Trinias

K203535 · Shimadzu Corporation Medical Systems · OWB · Apr 28, 2021 · Radiology

Device Facts

• Record ID: K203535
• Device Name: Trinias
• Applicant: Shimadzu Corporation Medical Systems
• Product Code: OWB · Radiology
• Decision Date: Apr 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

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

Device Story

Trinias is an angiographic X-ray system for diagnostic and interventional procedures. It captures X-ray images using a digital flat panel detector and high-voltage generator; images are processed by the DAR-9500f digital angiography system. The system includes a patient table (KS-100), C-arm (MH-500/MH-600), and collimator (F-100). Operated by clinicians in clinical settings, the system provides real-time fluoroscopic and radiographic visualization to guide interventional procedures. Output is displayed on monitors for physician review, facilitating clinical decision-making during minimally invasive interventions. Benefits include high-resolution imaging for complex vascular and cardiac procedures. Modifications include updated user interfaces, new table/C-arm models, and expanded flat panel detector options.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, standards compliance (electrical safety, electromagnetic compatibility, radiation protection, and usability), and software validation.

Technological Characteristics

Angiographic X-ray system; 100kW high-voltage generator (D150GC-40); 50kHz inverter control; flat panel detectors (Varex PaxScan X-series); F-100 collimator with 16 beam hardening filters; wireless/Ethernet connectivity. Complies with 21 CFR 1020.30-32, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-43, IEC 62366, and IEC 62304.

Indications for Use

Indicated for patients requiring diagnostic imaging and interventional procedures, including cardiac, neurovascular, abdominal, peripheral, and rotational angiography, as well as whole-body radiographic/fluoroscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Trinias (K123508)

Submission Summary (Full Text)

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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 [phone] 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)

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) | 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: [phone] Fax : [phone] Date Prepared: March 29, 2021 Contact: Shigeru Naganishi; Phone: [phone] E-mail: [e-mail]@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

- 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

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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.

| | Trinias K123508 | Modified Trinias |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use: | The Trinias is an angiographic X-ray system,<br>which is used for diagnostic imaging and<br>interventional procedures as described in 21<br>CFR 892.1650. The Trinias is intended to be<br>used for cardiac angiography, neurovascular<br>angiography, abdominal angiography,<br>peripheral angiography, rotational<br>angiography, multi-purpose angiography and<br>whole body radiographic/fluoroscopic<br>procedures | The Trinias is an angiographic X-ray system, which<br>is used for diagnostic imaging and interventional<br>procedures. The Trinias is intended to be used for<br>cardiac angiography, neurovascular angiography,<br>abdominal angiography, peripheral angiography,<br>rotational angiography, multi-purpose<br>angiography and whole body<br>radiographic/fluoroscopic procedures. (SAME<br>except CFR reference removed for international<br>consistency) |
| Patient Table | Image: KS-70 patient table | Newly available: KS-100, table top can tilt.<br>Image: KS-100 patient table |
| | C-arms | |
| Ceiling | Image: MH-200S C-arm<br>MH-200S | Image: MH-500 C-arm<br>MH-500 |
| | Trinias K123508 | Modified Trinias |
| Floor | MH-300<br>Image: MH-300 | MH-600<br>Image: MH-600 |
| | MH-300/400 Biplane<br>Image: MH-300/400 Biplane | MH-300/400 Biplane is still available under<br>K123508. |
| Digital X-Ray Receptor Panels Comparison | | |
| SIZE: | Shimadzu Reference/<br>Manufacturer Model | Shimadzu Reference/<br>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-0808<br>Varex PaxScan 2020+ (194μm) | SFD-0808AF<br>Varex PaxScan 2020X (194μm) (Updated version<br>of the predicate) |
| 12" x 12" | SFD-1212<br>Varex PaxScan 3030+ 194μm | SFD-1212AF<br>Varex PaxScan 3030X (194μm) (Updated version<br>of the predicate) |
| 16" x 12" | This size was not available | SFD-1612AF<br>Varex PaxScan 4030X (194μm) (Updated version<br>of 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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- 7. 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.

- 8. 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.
- 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.