Optional movable gantry base unit for use with an Aquilion PRIME system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).

Note: When installed with the movable gantry base unit, Aquilion PRIME can be used with the INFX-8000C system in the same room.

Device Description

The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion PRIME. This combination enables patient access and efficient workflow for interventional procedures. CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT is an optional kit intended to be used in conjunction with an Aquilion PRIME / INFX-8000C based IVR-CT system. The subject device is attached to the CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is selected, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, Toshiba INFX-8000C. The intended uses and technological characteristics of the Aquilion PRIME CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "CGBA-032A, Aquilion™ PRIME Self-Propelled Scan Base Kit for IVR-CT." This notification is for a modification of an existing device and primarily addresses the physical and functional aspects of the new base unit for a CT system, rather than evaluating an AI-powered diagnostic or predictive algorithm.

Therefore, many of the requested criteria, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable or not detailed in this type of submission. This submission focuses on engineering, safety, and functionality verification.

Here's an analysis based on the information available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria and reported device performance in terms of diagnostic accuracy or clinical outcomes. The "acceptance criteria" discussed are related to the device's functional performance, safety, and substantial equivalence to a predicate device. The performance reported relates to the successful verification and validation of these functional aspects.

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary of results)
Base movement speed functions as specified	Performed according to specifications
Scanogram functions as specified	Performed according to specifications
Axial/helical scan functions as specified	Performed according to specifications
Interlocks (e.g., contact detection) function as specified	Performed according to specifications
Complies with Quality System Regulations (21 CFR § 820)	Designed and manufactured under QSR and ISO 13485
Conforms to applicable IEC standards (e.g., IEC60601 series)	Device conforms to specified IEC standards
Complies with radiation safety performance standards (21 CFR §1010, §1020)	Device complies with applicable radiation safety standards
Software functionality as specified (Moderate Level of Concern)	Software validation successfully completed

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This submission does not involve clinical data or "test sets" in the context of diagnostic algorithm evaluation. The "testing" refers to non-clinical bench testing, verification, and validation of the hardware and software components. Therefore, information about sample size for test sets (e.g., number of patients/cases), data provenance, or retrospective/prospective studies is not relevant or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As this is a submission for a mechanical/electronic device modification and not a diagnostic algorithm, there is no "ground truth" to be established by clinical experts for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for the same reasons as above.

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. This device is an optional physical kit for a CT system, not an AI or diagnostic algorithm, so no MRMC study or AI-assistance evaluation was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hardware accessory (a self-propelled scan base kit), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" equivalent in this context would be the engineering specifications and safety standards against which the device's functional performance was verified.

8. The sample size for the training set

Not applicable. This document does not describe the development of a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there's no ground truth for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black and white, and the text is in a simple, sans-serif font.

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

January 12, 2015

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

Re: K143223

Trade/Device Name: CGBA-032A, Aquilion™ PRIME Self-Propelled Scan Base Kit for IVR-CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 12, 2014 Received: November 13, 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

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forth in the quality systems (OS) 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/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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510(k) Number (if known)

K143223

Device Name

CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT

Indications for Use (Describe)

Optional movable gantry base unit for use with an Aquilion PRIME system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).

Note: When installed with the movable gantry base unit, Aquilion PRIME can be used with the INFX-8000C system in the same room.

Type of Use (Select one or both, as applicable)

Y Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Toshiba. The word "TOSHIBA" is written in large, bold, red letters. Below the company name is the slogan "Leading Innovation" in black font, followed by three right-pointing arrows.

TOSHIBA AMERICA MEDICAL SYS

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

SUBMITTER'S NAME:

Toshiba America Medical Systems, Inc.

1. ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563

3. CONTACT PERSON:

Paul Biggins Director, Regulatory Affairs (714) 730-5000

1. Date Prepared: November 7th, 2014
- 1. TRADE NAME(S): CGBA-032A, Aquilion™ PRIME Self-Propelled Scan Base Kit for IVR-CT

6. COMMON NAME: Computed Tomography X-Ray System

1. DEVICE CLASSIFICATION: Class II 21 CFR 892.1750 - Computed Tomography X-Ray System
1. PRODUCT CODE / DESCRIPTION: JAK - System, X-Ray, Tomography, Computed
1. PERFORMANCE STANDARD: This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

10. PREDICATE DEVICES:

Product	Marketed by	510(k) Number	Clearance Date	RTA AcceptanceDate
Aquilion™ ONE Vision Self-Propelled Scan Base for IVR CT	Toshiba AmericaMedical Systems	K134025	September 5, 2014	N/A
Aquilion™ PRIME	Toshiba AmericaMedical Systems	K141741	N/A	July 11, 2014
Infinix™ INFX-8000C	Toshiba AmericaMedical Systems	K113052	November 22, 2011	N/A

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11. REASON FOR SUBMISSION:

Modification of a cleared device.

