Arterys Viewer

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 18, 2017 Arterys, Inc. % Ms. Golnaz Moeini Director of Quality and Regulatory Affairs 51 Federal Street, Suite 305 SAN FRANCISCO CA 94107 Re: K171544 Trade/Device Name: Arterys Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 24, 2017 Received: May 26, 2017 Dear Ms. Moeini: 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 {1}------------------------------------------------ forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/ResourcesforYou/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, 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) K171544 Device Name Arterys Viewer #### Indications for Use (Describe) Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 | | 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, RAC<br>Director of Quality and Regulatory<br>Arterys Inc. | | Contact Information | Email: quality@arterys.com<br>Phone: 408-504-3187 | | Date Prepared | May 24, 2017 | ## 2. Proposed Device | Proprietary Name | Arterys Viewer | |---------------------|----------------------------------------| | Common Name | Viewer | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 | | Product Code | LLZ | | Regulatory Class | II | ## 3. Predicate Device Primary Predicate | Proprietary Name | HealthMyne PACS | |------------------------|----------------------------------------| | Premarket Notification | K152186 | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 | | Product Code | LLZ | | Regulatory Class | II | #### Reference Device | Proprietary Name | Arterys Software 2.0 | |------------------------|----------------------------------------| | Premarket Notification | K162513 | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 | | Product Code | LLZ | | Regulatory Class | II | ## 4. Device Description Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides {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. the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings. The following visualization, quantification and data-reporting functionalities are provided by the software: Visualization: - 2D image review - - 3D image review by means of MIP, MinIP, Surface or Average - - Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) - - Image navigation tools - - Cine play - Quantification: - Distance and area measurements - ### Data reporting: The distance, area, and 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 data to PACS, for review. ## 5. Indications for Use Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings. {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 running parallel to each other. The lines appear to be of equal thickness and are black in color, contrasting with the white background. # 6. Comparison of Technological Characteristics with the Predicate and Reference Device | Feature/<br>Function | Proposed Device:<br>Arterys Viewer | Primary Predicate<br>Device:<br>HealthMyne PACS<br>(K152186) | Reference Device:<br>Arterys Software v2.0<br>(K162513) | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Support<br>Mammography | No | No | No | | Operating System | Client server<br>architecture using<br>Linux server and web<br>browser client<br>(Web-based only) | Client server<br>architecture utilizing<br>Windows and Linux<br>Platforms<br>(Installed-client only) | Client server<br>architecture using<br>Linux server and web<br>browser client<br>(Web-based only) | | Image storage/<br>compression | Support JPEG2000<br>and compression | Support JPEG2000<br>and compression | Support JPEG2000<br>and compression | | DICOM<br>Compliant | Yes | Yes | Yes | | Worklists | Yes | Yes | | | Filter and Search<br>capabilities | Yes | Yes | | | Ability to search<br>studies | Yes | Yes. Dynamic<br>(freeform) search and<br>matching. Also<br>customized, indexed<br>search parameters. | | | View study-related<br>documents | Yes. Can view<br>reports/documents<br>(except RT Struct) | Yes. Presentation<br>states and RT Struct<br>(regions of interest) | | | Priority "stat"<br>studies | No | Yes. Studies with a<br>DICOM priority tag<br>("Stat" studies) are<br>given priority order<br>(top of the list) in the<br>exam view. | No | | Managed pushed<br>studies | Yes. This product<br>supports only pushed<br>studies. No studies<br>originate within the<br>product | Yes. This product<br>support only pushed<br>studies. No studies<br>originate within the<br>product | | | View current and<br>prior studies at the<br>same time | No | Yes. Called current<br>study and prior study.<br>Prior studies have a<br>large "PRIOR" label in<br>each viewport. | No | | Feature/<br>Function | Proposed Device:<br>Arterys Viewer | Primary Predicate<br>Device:<br>HealthMyne PACS<br>(K152186) | Reference Device:<br>Arterys Software v2.0<br>(K162513) | | Re-organize series<br>in a study (for<br>viewing) | Yes | Yes. Has a thumbnail<br>view with the ability to<br>drag and drop the<br>thumbnail into a<br>viewport. Cannot save<br>the order. | | | Create separate<br>displays | Yes | Yes. Can display a<br>viewport as a single<br>viewport, can select a<br>viewport layout and<br>add series to it. | | | Cycle through<br>series | Yes | Yes. Can show the<br>"next" and "previous"<br>sets of series | | | Image display<br>modes | Yes. Static and cine | Yes. Static and manual<br>cine. | | | Select images | Yes. The images<br>currently being viewed<br>are highlighted, and<br>can be chosen by the<br>user. | Yes. There is an active<br>image indicator. The<br>active image can be<br>chosen or is<br>automatically set based<br>on tool use. | | | Delete Images | No | Yes. Only with PACS<br>admin privileges and<br>from the