CORVIEW

K131158 · Marrek, Inc. · LLZ · Aug 21, 2013 · Radiology

Device Facts

• Record ID: K131158
• Device Name: CORVIEW
• Applicant: Marrek, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance images (MRIs) to obtain Left Atrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the left atrial wall. It enables: Importing Cardiac MRIs in DICOM format Qualitative analysis of the cardiac MRIs using display functionality such as panning, windowing, zooming, and navigation through series/slices and phases Quantitative measurement in cardiac MRIs, specifically LAE It is intended for use by qualified medical professionals experienced in examining and evaluating cardiovascular MRIs, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. The target population of Corview is not restricted. However image acquisition by an MRI scanner with cardiac capability may limit the use of the device for certain sectors of the general public. Corview is intended to view only cardiac magnetic resonance images acquired from an MRI scanner with cardiac capabilities. The CORVIEW software application is intended for use in the clinical setting.

Device Story

CORVIEW is a standalone software application for processing digitized cardiac MRI datasets. It imports DICOM-formatted images from commercial MRI scanners. The software allows clinicians to perform qualitative analysis (panning, windowing, zooming, slice navigation) and quantitative analysis of the left atrial wall. Using a feature classification algorithm on 3D-acquired datasets, the device identifies endo- and epi-cardial borders to construct a 3D model of the left atrium and calculate the total percentage of left atrial enhancement (LAE). The output is visualized for the clinician to assist in diagnostic decision-making. It is intended for use in clinical settings by qualified medical professionals experienced in cardiovascular MRI evaluation.

Clinical Evidence

Bench testing only. Software verification and validation were performed at the code and system level according to pre-established protocols. All software requirements were verified, and results met pass/fail criteria. No clinical data provided.

Technological Characteristics

Standalone software application for PC or Apple computers. Processes DICOM-formatted cardiac MRI images. Features include 3D modeling, image segmentation, and feature classification algorithms for LAE quantification. Software verification and validation conducted per internal protocols.

Indications for Use

Indicated for viewing and post-processing cardiovascular MRI images to quantify and visualize Left Atrial Enhancement (LAE) in a 3D model. Intended for use by qualified medical professionals in clinical settings. No specific age or gender restrictions; use limited by availability of cardiac-capable MRI image acquisition.

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

• 2D Cardiac Performance Analysis MR 1.0 device (K120135)
• Virtue (CORE Module) (K111833)

Submission Summary (Full Text)

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K13/1158
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#### SECTION 5: 510(k) SUMMARY

#### 510(k) Summary

| Date Prepared: | July 16, 2013 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Marrek, Inc.<br>3293 Niblick Drive<br>Park City, UT 84098<br>Phone: [phone]<br>Facsimile: 1 [phone] |
| Contact: | Jeremy M. Fotheringham, President & CEO<br>Mobile: [phone] |
| Trade/Proprietary<br>Name of Device: | CORVIEW |
| Common Name<br>of Device: | System, Image Processing, Radiological |
| Classification: | Class II per 21 CFR 892.2050, Picture archiving and<br>communications system, Product Code LLZ |
| Legally Marketed<br>Predicate<br>Device: | 1. 2D Cardiac Performance Analysis MR 1.0 device<br>(K120135), manufactured by TomTec Imaging<br>Systems<br>2. Virtue (CORE Module) (K111833), manufactured by<br>Diagnosoft, Inc. |

#### Description of New CORVIEW Device:

CORVIEW is an independent software solution for the segmentation and quantitative analysis of digitized cardiac magnetic resonance images (MRIs). CORVIEW operates on higher-end off-the-shelf PC or Apple computers and is compatible with Cardiac MRI digital images in DICOM format from a range of commercial MRI machine vendors. The CORVIEW software platform is also designed to process MRIs received from various modes of image exchange.

CORVIEW presents a state-of-the-art method to process and quantify the extent of left atrial enhancement (LAE) within the left atrial wall by contouring and identifying the endo- and epi-cardial borders from contrast enhanced MR image sequences that have been acquired as part of a conventional cardiac MRI examination.

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CORVIEW is designed for the processing of 3D image datasets allowing users to produce contour models and visualizations of left atrial structure and contrast enhancement. Based on 3D-acquired datasets, a feature classification algorithm supports the calculation of LAE. From these corresponding algorithms, total percentage of enhancement can be derived. In addition, the corresponding shape of the left atrium can also be obtained.

