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.

Device Description

AI/ML Overview

This document is a 510(k) summary for the Shimadzu Trinias angiographic X-ray system. It describes modifications to an existing device and demonstrates substantial equivalence to a predicate device (K123508).

Based on the provided document, the device in question is a medical imaging system (angiographic X-ray system), not an AI/ML-based device. Therefore, the typical acceptance criteria and study designs associated with AI/ML systems (e.g., performance metrics like sensitivity/specificity, multi-reader multi-case studies, ground truth establishment by experts, training/test set provenance) are not applicable here.

The regulatory approval for this device is based on showing substantial equivalence to a previously cleared predicate device, rather than proving performance against specific AI/ML acceptance criteria. The modifications are hardware and software updates to the existing X-ray system.

Here's an analysis of the provided information in the context of device approval, highlighting why AI/ML-specific criteria are not met or relevant:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (for AI/ML performance).

Since this is not an AI/ML device, there are no acceptance criteria related to typical AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).

The "acceptance criteria" for this submission are compliance with various safety and performance standards for X-ray systems. The reported "performance" is that the modified device meets these standards and is comparable to the predicate.

Acceptance Criteria (based on standards compliance)	Reported Device Performance
Compliance with US Performance Standard 21CFR1020.30, .31, .32	Device tested and certified to comply.
Compliance with IEC 60601-1 (general safety)	Device found to comply.
Compliance with IEC 60601-1-2 (EMC)	Device found to comply.
Compliance with IEC 60601-1-3 (radiation protection)	Device found to comply.
Compliance with IEC 60601-1-6 (usability)	Device found to comply.
Compliance with IEC 60601-2-43 (interventional procedures)	Device found to comply.
Compliance with IEC 62366 (usability engineering)	Evaluated in accordance with and found to comply.
Compliance with IEC 62304 (software life cycle processes)	Evaluated in accordance with and found to comply.
Software validation (FDA Guidance May 11, 2005)	Software was validated.
Cybersecurity management (FDA Guidance Oct 2, 2014)	Recommendations observed for Wi-Fi and Ethernet.
Pediatric Information Labeling (FDA Guidance Nov 2017)	Labeling developed in accordance, includes Image Gently.
Wireless Technology Recommendations (FDA Guidance Aug 2013)	Recommendations incorporated into labeling.
Safety and effectiveness comparable to predicate device K123508	"as safe and effective as the predicate device," "few technological differences," "same indications for use."

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable (for AI/ML test set data).

There is no "test set" in the sense of a clinical image dataset used to evaluate an AI algorithm's diagnostic performance. The testing performed was non-clinical bench and standards testing. This involves engineering tests, electrical safety tests, radiation safety compliance tests, and software validation tests.

The data provenance refers to the origin of the device's design, manufacturing, and testing; it does not refer to clinical image data. The manufacturer is Shimadzu Corporation, based in Kyoto, Japan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable.

No "ground truth" derived from expert interpretation of medical images was established for this submission, as it's not an AI/ML diagnostic aid. The device's performance is validated against engineering specifications, safety standards, and functional requirements.

4. Adjudication Method for the Test Set

Not Applicable.

Since there's no expert interpretation of a test set, there is no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC study was not done.

MRMC studies are typically performed for AI/ML diagnostic devices to assess how human reader performance (e.g., radiologists) improves with AI assistance compared to without it. This submission is for an X-ray imaging system itself, not an AI-assisted diagnostic tool.

Therefore, there is no effect size of how human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No.

This concept applies to AI/ML algorithms that can produce an output independently. The Trinias is an imaging system; its "performance" is its ability to acquire images, comply with safety standards, and function as intended.

7. The Type of Ground Truth Used

Compliance with regulated standards and functional specifications.

The "ground truth" for this device's approval lies in its adherence to international safety standards (e.g., IEC 60601 series, IEC 62304 for software) and U.S. performance standards (21 CFR 1020.30, .31, .32), as well as verification of its mechanical and electrical functions. This is demonstrated through "bench and standards testing" and "proper system operation is fully verified upon installation."

8. The Sample Size for the Training Set

Not Applicable.

This refers to training data for AI/ML models. The Trinias is a hardware and software system. While its internal software components undergo development and testing, there isn't a "training set" in the AI/ML sense.

9. How the Ground Truth for the Training Set Was Established

Not Applicable.

As there is no AI/ML training set, there is no ground truth established for it. Software validation (IEC 62304) and adherence to design specifications guide the software development, but this is distinct from training an AI model.

