MEDVOXEL HEARTPRO SOFTWARE APPLICATION

{0}------------------------------------------------ : : . Image /page/0/Picture/1 description: The image shows the logo for MedVoxel. The logo consists of a grid of nine squares arranged in a diamond shape, followed by the text "MedVoxel". The squares are all black, and the text is in a simple, sans-serif font. The logo is simple and modern. 510(k) Premarket Notification for MedVoxel HeartPro APR 1 2 2011 | 510(k) Summary | | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | MedVoxel Systems Inc. | | | 7363-515 W. Hastings Street<br>Vancouver, British Columbia<br>Canada V6B 5K3<br>Phone: (604)889-3512/(778) 960-5401 | | | Web: www.medvoxel.com | | Contact: | Bonnie Sewlochan | | | Regulatory Consultant on behalf of MedVoxel Systems Inc.<br>2867 Crosscurrent Drive, Mississauga<br>Ontario, Canada L5N 6L1<br>Phone: (647) 234-6643 | | Device Name: | | | Trade Name | MedVoxel HeartPro Software Application | | Common Name | Cardiovascular Image Analysis Software | | Classification | System, Image Processing, Radiological | | CFR Section /Product Code | 21 CFR 892.2050, LLZ | | Device Class | Class II | | Date of Preparation of | March 28, 2011 | . ## Predicate Device Summary: . `--. | Trade Name | 510(k) Submitter/Manufacturer | 510(k) Number | Date Cleared | |--------------------------------------------------|---------------------------------------------------------------------------------|---------------|-----------------------| | Leonardo Syngo Cardiology<br>Workstation (Argus) | Siemens Medical Solutions Inc.<br>51 Valley Stream Parkway<br>Malvern, PA 19355 | K042203 | September 24,<br>2004 | ## 510(k) Summary: Page 1 of 4 : . {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for MedVoxel. The logo consists of a diamond shape made up of smaller squares, followed by the text "MedVoxel" in a sans-serif font. The diamond shape is black, and the text is also black. #### Device Description MedVoxel is a software company that focuses primarily on cardiac specific, clinical post-processing packages and has made it their mandate to offer a product solution that will allow the user to manipulate the image set such that the background phase aliasing errors can be minimized if not eliminated from the images. MedVoxel HeartPro is a web-accessible, self-contained image analysis software application. The application uses cardiac-specific MR scans as a data source for their blood flow analysis computations. Pre-existing MR images are sent from the PACS (or scanner) to the MedVoxel HeartPro software application, image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user, contour are placed and advanced analysis algorithms are applied. Easily reproducible test results are produced and stored in the Measurement Record of the patients' study. HeartPro does not interface directly with any MR or data collection equipment; instead HeartPro imports data files previously generated by such equipment. HeartPro provides quantitative measurements specific to blood flow analysis for MRI data sequences. The software application focuses on what is visible to the eye and applies advanced automated methods to avoid tedious, time-consuming manual methods. The software does not perform any functions which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential error-prone manual tasks. The software has functions for loading, analysing, saving datasets and will generate screen displays, computation and aggregated statistics. #### Intended Use HeartPro consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartPro is intended to be used to support qualified cardiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient. #### Comparison to the Predicate The intended use and technological characteristics of the MedVoxel HeartPro software application are substantially equivalent, in the opinion of MedVoxel Systems, to those of the predicate device and do not pose any new issues of safety and effectiveness. A comparison table has been included on the next page. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for MedVoxel. The logo consists of a geometric shape made up of nine smaller squares arranged in a larger square pattern, with the name "MedVoxel" written to the right of the shape. The geometric shape is black, and the text is in a simple, sans-serif font. | TABLE: Comparison of features and specifications of HeartPro vs. Predicate Device | | | |-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Feature | MedVoxel HeartPro | Siemens Argus | | 510(k) Number | K103565 | K042203 | | | Overview | | | DICOM compliance | Supports DICOM 3.0 | Supports DICOM 3.0 | | Comparative review | 2D | 2D | | 2D measurements | ROI tools with statistics | ROI tools with statistics | | Workflow | Automated contouring | Automated contouring | | | Automated measurements | Automated measurements | | | Manual correction. | Manual correction. | | | GUI Interface/Input/output | | | Image input | DICOM 3.0 via TCP/IP<br>DICOM via secure FTP | DICOM 3.0 via TCP/IP | | Data Acquisition<br>Protocol for Blood<br>Flow Analysis | Cardiovascular images (specifically, multi-phase,<br>multi-slice and velocity encoded images acquired<br>from magnetic resonance scanners).