admin<br>console. | No | | Sort Images | Yes | Yes. Sorting and<br>grouping are by<br>system-defined rules | | | Scrolling through<br>slices | Yes | Yes. Linked series are<br>scrolled together. Can<br>"swipe" on a scroll bar<br>to move through slices<br>quickly. Can<br>lock/unlock scrolling<br>through every image. | | | Zoom in/out | Yes. Default settings<br>can zoom interactively | Yes. Default settings<br>can zoom interactively | | | Feature/<br>Function | Proposed Device:<br>Arterys Viewer | Primary Predicate<br>Device:<br>HealthMyne PACS<br>(K152186) | Reference Device:<br>Arterys Software v2.0<br>(K162513) | | Pan an image | Yes | Yes | | | Standard viewport<br>layouts | Yes | Yes. Viewport layouts<br>that are independent of<br>any modality or<br>common features of<br>series | | | Labels | Yes | Yes. There are labels<br>in the viewport for<br>patient, study, and<br>image information. | | | Orientation labels | Yes | Yes | | | Cross-reference<br>indicator | Yes | Yes. There is a cutline<br>in linked viewports to<br>indicate intersection | | | View DICOM data | Yes. You can view the<br>DICOM information<br>about the patient and<br>study, and the pixel<br>information | Yes. You can view the<br>DICOM information<br>about the patient and<br>study, and the pixel<br>information | | | Create MPR<br>images | Yes | No. MPRs from the<br>external source are<br>supported/displayed. | Yes | | Feature/<br>Function | Proposed Device:<br>Arterys Viewer | Primary Predicate<br>Device:<br>HealthMyne PACS<br>(K152186) | Reference Device:<br>Arterys Software v2.0<br>(K162513) | | Window/level<br>determination | Yes<br>Same approach as<br>predicate but we let<br>the user adjust W/L | Determined by a<br>lookup table function<br>(linear) and the W/L<br>values of the image. If<br>the image has a custom<br>lookup table or a fixed<br>W/L, those settings are<br>used instead of<br>allowing changing of<br>W/L. If no W/L, then a<br>histogram is used. | | | Window/level<br>access series | Yes | Yes. W/L settings are<br>applied to the active<br>image and any linked<br>images. | | | Window/level<br>presets | Yes | Yes. Factory default | | | Adjust<br>window/level | Yes. Can interactively<br>adjust the window and<br>level | Yes. Can interactively<br>adjust the window and<br>level | | | Annotation | Yes. Display Only | Yes. Display Only | | | Measuring tools | Yes. Linear, area, and<br>pixel intensity and<br>location of a point | No. Pixel intensity and<br>location. | Yes. Linear, area, and<br>pixel intensity and<br>location of a point | | Feature/<br>Function | Proposed Device:<br>Arterys Viewer | Primary Predicate<br>Device:<br>HealthMyne PACS<br>(K152186) | Reference Device:<br>Arterys Software v2.0<br>(K162513) | | Detect<br>image/patient<br>issues | No | Yes. Can view patients<br>and studies with errors | No | | Custom filters | Yes. Can set filters to<br>affect the studies listed | Yes. Can set filters to<br>affect the studies listed | | | Set reading state | Yes | Yes. Can mark a study<br>as read. | | | Custom search<br>groups | Yes | Yes. Can set "codes"<br>to index elements for<br>searching (for<br>example, referring<br>physician or sets of<br>exam types_ for faster<br>auto-complete during<br>search | | | Display radiation<br>therapy<br>information | No | Yes. Supports DICOM<br>RT Structures | No | | Surface Rendering | Yes | No | Yes | | Annotation<br>Propagation | Yes | No | Yes | | Feature/<br>Function | Proposed Device:<br>Arterys Viewer | Primary Predicate<br>Device:<br>HealthMyne PACS<br>(K152186) | Reference Device:<br>Arterys Software v2.0<br>(K162513) | | Time Curve<br>Display | Yes | No | Yes | | Contour Creation | Yes | No | Yes | | Report Creation | Yes | No | Yes | Arterys Inc., Traditional 510(k) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Arterys. The logo consists of three curved lines on the left side, followed by the word "ARTERYS" in a simple, sans-serif font. The logo is black and white. {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 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. {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 create a sense of movement. {9}------------------------------------------------ Image /page/9/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 flowing or waving, adding a dynamic element to the logo. {10}------------------------------------------------ Image /page/10/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. ## 7. Substantial Equivalence Summary Arterys Viewer has the same intended use, indications for use and technological characteristics as the HealthMyne PACS predicate device (K152186). The added features to allow for usability enhancements is similar to the features in the reference device, Arterys Software v2.0, which was cleared by the FDA under K162513. Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness. The implemented design controls, risk management activities, labeling and performed verification and validation tests demonstrate the safety and efficacy of the proposed device. Based on the comparison information provided above. Artervs Viewer is substantially equivalent to the predicate device. ## 8. Performance Data Safety and performance of Arterys Viewer has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation 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 Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices." ## 9. Conclusion Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys Viewer raises no new {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a 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. questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.