RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0

K071086 · Calgary Scientific, Inc. · LLZ · Jun 1, 2007 · Radiology

Device Facts

• Record ID: K071086
• Device Name: RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
• Applicant: Calgary Scientific, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ Cardiac Product Family is intended for use as a diagnostic, review. and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

ResolutionMD™ Cardiac Product Family is a software-based PACS for general-purpose computing hardware; inputs DICOM 3.0 compliant CT and MRI image data. Device performs 3D volume rendering, maximal intensity projection (MIP), 2D/3D measurements, calcium scoring (Agatston/volumetric), and coronary artery analysis. Operated by trained professionals (physicians, technologists, nurses) in clinical settings. Users interact via menus/tools to visualize and analyze images; output supports diagnostic decision-making by physicians. Benefits include enhanced visualization and automated/manual analysis tools for cardiac imaging. Software is platform-agnostic (Windows/Mac OS) and utilizes dedicated graphics hardware for rendering.

Clinical Evidence

Bench testing only. Software extensively tested on supported platforms by development and quality control teams. Beta testing conducted by trained cardiology professionals and potential customers prior to release. No clinical trial data provided.

Technological Characteristics

Software-based PACS; runs on Windows or Mac OS; utilizes dedicated graphics hardware for 3D rendering. Supports DICOM 3.0 standard. Features include 2D/3D visualization, MIP, calcium scoring, and automated/manual artery centerline detection. Software level of concern: minor.

Indications for Use

Indicated for use by trained professionals (physicians, technologists, nurses) for display, 3D visualization, and analysis of DICOM 3.0 compliant CT and MRI medical image data. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen 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)

Submission Summary (Full Text)

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K071086

# 510(k) Summary

| Date Prepared: | April 12, 2007 | JUN - 1 2007 |
|---------------------------------|-----------------------------------------------------------------------------------------------|--------------|
| Submitter's Name: | Calgary Scientific, Inc. | |
| Submitter's Address: | 1210 20th Ave. SE, Calgary, Alberta, Canada T2G 1M8 | |
| Submitter's Phone: | 403.270.7159 | |
| Submitter's Fax: | 403.668.1689 | |
| Contact: | Pierre Lemire, President & Chief Operations Officer | |
| Proprietary Name: | ResolutionMD™ Cardiac Product Family | |
| Common Name: | Software PACS | |
| Classification: | 892.2050 Picture archiving and communications system,<br>Product Code LLZ, (Class II) | |
| Substantially<br>Equivalent to: | Tradename: Vitrea2, Version 3.8<br>Manufacturer: Vital Images, Inc.<br>510(k) Number: K052632 | |

### Device Description:

The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.

The ResolutionMDTM Cardiac Product Family is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, 2D and 3D image measurements, calcium scoring, and coronary artery analysis. The user controls these functions with a system of interactive menus and tools.

A hazard analysis has been conducted and the level of concern has been classified as minor. The ResolutionMD™ Cardiac Product Family software will be extensively tested on supported platforms by members of the development and quality control team prior to beta testing. Beta testing by trained cardiology professionals and potential customers will be completed prior to product release. The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria.

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| Feature | ResolutionMDTM | Vital<br>Vitrea2TM |
|-------------------------------------------|--------------------------------------------------------------------|--------------------|
| Computer Platform | Windows OS or Mac OS | Windows OS |
| DICOM<br>compliance | DICOM 3.0 | same |
| 2D Imaging | 2D image viewer with<br>interactive user controls | same |
| 3D Imaging | 3D volume rendering with<br>interactive controls | same |
| Measurement | 2D measurement tools | same |
| Maximum Intensity<br>Projection (MIP) | MIP with interactive<br>controls and clipping planes | same |
| Prescription Use | Yes | same |
| Intended Users | Trained professionals | same |
| Calcium Score | Agatston and volumetric<br>scores | same |
| Artery detection | Automated and manual<br>centerline detection | same |
| Curved multi-<br>planar<br>reconstruction | Curved MPR of artery<br>centerline with cross-<br>sectional images | same |
| Reporting | Report summary generation<br>from Cardiac analysis | same |

# Substantial Equivalence Comparisons to Predicate Device:

### Intended Use:

The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ Cardiac Product Family is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 1 2007

Mr. Pierre Lemire President & Chief Operations Officer Calgary Scientific, Inc. Suite 208 - 1210 20th Avenue., SE Calgary, Alberta CANADA T2G 1M8

Re: K071086

Trade/Device Name: ResolutionMD™ Cardiac Product Family Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2007 Received: April 17, 2007

Dear Mr. Lemire:

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/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, and the letters "FDA" in a large font in the center. Below the letters are the words "Centennial" and three stars. The text "U.S. Food & Drug Administration" is written around the border of the circle.

Protecting and Promoting Public Health

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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.xxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

240-276-0115 240-276-0115 240-276-0120 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.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

Applicant: Calgary Scientific, Inc., Suite 208 - 1210 20th Ave. SE, Calgary, Alberta, CANADA T2G 1M8

510(k) Number (if known):

Device Name: ResolutionMD™ Cardiac Product Family

Indications for Use:

The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ Cardiac Product Family is intended for use as a diagnostic, review. and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Hulu Remunduz
(Division Sign Off)

e. Abdomina

Confidential