Arterys MICA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Arterys Inc. Sharon Cholowsky Director of Regulatory and Compliance 51 Federal Street, Suite 305 SAN FRANCISCO. CA 94107 October 17, 2018 ### Re: K182034 Trade/Device Name: Arterys MICA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 22, 2018 Received: September 25, 2018 Dear Sharon Cholowsky: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. 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) K182034 Device Name Arterys MICA ### Indications for Use (Describe) Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers. Arterys MICA includes an optional Cardio Al module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (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. Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. 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 ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="padding-right: 20px;"> <b> <span style="font-size: 120%;">☑</span> Prescription Use </b> (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 120%;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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General Information | 510(k) Sponsor | Arterys Inc. | |-----------------------|------------------------------------------------------| | Address | 51 Federal St. Suite 305<br>San Francisco, CA 94107 | | Correspondence Person | Sharon Cholowsky | | Contact Information | Email: regulatory@arterys.com<br>Phone: 403-923-9688 | | Date Prepared | July 26, 2018 | ### Proposed Device | Proprietary Name | Arterys® MICA | |---------------------|----------------------------------------| | Common Name | MICA | | Model Number | AMM5 | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 | | Product Code | LLZ | | Regulatory Class | II | ### Predicate Devices | Primary Predicate Device | Arterys Viewer, K171544 | |----------------------------|------------------------------| | Secondary Predicate Device | Arterys Cardio DL, K163253 | | Tertiary Predicate Device | Arterys Oncology DL, K173542 | ### 2. Device Description Arterys MICA is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Arterys MICA can also be used for analyzing multi-slice and multi-phase computed tomography (CT) or magnetic resonance (MR) image. Pre-existing CT or MR images are uploaded into Arterys MICA in a DICOM format from PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system. The basic image Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up the basic image Viewer. These components include {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ARTERYS" with a stylized graphic to the left. The graphic consists of three curved lines that are parallel to each other. The text is in a simple, sans-serif font and is all uppercase. The overall impression is clean and modern. the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization and the basic image Viewer itself, which allows for viewing and working with 2D and 3D images. Functionality provided by the basic image Viewer is extended by additional Cardio Al and Oncology AI application modules and can add support for specific clinical workflows. The Cardio module adds support for flow-4D studies and provides additional functionality specific to cardiac studies. The Oncology module adds functionality specific to evaluating and measuring lesions, including lung and liver lesions/nodules. NOTE: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of images. Arterys MICA software is a complement to these standard procedures. ### 3. Indications for Use Indications for Use Statement for Arterys MICA with optional Cardio and Oncology modules: Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers. Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (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. Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. 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 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 Indications for Use Statement is a unification of the statements of the three previously cleared devices. The first and fourth paragraphs contain information about the base image Viewer as well as information that is applicable for all three areas of the product, while the second and third paragraphs contain information about the Cardio module and Oncology module, respectively. This unification is because of the similar architecture and device use of the three cleared products. The intended use is the same between the predicates and new products and there are no new diagnostic claims involved in the wording change. #### 4. Comparison of Technological Characteristics with the Predicate Device The Arterys MICA software has the same technological characteristics