Arterys MICA

{0}------------------------------------------------ March 25, 2020 Image /page/0/Picture/1 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 Re: K192437 Trade/Device Name: Arterys MICA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH, LLZ Dated: February 15, 2020 Received: February 19, 2020 Dear Ms. 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/cfpmp/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. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192437 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. 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 and on monitors/screens that meet appropriate technical specifications for image diagnosis. 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 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 (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED#### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The lines are thin and black, and they curve upwards and to the right. # 510(k) Summary # 1. General Information Date Prepared: September 4, 2019 Date Updated: March 19, 2020 ### Submitter Information | Company Name | Arterys Inc. | |---------------------|----------------------------------------------------------| | Company Address | 51 Federal St., Suite 305<br>San Francisco, CA 94107 | | Contact Person | Sharon Cholowsky<br>Director of Regulatory & Compliance | | Contact Information | Email: regulatory@arterys.com<br>Phone: 1 (650) 319-7230 | ### Proposed Device | Proprietary Name | Arterys® MICA | |---------------------|----------------------------------------| | Common Name | Medical image processing software | | Model Number | AMM6 | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 | | Product Code | QIH/LLZ | | Regulatory Class | II | Predicate & Reference Devices | Predicate Device | Arterys® MICA, K182034<br>Product Code LLZ | |------------------|----------------------------------------------| | Reference Device | Medis MR-CT VVA, K140587<br>Product Code LLZ | # 2. Device Description Arterys MICA, already cleared as per the predicate, is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Pre-existing DICOM images, such as CT or MR, are uploaded into {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "ARTERYS" in all capital letters. 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 the word is also black. The background is white. Arterys MICA from a 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 Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up a basic image viewer. These components include 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 display itself, which allows for viewing and working with 2D and 3D images. Functionality provided by the Viewer is extended by the additional Cardio AI and Oncology AI (Oncology AI: Lung AI and Oncology AI: Liver AI) application modules which add support for specific clinical workflows: - · Cardiac Workflow Module: evaluates multi-slice and multi-phase velocity-encoded cardiovascular MR images to quantify blood flow and ventricular function. - Oncology Workflow Module: supports the oncological workflow by helping the user . confirm the absence or presence of lesions including evaluation, quantification, follow-up and documentation of any such lesions within MR or CT images. 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 is as follows: Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. 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 and on monitors/screens that meet appropriate technical specifications for image diagnosis. 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. {5}------------------------------------------------ Image /page/5/Picture/1 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 start close together and then spread out as they curve to the right. 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. ## 4. Predicate Device Comparison The indications for use of the proposed device Arterys MICA is similar to the predicate device. They are intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. The devices are 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 indications for use of the proposed device consists of the indications for use statement of the predicate, Arterys MICA (K182034), with a phrase removed to allow for mammography diagnostic viewing and a phrase added regarding minimum technical specifications for monitors/screens. The differences in the indications for use don't raise different questions of safety and effectiveness. The Arterys MICA software has the similar technological characteristics as the predicate device and has the same uses and applications as the predicate device. Differences include minor incremental updates to some of the existing software for user experience improvements. These software changes do not impact safety or efficacy of the device. ## 5. 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. The software verification and validation activities were performed as per 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 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "ARTERYS" with a stylized graphic to the left of the word. The graphic consists of three curved lines that are parallel to each other. The word "ARTERYS" is written in a simple, sans-serif font, with each letter evenly spaced. Contained in Medical Devices and Content of Premarket Submission for Management of Cybersecurity in Medical Devices. Hundreds of software verification and validation tests, including the display quality of mammography images and a performance test comparison to Medis MR-CT VVA, were repeatedly conducted throughout the software development effort, with any defects logged and traced to the failed tests. Defects were then fixed or were assessed for approval in the released product. #### Conclusion 6. 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 or different questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.