The purpose of this submission is to seek market clearance for CGBA-032A, Aquillion PRIME Self-Propelled Scan Base Kit for IVR-CT. This device is an optional kit intended to be used on an Aquilion PRIME / INFX-8000C based IVR-CT system. It is attached to the CT gantry to support longitudinal movement and allow image acquisition in the zdirection (Z-axis), both axial and helical. When this option is selected, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, Toshiba INFX-8000C. The Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT will be used as part of an Aquilion PRIME / INFX-8000C based IVR-CT system. Please note, the intended uses and technological characteristics of the Aquilion PRIME CT System and the INFX-8000C Interventional X-Ray System remains the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.

Please note: The terms "Self-Propelled Scan Base", "Moving Base" and "Movement Base" are used interchangeably throughout this submission. They all refer to the same unit.

12. DEVICE DESCRIPTION:

The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system. Aquilion PRIME. This combination enables patient access and efficient workflow for interventional procedures. CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT is an optional kit intended to be used in conjunction with an Aquilion PRIME / INFX-8000C based IVR-CT system. The subject device is attached to the CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is selected, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, Toshiba INFX-8000C. The intended uses and technological characteristics of the Aquilion PRIME CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.

13. INDICATIONS FOR USE:

Optional movable gantry base unit for use with an Aquilion PRIME system to support longitudinal movement and allow acquisition of images in the z-direction (Z-axis).

14. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to CGBA-033A, Aquilion ONE Movement Base Kit, which received premarket clearance under K134025, marketed by Toshiba America Medical Systems.

CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT, incorporates modifications to the cleared device in order for the self-propelled scan base unit to be connected to an Aquilion PRIME gantry. This allows the CT system to acquire images in the z-direction (Z-axis) when a fixed catheterization table is used for patient support instead of a dedicated CT patient couch. The indications for use, method of operation

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including the imaging chain, base software and manufacturing process of the CT and Interventional XR systems remain unchanged from the cleared devices.

A complete comparison table is included in this submission. See below for a brief summary of changes from CGBA-033A, Aquilion ONE Vision Self-Propelled Base Kit:

Item	CGBA-032A, Aquilion™PRIME Self-Propelled ScanBase Kit for IVR-CT	CGBA-033A, Aquilion™ONE Vision Self-PropelledScan Base Kit for IVR-CT	Comments
CT System	Aquilion™ PRIME	Aquilion™ ONE Vision	Changed
Gantry drive	Movement along rails laid onthe floor	Movement along rails laid onthe floor	Same
Cabling	Floor cabling	Roof cabling	Same
Couch	Fixed catheterization table(INFX-8000C System)	Fixed catheterization table(INFX-8000C System)	Same
Scan direction	IN/OUT directions	IN/OUT direction	Same
Direction ofScanogramacquisition	IN/OUT directions	IN/OUT directions	Same

The Aquilion PRIME (TSX-303A/A, 303A/B and 303A/F) received RTA Acceptance (K141741) as of July 11th, 2014. The changes made to the predicate device (K141741) include implementation of a new detector and optional software features which have been separately cleared under the 510(k) premarket notification process. CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT, is an optional kit intended to be used on an Aquilion PRIME / INFX-8000C based IVR-CT system.

15. SAFETY:

The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44. IEC60825-1. IEC62304. IEC62366. IEC 60825. NEMA PS 3.1-3.18. NEMA XR-25 and NEMA XR-26. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

16. NON-CLINICAL TESTS

This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that base movement speed, scanogram and axial/helical scan functions, and interlocks including contact detection, performed according to specifications.

Software Documentation for a Moderate Level of Concern, per the FDA quidance 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, testing of the modified system was conducted in accordance with the

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applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

17. CONCLUSION

The modifications incorporated into CGBA-032A, Aquilion™ PRIME Self-Propelled Scan Base Kit for IVR-CT, do not change the indications for use or the intended use of the previously cleared devices. Based upon bench testing, successful completion of software validation, and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.