RESOLUTIONMD, RELEASE 2.1

K082693 · Calgary Scientific, Inc. · LLZ · Feb 23, 2009 · Radiology

Device Facts

• Record ID: K082693
• Device Name: RESOLUTIONMD, RELEASE 2.1
• Applicant: Calgary Scientific, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ResolutionMD™ 2.1 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ 2.1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on noncontrast enhanced cardiac CT data sets. It also includes the Coronary Artery Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets. The ResolutionMD™ 2.1 software 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. Calgary Scientific recommends that users of the ResolutionMD™ 2.1 software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied. 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 2.1 is a software-based PACS for display and 3D visualization of DICOM 3.0 medical images (CT, MRI). Inputs include medical image data; software utilizes dedicated graphics hardware for 3D rendering, MIP, and MPR. Features include 2D/3D measurements, calcium scoring, and coronary artery analysis. Used in clinical settings by physicians, technologists, and nurses. Output is displayed on general-purpose computing hardware; interpreted by physicians to support clinical diagnosis. Benefits include enhanced visualization and quantitative analysis of cardiac data to assist in identifying plaque and stenoses.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, hazard analysis, and verification of software functionality on supported platforms. Beta testing by cardiology professionals and potential customers was conducted prior to release to ensure performance against predefined criteria.

Technological Characteristics

Software-based PACS; DICOM 3.0 compliant. Supports Windows, .NET SDK, Linux, and Mac OS. Utilizes dedicated graphics hardware for 3D rendering. Features include 2D/3D visualization, MIP, MPR, calcium scoring, and coronary artery analysis. Connectivity via LAN, WAN, and Web. 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 medical images (CT, MRI). Includes modules for identifying/quantifying coronary artery calcified plaque (non-contrast cardiac CT) and identifying/measuring coronary artery stenoses (contrast-enhanced cardiac CTA). Contraindicated for primary interpretation of lossy compressed mammographic images or 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

• Vitrea, Version 4.0 (K071331)
• Vital Connect 4.1 (K071362)

Submission Summary (Full Text)

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KOr2693

FEB 2 3 2009

## 510(k) Summary

| Date Prepared: | August 15, 2008 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 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: | 403.270 2771 |
| Contact: | Pierre Lemire, President & Chief Operations Officer |
| Proprietary Name: | ResolutionMD™ 2.1 |
| Common Name: | Software PACS |
| Classification: | 892.2050 Picture archiving and communications system,<br>Product Code LLZ, (Class II) |
| Substantially<br>Equivalent to: | Tradename: Vitrea, Version 4.0 and Vital Connect 4.1<br>Manufacturer: Vital Images, Inc.<br>510(k) Number: K071331 and K071362 |

#### Device Description:

The ResolutionMD™ 2.1 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 ResolutionMD™ 2.1 is available in a Microsoft Windows version, a Microsoft .NET software development kit version (SDK), a Linux Web server version and in a Macintosh OS version. All 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) and multiplanar reconstruction images (MIP/MPR), 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™ 2.1 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>Vitrea2™ | Vital Connect<br>4.1 |
|-------------------------------------------|-----------------------------------------------------------------------------------------|-------------------|----------------------|
| Computer Platform | Windows OS, Microsoft<br>.NET SDK, Linux OS, or<br>Mac OS | Windows OS | Windows OS |
| DICOM<br>compliance | DICOM 3.0 | same | same |
| LAN, WAN and<br>Web access | Server with PC Client<br>access via the Internet, LAN<br>or WAN | N/A | same |
| 2D Imaging | 2D image viewer with<br>interactive user controls | same | same |
| 3D Imaging | 3D volume rendering with<br>interactive controls | same | same |
| Measurement | 2D measurement tools | same | same |
| Maximum Intensity<br>Projection (MIP) | MIP with interactive<br>controls and clipping planes | same | same |
| Multiplanar<br>Reformatting<br>(MPR) | MPR with oblique slicing<br>and variable thickness<br>slabbing | same | same |
| Segmentation | Manual, semi-automatic and<br>automatic delineation of an<br>sub-region within an image | same | same |
| Prescription Use | Yes | same | same |
| Intended Users | Trained professionals | same | same |
| Calcium Score | Agatston and volumetric<br>scores | same | same |
| Artery detection | Automated and manual<br>centerline detection | same | same |
| Curved multi-<br>planar<br>reconstruction | Curved MPR of artery<br>centerline with cross-<br>sectional images | same | same |
| Reporting | Report summary generation<br>from Cardiac analysis | same | same |

:

:

# Substantial Equivalence Comparisons to Predicate Device:

-

:

.

:

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#### Intended Use:

The ResolutionMD™ 2.1 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ 2.1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on noncontrast enhanced cardiac CT data sets. It also includes the Coronary Artery Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.

The ResolutionMD™ 2.1 software 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. Calgary Scientific recommends that users of the ResolutionMD™ 2.1 software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.

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.

#### Confidential

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Pierre Lemire President & Chief Technology Officer Calgary Scientific, Inc. Suite 208, 1210 20th Avenue SE Calgary, AB T2G 1MB CANADA

Re: K082693

Trade/Device Name: ResolutionMDTM 2.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2009 Received: February 10, 2009

#### 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 (PMA), 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.

8 9 3 2004

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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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Exhibit 1 - Revised Indications for Use statement

## 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™ 2.1

Indications for Use:

The ResolutionMD™ 2.1 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ 2.1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on noncontrast enhanced cardiac CT data sets. It also includes the Coronary Artery Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.

The ResolutionMD™ 2.1 software 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. Calgary Scientific recommends that users of the ResolutionMD™ 2.1 software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.

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.

GE OF

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED

(Division Sign-Off)

Concurrent Division CDRH reproductive Devic Evaluation (ODE)

Radiological Devices

| 510(k) Number | K082693 |
|---------------|---------|
|---------------|---------|