(14 days)
Not Found
No
The summary describes image processing and measurement tools, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as "post processing software" that provides "display and measurement tools" for analyzing CT angiography images. It aids physicians in visualizing and assessing blood vessels, but it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device provides analysis, display, and measurement tools for visualizing and assessing blood vessels from CT angiography images, which aids physicians in making medical judgments.
No
The device is described as a "post processing software option for the TSX-101A CT system" and requires "software modifications to the existing device." This indicates it is an add-on software component integrated into a hardware medical device (the CT system), not a standalone software-only device.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic), although it's not explicitly stated as such. Here's why:
- Intended Use: The intended use is for the "analysis of CT angiography images" to "aid trained physicians for visualizing and assessing various blood vessels." While this involves imaging, the analysis and assessment of these images to provide information about the patient's condition (the state of their blood vessels) aligns with the core purpose of an IVD. IVDs are used to examine specimens (in this case, the CT images representing the patient's anatomy) to provide information for diagnosis, monitoring, or treatment.
- Post-processing Software: The fact that it's "post-processing software" suggests it's taking data already acquired from the patient (the CT images) and performing analysis on it. This is a common characteristic of IVD software that analyzes biological samples or data derived from them.
- Provides Display and Measurement Tools: These tools are used to extract quantitative and qualitative information from the images, which is then used by the physician for clinical decision-making. This is a key function of many IVDs.
- Predicate Device: The mention of a predicate device, "GE CardIQ Analysis II; K020796," is a strong indicator that this device is being compared to a previously cleared device that is likely also considered an IVD. Looking up the predicate device's K number (K020796) would likely confirm its IVD classification.
Why it's not definitively stated as an IVD:
The provided text doesn't explicitly use the term "In Vitro Diagnostic" or state that it's intended for diagnostic purposes in the most direct language. However, the function and intended use strongly point towards it being an IVD.
In summary:
While the document doesn't explicitly label it as an IVD, the intended use of analyzing CT angiography images to aid physicians in assessing blood vessels, the nature of it being post-processing software providing analysis and measurement tools, and the mention of a predicate device that is likely an IVD, all strongly suggest that CVV-001A, Vessel View Software is intended to be an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT angiography images
Anatomical Site
blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GE CardIQ Analysis II; K020796
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Registration | |
| Number: | 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.
1
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
2
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
3
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
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