Vitrea CT Myocardial Perfusion

K150104 · Vital Images, Inc. · JAK · Apr 17, 2015 · Radiology

Device Facts

• Record ID: K150104
• Device Name: Vitrea CT Myocardial Perfusion
• Applicant: Vital Images, Inc.
• Product Code: JAK · Radiology
• Decision Date: Apr 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue. The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Device Story

Post-processing software for Vitrea platform; processes cardiac CT studies (DICOM). Inputs: ECG-gated contrast-enhanced cardiac CT volumes. Operation: semi-automated segmentation of heart and left ventricle; calculates Perfusion Index (PI) and Transmural Perfusion Ratio (TPR) based on Hounsfield attenuation (HU) values; generates color polar maps and 3D fusion overlays. Used in clinical settings by radiologists/cardiologists. Output: visual maps, quantitative ratios, and defect size measurements. Benefit: aids identification/follow-up of myocardial enhancement defects; supports assessment of cardiac disease/function.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software verification (requirements coverage, RTM), risk management, and validation via phantom testing and simulated usability testing by experienced professionals.

Technological Characteristics

Post-processing software for cardiac CT; leverages existing Vitrea platform (MPR, MIP, volume rendering). Connectivity: DICOM standard compliant. Software lifecycle: IEC 62304:2006. Risk management: ISO 14971:2007. Features: semi-automated segmentation, color polar maps, PI/TPR ratio calculation, 3D fusion, defect size scoring.

Indications for Use

Indicated for patients with angina or previous myocardial infarction to assist trained users (radiologists/cardiologists) in visualizing hypo/hyper dense areas, assessing disease state/treatment, and identifying myocardial enhancement defects.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• MyoPerfusion, CSMP-001A (K132523)
• CT Myocardial Analysis (K112531)

Submission Summary (Full Text)

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

April 17, 2015

Vital Images, Inc % Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414

Re: K150104

Trade/Device Name: Vitrea CT Myocardial Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: II Product Code: JAK, LLZ Dated: January 19, 2015 Received: January 20, 2015

Dear Parthiv Shah,

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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K150104

Device Name Vitrea® CT Myocardial Perfusion

### Indications for Use (Describe)

Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.

The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle.

# 510(k) Summary

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

| Basis for the<br>Submission: | Modifications to a legally marketed device which are not qualified for a<br>Special 510(k) notification |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway<br>Suite 300<br>Minnetonka, MN, 55343-4414 |
| Establishment<br>Registration: | 2134213 |
| Contact Person: | Parthiv Shah<br>Sr. Regulatory Affairs Specialist<br>Phone : 952—487—9574<br>Fax: [phone]<br>E-mail: [e-mail] |
| 510(k) Type: | Traditional |
| Summary Date: | March 31, 2015 |
| Device Trade Name: | Vitrea® CT Myocardial Perfusion Software |
| Device Common<br>Name / Regulatory<br>Description: | An accessory of Computed Tomography X-ray System |
| Device<br>Classification<br>Name: | System, X-ray, Tomography, Computed |
| Regulation Number: | 21 C.F.R. 892.1750 |
| Primary Product<br>Code: | JAK |
| Secondary Product<br>Code: | LLZ |
| Regulatory<br>Classification: | Class II |
| Device Panel: | Radiology |

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Image /page/4/Picture/0 description: The image shows the word "VITAL" in black, with a red tagline underneath that reads "A Toshiba Medical Systems Group Company". The font is sans-serif and modern. The dot on the "i" in "VITAL" is a perfect circle.

## Predicate Devices:

| Predicate Device(s) | Predicate Type | Manufacturer | FDA 510(k)<br>number |
|-------------------------|----------------------------------|----------------------------------------|----------------------|
| MyoPerfusion, CSMP-001A | Primary<br>Predicate<br>Device | Toshiba Medical<br>Systems Corporation | K132523 |
| CT Myocardial Analysis | Secondary<br>Predicate<br>Device | Vital Images, Inc. | K112531 |

## Device Description:

Vitrea CT Myocardial Perfusion is a post-processing software option for the already cleared Vitrea software platform (K071331). It leverages the existing Vitrea platform functionalities such as Multi-Planar Reconstruction (MPR) images, Maximum Intensity Projections (MIP) and volume rendering.

Vitrea CT Myocardial Perfusion enables the visualization and analysis of perfusion defects in the myocardium. The software is intended for use with cardiac CT (Computed Tomography) studies to analyze cardiovascular anatomy and pathology and to assess the presence of hypo/hyper dense areas of myocardial tissue.

