ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3

K990442 · Vital Images, Inc. · LLZ · May 11, 1999 · Radiology

Device Facts

• Record ID: K990442
• Device Name: ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Cardiac Scoring from whole body computed tomography derived measurements. For non-invasive detection and quantification of atherosclerotic plaque.

Device Story

Vitrea 1.3 is an image processing software module for CT/MRI workstations; processes Electron Beam or spiral/helical CT scan data. Core function is Coronary Artery Calcification Scoring (CACS); utilizes Agatston method to quantify high-density structures (calcified plaque). Operates on workstation; requires physician review of data and scoring. Output includes visualization, quantification, and reporting of coronary artery calcium. Assists clinicians in non-invasive assessment of atherosclerotic plaque; intended for prescription use.

Clinical Evidence

Bench testing and software beta testing performed to validate feature performance. No clinical trial data provided.

Technological Characteristics

Software-based image processing module for CT/MRI workstations. Implements Agatston method for quantification of high-density structures. DICOM 3.0 compatible. Operates on workstation hardware. Software developed and validated per internal procedures.

Indications for Use

Indicated for patients undergoing whole body computed tomography for the non-invasive detection and quantification of atherosclerotic plaque.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Cardiac Scoring Option (K970980)

Submission Summary (Full Text)

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K990442

## 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 # [phone] Fax # [phone]

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 derived<br>measurements. | |
| 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.<br>Cardiac scoring Option<br>(K970980) | Vital Images, Inc.<br>Cardiac Scoring Option |
|----------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use: | Cardiac scoring from whole<br>body computed tomography<br>derived measurements. | Cardiac scoring from whole<br>body computed tomography<br>derived measurements. |
| Data Source: | CT Scanner | CT Scanner |
| Physical<br>Characteristics<br>(workstation) | DICOM 3.0 compatible<br>Archive capability<br>Manual segmentation/<br>contour | DICOM 3.0 compatible<br>Archive capability<br>Manual segmentation/<br>contour |
| Performance<br>Measurement<br>Testing | See Attached Clinical Comparison<br>Summary/Data | |
| Safety: | Physician review of data/<br>scoring integral to use of<br>feature. | Physician review of data/<br>scoring integral to use of<br>feature. |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)