(35 days)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head.
The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
The TSX-301Bis 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 is a 510(k) Pre-market Notification for the Toshiba TSX-301B Aquilion CT System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, the requested information, particularly regarding specific performance metrics, study designs, sample sizes, expert involvement, and ground truth establishment, is largely not available in this submission. This type of submission (a 510(k) for a modification to an existing CT system) typically does not include such rigorous clinical studies as it relies on the established safety and effectiveness of the predicate device.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Compliance with Quality System Regulations (21 CFR § 820) | "This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820." |
| Safety and Effectiveness: Compliance with Federal Diagnostic X-ray Equipment Standard (21 CFR § 1020.30 and 1020.33) | "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." |
| Safety and Effectiveness: Conformance with Medical Device Safety standards (IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44) | "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: Similar materials and processes to predicate device (TSX-301A/2 Aquilion ONE CT scanner) | "This device is similar in materials and processes to that of the predicate device, Toshiba TSX-301A/2 Aquilion ONE CT scanner." |
| Intended Use: Acquire and display cross-sectional volumes of the whole body, including the head | "This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head." |
| Intended Use: Capability to provide volume sets for specialized studies | "The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician." |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The submission focuses on demonstrating substantial equivalence through compliance with regulations and technical standards and comparison to a predicate device, not through a clinical performance study with a test set. There is no mention of a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not explicitly stated. As there's no mention of a test set requiring ground truth establishment by experts for clinical performance, this information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or associated adjudication method is described.
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 is for a CT system, not an AI-powered diagnostic aide. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This document describes a CT system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical ground truth is described as part of this 510(k) submission. The "ground truth" implicitly referred to is the established regulatory compliance and performance of the predicate device and the new device's adherence to relevant technical standards.
8. The sample size for the training set
- Not applicable. This submission does not describe a machine learning algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, this question is not relevant.
In summary: This 510(k) submission is for a modification to an existing CT system. The primary method of demonstrating acceptance criteria is by showing compliance with established regulations and safety standards, and by demonstrating substantial equivalence to a legally marketed predicate device. It does not involve a clinical study with a test set, training set, or expert-established ground truth in the way one would expect for a novel diagnostic device or AI application.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; TSX-301B Aquilion CT System
10083282
DEC 1 2 2008
510(k) Summary
| Date: | October 24, 2008 |
|---|---|
| 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-301BAquilion CT System |
| 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/2, Aquilion ONE CT System, K072606TSX-101A/h, /I Aquilion 32/64 SP CT System,K051833 |
| Reason For Submission | Modification to existing device |
Description of this Device:
The TSX-301Bis 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 indicated to acquire and display cross sectional volumes of the whole body, to include the head.
The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
510(k) Summary Statement. 1 of 2
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; TSX-301B Aquilion CT System
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 All requirements of the Federal Diagnostic Equipment outlined in 21 CFR § 820. 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/2 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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2008
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
Re: K083282
Trade/Device Name: TSX-301B; Aquilion CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 2, 2008 Received: December 3, 2008
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 udications 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 Amendmonto or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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 (ct. The general controls provisions of the Act include requirements for annual registation, its in of devices, good manufacturing practice, labeling, and prohibitions against misbrand instine adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your it invice 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.
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Page 2
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 Dan); 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 logally marketed predicate device results in a classification for your device and thus, permits wounderyice 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 mumber 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
forgel Mr. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ Ko33282
Device Name: 7 TSX-301B; Aquilion CT System
Indications for Use;
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head.
The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene
Page of
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K083282
§ 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.