The software visualization tools provide semi-automated heart and Left Ventricle (LV) segmentation, and color overlay and polar maps of the myocardial tissue based on the Hounsfield attenuation (HU) values. The software displays the values associated with the generation of the Perfusion Index (PI) and Transmural Perfusion Ratio (TPR) maps. Perfusion Index (PI) is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. Transmural Perfusion Ratio (TPR) is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value. The defect size scoring tool allows a user to delineate one or more contiguous 3D regions within the myocardium for independent size measurements. The user may observe the interpolated result as they are constructing the defect.

The software analysis tools include measurements and comparison ratios. The CT Myocardial Perfusion application allows users to load one or two volumes. In dual-volume cases, the volumes are displayed based on time. It also includes reporting tools for formatting findings and user selected areas of interest.

### Intended Use / Indications for Use:

Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.

The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.

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Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image.

# Intended for Disease / Condition / Patient Population:

The software provides Radiologists and Cardiologists with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their assessment of cardiac disease and functions for patients with angina or those who have had a previous myocardial infarction.

## Substantial Equivalence Comparison:

#### . Regulatory Comparison

| Characteristic | Vitrea CT<br>Myocardial<br>Perfusion<br>software<br>(Submission<br>Subject) | MyoPerfusion,<br>CSMP-001A<br>(K132523)<br>(Predicate<br>Device-1)<br><br>Primary<br>Predicate Device | CT Myocardial<br>Analysis<br>(K112531)<br>(Predicate<br>Device-2)<br><br>Secondary<br>Predicate Device | Noted Differences |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Classification<br>Name | Computed<br>tomography<br>x-ray System | Computed<br>tomography<br>x-ray System | Picture Archiving<br>and<br>Communications<br>System | None<br>Note: The subject<br>device has both JAK<br>and LLZ product<br>codes. |
| Regulatory<br>Number | 892.1750 | 892.1750 | 892.2050 | None<br>Note: The subject<br>device has both JAK<br>and LLZ product<br>codes. |
| Product Code | Primary: JAK<br>Secondary:<br>LLZ | JAK | LLZ | None |
| Classification | Class II | Class II | Class II | None |
| Review Panel | Radiology | Radiology | Radiology | None |
| Decision Date | Under Review | December 12,<br>2013 | November 18,<br>2011 | Both predicates are<br>cleared. |
| Characteristic | Vitrea CT Myocardial<br>Perfusion software<br>(Submission Subject) | MyoPerfusion,<br>CSMP-001A (K132523)<br>(Predicate Device-1) | Noted Differences | |
| Intended Use | Vitrea® CT Myocardial<br>Perfusion is intended<br>to assist a trained user<br>for the visualization of<br>hypo/hyper dense<br>areas in patients with<br>angina or with a<br>previous myocardial<br>infarction to assess<br>the disease state and<br>treatment. This<br>software provides<br>semi-automated heart<br>and left ventricle<br>segmentation and<br>color polar maps of<br>the myocardial tissue.<br>The information<br>provided is intended to<br>be qualitative in nature<br>and, when used by a<br>qualified physician,<br>may aid in the<br>identification of<br>myocardial<br>enhancement defects<br>and the follow up of<br>such findings. | This software is<br>intended to be used for<br>the visualization of non-<br>reversible perfusion<br>defects (hypo/hyper<br>dense areas) in<br>patients with angina or<br>with a previous<br>myocardial infarct.<br>Included software tools<br>may aid a trained user<br>in monitoring the<br>disease state and<br>treatment over time.<br>This software provides<br>maps and the values<br>used to generate the<br>maps.<br>The information<br>provided is intended to<br>be qualitative in nature<br>and when used by a<br>qualified physician may<br>aid in the identification<br>of myocardial<br>enhancement defects<br>and the follow up of<br>such findings. | None | |
| Intended<br>Users | Radiologists and<br>Cardiologists | Radiologists and<br>Cardiologists | None | |
