(90 days)
No
The summary describes image processing and quantification of calcium, but does not mention AI, ML, or related terms. The description of the technology is consistent with traditional image analysis techniques.
No
The device is for the detection and quantification of atherosclerotic plaque, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as for "non-invasive detection and quantification of atherosclerotic plaque," which is a diagnostic purpose.
Yes
The device is described as a "software feature/option" to existing image processing software and its function is solely based on processing image data. There is no mention of any hardware component being part of this specific device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device processes computed tomography image data from the patient's body directly, not a biological specimen taken from the body.
- The process is image processing and analysis. The device analyzes images of the coronary arteries to detect and quantify calcium. This is a form of medical imaging analysis, not an in vitro test.
Therefore, this device falls under the category of medical imaging software or a medical device that processes imaging data, not an IVD.
N/A
Intended Use / Indications for Use
Cardiac Scoring from whole body computed tomography derived measurements. For non-invasive detection and quantification of atherosclerotic plaque.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
The Vitrea 1.3 Coronary Artery Calcification Scoring (CACS) module is an additional software feature/option to K963697, Advanced Diagnostic Viewer (ADV). ADV was subsequently marketed as Vitrea - Image Processing Software by Vital Images, Inc. This feature provides visualization, quantification and reporting of the amount of calcium detected in the coronary arteries by processing data from Electron Beam or spiral/helical scanning image data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Testing: All software testing specified in the Software Development and Test Plan will be successfully completed prior to market release.
Clinical Evaluation: Software Beta testing will be successfully completed validating feature/performance prior to market release.
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.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Section 510(k) Premarket Notification Summary (as required by 807.92 (j))
Submitter: Vital Images, Inc. 3100 West Lake Street Minneapolis, MN 55416-4510 Phone # (612) 915-8001 Fax # (612) 915-8030
Date Prepared: February 8, 1999.
Contact Person: Robert C. Samec
Device Trade Name: Vitrea 1.3 Image Processing Software
Device Common Name: Image Processing Software for CT/MRI Scanners
Classification Name: 90LLZ - System, Image Processing
Substantially Equivalent to: Cardiac Scoring Option (K970980) Elscint, Inc.
Indications for Use: Cardiac scoring from whole body computed tomography derived measurements. For non-invasive detection and quantification of alterosclerotic plaque.
Device Description: The Vitrea 1.3 Coronary Artery Calcification Scoring (CACS) module is an additional software feature/option to K963697, Advanced Diagnostic Viewer (ADV). ADV was subsequently marketed as Vitrea - Image Processing Software by Vital Images, Inc. This feature provides visualization, quantification and reporting of the amount of calcium detected in the coronary arteries by processing data from Electron Beam or spiral/helical scanning image data.
Software Development: The software utilized was designed, developed, tested and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation and maintenance.
Performance Testing: All software testing specified in the Software Development and Test Plan will be successfully completed prior to market release.
Clinical Evaluation: Software Beta testing will be successfully completed validating feature/performance prior to market release.
10
1
Substantial Equivalence Comparison Chart
| Item | Vitrea 1.3 | Elscint (K970980) |
|---|---|---|
| Intended Use: | Cardiac Scoring from whole body computed tomography derived | |
| measurements. | ||
| Data Source: | CT Scanner | |
| Computing Method: | Agatston method for quantification of high density structures |
(D
2
Substantial Equivalence Comparison Chart
| System: | Elscint, Inc.
Cardiac scoring Option
(K970980) | Vital Images, Inc.
Cardiac Scoring Option |
|----------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use: | Cardiac scoring from whole
body computed tomography
derived measurements. | Cardiac scoring from whole
body computed tomography
derived measurements. |
| Data Source: | CT Scanner | CT Scanner |
| Physical
Characteristics
(workstation) | DICOM 3.0 compatible
Archive capability
Manual segmentation/
contour | DICOM 3.0 compatible
Archive capability
Manual segmentation/
contour |
| Performance
Measurement
Testing | See Attached Clinical Comparison
Summary/Data | |
| Safety: | Physician review of data/
scoring integral to use of
feature. | Physician review of data/
scoring integral to use of
feature. |
1
3
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/3/Picture/2 description: The image shows a black and white logo. The logo is a stylized depiction of an eagle or bird in flight. The bird is facing left. The logo is associated with the Department of Health & Human Services.
MAY 1 1 1999
Robert C. Samec Vice President, QA/RA Vital Images, Inc. 3100 West Lake Street Suite 100 Minneapolis, Minnesota 55416-4510 Re:
K990442 Advanced Diagnostic Viewer (ADV), Model Vitrea 1.3 CT/MRI Workstation Dated: February 8, 1999 Received: February 10, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Samec:
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 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K 990442
Cardiac Scoring (Option) Device Name:
INDICATIONS FOR USE:
Intended Use:
Indications for Use: Cardiac Scoring from whole body computed tomography derived measurements. For non-invasive detection and quantification of atherosclerotic plaque.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segeen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter Use -------
(Optional Format 1-2-96)