HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, 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 HeartScan 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

Morpheus HeartScan is a web-accessible image analysis software application. The application is intended to visualize and quantify cardiac-specific MRI data in DICOM format. HeartScan has features for loading, saving, generating screen displays, and aggregating flow statistics.

Pre-existing MR images are uploaded via the web to the HeartScan software application where image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user. Automatic or manual vessel segmentation is performed and advanced analysis algorithms are applied to quantify blood flow. The images and blood flow can be simultaneously visualized at any plane using multi-planar reconstruction (MPR) with color flow fusion. Reproducible test results are produced and stored in the image study.

HeartScan does not interface directly with any MR or data collection equipment, instead HeartScan imports data files previously generated by such equipment. The software application applied 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 purpose of the software is to save time and automate potential error-prone manual tasks.

AI/ML Overview

The provided text describes the Morpheus HeartScan Software, a web-accessible image analysis application intended to visualize and quantify cardiac-specific MRI data. The document focuses on demonstrating its substantial equivalence to a predicate device, MedVoxel HeartPro Software System (K103565).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present explicit "acceptance criteria" in a quantified table format for each feature. Instead, the performance is demonstrated through a comparison to a predicate device, aiming to show that the HeartScan device performs "as well as" the predicate device and generates "clinically acceptable reproducible data."

However, we can infer some criteria from the "Performance Data" section and the comparison table. The primary performance claim is that the device generates reproducible data and that "HeartScan outputs were within a clinically acceptable range compared to that of the predicate."

Based on the provided text, the most direct 'acceptance criteria' and 'reported device performance' can be summarized as follows:

Acceptance Criteria (Implied)	Reported Device Performance
Reproducible data generation for the same ROI within the same dataset.	"Specific test cases were created during verification that included multiple analysis of the same ROI within the same dataset to confirm that the device generated the same output within an acceptable criterion." (The acceptable criterion itself is not specified quantitatively).
Clinically acceptable range of outputs compared to the predicate device for analyzed datasets and ROIs.	"Validation between HeartScan and the predicate device included analyzing the same datasets and ROI to confirm that HeartScan outputs were within a clinically acceptable range compared to that of the predicate. Results conclude that HeartScan is capable of generating clinically acceptable reproducible data in comparison with a similar currently marketed device." (The "clinically acceptable range" is not quantitatively defined).
Meeting design requirements and intended use	"Nonclinical verification and validation test results established that the device meets its design requirements and intended use..."
Equivalence in safety and effectiveness to the predicate device, raising no new issues.	"...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."
Compliance with specified standards	The device was verified and validated according to the company's Design Control process and complies with DICOM; PS 3.1 3.20 (2011), IEC 62304, ISO 14971, and ISO 62366.

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

Sample Size for Test Set: The document mentions "the same datasets" and "multiple analysis of the same ROI" but does not specify the number of datasets or ROIs used in the test set.
Data Provenance: The document states that the software has been "tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners." It does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The validation appears to rely on a comparison to "clinically acceptable range" relative to the predicate device, rather than a hard "ground truth" established by experts.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not discussed or conducted according to the provided text. The evaluation focuses on the standalone device's performance in comparison to a predicate, not human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "Performance Data" section describes nonclinical verification and validation tests performed on the HeartScan software itself, comparing its outputs for reproducibility and against a predicate device. This confirms an "algorithm only" evaluation.

7. Type of Ground Truth Used

The primary "ground truth" or reference standard for comparison appears to be:

Internal Consistency/Reproducibility: The device producing "the same output within an acceptable criterion" when analyzing the same ROI multiple times.
Comparison to a Predicate Device: HeartScan outputs being "within a clinically acceptable range compared to that of the predicate."

There is no mention of pathology, outcomes data, or expert consensus establishing a definitive absolute ground truth for the measurements. The focus is on consistency and similarity to an already approved device.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. As the device's description highlights "advanced automated methods" and its purpose to "automate potential error-prone manual tasks," it implies an algorithm, but details about its development (and thus, a training set) are not provided in this 510(k) summary. The summary focuses on verification and validation, not model development.

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

Since no training set is mentioned or described, the method for establishing its ground truth is not provided in the document.

Summary

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APR 0 3 2014

K133937
Page 1 of 4

510(k) Summary Prepared November 6, 2013 (Revised: March 14, 2014)

Sponsor:	Morpheus Imaging, Inc
Contact Person:	John Axerio-Cilies Ph.D.
Address:	1700 4th St. MC 2522 Byers Hall 214San Francisco, California 94158-2330
Telephone:	650 391 7111
Fax:	650 319 7231
Submission Date:	November 6, 2013
Device Name:	HeartScan Software
Common Name:	Radiology Imaging Software
Classification:Regulatory Class:Review Category:Classification Panel:	II21 CFR 892.2050 (LLZ)Radiology

A. Legally Marketed Predicate Devices

The Morpheus HeartScan software device is substantially equivalent to the MedVoxel Systems Inc. Med Voxel HeartPro Software System (K103565).