In summary: The provided document is a 510(k) submission for an updated medical imaging hardware system (X-ray). Its approval focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing, and compliance with established regulatory standards. It does not involve AI/ML technology or associated clinical performance studies with diagnostic accuracy endpoints.

Summary

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Shimadzu Corporation Medical Systems % 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

April 28, 2021

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-leam). 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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
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

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Indications for Use

510(k) Number (if known)

K203535

Device Name Trinias

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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

4 SHIMADZU

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: shige@shimadzu.co.jpshige@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: II 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: II Product Code: OWB Common/Usual Name: Interventional Fluoroscopic X-Ray System

1. 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

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New MH-600 Lateral C-Arm D150GC-40 High Voltage Generator

1. 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.

	Trinias K123508	Modified Trinias
Indications forUse:	The Trinias is an angiographic X-ray system,which is used for diagnostic imaging andinterventional procedures as described in 21CFR 892.1650. The Trinias is intended to beused for cardiac angiography, neurovascularangiography, abdominal angiography,peripheral angiography, rotationalangiography, multi-purpose angiography andwhole body radiographic/fluoroscopicprocedures	The Trinias is an angiographic X-ray system, whichis used for diagnostic imaging and interventionalprocedures. The Trinias is intended to be used forcardiac angiography, neurovascular angiography,abdominal angiography, peripheral angiography,rotational angiography, multi-purposeangiography and whole bodyradiographic/fluoroscopic procedures. (SAMEexcept CFR reference removed for internationalconsistency)
Patient Table	Image: KS-70 patient table	Newly available: KS-100, table top can tilt.Image: KS-100 patient table
	C-arms
Ceiling	Image: MH-200S C-armMH-200S	Image: MH-500 C-armMH-500
	Trinias K123508	Modified Trinias
Floor	MH-300Image: MH-300	MH-600Image: MH-600
	MH-300/400 BiplaneImage: MH-300/400 Biplane	MH-300/400 Biplane is still available underK123508.
Digital X-Ray Receptor Panels Comparison
SIZE:	Shimadzu Reference/Manufacturer Model	Shimadzu Reference/Manufacturer Model
9" x 9"	PANEL MAIN ASSY, A-9	(No longer available)
17" x 17"	PANEL MAIN ASSY, S-17	(No longer available)
8" x 8"	SFD-0808Varex PaxScan 2020+ (194μm)	SFD-0808AFVarex PaxScan 2020X (194μm) (Updated versionof the predicate)
12" x 12"	SFD-1212Varex PaxScan 3030+ 194μm	SFD-1212AFVarex PaxScan 3030X (194μm) (Updated versionof the predicate)
16" x 12"	This size was not available	SFD-1612AFVarex PaxScan 4030X (194μm) (Updated versionof the predicate)
X-Ray Generation
	Trinias K123508	Modified Trinias
Generator	100 kW	SAME
Model #	D150GC-40	Same as predicate
Control Method	50kHz Inverter	Same as predicate
Rated output	100kW	Same as predicate
Radiography tube Voltage	40kV - 150kV	Same as predicate
Radiography tube current	10 to 1250mA	Same as predicate
Radiography mAs	0.5 to 800mAs	Same as predicate
Radiography time	0.001 to 10sec	Same as predicate
Fluoroscopy tube voltage	50kV to 125kV	Same as predicate
Fluoroscopy tube current	0.3 to 30mA	0.3 to 38mA
Short time rating	100kv - 1000mA	Same as predicate
Long time rating	100kv - 30mA	100kV - 38mA
Collimator	F-50: Has 4 BH (beam hardening) filters with Irradiation area of 400 x 400 mm max	F-100: Has 16 BH filters with irradiation area of 421 x 421 mm max. New collimator offers more filtration options.
Safety Standards
US Performance Standard	21CFR1020.30, 21CFR1020.31 and 21CFR2020.32	SAME
IEC Safety Standards	See list below	SAME

6. Substantial Equivalence Chart: Below.

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1. Summary of non-clinical testing: Software was validated according to the FDA 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: October 2, 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, Guidance for 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 - Guidance for Industry and FDA Staff, AUGUST 2013 and we incorporated those recommendations into our labeling.

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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
0 IEC 60601-1-2:2014 Collateral Standard: Electromagnetic disturbances - Requirements and tests FDA 19-8
9 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 Xray 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 + A1: 2014 Medical devices Part 1: Application of usability engineering to medical 0 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 Submissions for 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.

1. Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
1. 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.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.