VITREA CT MYOCARDIAL ANALYSIS

K112531 · Vital Images, Inc. · LLZ · Nov 18, 2011 · Radiology

Device Facts

• Record ID: K112531
• Device Name: VITREA CT MYOCARDIAL ANALYSIS
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Vitrea® CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.

Device Story

Vitrea CT Myocardial Analysis is a post-processing software module for the Vitrea platform; processes cardiac CT images. Input: DICOM-compliant cardiac CT studies. Transformation: utilizes multiplanar reconstruction (MPR), maximum intensity projections (MIP), and volume rendering to segment and analyze myocardial tissue. Output: visualization tools including color-coded maps, polar maps, and quantitative measurements/comparison ratios; reporting tools for findings. Used in clinical settings by radiologists and cardiologists to assess myocardial density. Output assists clinicians in identifying and characterizing myocardial pathology, supporting diagnostic decision-making.

Clinical Evidence

Bench testing only. Software verification and validation performed according to written procedures and risk management. Testing confirmed feature functionality against requirements, interoperability with DICOM standards (NEMA PS 3.1-3.18), and usability for intended clinical tasks without impacting existing platform functions.

Technological Characteristics

Software-only medical device; post-processing application for Vitrea platform. Implements MPR, MIP, and volume rendering. Compliant with NEMA PS 3.1-3.18 (DICOM) standards. Connectivity via existing Vitrea platform infrastructure.

Indications for Use

Indicated for use by clinicians for cardiac CT image analysis to visualize cardiovascular anatomy and pathology, specifically highlighting and color-coding hypo/hyper dense myocardial tissue areas.

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

• GE Medical Systems CardIQ Express Version 2.0 (K073138)
• Siemens AG syngo.CT Cardiac Functions (K110366)

Submission Summary (Full Text)

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## 510(k) Summary

NOV 1 8 2011

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.

| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway<br>Suite 300<br>Minnetonka, MN 55343-4414 |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Person: | Daniel T. Biank<br>Regulatory Affairs Manager |
| Telephone: | 952 - 487 - 9514 |
| Fax: | 952 - 487 - 9510 |
| Email: | [e-mail] |
| Date Prepared: | August 30, 2011 |
| Device Name | Trade Name: Vitrea® CT Myocardial Analysis |

Picture Archiving and Communications System

System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ)

## Predicate Devices:

Common Name:

Classification Name:

GE Medical Systems CardIQ Express Version 2.0 (K073138) Siemens AG syngo.CT Cardiac Functions (K110366)

### Device Description:

Vitrea CT Myocardial Analysis is a post-processing software option for the Vitrea® software platform. it leverages existing Vites functionality such as multiplanar reconstruction (MPR) images, maximum intensity projections (MIP), and volume rendering. Vitrea CT Myocardial Analysis enables the visualization and analysis of the myocardium. It assists in analyzing the hyperhypo dense areas of myocardial tissue. Its visualization tools include segmentation, color coding, and polar maps. Its analysis tools include measurements and companison ratios. It also includes reporting tools for formatting findings and user selected areas of interest.

#### Intended Use:

Vitrea CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular andiomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.

### Comparison with Predicate Devices:

The Vitrea® CT Myocardial Analysis application provides radiologists and cardiologists workflows similar to Cardia Xpress 2.0 and syngo.CT Cardiac Function. These devices all include the ability to display two and three dinensional images of the cardiovascular anatomy generated from CTA exams of the heart. Vitrea CT Myocardial Analysis is an option to enable a particular cardial postprocessing workflow for the myocardium. CardIQ Xpress 2.0 and syngo.CT Cardian include the myocardium tool as part of a package of additional cardiac functions. Vitrea" CT Myocardial Analysis is substantially equivalent to the relevant Cardid Xpress 2.0 and syngo. CT Cardian Function tools.

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### Summary of Studies:

The software was designed, developed, and tested according to written procedures and applying risk management. Testing included verification, valider procedures and applying rise.
management. Testing included verification, validating previously acquired diagnostic images. Software testing confirmed that the feature firetions according to its requirements without impacting existing function found that no round that users can operate the software and successfully perform the desired function. The software is designed to meet NEMA PS 3.1 - 3.18 Digital Inaging and Communications in Medicine (DICOM).

Testing supports a determination of substantial equivalence.

### Conclusion:

Vitrea CT Myocardial Analysis is substantially equivalent to the current cleared and marketed GE Medical Systems CardIQ Express Version 2.0 (K073138) and Siemens AG syngo.CT Cardiac Functions (K110366) based on the included studies.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of human figures within a circle. The text is in a bold, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Daniel Biank Regulatory Affairs Manager Vital Images, Inc. 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343

MAR - 8 2012

Re: K112531

Trade/Device Name: Vitrea® CT Myocardial Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 30, 2011 Received: August 31, 2011

Dear Mr. Biank:

This letter corrects our substantially equivalent letter of November 18, 2011.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Vitrea® CT Myocardial Analysis

### Indications for Use:

Vitrea® CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.

Prescription Use × (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 In Vitro Diagnostic Devices (OIVD)

Division Sign Off

ision Sign-Off Office of In Vitro Diagnostic Device Evaluatio

510(k) K112531

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