(15 days)
This device is designed to produce cross-sectional images of a human body by reconstruction of xray 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 LB is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 32 axial slices per second using a selectable slice-thickness multi-row detector.
This document is a 510(k) Summary for the Toshiba Aquilion LB CT Scanner. It's a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, not a performance study report with explicit acceptance criteria and device performance table. Therefore, much of the requested information regarding specific acceptance criteria and detailed study results is not present in this document.
However, based on the document's content, here's what can be inferred or stated about the device and its regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The entire submission implies that the acceptance criterion is "substantial equivalence" to the predicate device (Aquilion MS-16 CT scanner, K022050) in terms of intended use, technological characteristics, and safety and effectiveness. This is achieved by demonstrating that the new device does not raise new questions of safety or effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, image resolution values) are reported in this summary. The document states that the device is "designed to produce cross-sectional images of a human body by reconstruction of xray transmission data... These images have been proven to be clinically useful..." without providing quantitative performance data for this specific device model.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred from Submission) |
|---|---|
| Substantially equivalent to predicate device (Aquilion MS-16 CT scanner, K022050) regarding: | The device employs the same technological characteristics as the predicate, differing only in subassembly component composition. |
| - Intended Use | The device employs no intended uses that are not in cleared devices already found in the marketplace. |
| - Technological Characteristics | Both systems use high-frequency x-ray controllers, detect x-ray transmission data with an x-ray detector, and reconstruct data with a computer to produce 2D/3D black and white images. |
| - Safety and Effectiveness | Designed and manufactured under Quality System Regulations (21 CFR § 820). Meets Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33) and conforms to applicable parts of IEC-60601 Medical Device Safety standards. No new safety or effectiveness concerns are raised. |
| Production of clinically useful cross-sectional images for specified indications for use (e.g., spine/head injuries, tumors, soft tissue lesions, abdominal/pelvic malignancies, etc.) | The device produces images proven to be clinically useful for the listed indications. (No specific performance data provided for this device model, relying on equivalence to predicate and general CT utility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided: This document describes a regulatory submission for substantial equivalence based on technological characteristics and compliance with standards, not a clinical performance study with a test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not Applicable / Not Provided: No test set or ground truth establishment by experts is described in this regulatory summary.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. This is a submission for a traditional CT scanner.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No. This document pertains to a physical CT scanner, not an algorithm, and does not describe standalone performance testing as typically understood for AI/software devices.
7. The Type of Ground Truth Used:
- Not Applicable / Not Provided: Ground truth, in the context of clinical performance studies, is not described in this regulatory submission. The "truth" being established is that the device is substantially equivalent to a predicate, not clinical accuracy against a "ground truth" diagnosis.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided: As this is an application for a CT scanner and not an AI/ML device, a "training set" in that context is not relevant or mentioned.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Not Provided: See point 8.
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Image /page/0/Picture/0 description: The image shows the text "K050458" written in a handwritten style. The text is oriented diagonally, sloping upwards from left to right. The characters are bold and slightly distorted, giving them a unique, informal appearance.
510(k) Summary
MAR 1 0 2005
| Date: | January |
|---|---|
| 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, Senior Manager Regulatory Affairs(714)730-5000 |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | TSX-201A, Aquilion LB CT 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: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | TSX-101A, Aquilion MS-16 [K022050] |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The Aquilion LB is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 32 axial slices per second using a selectable slice-thickness multi-row detector.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of xray 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.
Technological Characteristics:
This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these systems employ the use of
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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 two-dimensional and three-dimensional, black and white 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, 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 Aquilion LB CT scanner is substantially equivalent to the predicate Aquilion MS-16 CT scanner [K022050].
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Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is composed of three curved lines that suggest wings and a body. The logo is encircled by text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES' in a circular arrangement around the bird. The text is in all capital letters and is smaller than the central bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2005
Toshiba America Medical Systems, Inc. c/o Mr. Mark Job Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K050458
Trade/Device Name: Aquilion LB CT Scanner TSX-201A Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 18, 2005 Received: February 23, 2005
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.
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) I his letter will anow you to begin manxeting of substantial equivalence of your device to a legally premarket nothleation. "The I Dri munity of bactuation 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 If you desire specific advice for your cerros on our of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation emilited, formation on your responsibilities under the Act from the 807.97). You may obtain other general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hodgdon
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 l of l
KUS 0458 510(k) Number (if known):
Aquilion LB CT Scanner TSX-201A Device Name:
Indications for Use:
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
David G. Leppmann
(Division Sign-Off) (Division Sign-Coluctive, Abdominal, 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.