#### Indications for Use of the New Device:

Indications for Use:

The Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance images (MRIs) to obtain Left Atrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the left atrial wall.

#### It enables:

- . Importing Cardiac MRIs in DICOM format
- Qualitative analysis of the cardiac MRIs using display functionality such as . panning, windowing, zooming, and navigation through series/slices and phases
- . Quantitative measurement in cardiac MRIs, specifically LAE

It is intended for use by qualified medical professionals experienced in examining and evaluating cardiovascular MRIs, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.

The target population of Corview is not restricted. However image acquisition by an MRI scanner with cardiac capability may limit the use of the device for certain sectors of the general public.

Corview is intended to view only cardiac magnetic resonance images acquired from an MRI scanner with cardiac capabilities.

The CORVIEW software application is intended for use in the clinical setting.

## Comparison of the Technological Features of the New Device and Predicate Devices:

The new CORVIEW device, the lawfully marketed predicate Tom Tec Imaging Systems 2D Cardiac Performance Analysis MR 1.0 device (K120135), and the Diagnosoft Virtue-CORE device (K111833) are all stand-alone software

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applications using cardiac data obtained from standard magnetic resonance images. Features of CORVIEW are comparable to those of the predicate devices. The main differences include:

- 1. The new CORVIEW quantifies the amount of contrast enhancement within the left atrial wall. The predicate Tom Tec Imaging Systems 2-D Cardiac Performance Analysis MR 1.0 device quantifies the myocardial deformation and movement of the entire heart muscle.
- 2. The new CORVIEW constructs and visualizes a 3D model of the left atrium.
- 3. The new CORVIEW quantifies the amount of contrast enhancement within the left atrial wall. The predicate Diagnosoft Virtue - CORE device quantifies the amount of contrast enhancement within the right and left ventricles as well as the surrounding vessels.

### Testing:

#### Non-Clinical Performance Data Testing:

Software testing and validation were done at the code and system level according to written test protocols established before testing was conducted.

The test procedure was performed and documented. The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied prior to the release of the software.

The results are summarized in the test summary report. The conclusion states that:

- Verification strategies and test procedures used are appropriate
- Software system test procedures trace to software requirements
- All software requirements are tested or otherwise verified
- Test results meet the required pass/fail criteria

#### Adverse Effects on Health:

The potential risks are identified in a risk management analysis and report and are controlled by the software development team, risk management processes, documented verification and validation processes to ensure performance to specifications, Federal Regulations, user requirements, and adherence to industry and international standards.

Risk analysis aspects were treated in the risk management report. Based on this document, the applied methods in the literature and the techniques of the product (which are considered in the risk analysis) were evaluated. No further risks were identified.

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### Conclusion:

The conclusions drawn from the specifications and performance testing of the new CORVIEW device demonstrate that the new CORVIEW device is at least as safe and as effective and performs as well as or better than the predicate TomTec Imaging Systems 2D Cardiac Performance Analysis MR 1.0 device, (K120135) and the Diagnosoft Virtue - CORE device (K111833). For these reasons, we believe the new CORVIEW device is substantially equivalent to the predicate devices.

Signed,

Jeremy M. Fotheringham President & CEO Marrek, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings and body. The logo is rendered in black and white.

Public Health Service

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

August 21, 2013

Marrek, Inc. % Mr. Jeremy M. Fotheringham President & CEO 3293 Niblick Drive PARK CITY UT 84098

Re: K131158 Trade/Device Name: Corview Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 16, 2013 Received: August 19, 2013

Dear Mr. Fotheringham:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Mr. Fotheringham

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/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/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): K131158

Device Name: Corview

Indications for Use:

The Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance intris) to obtain Left Arrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the lett atrial wall.

It enables:

- . Importing Cardiac MRIs in DICOM format
- . Qualitative analysis of the cardiac MRIs using display functionality snch as paming. windowing. and navigation through senes shees and phases
- . Quantitative measurement in cardiae MRIs. specifically LAE

It is intended for use by qualified medical professionals experienced in examining cardiovascular MRIs. for the purpose of obtaining diamanon as part of a comprehensve diagnostic decision-making process.

The target population of Corview is not restricted. However image acquisition by an MRI scardiac capability may linit the use of the device for certain sectors of the general public.

Corview is intended to view only cardine resonance intages acquired from an MRI scamer with cardiac capabilities.

The CORVIEW sothware application is intended for use in the clinical setting.

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 IF NEEDED)

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> 510(k) K131158

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