(8 days)
K0041267, K990426
Not Found
No
The document describes image analysis and visualization software but does not mention AI, ML, deep learning, or any related terms or concepts. The focus is on post-processing and measurement tools.
No.
The device is an image analysis software package intended to assist physicians in stratifying patients with coronary disease by post-processing CT images for measurement and visualization, not to treat the disease itself.
Yes.
The device is intended to assist physicians in the "stratification of patients identified to have coronary disease (CAD)", and it provides "tools for the measurement and visualization (color coded maps) of coronary arteries," thus aiding in the diagnosis or assessment of a medical condition.
Yes
The device is explicitly described as an "image analysis software package" and "post processing software" that is applied to images obtained from a separate CT scanner. It does not include or control any hardware components of the CT system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The PlaqueView (SurePlaque) tool kit application software package processes images obtained from a CT scanner. It analyzes and visualizes anatomical structures (coronary arteries, plaques, etc.) within the body, not specimens taken from the body.
- Input: The input is image data from a CT scanner, not biological samples.
- Output: The output is processed images, visualizations, and numeric data related to the anatomical structures, not diagnostic results derived from analyzing biological specimens.
Therefore, the device falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The PlaqueView (SurePlaque) tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
The CSPV-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) CT scanner, that allows the user to process acquired image data. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography, X-Ray
Anatomical Site
cardiovascular lumens, vessel walls, plaques, coronary arteries
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.
K0041267, K990426
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
| NOV 18 2004 | K043111 | ||
|---|---|---|---|
| 510(k) Summary | |||
| Date: | October 27, 2004 | ||
| 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 Regulatory Affairs Manager, | ||
| (714) 730-5000 | |||
| Establishment Registration | |||
| Number: | 2020563 | ||
| Device Proprietary Name: | PlaqueView (a.k.a. SurePlaque) CSPV-0001A | ||
| Common Name: | Scanner, Computed Tomography, X-Ray | ||
| [Fed. Reg. No. 892.1750, Product 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): | General Electric Perfusion CT 2 [K0041267] | ||
| Siemens Perfusion CT [K990426] | |||
| Reason For Submission: | Modification of Cleared Device |
Description of this Device:
The CSPV-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) CT scanner, that allows the user to process acquired image data. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.
Summary of Intended Uses:
Plaque View/SUREPlaque is a post processing software that facilitates faster and casier visualization of cardiovascular lumens, vessel walls, plaques, and other bodies. This software can lay vessels out in curved planar reformats, cross sectional views, and maximum intensity projection views. Color based on a density range can then be applied to the vanous parts of the anatomy for easier reading.
1
Technological Characteristics:
This package is similar in uses and applications as those of the predicate devices. The man difference is in the method used to obtain the final results. Both this and the prodicate devices are used as post-processing software applied to images collected by the parent CT Scanner.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. 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 this upgrade package, Plaque View/SurePlaque, Model Number CSPV-0000 A is substantially equivalent to the predicate devices. This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official 'Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K043111
Trade/Device Name: Plaque View. Model Number CSPV-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography ' x-ray system
Regulatory Class: II Product Code: 90 JAK Dated: November 8, 2004 Received: November 10, 2004
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.
3
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.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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.html
Sincerely yours,
Nancy C. brogdon
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
Page l of ــــﺮ
510(k) Number (if known): K043///
Device Name: Plaque View, Model Number CSPV-001 A
Indications for Use:
The PlaqueView (SurePlaque) tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
(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) (Optional Format 1-2-96)
OR
Over-The-Counter Use
Daniel M. Layman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number