The Arterys Software consists of software that analyzes DI COM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software 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 it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software 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 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

The Arterys Software is a web-accessible image post-processing analysis software device for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for the analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. The Arterys Software is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.

AI/ML Overview

The provided text describes the Arterys Software v2.0 and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria.

The document states that "Safety and performance of the Arterys Software has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing, as well as software usability testing." However, the results of these tests, including the acceptance criteria used and the reported performance values, are not included in this summary.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This information would typically be found in the detailed performance data section of a 510(k) submission, which is summarized or referenced here but not fully disclosed.

Summary

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

October 28, 2016

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

Re: K162513

Trade/Device Name: Arterys Software v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2016 Received: October 21, 2016

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. 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. 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) K162513

Device Name Arterys Software v2.0

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 5. 510(k) Summary

1. General Information

510(k) Sponsor	Arterys Inc.
Address	51 Federal St. Suite 305San Francisco, CA 94107
Correspondence Person	Golnaz MoeiniDirector of Quality and Regulatory, RACArterys Inc.
Contact Information	Email: golnaz@arterys.comPhone: 408-504-3187
Date Prepared	08/01/2016

2. Proposed Device

Proposed Device:

Proprietary Name	Arterys Software v2.0
Common Name	Arterys Software v2.0
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Product Code	LLZ
Regulatory Class	II

3. Predicate Device

Primary Predicate Device:

Proprietary Name	Morpheus HeartScan
Premarket Notification	K133937
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Product Code	LLZ
Regulatory Class	II

Secondary Predicate Device:

Proprietary Name	Medis Imaging QMass
Premarket Notification	K140587
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Product Code	LLZ
Regulatory Class	II

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4. Device Description

The following visualization, quantification and data-reporting functionalities are provided by the software:

Visualization:

-2D image review
3D image review by means of MIP, Surface MinIP, Surface and Average -
Multi-planer reconstruction (MPR) views (axial, coronal and sagittal) -
-Image navigation tools
Cine play -
Cardiac view -

Quantification:

-Anatomy and tissue segmentation
-Linear distance and area measurements
-Flow quantification, including net flow, forward flow, regurgitation fraction, pressure gradient and primary flow direction, at user-specified locations where contours have been created (i.e. aortic valve, pulmonary valve, mitral valve, tricuspid valve, and superior vena cava).
-Cardiac function volume quantification including stroke volume, ejection fraction, cardiac output, end-diastolic mass and volume, end-systolic mass and volume
-Phase correction

Data reporting:

The volume, blood flow and linear distance statistics, along with user-selected, annotated images, are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the clinician database, such as PACS, for review.

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5. Indications for Use

The Arterys Software consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software 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 it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software 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.

Feature/Function	Proposed Device:Arterys Software	Primary PredicateDevice:Morpheus HeartScan(K133937)	SecondaryPredicate Device:Medis ImagingQMass(K140587)
OperatingSystem	Linux	Linux	Not Applicable
Platform	Client-server, ChromeDesktop	Client-server, ChromeDesktop	Not Applicable
Scanners	Both 1.5T and 3.0T	Both 1.5T and 3.0T	Not Applicable
Image input	Supports DICOM 3.0	Supports DICOM 3.0	Not Applicable
Data acquisitionprotocol for flowand volumeanalysis	Cardiovascularimages: multi-phase,multi-slice andvelocity encodedimages acquired fromMRI scanners	Cardiovascularimages: multi-phase,multi-slice andvelocity encodedimages acquired fromMRI scanners	Not Applicable
Image displaymode	Static and cine	Static and cine	Not Applicable
ImageNavigationTools1	Pan, zoom, rotate,maximize/minimize,slice scroll (viewmultiple slices),adjust window/level,slab thickness, flowdirection and timescroll (view multiple	Pan, zoom, rotate,maximize/minimize,slice scroll (viewmultiple slices),adjust window/level,time scroll (viewmultiple phases),image ROI placement;	Not Applicable
Feature/Function	Proposed Device:Arterys Software	Primary PredicateDevice:Morpheus HeartScan(K133937)	SecondaryPredicate Device:Medis ImagingQMass(K140587)
	phases), image ROIplacement; automated2D ROI (with editfunctions); 2D speedcolor map.	automated 2D ROI(with edit functions);2D speed color map.
2D imagereview	Yes	Yes	Not Applicable
3D (volumerendered) imagereview	Yes	Yes	Not Applicable
Cardiac View2	Yes	No	Not Applicable
Orientation label	Yes	Yes	Not Applicable
Cross-referenceindicator3	Yes	No	Not Applicable
View DICOMdata	Yes, users can viewthe DICOMinformation about thepatient, study andcurrent image	Yes, users can viewthe DICOMinformation about thepatient, study andcurrent image	Not Applicable
SecondaryCapture4	Yes	No	Not Applicable
Segmentation ofregion of interest	Manual and semi-automatic	Manual and semi-automatic	Not Applicable
Phase errorcorrection	Yes, Eddy CurrentCorrection	Yes, Eddy CurrentCorrection	Not Applicable
QuantitativeAnalysis, flow	Yes	Yes	Not Applicable
QuantitativeAnalysis, area	Yes	Yes	Not Applicable
Feature/Function	Proposed Device:Arterys Software	Primary PredicateDevice:Morpheus HeartScan(K133937)	SecondaryPredicate Device:Medis ImagingQMass(K140587)
QuantitativeAnalysis, lineardistance5	Yes	Yes	Not Applicable
QuantitativeAnalysis,volume	Yes	Not Applicable	Yes
2D PhaseContrast6	Yes	No	Not Applicable
Directional/vector display ofthe bloodparticle travel8	Blood flow and flowdirection are availableby means of coloroverlay and vectorsand/or streamlines	Blood flow isavailable by meansof color overlay.Vector componentinformation isdisplayed.	Not Applicable
Flowquantificationof valves9	Option to adjustplane at eachTimepoint for flowmeasurement. Sameflow algorithm aspredicate.	Flow measurementin a static plane,with the option tocreate a separateflow measurement atdifferent planes foreach Timepoint.	Not Applicable
Automaticselection of theTemporalLandmarkTimepoints10	Available as aprerequisite step tovolumemeasurement.	Not Applicable	Available as aprerequisite stepto volumemeasurement.

6. Comparison of Technological Characteristics with the Predicate Device

Arterys, Inc., Traditional 510(k)

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Performance Data 7.

Safety and performance of the Arterys Software has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing, as well as software usability testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008-Medical device software - Software life cycle processes in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in

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Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."

8. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Arterys Software raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performanc

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).