This device is a digital radiography/fluoroscopy system use 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

This device in 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a modified medical device, the INFX-8000V with Wireless Footswitch. The submission is a "Special 510(k)", which typically implies minor modifications to a previously cleared device that do not raise new questions of safety or effectiveness. As such, the study conducted is primarily for verification testing to ensure the modification (addition of a wireless footswitch) does not negatively impact the device's performance compared to the predicate device.

Here's an analysis based on the information provided, specifically regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of acceptance criteria with specific numerical targets. Instead, it states that the performance of the modified device is "equal to or better than the predicate device." This is a common approach for Special 510(k) submissions where the focus is on maintaining equivalence rather than achieving new performance benchmarks.

Acceptance Criterion (Inferred)	Reported Device Performance
Performance of the modified device (INFX-8000V with wireless footswitch) compared to the predicate device.	"The performance of the modified device is equal to or better than the predicate device."
No change in Indications for Use or Intended Use due to the modification.	"The addition of the wireless footswitch does not change the indications for use or the intended use of the device."
Continued conformance with applicable safety and performance standards (e.g., IEC60601-1, IEC 60601-2-43, IEC 60601-2-28, 21 CFR §1020).	"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."
Safety and effectiveness verified via risk management and application of design controls.	"Safety and effectiveness have been verified via risk management and application of design controls to the modification."

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

The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing described is "verification testing," which for a modification like a wireless footswitch, would likely involve engineering tests, functional tests, and EMC/wireless compatibility tests rather than clinical studies with patient data.

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

This information is not provided in the document. Given the nature of the modification (a wireless footswitch for an X-ray system), the "ground truth" would likely relate to the functionality and safety of the footswitch (e.g., signal integrity, latency, safety interlocks) rather than diagnostic accuracy requiring expert image interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This type of method (e.g., 2+1, 3+1) is typically associated with studies involving human interpretation of medical images where disagreements among experts need to be resolved to establish a definitive ground truth. Such a process is not applicable to the verification testing of a wireless footswitch's functionality.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies compare the diagnostic performance of human readers, often with and without AI assistance, across a set of cases. This type of study is not relevant to the modification of adding a wireless footswitch to an X-ray system.

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

A standalone performance study was not done in the context of an AI algorithm. The device in question is an X-ray system with a wireless footswitch, not an AI diagnostic algorithm. The "standalone" performance here would refer to the functional performance of the footswitch itself (e.g., responsiveness, signal range, battery life), which would be part of the verification testing. However, the document doesn't detail these specific tests.

7. The Type of Ground Truth Used

For the purpose of verifying the wireless footswitch modification, the "ground truth" would likely be based on:

Engineering specifications and standards: Confirming the footswitch meets its design requirements.
Functional performance metrics: Demonstrating reliable operation, accurate signal transmission, and appropriate response times.
Safety standards conformance: Ensuring electrical safety, electromagnetic compatibility, and risk mitigation related to wireless communication.

The document does not explicitly state the "type of ground truth" using these terms but implies conformance to standards and verification through risk management.

8. The Sample Size for the Training Set

This concept is not applicable to this submission. "Training set" refers to data used to train machine learning models. The device being modified is an X-ray system, and there is no indication that any AI or machine learning component was introduced or significantly altered that would require a training set.

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

This question is not applicable as there is no mention of a training set or AI model development in this submission.

Summary

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

January 9, 2015

Toshiba Medical Systems Corporation % Mr. Paul Biggins U.S. Agent/Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K143225

Trade/Device Name: INFX-8000V with Wireless Footswitch Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: II Product Code: OWB, JAA Dated: December 9, 2014 Received: December 10, 2014

Dear Mr. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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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/Resourcesfor You/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 yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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) K143225

Device Name INFX-8000V with Wireless Footswitch

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 OF SAFETY AND EFFECTIVENESS

1. CLASSIFICATION and DEVICE NAME:

Classification Name:	Image Intensified Fluoroscopic X-ray System
Regulation Number:	21 CFR 892.1650 (Class II)
Product Code	OWB – Interventional Fluoroscopic X-ray SystemJAA – System, x-ray, fluoroscopic, image-intensified
Trade Proprietary Name:	Infinix
Model Number:	INFX-8000V, with wireless footswitch

2. ESTABLISHMENT REGISTRATION: 9614698

3. CONTACT PERSON, U.S. AGENT and ADDRESS:

Contact Person/U.S. Agent:

Paul Biggins Director, Regulatory Affairs (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com

Establishment Name and Address:

Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780

4. MANUFACTURING SITE

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

5. Date OF SUBMISSION:

November 12, 2014

6. PERFORMANCE STANDARD:

21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

7. PREDICATE DEVICE:

INFX-8000V,v5.30 (K133535)

8. REASON FOR SUBMISSION: Modification of a cleared device

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9. SUBMISSION TYPE:

Special 510(k)

10. DEVICE DESCRIPTION:

11. Indication 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.

12. SUMMARY OF CHANGE(S)

This device has been modified to use an interchangeable BlueTooth wireless footswitch. The introduction of this footswitch does not change any hardware or software requirements of the cleared device.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the INFX-8000V, v5.30 K133535, marketed by Toshiba America Medical Systems. The basic system 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.

14. 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.

15. CONCLUSION

Based upon the results of the verification testing the performance of the modified device is equal to or better than the predicate device. The addition of the wireless footswitch does not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modification. Toshiba concludes that it has demonstrated that the modified INFX-8000V is substantially equivalent to the previous version.

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.