4 U.S.

FOOD & DRUG

AD INISI RATION

Shimadzu Corporation Medical Systems April 28, 2021

% Mr. Daniel Kamm
Principal Engineer
Kamm & Associates
8870 Ravello Ct
NAPLES FL 34114

Re: K203535
Trade/Device Name: Trinias
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-intensified fluoroscopic x-ray system
Regulatory Class: Class II
Product Code: OWB
Dated: March 29, 2021
Received: March 30, 2021

Dear Mr. Kamm:

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
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
K203535 - Mr. Daniel Kamm Page 2

https://www.fda.gov/combination-products/guidance-regulatory-informationlpostmarketing-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 (DICE(i~fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

'2

A
For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
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: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K203535

Device Name
Trinias

Indications for Use (Describe)

The Trinias is an angiographic X-ray system, which is used for diagnostic imaging and
interventional procedures. The Trinias is intended to be used for cardiac angiography,
neurovascular angiography, abdominal angiography, peripheral angiography, rotational
angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures

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

X Prescription Use (Part 21 CFR 801 Subpart D) [I 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 (7/17) Page 1 of 1 PSC Pu,blhiScrvs, (301)443-6740 EF

 510(k) Summary: 510(k) Number K203535

ro wh Sl-HIMADZU
Shimadzu Corporation
1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto, 604-8511, Japan
Registration Number: 8030233
Phone: +81-75-823-1305 Fax : +81-75-823-1377
Date Prepared: March 29, 2021
Contact: Shigeru Naganishi; Phone: +81-75-823-1920
E-mail: [email protected]@shimadzu.co.jp

1. Identification of the Device:

Trade/Device Names: Trinias
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: 11
Product Code: OWB
Common/Usual Name: Interventional Fluoroscopic X-Ray System

2. Equivalent legally marketed device: K123508

Trade/Device Name: Trinias
Manufacturer: Shimadzu.
Regulation Number: 21CFR892.1650
Regulation Name: Interventional Fluoroscopic X-Ray System
Regulatory Class: 11
Product Code: OWB
Common/Usual Name: Interventional Fluoroscopic X-Ray System

3. Indications for Use (intended use): The Trinias is an angiographic X-ray system, which is used for
diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac
angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational
angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

4. Description of the Device:

This notification is for a modified device. The modifications are:
Updated user interfaces (wireless mouse, keyboard)
A new model of catheterization table
A new type of digital system console
Additional x-ray tube choices
Add alternate choices for the same sizes of digital flat panel detectors
An additional size of available flat panel detector (12" x 16")
An additional type of control cabinet.
Model identifications:
KS-70 Patient Table
KS-100 New Patient Table
F-100 New Collimator
LX-6308, LX-6311, E79039X: X-ray Tubes
DAR-9500f, Digital Angiography System; Flat panel.
New MH-500 Suspended C-Arm
 New MH-600 Lateral C-Arm
D150GC-40 High Voltage Generator

5. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing
indicates that the new device is as safe and effective as the predicate device. Proper system operation
is fully verified upon installation. Most of the components employed are identical to the predicate
device.

6. Substantial Equivalence Chart: Below.

Trinias K123508 Modified Trinias
Indications for The Trinias is an angiographic X-ray system, The Trinias is an angiographic X-ray system, which
Use: which is used for diagnostic imaging and is used for diagnostic imaging and interventional
interventional procedures as described in 21 procedures. The Trinias is intended to be used for
CFR 892.1650. The Trinias is intended to be cardiac angiography, neurovascular angiography,
used for cardiac angiography, neurovascular abdominal angiography, peripheral angiography,
angiography, abdominal angiography, rotational angiography, multi-purpose
peripheral angiography, rotational angiography and whole body
angiography, multi-purpose angiography and radiographic/fluoroscopic procedures. (SAME
whole body radiographic/fluoroscopic except CFR reference removed for international
procedures consistency)
Patient Table Newly available: KS-100, table top can tilt.

KS-70
---- II

C-arms
Ceiling MH-200S MH-500

Al

K
I
 Trinias K123508 Modified Trinias
Floor MH-300 MH-600

I'7

f~
~\~\

MH-300/400 Biplane

V
MH-300/400 Biplane is still available under
K123508.

