(14 days)
CSTC-002A, Extended Field of View Software is a post processing software option for the TSX-201A CT system. This product increases the amount of image information from the Large 70 cm field of view (FOV) to a 85 cm field of view.
The CSTC-002A will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires software modifications to the existing device. Addition of this option will allow for visualization of the body and patient couch beyond the normal field of view.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It is a 510(k) summary for a software option (CSTC-002A, Extended Field of View Software Option) for a CT system.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a table of reported device performance. The entire submission focuses on establishing substantial equivalence to a predicate device (Siemens Extended Field of View; K032536) rather than demonstrating specific performance against predefined metrics.
The "Summary of Intended Uses" states: "CSTC is intended to display the body and patient table beyond the normal field of view. Images generated by this software are not to be used for diagnostic purposes. Standard distance measurements are allowed." This implies that the primary "performance" is the ability to display a wider field of view, but no quantitative measure of this display capability (e.g., image quality, distortion levels) is presented as an acceptance criterion or reported performance.
2. Sample Size Used for the Test Set and the Data Provenance:
No information regarding a "test set" in the context of clinical or performance data is provided. The submission focuses on software modifications and its similarity to a predicate device. Therefore, no sample size for a test set or data provenance (country of origin, retrospective/prospective) is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Since no test set with clinical data is described, there is no mention of experts, ground truth establishment, or their qualifications.
4. Adjudication Method:
No adjudication method is mentioned as there is no clinical or performance data requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or referenced. The submission does not discuss human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
While the device itself is a software option (an algorithm), a standalone performance study in the sense of demonstrating specific quantifiable metrics outside of integration with the CT system is not detailed. The focus is on its functional equivalence and safety within the existing CT system. The statement "Images generated by this software are not to be used for diagnostic purposes" significantly limits the scope of performance validation typically associated with diagnostic AI.
7. Type of Ground Truth Used:
No ground truth is mentioned, as no performance study or diagnostic claim is being made that would require it.
8. Sample Size for the Training Set:
No information about a training set is provided. The document outlines a modification to existing software and its similarity to a predicate device, not the development of a new algorithm based on machine learning from a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is discussed.
Summary of what the document does indicate regarding substantial equivalence:
The submission focuses on the technological characteristics and intended uses being similar to the predicate device.
- Technological Characteristics: "This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results."
- Safety and Effectiveness Concerns: The device is designed and manufactured under Quality System Regulations (21 CFR § 820) and conforms to applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44.
- Substantial Equivalence Argument: "This package provides similar tools to those found in the predicate device. This package does not provide new indications or functions when compared to those that are already available in products already being marketed."
Essentially, the "proof" the device meets acceptance criteria, in this context, is that it is substantially equivalent to a previously cleared device, performing a similar function (extended field of view display) for non-diagnostic purposes, while adhering to relevant safety and quality standards. Specific quantitative performance data and clinical studies are not presented because the device is a software option for display only, with no diagnostic claims.
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3rd party renew
NOV - 9 2006
510(k) Summary
| Date: | October 16, 2006 |
|---|---|
| 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 Specialist, |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | CSTC-002A, Extended Field of ViewSoftware Option |
| 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): | Siemens Extended Field of View; K032536 |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The CSTC-002A will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires software modifications to the existing device. Addition of this option will allow for visualization of the body and patient couch beyond the normal field of view.
Summary of Intended Uses:
CSTC is intended to display the body and patient table beyond the normal field of view. Images generated by this software are not to be used for diagnostic purposes. Standard distance measurements are allowed.
Technological Characteristics:
This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results.
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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 package provides similar tools to those found in the predicate device. This package does not provide new indications or functions when compared to those that are already available in products already being marketed.
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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
NOV - 9 2006
Re: K063241
Trade/Device Name: CSTC-002A, Extended Field of View Software Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 23, 2006 Received: October 26, 2006
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 has the letters "FDA" in the center, with the word "Centennial" underneath. Above the letters "FDA" are the numbers "1906-2006". There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualice of a becement.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a delerimiation that Journer Federal agencies. You must or any Federal Statutes and regulations admindents of the registration and listing (21 comply with all the Act s requirements, moraliantes, woulfacturing practice requirements as set a CFR Park 807); labeling (21 CFR Part 800); good will and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 1050 forth in the quality systems (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) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket nothcation. The IDA miding of bassification 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 device on 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" Also, please note the regulation childed, "Theoration on your responsibilities under (21CFR Part 607.97). Tod may other general the Free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlVindustry/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
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: CSTC-002A, Extended Field of View Software Option
Indications For Use:
CSTC-002A, Extended Field of View Software is a post processing software option for the TSX-201A CT system. This product increases the amount of image information from the Large 70 cm field of view (FOV) to a 85 cm field of vicw.
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 __
Nancy Chaplin
(Division 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.