A N/A N/A Different

asive (± 3 mmHg) The subject device
Blood may be used with
Pressur an FDA cleared BP
e (NIBP) monitor.

ECG Compliant to IEC Continuous ECG Continuous ECG N/A N/A Compliant to IEC Different
Wavefor 60601-2-27 waveform waveform 60601-2-47 While the K211305
m Compliant to IEC collection collection predicate device
Display 60601-2-47 collects ECG
signals, the
waveform is not
displayed on the
application. Safety
and effectiveness
for the ECG
waveform display
are established
through recognized
consensus
standards including
IEC 60601-2-27
and IEC
60601-2-47 as well
as the K212317
reference.

ECG ECG Sampling ECG Sampling ECG Sampling N/A N/A Not publicly Equivalent
Samplin Frequency: 512 Hz Frequency: 512 Frequency: 512 available
g Streaming Hz Hz
Frequen Frequency: 256 Hz Streaming Streaming
cy Frequency: 256 Frequency: 256
Hz Hz

ECG 18 bit 18 bit 18 bit N/A N/A Not publicly Equivalent

Resoluti available
on

510(k) Summary Page 11 of 15

K223711
Data Data is transmitted Data is Patient data is Data is Data is Data is Similar
wirelessly via transmitted wirelessly transmitted transmitted transmitted from The subject device
Bluetooth from the wirelessly via transferred via wirelessly via wirelessly via Leaf the sensor to a allows data
sensors to a Bluetooth from the Bluetooth from the Bluetooth from the Antennas to a computer with a download to the
mobile device. sensors to a sensors to a sensor to a mobile monitoring station standard USB mobile device. This
Data may be mobile device. mobile phone. device for storage equipped with a cable functionality was
downloaded for Data is then and analysis. USB RF verified through
later storage and wirelessly Transceiver and testing.
analysis. transferred from the Leaf Turn
the phone to the Management
cloud when Software.
connected to the
internet.

Notificati Provides visual No notification No notification No notification Provides alerts on N/A Similar
on notification on ability ability ability patient orientation. The subject device
patient orientation. provides a visual
notification on
patient orientation.

Motion Respiratory rate, Heart rate and Not indicated for Not indicated for N/A ECG during Similar
SpO2, and pulse respiratory rate use during motion use during motion motion. Both the subject
rate not indicated for and predicate
measurements use during motion. devices are not
should not be indicated for
taken during respiratory rate
motion. measurements
during motion. The
subject and ANNE
Heart rate and
Sleep reference are
ECG may be taken
not indicated for
during motion. SpO2 or pulse rate
measurements
during motion. The
ANNE One device
is indicated for
heart rate
measurements
during motion. This
difference is
supported by
testing on standard
ambulatory

510(k) Summary Page 12 of 15

K223711
 databases as
described in IEC
60601-2-47.

Measure Continuous Continuous Continuous Continuous Continuous Continuous Similar

ment Measurements: Measurements: measurements: measurements: measurements: measurements: ANNE One and the
modality Respiratory rate, Respiratory rate, SpO2, pulse rate, Heart rate, Body Position ECG predicate K211305
ECG, heart rate, heart rate, skin heart rate, respiratory rate, display continuous
SpO2, pulse rate, temperature, body peripheral arterial skin temperature heart rate,
skin temperature, temperature, body tonometry, snore, respiratory rate,
body position position, step chest movement, skin temperature,
count body position and body position.
The ANNE One
Spot Check
subject device also
Measurements
streams continuous
with third party ECG for display on
devices: the ANNE View
Blood pressure, application. This
body temperature difference is
demonstrated to
not influence safety
or effectiveness
through testing
according to
consensus
standards. The
subject device and
ANNE Sleep
reference include
continuous SpO2
and pulse rate
measurement from
PPG. The ANNE
One subject device
does not include
continuous body
temperature
measurements, but
instead allows
users to take spot
check
measurements with
a standard,
FDA-cleared

510(k) Summary Page 13 of 15

K223711
 third-party
thermometer. The
ANNE One subject
device is also
compatible with an
optional
FDA-cleared third
part blood pressure
monitor for spot
check NIBP
measurements.

Monitori Real time Real time Data storage for Real time Real time Data storage for Equivalent
ng Type monitoring monitoring later analysis monitoring monitoring later analysis The subject and
Data storage for Data storage for predicate devices
later analysis later analysis continuously
stream
physiological data
for display on the
ANNE Tablet via
Bluetooth. Data is
also stored on the
sensors in the
subject device and
can be offloaded to
the ANNE Tablet at
the end of the
monitoring session,
similar to the ANNE
Sleep reference
device. The ability
of the device to
stream data is not
impacted by the
storage feature.
Both real time
streaming and
storage for later
analysis were
verified in software
system testing.

Alarms No alarming No alarming No alarming No alarming No alarming No alarming Equivalent

capabilities capabilities capabilities capabilities capabilities capabilities ANNE One is

510(k) Summary Page 14 of 15

K223711
 Visual alerts for Visual alerts for equivalent to the
turn management. turn management. Leaf Healthcare
reference device.

Apnea Not an apnea Not an apnea Not an apnea Not an apnea Not an apnea Not an apnea Equivalent
Claims monitor monitor monitor monitor monitor monitor

510(k) Summary Page 15 of 15

K223711