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

This notification is for a modification is the addition of the new MH-700 (ceiling mounted C-Arm). This is the functional equivalent of previous C-Arm MH-400. All options declared under K203535 remain available. The Lateral Angiographic C-arm Support MH-700 allows examination of a patient by fluoroscopy or radiography from different angles with the patient kept in a horizontal position in combination with a Frontal C-arm Support MH-600, an X-ray high voltage unit, X-ray tube unit, X-ray image recording unit (FPD), digital angiography system, catheterization table, etc. The range of available digital receptor panels remains unchanged from our predicate K203535. For installation, ceiling strength is important because the total weight of MH-700 exceeds 1200 kg. The MH-700 features faster movement speeds as compared to the previous model, the MH-400.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called "Trinias." It focuses on a modification to the device (addition of a new C-Arm model MH-700) and its substantial equivalence to a predicate device (Trinias K203535).

Based on the information provided, no clinical study was conducted to establish acceptance criteria for device performance related to diagnostic accuracy or interventional outcomes with human-in-the-loop or standalone AI performance. This document primarily focuses on demonstrating substantial equivalence through non-clinical testing, compliance with standards, and comparison of technical specifications.

Therefore, many of the specific points requested regarding acceptance criteria and clinical study details cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the context of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or interventional success rates. Instead, the "performance" described pertains to technical specifications and compliance with safety and electrical standards.

Feature/Parameter	Acceptance Criteria (Implied: Substantial Equivalence to Predicate, Compliance with Standards)	Reported Device Performance (Modified Trinias)
Indications for Use	Same as predicate device	Same as predicate: diagnostic imaging and interventional procedures including cardiac, neurovascular, abdominal, peripheral, rotational, multi-purpose angiography, and whole body radiographic/fluoroscopic procedures.
Patient Table	Functionally equivalent to predicate	Same as predicate (KS-100, table top can tilt)
Biplane C-arm (MH-700)	Safe and effective as predicate MH-400; compliance with standards, faster movement permissible	MH-700 is new, replaces MH-400. Features faster movement speeds.
C-arm Rotation Range (LL primary angle)	LAO120 - PA0	LAO120 - PA0
C-arm Rotation Speed (LL primary angle)	Max 15deg/sec (predicate)	Max 25deg/sec (Faster response)
C-arm Rotation Range (RL primary angle)	PA0 - RAO120	PA0 - RAO120
C-arm Rotation Speed (RL primary angle)	Max 15deg/sec (predicate)	Max 25deg/sec (Faster response)
C-arm Rotation Range (LL secondary angle)	CRAN45 - CAUD45 (predicate)	CRAN45 - CAUD45
C-arm Rotation Speed (LL secondary angle)	Max 15deg/sec (predicate)	Max 25deg/sec (Faster response)
C-arm Rotation Range (RL secondary angle)	CRAN30°~CAUD30° (predicate)	CRAN45 - CAUD45
C-arm Rotation Speed (RL secondary angle)	Max 15deg/sec (predicate)	Max 25deg/sec (Faster response)
SID range/speed	95cm - 125cm, 8cm/sec max (predicate)	95cm - 125cm, 10cm/sec max (Faster response)
Digital Image Processor	Same as predicate	Same as predicate (DAR-9500f)
Digital X-Ray Receptor Panels	No changes; same models and sizes as predicate	Same as predicate (SFD-0808AF, SFD-1212AF, SFD-1612AF with Varex PaxScan panels)
X-Ray Generator (Model #, Rated output, Control Method, Voltage, Current, mAs, Time)	Same as predicate	Same as predicate (D150GC-40, 100 kW, 50 kHz Inverter, various kV/mA/mAs/sec specifications)
Collimator	Same as predicate	Same as predicate (F-100)
US Performance Standard Compliance	Compliance with 21CFR1020.30, 21CFR1020.31, 21CFR2020.32	Certified to comply with 21CFR1020.30, 21CFR1020.31, 21CFR2020.32
IEC Safety Standards Compliance	Compliance with listed IEC standards	Certified to comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-43, IEC 62366, IEC 62304, EN 60601-1, EN 60601-1-3, EN 60601-1-6, EN 60601-2-43, EN 62304, ANSI/AAMI ES60601-1.
Software Validation	Compliance with FDA Guidance: "Content of Premarket Submissions for Software Contained in Medical Devices"	Validated according to FDA guidance issued May 11, 2005.
Cybersecurity	Compliance with FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"	Recommendations from guidance issued Oct 2, 2014, were observed and incorporated.
Pediatric Information/Labeling	Compliance with FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications"	Labeling developed per guidance. Includes reference to Image Gently website.
Wireless Technology	Compliance with FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices"	Recommendations from guidance issued August 2013, were incorporated into labeling.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set. The testing was non-clinical (bench and standards testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study was done, nor does the device appear to include AI for interpretation or improvement of human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an X-ray system, not an AI algorithm for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. For non-clinical testing, "ground truth" would relate to engineering specifications and performance against established standards, confirmed by third-party laboratories.

8. The sample size for the training set: Not applicable. This document does not describe training of an AI algorithm based on a dataset.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary focuses entirely on non-clinical aspects to demonstrate substantial equivalence of a modified X-ray system to its predicate. It explicitly states: "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." Therefore, questions related to clinical study design, performance metrics (like sensitivity, specificity), ground truth, expert readers, or AI-related evaluations cannot be answered from this document.

