This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Device Description

INFX-8000V, V6.40, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table. This system offers an optional hybrid (aSi/CMOS) 12 inch flat panel detector (TFP-1200C) to provide high definition (HD) imaging.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Toshiba Medical Systems Corporation's INFX-8000V, V6.40, an image-intensified fluoroscopic X-ray system. The submission aims to demonstrate substantial equivalence to a predicate device (INFX-8000V, V6.35, K162614).

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical quantitative clinical trial sense with specific metrics for disease detection or diagnostic accuracy (e.g., sensitivity, specificity). Instead, the acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to a cleared predicate device. This is achieved by proving that the modified device's performance is equal to or better than the predicate device, especially regarding imaging performance, and that the changes do not introduce new safety issues or alter the intended use.

The reported device performance presented focuses on technical and physical characteristics, rather than diagnostic efficacy with human-in-the-loop studies.

Here's a table summarizing the implicit acceptance criteria based on the information provided and the reported device performance:

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance
Safety	Compliance with IEC 60601-1 and collateral standards	Conforms to applicable parts of IEC60601-1, -2-28, -2-43.
	Compliance with Federal Diagnostic X-ray Equipment Standard	Conforms to 21 CFR Subchapter J. Radiation output does not exceed 88mGy/min.
	Risk Mitigation	All known risks mitigated to an acceptable level via design controls.
Imaging Performance Equivalence/Improvement	Spatial Resolution	Equivalent or improved compared to predicate.
	Low Contrast Resolution	Equivalent or improved compared to predicate.
	Dynamic Range	Equivalent or improved compared to predicate.
	Artifacts	Equivalent or improved compared to predicate.
	Contrast	Equivalent or improved compared to predicate.
Functionality	Live Zoom in HD Mode (with TFP-1200C)	Not allowed in HD mode; requires FOV of 6" or greater.
	Dose Tracking (with TFP-1200C)	Toshiba XDIF-DTS802 Dose Tracking System incorporated.
Substantial Equivalence	No new indications for use	Confirmed: Indications for Use remain the same.
	No new intended use	Confirmed: Intended Use remains the same.
	Basic system configuration unchanged	Confirmed.
	Method of operation unchanged	Confirmed.
	Base software unchanged	Confirmed (minor software changes to support hardware are acknowledged).
	Manufacturing process unchanged	Confirmed.

Study Information:

Sample sizes used for the test set and the data provenance:
- The document describes "Bench Testing" conducted to compare the modified system to the predicate device. However, it does not specify the sample size for this test set (e.g., number ofphantoms, or measurements taken).
- The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. It's implied to be internal testing conducted by Toshiba Medical Systems Corporation, likely in Japan (given TMSC's location). This type of testing is generally prospective in nature for a 510(k) submission, where new measurements are taken with the modified device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission focuses on technical and physical performance metrics (spatial resolution, contrast, etc.) rather than diagnostic accuracy involving human interpretation. Therefore, there is no mention of experts being used to establish a "ground truth" for interpretations of images from the test set. The ground truth for technical performance would be established by physical measurements and engineering specifications, not expert consensus on clinical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned as the testing performed was bench testing on physical and technical performance, not human-in-the-loop diagnostic accuracy studies.
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:
- No MRMC comparative effectiveness study was performed or is mentioned. This device is an X-ray system, not an AI-powered diagnostic tool. The submission is for a hardware modification (new detector) and supporting software updates to an existing X-ray system. Therefore, it does not involve AI assistance for human readers in the diagnostic process.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is a physical imaging system, not a software algorithm that performs diagnostic analysis. The "bench testing" evaluated the system's inherent imaging capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the tests performed was based on objective physical measurements and engineering specifications for parameters like spatial resolution, low contrast resolution, dynamic range, artifacts, and contrast. It was not based on expert clinical consensus, pathology, or outcomes data, as those are typically relevant for diagnostic accuracy claims.
The sample size for the training set:
- This submission describes a modification to an existing X-ray imaging system. There is no mention of a "training set" in the context of machine learning or AI. The system's operation is based on known physics and engineering principles, not a learned algorithm from a training dataset.
How the ground truth for the training set was established:
- As there is no training set for a machine learning algorithm, this question is not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

June 16, 2017

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation % Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, California 92780

