AZE VirtualPlace - MR Flow Analysis software option for use with AZE VirtualPlace workstation is intended for post-processing of DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves. The MR Flow Analysis software calculates and displays the following parameters: mean/minimum/maximum and standard deviation of blood velocity in the selected region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output, and provides graphs of the velocity and volume. These parameters may be useful for a trained physician in supporting the determination of a diagnosis.

Device Description

AZE VirtualPlace - MR Flow Analysis software is an optional post-processing software designed to be installed on and used with AZE VirtualPlace workstation (cleared under K060453), which accepts, transfers, displays, stores, and digitally process DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. The MR Flow Analysis retrieves velocity-encoded MRI imaging data via electric media (offline), such as CD-ROM, or digital network (online), and facilitates the visualization and quantitative analysis for arterial vessels and heart valves. The MR Flow Analysis enables to calculate blood flow velocity and flow volume in region(s) of interest (ROI[s]) from the velocity-encoded MR data, and provide quantitative and visual analysis by displaying graphical parameters such as Mean/Minimum/Maximum velocity, Standard deviation, Velocity and volume flow as function of time, Stroke volume, and Cardiac output.

AI/ML Overview

This document describes the AZE VirtualPlace - MR Flow Analysis software, which is intended for post-processing DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence to predicate devices (MRI-FLOW analytical software package, K994282, and cmr42 Cardiac MR Software, K082628) in technological characteristics, software features, and indications for use.	"AZE VirtualPlace - MR Flow Analysis software has similar technological characteristics to the currently marketed predicate devices listed above. The technological characteristics and performance data for AZE VirtualPlace - MR Flow Analysis software demonstrates it is substantially equivalent to the predicate device."
Quantitative validation by comparing its output to that of one of the predicate devices.	"the AZE VirtualPlace - MR Flow Analysis software was quantitatively validated by comparing its output to that of one of the predicate devices (cmr42 Cardiac MR Software) for the same set of test images."
Ability to calculate and display specified parameters: mean/minimum/maximum and standard deviation of blood velocity in ROI, velocity and volume flow as function of time, stroke volume, and cardiac output, with corresponding graphs.	The device description and intended use clearly state these capabilities. The quantitative validation implicitly confirms these functions work comparably to the predicate.

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

Sample Size: The document states "the same set of test images" was used for quantitative validation. However, the number of images in this test set is not specified.
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions "velocity-encoded MRI imaging data via electric media (offline), such as CD-ROM, or digital network (online)".

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

Number of Experts: The document does not specify the number of experts used.
Qualifications of Experts: The document does not specify the qualifications of any experts involved in establishing ground truth. The comparison was made against a predicate device's output, not necessarily an expert's assessment.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not describe an adjudication method for establishing ground truth, as the comparison was primarily against the output of a predicate device.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. The study focused on the standalone performance of the algorithm compared to a predicate device, not on human reader performance with or without AI assistance.
Effect Size: As no MRMC study was conducted, there is no reported effect size for human reader improvement with AI assistance.

6. Standalone Performance Study

Standalone Study: Yes, a standalone performance study was done. The document states: "the AZE VirtualPlace - MR Flow Analysis software was quantitatively validated by comparing its output to that of one of the predicate devices (cmr42 Cardiac MR Software) for the same set of test images." This is a standalone evaluation of the algorithm's output against a recognized standard (the predicate device). No human-in-the-loop performance evaluation is described.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance study was the output of a predicate device (cmr42 Cardiac MR Software). This implies that the predicate device's calculations and visualizations were considered the reference truth for comparison.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not specify a training set or its sample size. This type of software, performing quantitative analysis of existing MRI data, might not necessarily involve a machine learning model that requires a distinct "training set" in the conventional sense. The "performance data" describes validation against a predicate, not model training.

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

Ground Truth for Training Set: As no training set is described, information on how its ground truth was established is not provided.

Summary

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AZE VirtualPlace - MR Flow Analysis software 510(k) Premarket Notification

MAY 2 4 2011

510(k) Summary

Date Prepared

May 13, 2011

Submitter

AZE, Ltd. Marunouchi Trust Tower NORTH 13F, 1-8-1 Marunouchi Chiyoda-ku, Tokyo 100-0005, Japan Phone: +81-3-3212-7721 Fax: +81-3212-7722 Contact Person: Yuki Kitajima

General Information

Proprietary Name: AZE VirtualPlace – MR Flow Analysis software Common Name: MR Flow Analysis Classification Name: System, Image Processing, Radiology CFR Reference: 21 CFR 892.2050 Class: II Product Code: 90 LLZ

Predicate Devices

MRI-FLOW analytical software package (K994282) from MEDIS medical imaging systems B.V. and cmr42 Cardiac MR Software (K082628) from Circle Cardiovascular Imaging, Inc.

Device Description

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K102534
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AZE VirtualPlace - MR Flow Analysis software 510(k) Premarket Notification

manipulation, communication, printing and quantification. The MR Flow Analysis retrieves velocity-encoded MRI imaging data via electric media (offline), such as CD-ROM, or digital network (online), and facilitates the visualization and quantitative analysis for arterial vessels and heart valves. The MR Flow Analysis enables to calculate blood flow velocity and flow volume in region(s) of interest (ROI[s]) from the velocity-encoded MR data, and provide quantitative and visual analysis by displaying graphical parameters such as Mean/Minimum/Maximum velocity, Standard deviation, Velocity and volume flow as function of time, Stroke volume, and Cardiac output.

Intended Use

AZE VirtualPlace - MR Flow Analysis software for use with AZE VirtualPlace workstation is intended for post-processing of DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves. The MR Flow Analysis enables to calculate and display the parameters: mean/minimum/maximum and standard deviation of blood velocity in region of interest (ROI), velocity and volume flow as function of time, stroke volume and cardiac output, with graphs of the velocity and volume. These parameters may be useful for a trained physician in supporting the determination of a diagnosis.

Technological Characteristics

AZE VirtualPlace - MR Flow Analysis software has similar technological characteristics to the currently marketed predicate devices listed above.

Performance Data (non-clinical or clinical)

AZE VirtualPlace - MR Flow Analysis software is substantially equivalent to the predicate devices based on descriptive data, software features and indications for use. In addition, the AZE VirtualPlace - MR Flow Analysis software was quantitatively validated by comparing its output to that of one of the predicate devices (cmr42 Cardiac MR Software) for the same set of test images.

Conclusions

The technological characteristics and performance data for AZE VirtualPlace - MR Flow Analysis software demonstrates it is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

AZE: Ittd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

MAY 2 4 2011

Re: K102534

Trade/Device Name: AZE VitualPlace™ – MR Flow Analysis software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 17, 2011 Received: May 18, 2011

Dear Mr. Job:

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 (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 Patel

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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4.0 Indication for Use statement

510(k) Number (if known):	Not assigned
Device-Name:	AZE VirtualPlace™ - MR Flow Analysis software
Indications For Use:	AZE VirtualPlace - MR Flow Analysis software option for use with AZE VirtualPlace workstation is intended for post-processing of DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves. The MR Flow Analysis software calculates and displays the following parameters: mean/minimum/maximum and standard deviation of blood velocity in the selected region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output, and provides graphs of the velocity and volume. These parameters may be useful for a trained physician in supporting the determination of a diagnosis.

510(k) Number (if known):

Not assigned

Device-Name:

AZE VirtualPlace™ - MR Flow Analysis software

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mausfostel
(Division Sign-Off)

Division of Radiologic Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Sefety

510K K102534

Page 4-1 of 1

AZE, Ltd.

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).