(69 days)
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical)
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 image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blodd 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.
The Auklet is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "clice" of the body. As is common with today's CT Scanner, the Auklet has the capability to acquire volumetric (helical) data by initiating table movement during data acquisition. This data can be reconstructed per the operator's preference, to include three dimensional rendering of the patient data. This device incorporates a standard x-ray tube and xenon gas filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
This 510(k) submission for the Toshiba Auklet CT Scanner (TSX-003A) focuses on demonstrating substantial equivalence to a predicate device (Toshiba TSX-002A, Xvision [K941745]). As such, the submission primarily describes the device's technical characteristics and intended use, aligning with the predicate. It does not include a study with acceptance criteria and reported device performance in the way a clinical performance study would typically be presented for novel devices or highly complex algorithms.
Here's a breakdown of why this information isn't present in the provided text and what can be inferred:
Since this is a submission for a CT scanner, the "device performance" refers to the scanner's ability to produce images, and "acceptance criteria" relate to its safety and effectiveness, usually demonstrated through technical specifications and comparisons to a legally marketed predicate.
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail metrics in a table. For CT scanners, acceptance criteria would typically involve technical specifications like spatial resolution, contrast resolution, noise levels, dose output, scan times, image reconstruction speed, and safety features. These are usually established through national/international standards and regulatory guidance.
- Reported Device Performance: The document states, "This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition." This implies that its performance is equivalent to the predicate. The performance of the predicate device (Toshiba TSX-002A, Xvision [K941745]) would have been established through its own 510(k) clearance process, where it demonstrated its ability to produce clinically useful images.
2. Sample size used for the test set and data provenance:
- Not applicable in the context of this 510(k). This submission is for a medical imaging hardware device (CT scanner), not a diagnostic algorithm that analyzes medical images. Therefore, there isn't a "test set" of patient data in the typical sense for evaluating algorithm performance.
- Data Provenance: Not relevant here.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. No ground truth establishment related to interpreting images by experts is mentioned, as this is a hardware device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically performed for AI/CAD devices to assess how the AI impacts human reader performance. It is not relevant for a CT scanner hardware submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for a CT scanner's performance is its technical ability to acquire and reconstruct images that accurately represent the internal structures of the body, which is assessed through engineering tests and phantom studies, rather than clinical ground truth like pathology.
8. The sample size for the training set:
- Not applicable. This refers to a dataset used to train an algorithm. This is a hardware device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided 510(k) summary is for a CT scanner hardware device (Auklet CT Scanner, TSX-003A). The regulatory pathway for such a device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Toshiba TSX-002A, Xvision [K941745]) by showing similar technological characteristics and intended use. Therefore, the detailed methodologies for acceptance criteria and performance evaluation typically found in submissions for AI/CAD-driven diagnostic software are not present or applicable here.
The crucial information provided in this document is:
- Technological Characteristics are the same as the predicate.
- Intended Uses are the same as the predicate.
- The device incorporates standard technologies (slip ring, x-ray tube, xenon gas detector, microprocessor, hard disk storage).
These points are used to support the claim of substantial equivalence, which is the "study" in this context. The FDA's clearance letter confirms their agreement with this substantial equivalence, allowing the device to be marketed.
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K97 3908
DEG 22 1997
510(k) Summary
ﻤﺴﺴﺴ
| Date: | 20 August 1997 | |
|---|---|---|
| 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, Regulatory Affairs Specialist, (714)730-5000 | |
| Establishment RegistrationNumber: | 2020563 | |
| Device Proprietary Name: | Auklet CT Scanner, TSX-003A | |
| Common Name: | Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: 90JXD] | |
| Regulatory Class: | II (per 21 CFR 892.1750) | |
| Predicate Device: | Toshiba TSX-002A, Xvision [K941745] | |
| Reason For Submission | New Product |
Description of this Device:
The Auklet is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body. Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "clice" of the body. As is common with today's CT Scanner, the Auklet has the capability to acquire volumetric (helical) data by initiating table movement during data acquisition. This data can be reconstructed per the operator's preference, to include three dimensional rendering of the patient data. This device incorporates a standard x-ray tube and xenon gas filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry.
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 image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blodd 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:
11
This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these system 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. Both of these devices produce two dimensional, black and white image that can be filmed or electronically stored for future review.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard .... Rockville MD 20850
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068
Re:
DEC 2 2 1997 K973908 TSX-003A Auklet CT Scanner Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Biggins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the ise stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours
Wiliau Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
二
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical)
(PLEASE DO NOT WRITE BELOW THIS LINE , CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device, Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973908 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | -------------- | ---- | ---------------------- |
(Optional Format
(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.