Re: K170909

Trade/Device Name: INFX-8000V, V6.40 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: March 24, 2017 Received: March 28, 2017

Dear Paul Biggins:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael D. O'Hara
For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170909

Device Name INFX-8000V, Version 6.4

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92

1. CLASSIFICATION and DEVICE NAME

Classification Name	Solid State X-ray System, Interventional
Regulation Number	21 CFR 892.1650 (Class II)
Product Code	OWB - Interventional Fluoroscopic X-ray System
Trade Proprietary Name	Infinix
Model Number	INFX-8000V, V6.40

2. SUBMITTER'S NAME

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

3. OFFICIAL CORRESPONDENT

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

4. CONTACT PERSON, U.S. AGENT and ADDRESS

Paul Biggins Director Regulatory Affairs 2441 Michelle Drive Tustin, CA 92780 P. (714) 669-7808 F. (714) 730-1310 pbiggins@tams.com

5. MANUFACTURING SITE

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

6. ESTABLISHMENT REGISTRATION 9614698

1. DATE PREPARED March 24, 2017
1. DEVICE NAME INFX-8000V, V6.40
1. TRADE NAME

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INFX-8000V, V6.40

10. CLASSIFICATION NAME

Interventional Fluoroscopic X-ray System

1. CLASSIFICATION PANEL
  Radiology
1. DEVICE CLASSIFICATION
  Class II (per 21 CFR 892.1650)

13. PRODUCT CODE / DESCRIPTION

Product Code: OWB – Interventional Fluoroscopic X-ray System

14. PERFORMANCE STANDARD

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].

15. PREDICATE DEVICE

INFX-8000V, V6.35 (K162614)

Product	Marketed by	510(k) Number	Clearance Date
INFX-8000V, V6.35	Toshiba America Medical Systems	K162614	October 17, 2016

16. REASON FOR SUBMISSION

Modification of a cleared device

17. SUBMISSION TYPE

Traditional

18. DEVICE DESCRIPTION

19. INDICATIONS FOR USE

This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

20. SUMMARY OF CHANGE(S)

This notification is being submitted to inform the Food and Drug Administration of Toshiba Medical System intent to market a new image receptor, TFP-1200C. This notification contains the required information for the hardware change (primary) and the software changes required to support this change in hardware (secondary)

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21. SAFETY

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards, its collateral standards and particular standards; IEC 60601-2-43 and IEC60601-2-28. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.

LIST OF APPLICABLE STANDARDS

. IEC60601-1:2005
. IEC60601-1-2:2007
. IEC60602-1-3: 2008
IEC60601-1-6: 2010
. IEC60601-2-28: 2010
IEC60601-2-43:2010
. IEC62304:2006
. IEC62366:2007

Testing of this device demonstrated that the radiation output does not exceed the normal mode of operation limit of 88mGy/min as described in the Federal Standard. In order to reduce the risk of unnecessary radiation exposure when the system is configured with TP-1200C High Definition Detector the Toshiba XDIF-DTS802 Dose Tracking System is incorporated in the configuration. Additionally, Live Zoom is not allowed in HD mode and requires an FOV of 6" or greater.

22. TESTING

This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems. Additional testing is provided per FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Systems." Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.

Bench Testing was conducted to determine that equivalent or improved imaging performance resulted when compared to the predicate device. This testing included spatial resolution, low contrast resolution, dynamic range, artifacts and contrast. The results of this testing provided evidence that the modification to the predicate device did result in equivalent or improved performance when compared to the predicate.

23. SUBSTANTIAL EQUIVALENCE

This device is substantially equivalent to the INFX-8000V, V6.35, (K162614), marketed by Toshiba America Medical Systems. INFX-8000V, V6.40, includes a new Solid State Image receptor that is a continuum of previously introduced devices of this nature. The basic system

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configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. There are no new indications for use or intended use of the device.

24. CONCLUSION

The subject device is substantially equivalent to the INFX-8000V, V6.35, which was cleared via Pre-Market Notification 510(k), K162614. The INFX-8000V, V6.40, incorporates modifications to the cleared device which include a new solid state imaging receptor and software modifications required to support the hardware. The changes to this device do not alter the indications for use or the intended uses associated with the previously cleared device, as described in the labeling. It is the contention of Toshiba that all new safety issues have been addressed in the design of this change and that adequate evidence of this is presented with this submission.

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.