41P

Digital X-Ray Receptor Panels Comparison

Shimadzu Reference/ Shimadzu Reference/
SIZE: Manufacturer Model Manufacturer Model
9" x 9" PANEL MAIN ASSY, A-9 (No longer available)
17" x 17" PANEL MAIN ASSY, S-17 (No longer available)
SFD-0808 SFD-0808AF
8" x 8" Varex PaxScan 2020+ (194pm) Varex PaxScan 2020X (194pm) (Updated version
of the predicate)
SFD-1212 SFD-1212AF
12" x 12" Varex PaxScan 3030+ 194pm Varex PaxScan 3030X (194[im) (Updated version
of the predicate)
SFD-1612AF
Varex PaxScan 4030X (194pm) (Updated version
16" x 12" This size was not available
of the predicate)

X-Ray Generation
 Trinias K123508 Modified Trinias jI
Generator 100 kW SAME -I
Model# D150GC-40 Same as predicate
Control 50kHz Inverter Same as predicate
Method
Rated output 100kW Same as predicate
Radiography 40kV - 150kV Same as predicate
tube Voltage
Radiography 10 to 1250mA Same as predicate
tube current
Radiography 0.5 to 8OOmAs Same as predicate
mAs
Radiography 0.001 to 10sec Same as predicate
time
Fluoroscopy 50kV to 125kV Same as predicate
tube voltage
Fluoroscopy 0.3 to 30mA 0.3 to 38mA
tube current
Short time 100kv - 10OOmA Same as predicate
rating
Long time 100kv - 30mA 100kV - 38mA
rating
F-100: Has 16 BH filters with irridation area of421
F-50: Has 4 BH (beam hardening) filters with
Collimator x 421 mm max. New collimator offers more
Irradiation area of 400 x 400 mm max
filtration options.
Safety Standards
US
21CFR1D20.30, 21CFR1020.31 and
Performance SAME
21CFR2020.32
Standard
IEC Safety
See list below SAME
Standards

7. Summary of non-clinical testing: Software was validated according to the FDA Guidance: Guidance for
the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on:
May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations
contained in the FDA Guidance Document: Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff
Document Issued on: October2, 2014. The digital panel software employed was already reviewed by
FDA. Labeling was developed and information provided in accordance with this FDA Guidance
Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidancefor
Industry and Food and Drug Administration Staff, November 2017. Labeling also includes reference to
the Image Gently website (http://www.imagegently.org/). Because the device contains wireless
technology, we consulted Radio Frequency Wireless Technology in Medical Devices - Guidancefor
Industry and FDA Staff, AUGUST2013 and we incorporated those recommendations into our labeling.
 This device has been tested and is certified to comply with the US Radiation Safety Performance
Standards as listed in the table above. Performance and safety testing was conducted by third party
NRTL certified testing laboratories and the device was found to comply with the following FDA
recognized standards:
* US Performance Standard 21CFR1020.30, 21CFR1020.31 and 21CFR2020.32
* IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 Medical electrical equipment - Part
1: General requirements for basic safety and essential performance FDA 19-4
* IEC 60601-1-2:2014 Collateral Standard: Electromagnetic disturbances - Requirements and tests FDA
19-8
* IEC 60601-1-3:2008 + A1:2013 Medical electrical equipment - Part 1-3: General requirements for
basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-
ray equipment FDA 12-269
* IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability FDA 5-89
* IEC 60601-2-43:2010 + A1:2017 Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures FDA 12-308
* Additionally evaluated in accordance with
* IEC 62366: 2007 + Al: 2014 Medical devices - Part 1: Application of usability engineering to medical
devices FDA 5-114
* IEC 62304: 2006 Medical device software - Software life cycle processes FDA 13-79
* EN 60601-1:2006 + A11:2011 + A1:2013 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
* EN 60601-1-3:2008 + A1:2013 + A11:2016 Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance - Collateral Standard: Radiation protection
in diagnostic X-ray equipment
* EN 60601-1-6:2010 + A1:2015 Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability
* EN 60601-2-43:2010 + A1:2018 Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability
* EN 62304:2006 Medical device software - Software life cycle processes
* ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012

We consulted the following FDA guidance documents in the development of the Trinias:
Content of Premarket Submissionsfor Management of Cybersecurity in Medical Devices, Guidance
for Industry and Food and Drug Administration Staff; and Pediatric Information for X-ray Imaging
Device Premarket Notifications.

8. Summary of clinical testing: Not applicable. Clinical testing was not deemed to be required to show
substantial equivalence. We relied on non-clinical testing and compliance with standards.

9. Conclusion: After analyzing standards compliance results and bench tests, it is the conclusion of
Shimadzu Corporation that the MODIFIED Trinias is as safe and effective as the predicate device, has
few technological differences, and has the same indications for use, thus rendering it substantially
equivalent to the predicate device.