(14 days)
CVV-001A, Vessel View Software is a post processing software option for the TSX-101A CT system. This product can be used for the analysis of CT angiography images. It provides display and measurement tools that can aid trained physicians for visualizing and assessing various blood vessels.
The CVV-001A will be added to the previously cleared TSX-101A Aquilion CT system. This addition requires software modifications to the existing device. Addition of this option will provide trained physicians with visualization and measurements tools for assessing blood vessels.
Here's an analysis of the provided 510(k) summary for the CVV-001A Vessel View Software, focusing on acceptance criteria and study details.
Important Note: The provided 510(k) summary (K063184) for the "CVV-001A, Vessel View Software" is very brief and primarily focuses on the device description, intended use, and substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria or the studies conducted to prove device performance against those criteria.
510(k) summaries often serve as a high-level overview. For detailed performance and validation data, one would typically need to review the full 510(k) submission, which is not publicly available in its entirety in this format.
Based on the limited information provided, I will construct the answers as best as possible, indicating when information is "Not Provided in the Document".
Acceptance Criteria and Reported Device Performance
Given the nature of the device (software providing visualization and measurement tools for blood vessels) and the predicate (GE CardIQ Analysis II), the acceptance criteria would likely revolve around accuracy of measurements, clarity of visualization, and equivalence to manual methods or predicate device performance. However, these are not explicitly stated in the provided document.
| Acceptance Criterion (Hypothesized) | Reported Device Performance (Not provided, would need specific study results) |
|---|---|
| Accuracy of Vessel Measurements | Not Provided in the Document |
| Visualization Quality | Not Provided in the Document |
| Equivalence to Predicate Device | Substantially Equivalent in uses and applications to GE CardIQ Analysis II |
| Performance within specified ranges | Not Provided in the Document |
Study Details
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Provided in the Document.
- Data Provenance: Not Provided in the Document (e.g., country of origin, retrospective/prospective). While "Toshiba America Medical Systems, Inc." is the submitter, the origin of clinical data is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not Provided in the Document.
- Qualifications of Experts: Not Provided in the Document.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Provided in the Document.
4. 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
- MRMC Study: It is highly unlikely that a typical MRMC comparative effectiveness study was performed as understood for AI-assisted diagnostic tools. The device is described as "visualization and measurements tools for assessing blood vessels" that "facilitate the assessment of blood vessels by a trained physician." This suggests it's an image processing and measurement tool, not necessarily an AI-driven detection or classification system that alters diagnostic accuracy. The 510(k) summary does not mention any study of this nature.
- Effect Size: Not Applicable / Not Provided in the Document.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The document describes the device as providing "display and measurements tools" to "aid trained physicians." This indicates it's designed for human-in-the-loop use. A standalone performance evaluation in the context of an AI algorithm making independent decisions is not explicitly stated or implied by this description. Performance would likely be assessed for the accuracy of its measurements and displays, which are then used by a physician.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not Provided in the Document. For a measurement tool, ground truth would typically be established through highly accurate manual measurements (e.g., by experts using reference tools) or by comparison to other validated imaging modalities or invasive measurements, if applicable.
7. The sample size for the training set
- Sample Size for Training Set: Not Provided in the Document. Given the device description as "visualization and measurement tools," it's not explicitly stated that it uses machine learning/AI requiring a "training set" in the modern sense. It might be a rule-based or algorithmic image processing software. If it did involve training, the size is not mentioned.
8. How the ground truth for the training set was established
- Ground Truth for Training Set: Not Provided in the Document. If a training set was used, the methodology for establishing its ground truth is not detailed.
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063184
510(k) Summary
NOV - 3 2006
| Date: | September 8, 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: | CVV-001A, Vessel View Software |
| 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:Standard | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment |
| Predicate Device(s): | GE CardIQ Analysis II; K020796 |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The CVV-001A will be added to the previously cleared TSX-101A Aquilion CT system. This addition requires software modifications to the existing device. Addition of this option will provide trained physicians with visualization and measurements tools for assessing blood vessels.
Summary of Intended Uses:
CVV-001A is designed to facilitate the assessment of blood vessels by a trained physician in that it provides display and measurements tools.
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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Toshiba America Medical Systems, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313
NOV - 3 2006
,
Re: K063184
Trade/Device Name: CVV-001A, Vessel View Software Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 16, 2006 Received: October 20, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootton 910(t) prochantially equivalent (for the indications for relered above and nave acteriminar arketed predicate devices marketed in interstate commerce use stated in the enotosure) that of the Medical Device Amendments, or to devices that prior to May 20, 1770, and client date the provisions of the Federal Food, Drug, and Cosmetic have been roclassified in acceration of a premarket approval application (PMA). You may, Act (Act) market the device, subject to the general controls provisions of the Act. The general therefore, mainer the device, subject to an generation, listing of devices, good controls provisions or and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket tt your device is classified (bod as a very atitional controls. Existing major regulations affecting your Apploval), it thay be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the federal Register.
Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the logo. There are three stars below the word "Centennial". The text around the circle is difficult to read.
Protecting and Promoting Public Se
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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 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/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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Indications for Use
510(k) Number (if known): Қоб 318 Ч
Device Name: CVV-001A, Vessel View Software
Indications For Use:
CVV-001A, Vessel View Software is a post processing software option for the TSX-101A CT system. This product can be used for the analysis of CT angiography images. It provides display and measurement tools that can aid trained physicians for visualizing and assessing various blood vessels.
Prescription Use 1 (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)
Nancy C. Broadlon
(Division Sign-Off)
ductive, Abdom ological Devices
510(k) Number K063
Page 1 of
§ 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.