(15 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 ONE has the capability to provide volume sets of the entire organ. These volume sets can then be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
The TSX-301A/2 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.
This 510(k) premarket notification for the Toshiba Aquilion ONE TSX-301A/2 CT System does not contain the information needed to answer your request about acceptance criteria and a study proving device performance.
Here's why and what information is missing:
This submission is a "modification to existing device" and focuses on demonstrating substantial equivalence to a predicate device (TSX-301A Aquilion ONE CT System). The document covers:
- Device Description and Intended Use: Clarifies what the device is and what it's used for (whole body CT, volume data acquisition, dynamic and perfusion studies).
- Technological Characteristics, Safety & Effectiveness Concerns: States that the device uses similar materials/processes as the predicate, produces ionizing radiation, and complies with quality system regulations and applicable standards (21 CFR § 820, 21 CFR § 1020.30 and 1020.33, IEC 60601 series).
- Substantial Equivalence: Asserts similarity to the predicate device.
- FDA Clearance Letter: Confirms the FDA's review and determination of substantial equivalence.
- Indications for Use: Specifies the clinical applications (acquiring and displaying cross-sectional volumes of the whole body, including whole organs).
Missing Information (and why it's typically not in a 510(k) for this type of device/submission):
Consumer-facing acceptance criteria and detailed clinical performance studies proving specific image quality or diagnostic accuracy are generally not included in a 510(k) submission for a CT scanner, especially for a modification or an upgrade of an existing, already-cleared technology.
For general purpose X-ray CT systems, the "acceptance criteria" are primarily related to:
- Compliance with Federal Diagnostic X-ray Equipment Standards: This refers to technical performance standards related to radiation safety, dose, image uniformity, spatial resolution, contrast resolution, noise, etc., which are typically verified through engineering tests and phantom studies, not human clinical studies demonstrating diagnostic accuracy. The document explicitly states compliance with 21 CFR 1020.30 and 1020.33.
- Safety Standards: Compliance with electrical safety and other relevant IEC standards (IEC 60601 series) is also mentioned.
- Substantial Equivalence: The primary clinical "proof" in a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often relies on similarity in design, materials, and intended use, along with non-clinical performance data (e.g., phantom studies) if there are minor changes.
Therefore, I cannot provide the requested table and study details because the provided 510(k) summary does not contain performance metrics, clinical study design, or results related to human diagnostic efficacy or specific "acceptance criteria" in the way you've framed them (e.g., sensitivity, specificity, reader improvement).
To directly answer your numbered points based on the absence of this information in the document:
- A table of acceptance criteria and the reported device performance: Not provided. The document states compliance with general regulatory and safety standards, but no specific performance metrics like sensitivity/specificity or other diagnostic efficacy criteria are listed or reported from a clinical study.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is mentioned as part of this submission for demonstrating performance beyond technical compliance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is mentioned.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware CT scanner, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This is a hardware CT scanner, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; Aquilion ONE TSX-301A/2
510(k) Summary
| OCT 2` 2007 | ||
|---|---|---|
| Date: | September 12, 2007 | |
| 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: | Paul Biggins, Director Regulatory Affairs(714)730-5000 | |
| Establishment RegistrationNumber: | 2020563 | |
| Device Proprietary Name: | TSX-301A/1, Aquilion ONE CT System, K063189TSX-101A/h, /I Aquilion 32/64 SP CT System,K051833 | |
| 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: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | TSX-301A Aquilion ONECT System | |
| Reason For Submission | Modification to existing device |
Description of this Device:
The TSX-301A/2 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.
Summary of Intended Uses:
This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; Aquilion ONE TSX-301A/2
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate cross sectional images of the anatomy.
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, that 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 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-44. - Medical Device Safety standards.
Substantial Equivalence:
This device is similar in materials and processes to that of the predicate device, Toshiba TSX-301A Aquilion ONE CT scanner.
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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 is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
2007
Re: K072606
Trade/Device Name: TSX-301A/2, Aquilion ONE CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 14, 2007 Received: September 17, 2007
Dear Mr. Job:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a large, bold font. Below the letters, the word "Centennial" is written in a smaller font. Three stars are located at the bottom of the logo.
Proscions and Promoting Public Statte
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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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for TSX-301A/2 Aquilion ONE CT System
Indications for Use
510{k) Number (if known):
Device Name: TSX-301A/2, Aquilion ONE 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 ONE has the capability to provide volume sets of the entire organ. These volume sets can then be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Tomu M. Whing
fon Sign-Off) Division of Reproductive, AbdomInal and Radiological Devices 510(k) Number
§ 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.