| Patient<br>Population | Patients with angina or<br>those who have had a<br>previous myocardial<br>infarction | Patients with angina or<br>those who have had a<br>previous myocardial<br>infarction | None | |
| Modality<br>Support | CT | CT | None | |
| Characteristic | Vitrea CT Myocardial<br>Perfusion software<br>(Submission Subject) | CT Myocardial Analysis<br>(K112531)<br>(Predicate Device-2) | Noted Differences | |
| Intended Use | Vitrea® CT Myocardial<br>Perfusion is intended<br>to assist a trained user<br>for the visualization of<br>hypo/hyper dense<br>areas in patients with<br>angina or with a<br>previous myocardial<br>infarction to assess<br>the disease state and<br>treatment. This<br>software provides<br>semi-automated heart<br>and left ventricle<br>segmentation and<br>color polar maps of<br>the myocardial tissue.<br>The information<br>provided is intended to<br>be qualitative in nature<br>and, when used by a<br>qualified physician,<br>may aid in the<br>identification of<br>myocardial<br>enhancement defects<br>and the follow up of<br>such findings. | Vitrea® CT Myocardial<br>Analysis is an image<br>analysis software<br>application for cardiac<br>Computer Tomography<br>(CT) studies to<br>visualize cardiovascular<br>anatomy and pathology<br>and to highlight and<br>color code the<br>presence of hypo/hyper<br>dense areas of<br>myocardial tissue. | None<br>The language of Intended<br>Use has been updated to<br>be similar with the 510(k)<br>cleared predicate products<br>available in the US market. | |
| Intended<br>Users | Radiologists and<br>Cardiologists | Radiologists and<br>Cardiologists | None | |
| Patient<br>Population | Patients with angina or<br>those who have had a<br>previous myocardial<br>infarction | Patients with angina or<br>those who have had a<br>previous myocardial<br>infarction | None | |
| Modality<br>Support | CT | CT | None | |
| Characteristic | Vitrea CT Myocardial<br>Perfusion software<br>(Submission Subject) | MyoPerfusion,<br>CSMP-001A (K132523)<br>(Predicate Device-1) | Noted Differences | |
| Device<br>Description | Vitrea CT Myocardial<br>Perfusion is a post-<br>processing software<br>option for the already<br>cleared Vitrea<br>software platform<br>(K071331).<br>It leverages existing<br>Vitrea® functionality<br>such as Multi-Planar<br>Reconstruction (MPR)<br>images, Maximum<br>Intensity Projections<br>(MIP) and volume<br>rendering.<br>Vitrea CT Myocardial<br>Perfusion enables the<br>visualization and<br>analysis of perfusion<br>deficits in the<br>myocardium. The<br>software is intended<br>for use with cardiac<br>CT (Computed<br>Tomography) studies<br>to analyze<br>cardiovascular<br>anatomy and<br>pathology and to<br>assess the presence<br>of hypo/hyper dense<br>areas of myocardial<br>tissue.<br>The software<br>visualization tools<br>provide semi-<br>automated heart and<br>left ventricle<br>segmentation, and<br>color overlay and polar<br>maps of the<br>myocardial tissue | This device processes<br>ECG-gated contrast<br>enhanced cardiac scan<br>data using MPR<br>generated images<br>according to the cardiac<br>axis.<br>The software generates<br>polar maps, perfusion<br>index (PI) map and<br>Transmural Perfusion<br>Ration (TPR) maps<br>based upon the<br>measured CT values of<br>the tissue within the<br>specified region of<br>interest.<br>The software displays<br>the values associated<br>with the generation of<br>the Perfusion Index and<br>TPR Maps.<br>PI is the ratio of the<br>Mean Myocardial CT<br>value to the LV blood<br>pool CT value.<br>TPR is provided as a<br>ratio per sector of the<br>Endocardial CT value<br>to the mean Epicardial<br>CT value. | None<br>Note:<br>The added key features,<br>except Defect Size Scoring<br>tool, are similar to those<br>which are available in the<br>510(k) cleared Predicate<br>Device-1. | |
| Characteristic | Vitrea CT Myocardial<br>Perfusion software<br>(Submission Subject) | MyoPerfusion,<br>CSMP-001A (K132523)<br>(Predicate Device-1) | Noted Differences | |
| | based on the<br>Hounsfield attenuation<br>(HU) values. | | | |
| | The software displays<br>the values associated<br>with the generation of<br>the Perfusion Index<br>(PI) and Transmural<br>Perfusion Ratio (TPR)<br>maps. | | | |
| | PI is the ratio of the<br>Mean Myocardial CT<br>value to the LV blood<br>pool CT value. | | | |
| | TPR is provided as a<br>ratio per sector of the<br>Endocardial CT value<br>to the mean Epicardial<br>CT value. | | |…