Arterys Software v2.0

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K162513 Device Name Arterys Software v2.0 #### Indications for Use (Describe) 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. 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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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines running parallel to each other. The lines appear to be of equal thickness and are black. # Section 5. 510(k) Summary #### 1. General Information | 510(k) Sponsor | Arterys Inc. | |-----------------------|--------------------------------------------------------------------------| | Address | 51 Federal St. Suite 305<br>San Francisco, CA 94107 | | Correspondence Person | Golnaz Moeini<br>Director of Quality and Regulatory, RAC<br>Arterys Inc. | | Contact Information | Email: golnaz@arterys.com<br>Phone: 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 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow. # 4. 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. 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow. # 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/<br>Function | Proposed Device:<br>Arterys Software | Primary Predicate<br>Device:<br>Morpheus HeartScan<br>(K133937) | Secondary<br>Predicate Device:<br>Medis Imaging<br>QMass<br>(K140587) | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Operating<br>System | Linux | Linux | Not Applicable | | Platform | Client-server, Chrome<br>Desktop | Client-server, Chrome<br>Desktop | 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 acquisition<br>protocol for flow<br>and volume<br>analysis | Cardiovascular<br>images: multi-phase,<br>multi-slice and<br>velocity encoded<br>images acquired from<br>MRI scanners | Cardiovascular<br>images: multi-phase,<br>multi-slice and<br>velocity encoded<br>images acquired from<br>MRI scanners | Not Applicable | | Image display<br>mode | Static and cine | Static and cine | Not Applicable | | Image<br>Navigation<br>Tools1 | Pan, zoom, rotate,<br>maximize/minimize,<br>slice scroll (view<br>multiple slices),<br>adjust window/level,<br>slab thickness, flow<br>direction and time<br>scroll (view multiple | Pan, zoom, rotate,<br>maximize/minimize,<br>slice scroll (view<br>multiple slices),<br>adjust window/level,<br>time scroll (view<br>multiple phases),<br>image ROI placement; | Not Applicable | | Feature/<br>Function | Proposed Device:<br>Arterys Software | Primary Predicate<br>Device:<br>Morpheus HeartScan<br>(K133937) | Secondary<br>Predicate Device:<br>Medis Imaging<br>QMass<br>(K140587) | | | phases), image ROI<br>placement; automated<br>2D ROI (with edit<br>functions); 2D speed<br>color map. | automated 2D ROI<br>(with edit functions);<br>2D speed color map. | | | 2D image<br>review | Yes | Yes | Not Applicable | | 3D (volume<br>rendered) image<br>review | Yes | Yes | Not Applicable | | Cardiac View2 | Yes | No | Not Applicable | | Orientation label | Yes | Yes | Not Applicable | | Cross-reference<br>indicator3 | Yes | No | Not Applicable | | View DICOM<br>data | Yes, users can view<br>the DICOM<br>information about the<br>patient, study and<br>current image | Yes, users can view<br>the DICOM<br>information about the<br>patient, study and<br>current image | Not Applicable | | Secondary<br>Capture4 | Yes | No | Not Applicable | | Segmentation of<br>region of interest | Manual and semi-<br>automatic | Manual and semi-<br>automatic | Not Applicable | | Phase error<br>correction | Yes, Eddy Current<br>Correction | Yes, Eddy Current<br>Correction | Not Applicable | | Quantitative<br>Analysis, flow | Yes | Yes | Not Applicable | | Quantitative<br>Analysis, area | Yes | Yes | Not Applicable | | Feature/<br>Function | Proposed Device:<br>Arterys Software | Primary Predicate<br>Device:<br>Morpheus HeartScan<br>(K133937) | Secondary<br>Predicate Device:<br>Medis Imaging<br>QMass<br>(K140587) | | Quantitative<br>Analysis, linear<br>distance5 | Yes | Yes | Not Applicable | | Quantitative<br>Analysis,<br>volume | Yes | Not Applicable | Yes | | 2D Phase<br>Contrast6 | Yes | No | Not Applicable | | Directional/vec<br>tor display of<br>the blood<br>particle travel8 | Blood flow and flow<br>direction are available<br>by means of color<br>overlay and vectors<br>and/or streamlines | Blood flow is<br>available by means<br>of color overlay.<br>Vector component<br>information is<br>displayed. | Not Applicable | | Flow<br>quantification<br>of valves9 | Option to adjust<br>plane at each<br>Timepoint for flow<br>measurement. Same<br>flow algorithm as<br>predicate. | Flow measurement<br>in a static plane,<br>with the option to<br>create a separate<br>flow measurement at<br>different planes for<br>each Timepoint. | Not Applicable | | Automatic<br>selection of the<br>Temporal<br>Landmark<br>Timepoints10 | Available as a<br>prerequisite step to<br>volume<br>measurement. | Not Applicable | Available as a<br>prerequisite step<br>to volume<br>measurement. | ## 6. Comparison of Technological Characteristics with the Predicate Device Arterys, Inc., Traditional 510(k) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word ARTERYS in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are black. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic of three curved lines that are parallel to each other. The lines appear to be flowing or waving, adding a dynamic element to the otherwise static text. #### 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a graphic of three curved lines that are parallel to each other. The lines are thin and black, and they curve upwards and to the right. 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