(111 days)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
The TSX-301B is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
The provided text lacks specific details regarding acceptance criteria and a detailed study proving the device meets them. The submission primarily focuses on the device's substantial equivalence to a predicate device and its ability to reduce radiation exposure through an iterative reconstruction algorithm.
However, based on the information available, here's an attempt to answer the questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria (e.g., minimum spatial resolution, contrast-to-noise ratio). It broadly mentions "accepted image quality metrics" and "reduction of radiation exposure."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Image Quality (visual assessment) | "utilized phantoms and accepted image quality metrics." "modification allows for the use of an iterative reconstruction algorithm..." |
| Radiation Dose Reduction | "reduce radiation exposure to the patient." "provides the user the ability to perform scans at lower doses." |
| Functionality | Device continues to "acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation." Materials, hardware, method of operation, base software and manufacturing processes remain unchanged. |
| Safety | "designed and manufactured under the Quality System Regulations... in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard... will be met." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document states "The testing conducted on this device utilized phantoms." There is no mention of human subject data, and therefore no information on the sample size of a test set derived from human subjects.
- Data Provenance: Not applicable, as testing was conducted on phantoms.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as testing involved phantoms, not human data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable, as testing involved phantoms.
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 submission focuses on hardware and a reconstruction algorithm, not an AI-assisted diagnostic tool for human readers. There is no mention of a human-in-the-loop study or human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the testing described appears to be a standalone evaluation of the device and its iterative reconstruction algorithm using phantoms. The document states, "The testing conducted on this device utilized phantoms and accepted image quality metrics." The focus is on the technical performance of the device itself and its ability to achieve lower doses while maintaining image quality.
7. The Type of Ground Truth Used:
For the phantom testing, the ground truth would be the known physical properties and compositions of the phantoms themselves, along with established metrics for image quality (e.g., spatial resolution targets, contrast targets).
8. The Sample Size for the Training Set:
Not applicable. The document describes a modification to an existing CT scanner (TSX-301B Aquilion Premium) with the addition of an iterative reconstruction algorithm. This is not a description of a machine learning model that would require a "training set" in the conventional sense for a completely new AI algorithm. The iterative reconstruction algorithm itself might have been developed and "trained" on data internally by the manufacturer, but this information is not provided in the 510(k) summary.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as this information is not provided and the context suggests a traditional iterative reconstruction algorithm rather than a machine learning model with explicitly defined training and ground truth from external datasets.
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) TSX-301B Aquilion Premium w/4.74 Software
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): TSX-301B Aquilion Premium CT
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- COMMON NAME: System, X-ray, Computed, Tomography
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
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- PRODUCT CODE / DESCRIPTION: JAK - System, Computed Tomography
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
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- PREDICATE DEVICE: TSX-301B-K083282
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- REASON FOR SUBMISSION: Modification of a cleared device
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- DEVICE DESCRIPTION:
The TSX-301B is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
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13. SUMMARY OF INTENDED USES:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
14. SUBSTANTIAL EQUIVALENCE:
The modification to this device is to reduce radiation exposure to the patient. The modification allows for the use of an iterative reconstruction algorithm that provides the user the ability to perform scans at lower doses. The materials, hardware, method of operation, base software and manufacturing processes remain unchanged from the cleared device: TSX301B (K083282).
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 product report.
16. TESTING
The testing conducted on this device utilized phantoms and accepted image quality metrics. The results of this testing is included in the user information.
17. CONCLUSION
The additional features that are being added to the Aquilion Premium at this time do not change the indication for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to this modification.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
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. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
JUN 1 3 2012
Re: K120546
Trade/Device Name: TSX-301B, Aquilion Premium CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 15, 2012 Received: May 16, 2012
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 or 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 (QS) regulation (21 CFR Part 820). This letter requirences as 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/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 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,
Janine M. Morris
Acting 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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Indications for Use Form
| 510(k) Number (if known): | K120546 |
|---|---|
| Device Name: | TSX-301B, Aquilion Premium CT System |
Indications for Use:
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
hushid D'A
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120546
Page 1 of
§ 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.