(73 days)
Optional movable gantry base unit for use with the Aquilion LB CT Scanner to support the longitudinal movement and allow the acquisition of images in the z-direction (Z-axis).
This device is an optional kit that is attached to the gantry to provide z-axis image acquisitions, both axial and helical. When this option is selected the standard CT patient couch is replaced with a multipurpose patient handling system.
Here's an analysis of the provided text regarding the Toshiba Aquilion LB Movement Base Kit:
Acceptance Criteria and Device Performance Study for Toshiba Aquilion LB Movement Base Kit, CGBA-014B
Based on the provided K111633 submission, the Aquilion LB Movement Base Kit is a modification of a previously cleared device (TSX-201A, Aquillion LB CT Scanner (K050458)). As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo performance study with specific acceptance criteria as one might find for an entirely new algorithm or diagnostic device.
The core of this submission is that the modification (addition of an optional gantry moving base) does not affect the previously cleared indication for use or the safety and effectiveness of the underlying CT scanner. Therefore, the acceptance criteria implicitly align with maintaining the performance characteristics of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain the intended use of the Aquilion LB CT Scanner: The device must enable "scanning (including helical scanning) and scanoscopy... without patient couch movement." | "When this device is installed, scanning (including helical scanning) and scanoscopy can be performed without patient couch movement." |
| Maintain the safety of the Aquilion LB CT Scanner: The modification must not introduce new safety hazards or compromise existing safety standards. | "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 and its collateral standards. 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 an initial report." |
| Maintain substantial equivalence to the predicate device (Aquilion LB CT Scanner, K050458): The modification must not alter the fundamental technological characteristics or performance of the CT system in a way that raises new questions of safety or effectiveness. | "The Aquilion LB Movement Base Kit is an option that will be offered to customers that require this type of device. The change adds an optional gantry moving base and allows the removal of a dedicated CT Patient Couch. These changes do not affect the previously cleared indication for use for the Toshiba Aquilion LB CT Scanner (TSX-201A). Both devices are considered substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not detail a "test set" in the context of a clinical performance study with patient data. This is a technical modification rather than an imaging algorithm or diagnostic test. The evaluation for this 510(k) likely involved:
- Engineering bench testing and verification: To confirm mechanical functionality, electrical safety, and movement specifications.
- Compliance testing: Against relevant safety and performance standards (e.g., IEC60601-1, 21 CFR §1020).
- Comparison to the predicate device's established performance: Confirming that the addition of the movement base does not degrade image quality or other critical performance parameters of the CT scanner itself.
Therefore, there is no explicit sample size for a test set of patient data mentioned, nor is there information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a technical modification to a CT scanner base, rather than a diagnostic algorithm assessing medical images, there would not be a "ground truth" derived from expert review of patient cases in the traditional sense. The "ground truth" for this device would be its mechanical and electrical performance meeting engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is designed to evaluate the impact of a diagnostic device (often an AI algorithm) on human reader performance. This submission is for a mechanical/electrical modification to a CT scanner, not a diagnostic algorithm.
6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is hardware (a gantry movement base), not a standalone algorithm. Its "performance" is integrated into the overall CT system functionality.
7. The Type of Ground Truth Used
The "ground truth" for this device's approval is based on:
- Engineering specifications and measurements: Verifying the mechanical movement, stability, and electrical compatibility of the new base.
- Regulatory compliance: Demonstrating adherence to electrical safety standards (e.g., IEC60601-1) and radiation standards (21 CFR §1020).
- Substantial equivalence: The fundamental premise that the modification does not alter the established safety and effectiveness of the predicate CT scanner.
8. The Sample Size for the Training Set
Not applicable. This is a hardware modification, not an AI algorithm, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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Toshiba America Medical Systems, Inc Pre-Market Notification 510(k) Aquilion LB Movement Base Kit, CGBA-014B
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
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- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
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- ESTABLISHMENT REGISTRATION: 2020563
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- CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- TRADE NAME(S): Aquilion LB Movement Base Kit, CGBA-014B
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- COMMON NAME: Scanner, Computed Tomography, X-ray
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
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- PRODUCT CODE / DESCRIPTION: JAK - Computed tomography X-ray system
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
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- PREDICATE DEVICE: TSX-201A, Aquillion LB CT Scanner (K050458)
11. REASON FOR SUBMISSION:
Modification of a cleared device
12. DEVICE DESCRIPTION:
This device is an optional kit that is attached to the gantry to provide z-axis image acquisitions, both axial and helical. When this option is selected the standard CT patient couch is replaced with a multipurpose patient handling system.
Page 1 of 2
AUG 25 2011
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13. SUMMARY OF INTENDED USES:
When this device is installed, scanning (including helical scanning) and scanoscopy can be performed without patient couch movement.
14. SUBSTANTIAL EQUIVALENCE:
The Aquilion LB Movement Base Kit is an option that will be offered to customers that require this type of device. The change adds an optional gantry moving base and allows the removal of a dedicated CT Patient Couch. These changes do not affect the previously cleared indication for use for the Toshiba Aquilion LB CT Scanner (TSX-201A). Both devices are considered substantially equivalent.
15. 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 and its collateral standards. 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 an initial report.
16. CONCLUSION
The Aquilion LB Movement Base Kit (CGBA-014B) complies with the same or equivalent standards and has the same intended use as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of an eagle with three tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation, Japan % Mr. Raul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
AUG 2 5 2011
Re: K111633
Trade/Device Name: Aquilion LB Movement Base Kit, CGBA-014B Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 10, 2011 Received: June 13, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Toshiba America Medical Systems, Inc.
Aquilion LB Movement Notification 510(k)
Aquilion LB Movement Base Kit, CGBA-014B
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known): | K111633 |
|---|---|
| Device Name: | Aquilion LB Movement Base Kit, CGBA-014B |
| Indications for Use: |
|---|
| ---------------------- |
Optional movable gantry base unit for use with the Aquilion LB CT Scanner to support the longitudinal movement and allow the acquisition of images in the z-direction (Z-axis).
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|---|---|---|---|
| ---------------------------------------------- | ---------- | -------- | --------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) Number | K111633 |
|---|---|
| --------------- | --------- |
| Page 1 of ______ | |
|---|---|
| -- | ------------------ |
indication for Use Page 1 of 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
§ 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.