<br>Same approach to general usage - performs Blood<br>Flow calculations, and output the desired data<br>parameters. | Cardiovascular images (specifically, multi-phase,<br>multi-slice and velocity encoded images acquired<br>from magnetic resonance scanners).<br>Same approach to general usage - performs Blood<br>Flow calculations, and output the desired data<br>parameters. | | User Interactions | Users can browse, select, and load CMRI scan files.<br>Users can save and load analyses, export to files.<br>User can generate a report that displays quantitative<br>data items and can be saved to a PDF file. DICOM<br>info displayed. | User can browse, select, and load CMRI scan files.<br>Users can save and load analyses, export to files. User<br>can generate a report that displays quantitative data<br>items. | | Measurement<br>information page | Blood flow chart displayed | Blood flow chart displayed | | Repeatability | Re-enter the parameters recorded in the previously<br>made reports. Fully repeatable when relying on<br>automated ROI definition.<br>If manually defined - Not easily reproducible<br>(identical to predicate) due to significant manual<br>involvement. | Not easily reproducible due to significant manual<br>involvement | | Contouring/Editing | | | | ROI vessel contour detection | Automatic contour detection with user input (optional: can be followed by manual user editing). | Automatic contour detection without initial user input followed by manual user editing | | ROI vessel contour editing | Contour editor | Contour editor | | Analytical Processing /Quantitative Outputs | | | | Phase aliasing error correction | Phase alias correction provided via user interface | Phase alias correction provided via user interface | | | Measurement algorithm generates quantitative clinical data, including parameters such as net blood flow rate, and blood flow volume. | With manual assistance, measurement algorithm generates quantitative clinical data, including parameters such as net blood flow rate, and blood flow volume. | | Screen Functions and Image Manipulations | | | | Feature Sets | Extensive set of features for image manipulation, presented as toolbars, mouse-overs, screen-tips, pan/zoom, scroll bars, pull-down menus | Extensive set of features for image manipulation, presented as toolbars, mouse-overs, screen-tips, pan/zoom, scroll bars, pull-down menus: | | | Pan/zoom, magnify, maximize and minimize image displays. Scroll through slice stack Adjust window level, contrast, brightness Single image ROI placement, automated 2D ROI copy. ROI edit functions. 2D Velocity Color Map | Pan/zoom, magnify, maximize and minimize image displays. Scroll through slice stack Adjust window level, contrast, brightness Single image ROI placement, automated 2D ROI copy. ROI edit functions. 2D Velocity Color Map | | Scan quality assessments | | | | Expected Format | Expected format is DICOM, must receive DICOM compliant image studies. Only lossless compression. | Expected format is DICOM, must receive DICOM compliant image studies. Only lossless compression. | | User Base | Intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. | Intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making | . tures and specifications of HeartPro vs. Predicate Device 510(k) Summary: Page 3 of 4 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MedVoxel. The logo consists of a diamond shape made up of smaller squares on the left, and the word "MedVoxel" in a sans-serif font on the right. The diamond shape is black, and the word "MedVoxel" is also black. # Summary of Testing Nonclinical verification and validation test results established that the device meets its design requirements and intended use, and that it is as safe, as effective, and performs as well as the predicate device and that no new issues of safety and effectiveness were raised. 510(k) Summary: Page 4 of 4 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus is made up of three wavy lines that represent the snakes of Asclepius, the Greek god of medicine. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 MedVoxel Systems, Inc. % Ms. Bonnie Sewlochan Regulatory Consultant Bolynn Corp. 2867 Crosscurrent Drive, Mississauga Ontario, LSN 6L1 CANADA APR 1 2 2011 Re: K103565 Trade/Device Name: MedVoxel HeartPro Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: April 4, 2011 Received: April 7, 2011 Dear Ms. Sewlochan: 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 of {5}------------------------------------------------ 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours. Mary S Pastel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use Statement 510(k) Number: K103565 Device Name : MedVoxel HeartPro Software Application Indications for Use: HeartPro consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartPro is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient. Prescription Use __ AND/OR Over-The-Counter Use (per 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) Page 1 of 1 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mary S Pool Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K103565