VITREA, VERSION 3.9

K061624 · Vital Images, Inc. · LLZ · Jun 27, 2006 · Radiology

Device Facts

• Record ID: K061624
• Device Name: VITREA, VERSION 3.9
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Vitrea2® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea2 Version 3.9 has the following additional indication: The 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 proc sses images obtained using a multidetector Aquilion CT. The package provides tools for t a measurement and visualization (color coded maps) of coronary arteries.

Device Story

Vitrea2 is a medical diagnostic software system for processing, reviewing, and analyzing multi-dimensional digital images; inputs include DICOM image data from various imaging devices; system allows clinicians to retrieve, display, manipulate, annotate, and measure images; includes SUREPlaque tool kit for coronary artery disease (CAD) stratification; SUREPlaque processes multidetector Aquilion CT images to provide measurements and color-coded visualization maps of coronary arteries; used by trained physicians in clinical settings; output aids in clinical decision-making regarding patient stratification; supports communication and media interchange via DICOM protocol.

Clinical Evidence

No clinical data provided. Software validation was performed according to internal written procedures, including design, development, and testing phases. Potential hazards were addressed via a Risk Management Plan. Beta testing and validation were completed prior to release.

Technological Characteristics

Medical image processing software; operates on standard computing hardware; supports DICOM network protocol for image acquisition and communication; features multi-dimensional visualization, annotation, and measurement tools; includes SUREPlaque application for CT image post-processing and color-coded mapping of coronary arteries.

Indications for Use

Indicated for patients identified with coronary artery disease (CAD) to assist trained physicians in patient stratification. Software is used for post-processing of multidetector Aquilion CT images.

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

• Vitrea2, Version 3.8 (K052632)
• SUREPlaque™ (K043111)

Submission Summary (Full Text)

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## 6.0 510(k) Summary

# JUN 2 7 2006

### Submitter's Name / Contact Person

Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343

#### General Information

| Trade Name | Vitrea2®, Version 3.9 Medical Image Processing Software |
|---------------------|---------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Devices | Vitrea2, Version 3.8 (K052632)<br>Vital Images, Inc. SUREPlaque™ (K043111)<br>Toshiba America Medical Systems, Inc. |

## Device Description

The Vitrea2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.

The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 system user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

- . Retrieve image data over the network via DICOM
- . Display images that are automatically adapted to exam type via dedicated protocols
- Select images for closer examination from a gallery of up to six 2D or 3D views .
- Interactively manipulate an image in real-time to visualize anatomy and pathology .
- Annotate, tag, measure, and record selected views .

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- Output selected views to standard film or paper printers, or post a report to an Intranet . Web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server .

### Intended Use

Vitrea2® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea2 Version 3.9 has the following additional indication:

The 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 proc sses images obtained using a multidetector Aquilion CT. The package provides tools for t a measurement and visualization (color coded maps) of coronary arteries.

#### Predicate Device Comparison

The Vitrea2, Version 3.9 system and its predicate devices allow for the analysis, communication a: media interchange of digital images acquired from a variety of acquisition devices. All device support the DICOM protocol for communication of images with other medical imaging devices.

#### Summary of Stus s

The software utili: I 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, testing, validating and maintenance.

The Vitrea2, Verri testing prior to Bet validation. Software Beta testing/validation will be successfully completed prior to Dlease. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

## Conclusion

The Vitrea2, Versi very similar techn:

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ling safety or effectiveness of the device. Thus, the Vitrea2, Version 3.9 new questions re: ·'ly equivalent to the predicate devices. system is substar.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 7 2006

Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFAI.O MN 55313

Re: K061624

Trade/Device Name: Vitrea26, Version 3.9 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2006 Reccived: June 12, 2006

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.

Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

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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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely vours.

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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## 3.0 Intended Use Statement

# 510(k) Number (if known): 《んしくんとイ Device Name: Vitrea2 , Version 3.9 Medical Image Processing Software

Vitrea2 is a medical diagnostic system that allows the processing, review, analysis. communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea2 Version 3.9 has the following additional indication:

The 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.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Laird A. Lynam

(Division Sie. Off) · Septoductive, Abdominal rest revices