(13 days)
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The Aquilion Super 4 CT Scanner is similar to the Aquilion Multislice CT scanner. The major difference between the two devices is a change of hardware in the computational subsystem and an improved patient couch. This device uses the same software and scanning hardware as the predicate device.
The provided text is a 510(k) Summary for the Aquilion Super 4 CT System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device meets specific performance acceptance criteria through clinical studies in the way modern AI/ML device submissions typically do.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, and ground truth establishment cannot be found in this document because they are not typically required or included in a 510(k) for a modified conventional medical device like a CT scanner from 2003.
Here's an attempt to answer based only on the provided text, indicating where information is not available:
Acceptance Criteria and Study for Aquilion Super 4 CT System (TSX-101A/7)
This document is a 510(k) submission for the Aquilion Super 4 CT System, which seeks to demonstrate substantial equivalence to a predicate device (TSX-101A Aquilion CT w/ CGS-22A). As such, it focuses on comparing the new device's technological characteristics and intended uses to the predicate, rather than establishing new performance acceptance criteria through a clinical study. Performance is implicitly accepted if it is "substantially equivalent" to the already-cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as implied by Substantial Equivalence) |
|---|---|
| Same intended uses as predicate device. | "This device employs no intended uses that are not in cleared devices already found in the marketplace." |
| Same technological characteristics as predicate device. | "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly composition." |
| Design and manufacture under Quality System Regulations (21 CFR § 820). | "This device is designed and manufactured under the Quality System Regulations..." |
| Conformance with Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33). | "...All requirements of the Federal Diagnostic Equipment Standard... will be met..." |
| Conformance with applicable parts of IEC-60601 - Medical Device Safety standards. | "...this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards." |
| No explicit quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are stated as the device is not an AI/ML diagnostic tool. | No explicit quantitative performance metrics are provided, as the submission relies on substantial equivalence to a predicate CT scanner. |
2. Sample size used for the test set and data provenance
- Not Applicable / Not Provided. This submission is for a conventional CT scanner, not an AI/ML diagnostic device requiring a specific test set of images with established ground truth for performance evaluation. The substantial equivalence argument relies on comparing hardware and intended use.
3. Number of experts used to establish the ground truth for the test set and qualification of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts for a test set is not relevant for this type of conventional CT scanner submission.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods are not relevant for this type of conventional CT scanner submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/ML diagnostic devices to assess their impact on human reader performance, which is not applicable to a conventional CT scanner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Not Applicable / Not Done. This device is a CT scanner, not an AI algorithm evaluated for standalone performance. Its function is to produce images for human interpretation.
7. The type of ground truth used
- Not Applicable / Not Provided. Ground truth (e.g., pathology, outcomes data) is not established for the performance evaluation of this conventional CT scanner in the context of this 510(k) submission. The device's "ground truth" implicitly relies on the proven clinical utility of CT imaging for diagnosis, which has been established through decades of medical practice and research preceding this submission.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is a CT scanner, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As noted above, this is not an AI/ML device, so there is no training set or ground truth for it.
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510(k) Summary
| Date: | April 8, 2003MAY 22 2003 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 |
| Submitter's Contact:(714) 730-5000 | Paul Biggins, Regulatory Affairs Manager, |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | TSX-101A/7, Aquilion Super 4 MultisliceCT Scanner |
| Common Name: | Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code:90JAK] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard:Standard | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment |
| Predicate Device(s):Multislice kit | TSX-101A Aquilion CT w/ CGS-22A |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The Aquilion Super 4 CT Scanner is similar to the Aquilion Multislice CT scanner. The major difference between the two devices is a change of hardware in the computational subsystem and an improved patient couch. This device uses the same software and scanning hardware as the predicate device.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
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Technological Characteristics:
This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. This device produces digital images that can be filmed or electronically stored for future review.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, which apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.
Substantial Equivalence:
Based upon the above considerations TAMS believes that the Aquilion Super 4 CT System is substantially equivalent to the TSX-101A, Aquilion CT scanner. The major difference is a change in the configuration of the computational subsystem.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ----
MAY 22 2003
Toshiba America Medical Systems, Inc. c/o Ms. Laura Danielson Responsible Third Party Official TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K031469
Trade/Device Name: Aquilion Super 4 CT Systems, TSX-101A/7 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: May 8, 2003 Received: May 9, 2003
Dear Ms. Danielson:
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 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); 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Aquilion Super 4 CT System; TSX-101 A/7 Device Name: Indications for Use:
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
Daniel A. Lyons
(Division Sign-Off Division of Reproductive, Ab and Radiological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.