(90 days)
Cardiac Scoring from whole body computed tomography derived measurements. For non-invasive detection and quantification of atherosclerotic plaque.
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.
The provided 510(k) summary for Vitrea 1.3 Image Processing Software (K990442) outlines various aspects of the device and its regulatory submission. However, it does not contain specific details about acceptance criteria, the study proving the device meets them, or many of the specific study design elements requested in the prompt.
The document primarily focuses on establishing substantial equivalence to a predicate device (Elscint, Inc.'s Cardiac Scoring Option K970980) and mentions general software development and testing procedures.
Here's a breakdown of what can and cannot be extracted from the provided text, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- None explicitly stated in the provided text. The document states "Performance Testing: All software testing specified in the Software Development and Test Plan will be successfully completed prior to market release" and "Clinical Evaluation: Software Beta testing will be successfully completed validating feature/performance prior to market release." This implies acceptance criteria exist in internal documents but are not disclosed in the 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Not explicitly stated in the provided text. The document mentions "Clinical Evaluation: Software Beta testing," but the sample size, type of data (retrospective/prospective), and country of origin are not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not explicitly stated in the provided text. There is no mention of experts establishing ground truth for a test set. The submission focuses on the algorithm's performance against the Agatston method.
4. Adjudication Method for the Test Set:
- Not explicitly stated in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- Not explicitly stated in the provided text. The document describes comparisons in terms of intended use and computing method with the predicate, but not a comparative effectiveness study involving human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:
- Implied, but not detailed as a formal study. The device calculates a score based on the Agatston method. The "Performance Measurement Testing" section for the predicate device (Elscint) refers to "Attached Clinical Comparison Summary/Data," which might contain standalone performance data, but this is not provided for the Vitrea 1.3 in this specific document. The "Computing Method: Agatston method for quantification of high density structures" for Vitrea 1.3 suggests an algorithmic, standalone calculation.
7. The Type of Ground Truth Used:
- Implied to be the Agatston method. The document states the device uses the "Agatston method for quantification of high density structures" and is for "non-invasive detection and quantification of atherosclerotic plaque." For this type of device (early 1999), the Agatston score itself, derived from CT data, would be considered the benchmark or "ground truth" for calcification quantification. It's improbable that pathology or long-term outcomes data would have been a direct ground truth for a 510(k) submission for a calcification scoring tool at that time.
8. The Sample Size for the Training Set:
- Not explicitly stated in the provided text.
9. How the Ground Truth for the Training Set was Established:
- Not explicitly stated in the provided text. Given the device is based on the Agatston method, it's likely that the "ground truth" for any training or validation would involve application of the Agatston algorithm to known CT datasets.
Summary of what is available from the document:
The 510(k) submission for Vitrea 1.3 primarily relies on demonstrating substantial equivalence to an existing predicate device (Elscint's Cardiac Scoring Option K970980). The key elements of equivalence highlighted are:
- Intended Use: Cardiac scoring from whole body CT derived measurements.
- Data Source: CT Scanner.
- Computing Method: Agatston method for quantification of high density structures.
The document states that "All software testing specified in the Software Development and Test Plan will be successfully completed prior to market release" and "Software Beta testing will be successfully completed validating feature/performance prior to market release." However, the details of these tests, including specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies, are not included in this publicly available 510(k) summary. These details would typically be found in internal design controls and verification/validation documents submitted to the FDA but not necessarily released in the public summary.
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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.
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Substantial Equivalence Comparison Chart
| Item | Vitrea 1.3 | Elscint (K970980) |
|---|---|---|
| Intended Use: | Cardiac Scoring from whole body computed tomography derivedmeasurements. | |
| Data Source: | CT Scanner | |
| Computing Method: | Agatston method for quantification of high density structures |
(D
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Substantial Equivalence Comparison Chart
| System: | Elscint, Inc.Cardiac scoring Option(K970980) | Vital Images, Inc.Cardiac Scoring Option |
|---|---|---|
| Intended Use: | Cardiac scoring from wholebody computed tomographyderived measurements. | Cardiac scoring from wholebody computed tomographyderived measurements. |
| Data Source: | CT Scanner | CT Scanner |
| PhysicalCharacteristics(workstation) | DICOM 3.0 compatibleArchive capabilityManual segmentation/contour | DICOM 3.0 compatibleArchive capabilityManual segmentation/contour |
| PerformanceMeasurementTesting | See Attached Clinical ComparisonSummary/Data | |
| Safety: | Physician review of data/scoring integral to use offeature. | Physician review of data/scoring integral to use offeature. |
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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
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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)
§ 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).