Summary

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July 28, 2022

Shimadzu Corporation Medical Systems Division % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K221922

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: June 30, 2022 Received: July 1, 2022

Dear Daniel 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

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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 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 medical devices and radiation-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-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-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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K221922

Device Name Trinias

Indications for Use (Describe)

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)
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510(k) Summary: 510(k) Number K221922

HIMADZI

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: July 26, 2022

Koichi Kataoka, General Manager, Quality Assurance Department, Medical Systems Division Contact:

1. Identification of the Device:

Trade/Device Names: Trinias Regulation Number: 21CFR892.1650 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: K203535

Trade/Device Name: Trinias Manufacturer: Shimadzu. Regulation Number: 21CFR892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Interventional Fluoroscopic X-Ray System Common/Usual Name:

1. Indications for 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.
1. Description of the Device: This notification is for a modification is the addition of the new MH-700 (ceiling mounted C-Arm). This is the functional equivalent of previous C-Arm MH-400. All options declared under K203535 remain available. The Lateral Angiographic C-arm Support MH-700 allows examination of a patient by fluoroscopy or radiography from different angles with the patient kept in a horizontal position in combination with a Frontal C-arm Support MH-600, an X-ray high voltage unit, X-ray tube unit, X-ray image recording unit (FPD), digital angiography system, catheterization table, etc. The range of available digital receptor panels remains unchanged from our predicate K203535. For installation, ceiling strength is important because the total weight of MH-700 exceeds 1200 kg. The MH-700 features faster movement speeds as compared to the previous model, the MH-400.
1. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the modified 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.

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	Trinias K203535	Modified Trinias
Indications forUse:	The Trinias is an angiographic X-ray systemwhich is used for diagnostic imaging andinterventional procedures. The Trinias isintended to be used for cardiac angiography,neurovascular angiography, abdominalangiography, peripheral angiography, rotationalangiography, multi-purpose angiography andwhole body radiographic/fluoroscopicprocedures.	The Trinias is an angiographic X-ray systemwhich is used for diagnostic imaging andinterventional procedures. The Trinias isintended to be used for cardiac angiography,neurovascular angiography, abdominalangiography, peripheral angiography,rotational angiography, multi-purposeangiography and whole bodyradiographic/fluoroscopic procedures.Indications statement has not changed.
Patient Table	KS-100, table top can tilt.	Same as predicate
	Bi-plane C-Arms
Biplane C-arm(Combines afloor mounted C-arm with a ceilingmounted C-arm)	MH-300 plus MH-400	MH-600 plus MH-700 (MH-700 is new)(MH-600 previously cleared)
Picture ofequivalentassembly	Image: MH-300/MH-400	Image: MH-600/MH-700
	Comparison of Equivalent Assemblies: MH-400 vs MH-700
Lateral C-arm	MH-400 (K123508)	MH-700
Mounting	Ceiling	Same
Variation ofposition	LL position / RL Position	Same
LL positionPrimary angle)C-arm rotationrange and Speed	"LAO120 - PA0Max 15deg/sec"(LAO=Left Anterior Oblique)(PA= Postero-Anterior projection)	"LAO120 - PA0Max 25deg/sec" Faster response
RL positionPrimary angle)C-arm rotationrange and Speed	"PA0 - RAO120Max 15deg/sec"(RAO= Right Anterior Oblique)	"PA0 - RAO120Max 25deg/sec" Faster response
	Trinias K203535	Modified Trinias
LL positionSecondaryAngle C-armrotation rangeand Speed	"CRAN45 - CAUD45Max 15deg/sec"(CRAN=Caudo-Cranial projection)(CAUD=Cranio-Caudal projection)	"CRAN45 - CAUD45Max 25deg/sec"Faster response
RL positionSecondary AngleC-arm rotationrange and Speed	"CRAN30°~CAUD30°Max 15deg/sec"	"CRAN45 - CAUD45Max 25deg/sec"Faster response
SID range/speed	95cm - 125cm , 8cm/sec max	95cm - 125cm, 10cm/sec maxFaster response
Digital ImageProcessor	DAR-9500f	Same as predicate
Digital X-Ray Receptor Panels (No changes) Shimadzu Reference/Manufacturer Model
SIZE: 8" x 8"	SFD-0808AF Varex PaxScan 2020X (194µm)	Same as predicate
SIZE: 12" x 12"	SFD-1212AF Varex PaxScan 3030X (194µm)	Same as predicate
SIZE: 16" x 12"	SFD-1612AF Varex PaxScan 4030X (194µm)	Same as predicate
X-Ray Generation
Generator	100 kW	Same as predicate
Model #	D150GC-40	Same as predicate
Control Method	50 kHz Inverter	Same as predicate
Rated output	100 kW	Same as predicate
Radiographytube Voltage	40 kV- 150 kV	Same as predicate
Radiographytube current	10 to 1250 mA	Same as predicate
Radiography mAs	0.5 to 800 mAs	Same as predicate
Radiography time	0.001 to 10 sec	Same as predicate
Fluoroscopy tubevoltage	50 kV to 125 kV	Same as predicate
Fluoroscopy tubecurrent	0.3 to 38 mA	Same as predicate
Short time rating	100 kV – 1000 mA	Same as predicate
Long time rating	100 kV – 38mA	Same as predicate
Collimator	F-100: Has 16 BH filters with irridation area of421 x 421 mm max. New collimator offersmore filtration options.	Same as predicate
US PerformanceStandard	21CFR1020.30, 21CFR1020.31 and21CFR2020.32	Same as predicate
IEC SafetyStandards	See list below	Same as predicate

6. Substantial Equivalence Chart: Below.

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1. 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: 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 Druq 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.
  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 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 +A2:2019 Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures FDA 12-329
Additionally evaluated in accordance with
. IEC 62366: 2007 + A1: 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 - Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
EN 62304:2006 Medical device software - Software life cycle processes
ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012 ●

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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.