Arterys MICA

{0}------------------------------------------------ March 14, 2022 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. % Marina Codari Head of Clinical Evidence 51 Federal Street. Suite 305 SAN FRANCISCO CA 94107 Re: K203744 Trade/Device Name: Arterys MICA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: February 8, 2022 Received: February 11, 2022 Dear Marina Codari: 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. 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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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). 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Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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) K203744 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 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) imges. 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 (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow. # Traditional 510(k) Premarket Notification # for Arterys® MICA ## K203744/S002 Arterys Inc. 2100 Fillmore Street #100, San Francisco, CA 94115, U.S.A {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 running parallel to each other. The lines appear to be of equal thickness and are black in color, contrasting with the white background. ## Section 5. 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "ARTERYS" in all caps. To the left of the word is a symbol that looks like three curved lines that are stacked on top of each other. The font of the word is a simple sans-serif font. ### 510(k) Summary #### 1. General Information Date Prepared: December 17, 2020 Date Updated: March 08, 2022 #### Submitter Information | Company Name | Arterys Inc. | |---------------------|--------------------------------------------------------------| | Company Address | 2100 Fillmore Street #100, San<br>Francisco, CA 94115, U.S.A | | Contact Person | John Axerio-Cilies<br>CEO and CTO | | Contact Information | Email: regulatory@arterys.com<br>Phone: 1 (650) 391-7111 | #### Proposed Device | Proprietary Name | Arterys® MICA | |-------------------|----------------------------------------------------------------| | Common Name | Medical image processing software | | Model Number | AMM7 | | Regulation Number | 21 CFR 892.2050 Medical image management and processing system | | Product Code | QIH/LLZ | | Regulatory Class | II | #### Predicate Device | Predicate Device | Arterys® MICA, K192437<br>Product Code QIH/LLZ | |------------------|------------------------------------------------| |------------------|------------------------------------------------| {6}------------------------------------------------ Image /page/6/Picture/0 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. The image is in black and white. #### 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 Arterys MICA from a PACS or a scanner. Arterys MICA is completely hosted in the cloud and is accessed using a compatible web browser by navigating to the following https://app.arterys.com. Cloud servers are provided by Amazon Web Services (AWS) and service is accessible globally. The Viewer AI application of Arterys MICA is designed around a modular architecture of separate components that make up a basic image viewer. These include the Studylist, from which studies are selected and opened, the image display (2D, 3D, MIP, etc), view synchronization, metadata information, and various navigational, measurement, and other action tools. Functionality provided by the Viewer AI is extended by the additional Cardio AI and Oncology AI application modules which add support for specific clinical workflows: - Cardiac Workflow Module: Evaluates multi-slice and multi-phase velocity-encoded . cardiovascular magnetic resonance (MR) images to quantify blood flow and ventricular function. In addition, perfusion and delayed enhancement datasets are analyzed and quantified, and for parametric mapping, T1, T2, and T2* values are obtained to assess tissue changes in the myocardium, as well as ECV calculations. - 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 or presence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions. Arterys MICA uses many deep learning algorithms to reduce many tedious, time-consuming manual steps, such as segmentation, landmark identification, etc. The results of these AI models are available on-screen to the user for further review and editing. The software does not perform any functions that could not be accomplished by a trained user with a manual method; the purpose of the automation is to save time and automate potential error-prone manual tasks, while allowing the results to be reviewed as per the normal clinical workflow. NOTE: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of images. Artervs MICA software is a complement to these standard procedures. {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 text and graphic are in black and white. #### 3. Indications for Use Indications for Use Statement for Arterys MICA is as follows: Artervs® 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. Artervs MICA includes an optional Cardio AI module which is used to analyze the heart its major vessels using multi-slice, multi-phase, and velocity-encoded and cardiovascular 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 or presence 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. The indications for use of the proposed device consists of the indications for use statement of the predicate, Arterys MICA (K192437). The differences in the added indications for use are mainly due to duplication with other phrases in the existing Arterys MICA (K192437) indications for use statement and don't raise different questions of safety and effectiveness. {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 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 ability of Viewer AI to display annotations (segmentation, measurements, etc.) was expanded to integrate similar outputs of 3rd party models (bounding boxes, heatmaps, etc.). The safety and effectiveness of the 3rd party model is covered under the original manufacturer's regulatory clearance: Arterys only displays the simple output. The cardiac MRI T1 and T2 workflows were added to the proposed Cardio AI product. The workflows and feature lists are in alignment with the SCMR (Society for Cardiovascular Magnetic Resonance) Post Processing Consensus Statement (https://scmr.org/page/guidelines). The workflows and calculations are based on published industry technical standards and peer-reviewed publications, resulting in no different questions of safety and effectiveness. The Artervs 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 features for user experience improvements. These software changes do not impact safety or efficacy of the device. #### 5. Performance Data Safety and performance of Artervs 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 14971:2019 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. Hundreds of software verification and validation tests 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. In our validation assessment, we compared the average T1 and T2 values obtained with the Arterys software in delineated regions of interest (ROIs) to the average intensity value obtained in a similar ROI delineated in OEM vendor generated inline maps. The results showed that the difference between calculated and expected T1 and T2 values were within predefined accuracy requirements (i.e., 30 ms and 4 ms for T1 and T2 values, respectively). T1 and T2 values derived with the Arterys software depends on the ROI selected by the user. {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 of equal thickness and are black in color, contrasting with the white background. In the T1 workflow, endocardial and epicardial contours can be generated using a deep learning model. The generated contours are user-modifiable. These contours are used to derive Global T1 values. A standalone performance assessment was performed on 90 Cardiac T1 Mapping MRI short axis (SAX) scans from 16 studies. As a result, the device performed as intended compared to ground-truth contours. #### 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 or different questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.