as the predicate Arterys devices and has the same uses and applications as the predicate devices. There have been incremental minor updates to some of the software features for user experience improvements; these software changes do not impact safety or efficacy of the device. Both the device and predicates are used by the clinician as a support tool to aid in diagnosis of radiological images. | Feature/<br>Function | Proposed Device<br>Arterys MICA | Primary<br>Predicate<br>Arterys Viewer<br>(K171544) | Secondary<br>Predicate<br>Arterys Cardio<br>DL (K163253) | Tertiary Predicate<br>Arterys Oncology<br>DL (K173542) | |---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------| | Ability to load<br>different<br>optional modules<br>from same<br>worklist | Yes - all three modules<br>are in drop down menu | No - Cardio<br>module included<br>in Viewer | No - Module<br>included in<br>Viewer | No - Module loaded<br>separately | | Operating<br>System | Client server architecture<br>using Linux server and<br>web browser client | Same | Same | Same | | Image storage/<br>compression | Support JPEG2000 and<br>compression | Same | Same | Same | | DICOM<br>compliant | Yes | Same | Same | Same | | Type of scans/<br>Modality | Viewer: MR, CT<br>Cardio: MR<br>Onco: MR and CT | Same | Same | Same | | Worklist with<br>filter and<br>searching | Yes. Added tags for<br>further identification. | Yes. | N/A | N/A | | Image upload | Yes | Same | N/A | N/A | | 2D, 3D, MIP,<br>MPR image<br>display | Yes | Same | Same | Same | | Cine play | Yes | Same | Same | Same | | Image navigation<br>tools | Pan, zoom, rotate,<br>maximize/minimize, slice<br>scroll (view multiple<br>slices), adjust<br>window/level, slab<br>thickness, time scroll<br>(view multiple phases) | Same | Same | Same | | Image navigation<br>- Cardio | Yes. Flow direction and<br>2D speed color map | N/A | Same | N/A | | Image layouts;<br>side-by-side<br>viewing | Yes. Added multi-study<br>and that images are now<br>commonly aligned. | Yes. | Yes. | Yes. | | View DICOM<br>data | Patient, study,<br>orientation, and pixel<br>information | Same | Same | Same | | Measuring tools | Yes - linear, area, and<br>volume for all three<br>modules. | Yes - linear and<br>area only. | Yes - linear and<br>area only. | Yes - linear, area,<br>and volume. | | Semi-automated<br>segmentation of<br>region of interest | Yes. Cardio and<br>Oncology only. | No | Yes | Yes | | Cardio -<br>identification of<br>landmarks | Yes - Automatically<br>identified + user editable | N/A | Yes - Manually<br>identified +<br>editable | N/A | | Cardio<br>Visualization,<br>Quantification,<br>Volume in 4D<br>Flow | Yes. Added normalized<br>volume measurements<br>based on age and gender.<br>Added ability to edit the<br>valve plane to adjust<br>volume. | N/A | Yes | N/A | | Cardio - 2D<br>Contour<br>inference | Yes - Automatically<br>identified + user editable.<br>Added ability to edit the<br>valve plane to adjust<br>volume. | N/A | Yes - Manually<br>identified +<br>editable | N/A | | Cardio<br>Visualization,<br>Quantification,<br>Volume in 3D<br>Workflow for a<br>short axis stack | Yes. Added normalized<br>volume measurements<br>based on age and gender.<br>Added ability to edit the<br>valve plane to adjust<br>volume. | N/A | Same | N/A | | Eddy current<br>correction | Yes. Added ability to<br>download data. | N/A | Same | N/A | | Cardio<br>Reporting | Yes. Added minimal<br>content configurability. | N/A | Yes | N/A | | Co-registration | Yes | N/A | N/A | Same | | Onco<br>Longitudinal<br>tracking - linked<br>VOIs between<br>timepoints | Yes | N/A | N/A | Same | | Onco Reporting<br>- LI-RADS and<br>Lung-RADS | Yes | N/A | N/A | Same | | Secondary<br>Capture | Yes | Same | Same | Same | | Download report | Yes - to PACS and<br>computer | Yes - to PACS<br>only | N/A | N/A | Table 5.1: Technological characteristics of the proposed device and predicate devices {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains 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}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Arterys. The logo consists of a stylized wave-like graphic on the left, followed by the word "ARTERYS" in a simple, sans-serif font. The logo is in black and white. ### ડ. Performance Data Safety and performance of Arterys MICA has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software verification activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software - Software life cycle processes and ISO 14971:2007 Medical devices -- Application of risk management to medical devices, 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." ### 6. Conclusion Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys MICA raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.