(249 days)
No
The description focuses on the mechanical function of a movable gantry base for a CT system and does not mention any AI or ML capabilities.
No
The device is described as an optional kit that supports longitudinal movement and image acquisition in the z-direction for a CT system, indicating it is an accessory for diagnostic imaging, not a therapeutic device.
No
This device is an optional accessory for a CT system, designed to facilitate movement for image acquisition in the z-direction. It supports the imaging process but does not directly diagnose.
No
The device description explicitly states it is a "Self-Propelled Scan Base Kit" which is attached to a CT gantry to support longitudinal movement. This describes a physical hardware component, not software. The performance studies also detail bench testing and verification/validation of physical functions like movement speed and interlocks.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an "optional movable gantry base unit" for a CT system. Its purpose is to facilitate the physical movement of the CT gantry to acquire images in the z-direction.
- Lack of Biological Sample Testing: There is no mention of this device interacting with or analyzing biological samples. Its function is purely related to the physical operation and imaging capabilities of the CT system.
The device is a component that enhances the functionality of a medical imaging system (CT), which is used for diagnostic purposes, but it does not perform in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
Optional movable gantry base unit for use with an Aquilion ONE (TSX-301C) 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 ONE can be used with the INFX-8000C system in the same room.
Product codes
JAK
Device Description
The Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A is an optional kit intended to be used in conjunction with an Aquilion ONE Vision / 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 ONE Vision CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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, testing of the modified system was conducted in accordance with the applicable standards published by the International Clectrotechnical Commission (IEC) for Medical Devices and CT Systems.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of waving lines, possibly representing health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5. 2014
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K134025
Trade/Device Name: Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 29, 2014 Received: July 30, 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.
1
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.
FDA
for
Janine M. Morris 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)
Device Name
Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A
Indications for Use (Describe)
Optional movable qantry base unit for use with an Aquilion ONE (TSX-301C) system to support longitudinal movement and allow acquisition of images in the z-direction (Z-axis).
Note: When installed with the movable qantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.
Type of Use (Select one or both, as applicable)
7 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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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
-
- ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
-
- CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
-
- Date Prepared: January 21, 2014
-
- TRADE NAME(S): Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A
-
- COMMON NAME: System, X-ray, Computed Tomography
-
- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
-
- PRODUCT CODE / DESCRIPTION: JAK - System, Computed Tomography
10. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
11. PREDICATE DEVICES:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aquilion LB | |||
| Movement Base Kit | Toshiba America | ||
| Medical Systems | K111633 | August 25, 2011 | |
| Aquilion ONE Vision, | |||
| TSX-301C/1, v4.90 | Toshiba America | ||
| Medical Systems | K122109 | September 21, 2012 | |
| INFX-8000C | Toshiba America | ||
| Medical Systems | K113052 | November 22, 2011 |
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12. REASON FOR SUBMISSION:
Modification of a cleared device
13. DEVICE DESCRIPTION:
The Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A is an optional kit intended to be used in conjunction with an Aquilion ONE Vision / 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 ONE Vision CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.
14. INDICATIONS FOR USE:
Optional movable gantry base unit for use with an Aquilion ONE (TSX-301C) 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 ONE can be used with the INFX-8000C system in the same room.
15. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aquilion LB Movement Base Kit. CGBA-014A. which received premarket clearance under K111633, marketed by Toshiba America Medical Systems.
The Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A,
incorporates modifications to the cleared device in order for the self-propelled scan base unit to be connected to an Aquilion ONE Vision 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. Additional modifications allow scanning in the IN and OUT directions rather than just in the OUT direction. The indications for use, method of operation including the imaging chain, base software and manufacturing process of the CT and Interventional XR systems remain unchanged from the cleared devices.
| Item | Aquilion ONE Vision Self-
Propelled Scan Base Kit for
IVR-CT, CGBA-033A | Aquilion LB Movement
Base Kit, CGBA-014A | Comments |
|------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------|----------|
| CT System | Aquilion ONE Vision | Aquilion LB | Changed |
| Gantry drive | Movement along rails laid on
the floor | Movement along rails laid on
the floor | Same |
| Cabling | Floor cabling | Roof cabling | Changed |
| Couch | Fixed catheterization table
(INFX-8000C System) | Dedicated couches | Changed |
| Scan direction | IN/OUT directions | OUT direction only | Changed |
| Direction of
Scanogram
acquisition | IN/OUT directions | OUT direction only | Changed |
A complete comparison table is included in this submission. See below for a brief summary of changes from Aquilion LB Movement Base Kit, CGBA-014A:
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16. 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, IEC60601-1-8, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18 and NEMA XR-25. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
17. 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 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, testing of the modified system was conducted in accordance with the applicable standards published by the International Clectrotechnical Commission (IEC) for Medical Devices and CT Systems.
18. CONCLUSION
The modifications incorporated into the Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT. CGBA-033A, 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.