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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the MedVoxel HeartPro Software Application, based on the provided 510(k) summary:

Note: The provided document is a 510(k) summary, which often provides high-level information. While it states that "Nonclinical verification and validation test results established that the device meets its design requirements and intended use," it does not provide detailed quantitative acceptance criteria or a specific study report that explicitly lists those criteria and directly compares them to detailed device performance metrics. The information below is extracted and inferred from the available text.

Regarding the "study that proves the device meets the acceptance criteria," the document implicitly refers to the "Nonclinical verification and validation test results." However, it does not provide details about the specific study design, methodologies, or the raw performance data from that study.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific quantitative acceptance criteria are not explicitly detailed in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device and states that the device "meets its design requirements and intended use."

The primary reported performance claims relate to the device's capabilities and qualitative attributes, rather than specific numerical accuracy thresholds.

Acceptance Criteria Category (Inferred from product description)	Reported Device Performance (as stated in the document)
Functionality: DICOM Compliance	Supports DICOM 3.0
Functionality: Image Input Methods	DICOM 3.0 via TCP/IP, DICOM via secure FTP
Functionality: Data Acquisition Protocol for Blood Flow Analysis	Analyzes cardiovascular images (multi-phase, multi-slice, velocity encoded MR) to perform blood flow calculations and output data parameters.
Functionality: User Interactions	Browse, select, load CMRI scan files; save/load analyses; export to files; generate PDF reports with quantitative data; display DICOM info.
Functionality: Measurement Information Display	Blood flow chart displayed.
Functionality: Repeatability (Automated ROI)	Fully repeatable when relying on automated ROI definition.
Functionality: Repeatability (Manual ROI)	Not easily reproducible (identical to predicate) due to significant manual involvement.
Functionality: ROI Vessel Contour Detection	Automatic contour detection with user input (optional: can be followed by manual user editing).
Functionality: Phase Aliasing Error Correction	Phase alias correction provided via user interface.
Functionality: Quantitative Clinical Data Generation	Measurement algorithm generates quantitative clinical data, including parameters such as net blood flow rate, and blood flow volume.
Functionality: Image Manipulation Features	Extensive set of features: toolbars, mouse-overs, screen-tips, pan/zoom, scroll bars, pull-down menus; pan/zoom, magnify, maximize/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.
Functionality: Scan Quality Assessment (Input Format)	Expected format is DICOM, must receive DICOM compliant image studies. Only lossless compression.
Intended Use Fulfillment: Clinical Relevance	Provides clinically relevant and reproducible, quantitative data.
Compatibility: MR Scanners	Tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.
Safety & Effectiveness: Comparison to Predicate	Substantially equivalent to predicate device; does not pose any new issues of safety and effectiveness.
Overall Performance: Meets Design/Intended Use	Meets its design requirements and intended use.

Key Takeaway from the Table: The provided document emphasizes feature parity and functional equivalence with the predicate device (Siemens Argus). It does not present a statistical study with numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or inter-reader/intra-reader agreement thresholds) and corresponding test results against those criteria. The "Summary of Testing" section is a general declaration rather than a detailed report.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Nonclinical verification and validation test results established that the device meets its design requirements and intended use..." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) used for these verification and validation tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth, as it does not detail the methodology of the verification and validation tests.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set, as details of the verification and validation tests are not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of comparing human readers with AI assistance versus without AI assistance, nor any reported effect size for such a comparison. The focus is on the software automating "tedious, time-consuming manual methods" and providing "reproducible test results" that "save time."

6. Standalone (Algorithm Only) Performance Study

The document states that the software has functions for loading, analyzing, saving datasets, and generating displays and statistics. It also mentions "Automated contouring" and "Automated measurements." This implies a standalone algorithm's ability to perform these tasks.

However, the document also notes: "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." And for "Contouring/Editing," it specifically says "Automatic contour detection with user input (optional: can be followed by manual user editing)." This suggests that while the algorithm has standalone capabilities, the intended workflow may involve human oversight and potential correction.

Therefore, while the core algorithms likely have standalone performance, the provided summary does not present a dedicated standalone performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for the algorithm in isolation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the verification and validation tests. Given the nature of cardiac MR image analysis for blood flow, it's highly probable that some form of "expert consensus" or "expert manual tracing" would have been used as a comparator for automated measurements, but this is an inference.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. It focuses on the verification and validation of the product, not its development or training process.

9. How the Ground Truth for the Training Set Was Established

As no information is provided about the training set, the method for establishing its ground truth is also not mentioned.

Summary

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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 StreetVancouver, British ColumbiaCanada V6B 5K3Phone: (604)889-3512/(778) 960-5401
	Web: www.medvoxel.com
Contact:	Bonnie Sewlochan
	Regulatory Consultant on behalf of MedVoxel Systems Inc.2867 Crosscurrent Drive, MississaugaOntario, Canada L5N 6L1Phone: (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:

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Trade Name	510(k) Submitter/Manufacturer	510(k) Number	Date Cleared
Leonardo Syngo CardiologyWorkstation (Argus)	Siemens Medical Solutions Inc.51 Valley Stream ParkwayMalvern, PA 19355	K042203	September 24,2004

510(k) Summary: Page 1 of 4

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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.

HeartPro does not interface directly with any MR or data collection equipment; instead HeartPro imports data files previously generated by such equipment.

The software has functions for loading, analysing, saving datasets and will generate screen displays, computation and aggregated statistics.

Intended Use

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.

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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/IPDICOM via secure FTP	DICOM 3.0 via TCP/IP
Data AcquisitionProtocol for BloodFlow Analysis	Cardiovascular images (specifically, multi-phase,multi-slice and velocity encoded images acquiredfrom magnetic resonance scanners).Same approach to general usage - performs BloodFlow calculations, and output the desired dataparameters.	Cardiovascular images (specifically, multi-phase,multi-slice and velocity encoded images acquiredfrom magnetic resonance scanners).Same approach to general usage - performs BloodFlow calculations, and output the desired dataparameters.
User Interactions	Users can browse, select, and load CMRI scan files.Users can save and load analyses, export to files.User can generate a report that displays quantitativedata items and can be saved to a PDF file. DICOMinfo displayed.	User can browse, select, and load CMRI scan files.Users can save and load analyses, export to files. Usercan generate a report that displays quantitative dataitems.
Measurementinformation page	Blood flow chart displayed	Blood flow chart displayed
Repeatability	Re-enter the parameters recorded in the previouslymade reports. Fully repeatable when relying onautomated ROI definition.If manually defined - Not easily reproducible(identical to predicate) due to significant manualinvolvement.	Not easily reproducible due to significant manualinvolvement
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

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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

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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

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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 (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

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Indications for Use Statement

510(k) Number: K103565

Device Name : MedVoxel HeartPro Software Application

Indications for Use:

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).