B. Device Description:

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C. Intended Use

D. Substantial Equivalence

The submission device is substantially equivalent to MedVoxel Systems Inc. MedVoxel HeartPro Software Application (K103565) as described in the table below:

Feature/Specification	Predicate Device	Subject Device
	MedVoxel HeartPro Software	Morpheus HeartScan Software
	Application K103565
Indication 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-slice, 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 health care 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.	HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, 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 HeartScan is intended to be used to support qualified cardiologist, radiologist or other licensed professional health care 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.
Intended Users	qualified cardiologist, radiologist or other licensed professional health care practitioners	qualified cardiologist, radiologist or other licensed professional health care practitioners
Class	II	II

Table 1 Comparison Table

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Feature/Specification	Predicate DeviceMedVoxel HeartPro SoftwareApplication K103565	Subject DeviceMorpheus HeartScan Software
Regulation	21CFR 892.2050	21CFR 892.2050
Code	LLZ	LLZ
Data Acquisition
Workstation	Yes	Yes
operating system
Images from all MRIscanners supported	Yes both 1.5T and 3.0 T	Yes both 1.5T and 3.0 T
Image input	Supports DICIOM 3.0	Supports DICOM 3.0
Data acquisitionprotocol for bloodflow analysis	Cardiovascular images: multi-phase.multi-slice and velocity encodedimages acquired from MRI scanners	Cardiovascular images: multi-phase.multi-slice and velocity encodedimages acquired from MRI scanners
Workflow
User Interactions	User can browse, select and loadCMRI scan files: save and loadanalyses; export to files; generatereports with quantitative data; displayDICOM information	User can browse, select and load CMRIscan files; save and load analyses;export to files; generate reports withquantitative data; display DICOMinformation
Image manipulation	Pan/zoom; magnify; maximize andminimize; adjust window level,contrast, brightness; single imageROI placement; automated 2D ROIcopy/edit functions; 2D velocitycolor map.	Pan/zoom; magnify; maximize andminimize; scroll through slice stack;adjust window level, contrast,brightness; single image ROIplacement; automated 2D ROIcopy/edit functions; 2D velocity colormap.
ROI vessel contourdetection and editing	Automatic contour detection withuser input; can be changed manually	Automatic contour detection with userinput; can be changed manually
Data Analysis
2D measurements	ROI tools and statistics	ROI tools and statistics
Quantitativeassessment of cardiacfunction	Measurement algorithm generatesclinical data, including parameterssuch as net blood flow rate, and netblood flow volume.	Measurement algorithm generatesclinical data, including parameters suchas net blood flow rate, and net bloodflow volume.
Phase Aliasing ErrorCorrection	Phase alias error correction providedvia user interface	No
Eddy CurrentCorrection (ECC)	Yes	Yes
Data Output:
Dynamic display ofventricularcontractions	Yes	Yes
Comparative review	2D	2D
MeasurementInformation	Blood flow chart displayed; Netblood flow rate; Net blood flowvolume	Blood flow chart displayed; Net bloodflow rate; Net blood flow volume

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orpheus

K133937
Page 4 of 4

E. Performance Data

Nonclinical verification and validation test results established that the device meets its design requirements and intended use, 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. The HeartScan software was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

Digital Imaging and Communications in Medicine (DICOM); PS 3.1 3.20 . (2011)
Medical device software Software Life Cycle Process, IEC 62304 .
Medical devices Application of risk management to medical devices, 14971 ● Second edition 2007-03-01
Medical Devices Application of Usability Engineering to Medical Devices, ISO 62366

Nonclinical verification and validation test results establish that the device generates reproducible data. Specific test cases were created during verification that included multiple analysis of the same ROI within the same dataset to confirm that the device generated the same output within an acceptable criterion. Additionally, validation between HeartScan and the predicate device included analyzing the same datasets and ROI to confirm that HeartScan outputs were within a clinically acceptable range compared to that of the predicate. Results conclude that HeartScan is capable of generating clinically acceptable reproducible data in comparison with a similar currently marketed device.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Public Health Service

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

April 3, 2014

Morpheus Imaging, Inc. % John Axerio-Cilies, Ph.D. CEO 1700 4th Street MC 2522 Byers Hall 214 SAN FRANCISCO CA 95158-2330

Re: K133937

Trade/Device Name: HeartScan Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 14, 2014 Received: March 25, 2014

Dear Dr. Axerio-Cilies:

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 or any i 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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Page 2-Dr. Axerio-Cilies

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 (800) 638 2041 or (301) 796-7100 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.fdagov/McdicalDevices/Salietv/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES . Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133937

Device Name Morpheus HeartScan

Indications for Use (Describe)

HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its multi-slice, 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 HeartScan is intended 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 clintended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

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

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)

FORM FDA 3881 (1/14)

September (301) 443-6740 EF

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).