MediOMx

{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. PMX Inc. % Rory Carrillo Regulatory Consultant Cosm 45 Bartlett St. San Francisco, California 94110 June 17, 202 Re: K233331 Trade/Device Name: MediOMx Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 29, 2023 Received: May 13, 2024 Dear Rory Carrillo: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 mediation-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, Jessica Lamb Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233331 Device Name MediOMx Indications for Use (Describe) MediOMx is a software-based viewer intended to be used with off-the-shelf hardware for the display of DICOM data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage of image data. MediOMx allows users to perform image manipulations, including window/level, pan, zotation. MediOMx provides 2D display, Multi-planar Reformatting of medical image data. MediOMx is not intended for primary mammography interpretation. Mobile usage is for reference and referral only. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </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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General Information | 510(k) Sponsor | PMX Inc, | |-----------------------|---------------------------------------------------| | Address | 50 N Brockway St, Suite 3-3<br>Palatine, IL 60067 | | Correspondence Person | Rory A. Carrillo<br>Regulatory Consultant<br>Cosm | | Contact Information | Email: rory@cosmhq.com<br>Phone: 415-580-0916 | | Date Prepared | September 29, 2023 | ### Proposed Device 2. | Proprietary Name | MediOMx | |---------------------|------------------------------------------------| | Classification Name | System, Image Processing, Radiological | | Regulation Number | 892.2050 | | Regulation Name | Medical image management and processing system | | Product Code | LLZ | | Regulatory Class | II | ### 3. Predicate Device | Proprietary Name | MD.ai Viewer | |------------------------|------------------------------------------------| | Premarket Notification | K223425 | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 892.2050 | | Regulation Name | Medical image management and processing system | | Product Code | LLZ | | Regulatory Class | II | {4}------------------------------------------------ ### Device Description 4. MediOMx is a software-based medical image viewer used with web browsers for the 2D visualization of DICOM and non-DICOM medical images. MediOMx is intended for storage, display, manipulation, and processing of radiological data, including images, reports and other clinical information. It has the following primary features and functions: - . Zero-footprint HTML5 medical image upload, transfer and display of medical images between facilities - Easy access to images for all participants in the healthcare process, including . radiologists, technologists, physicians, nurses and other patient care practitioners - Serve as information and data management system for for DICOM and non-DICOM ● medical images - Tools for image manipulation (e.g.pan, zoom, rotate, window level) - Metadata information and orientation labels display ● - . Advanced image manipulation functions like view synchronization across series, 3D visualization like MIP and MPR - Encrypted transmission of medical images through secured networks ● - Encrypted storage of medical images ● - HIPAA-compliant data management, including centralized storage of user activity via ● audit trails. - Management of users, roles, and permissions ● - It supports optional integration with FDA-cleared 3rd party AI models. It sends the input study to the 3rd party AI model, receives the AI output and displays outputs of the 3rd party AI model "as-is" in MediOMx for visualization by the Radiologist to assist in diagnosing the study. Outputs are displayed in accordance with the 3rd party provider's regulatory clearance. The original image is always accessible MediOMx consists of a cloud-based application that displays and processes digital medical images, and associated medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. The web browser based medical image viewer serves as the frontend module which users interact with in viewing data. The backend module handles the connection and processing of data from a variety of sources within the health system, in view of preparing visualizations to be rendered by the viewer. MediOMx can connect and access the medical images across different sources in a health system: an existing PACS or VNA, cloud storage or local server-based storage. Users can also upload images securely into MediOMx which can be shared and enables collaboration with other users. The data connection and imaging data processing is handled by the MediOMx backend module which supports the standardized transmission protocol as defined in the DICOM standard. Users interact with {5}------------------------------------------------ MediOMx through a standard web browser, thus providing access to full quality images from anywhere and supporting a greater efficiency for care. MediOMx utilizes authorization and authentication mechanisms that enforces authorized users to access the imaging data. The system extends beyond the hospital and its internal network. With a proper network, MediOMx can be accessed by clinical users outside of the hospital network. This way referring physicians can easily call up the imaging data of their patients or external expert accessing the imaging data for additional opinion. MediOMx provides end-users with the ability for industry standard features such as Window/ Level, Image Flip and Rotate. Images are initially displayed in the 2D view mode, but with the ability to toggle into advanced viewing mode of MPR for relevant exam types. It supports processing and displaying Multiplanar Reconstruction (MPR). MediOMx provides an image rendering mechanism that preloads lower resolution images during image scrolling to improve interactivity and performance for users operang in lower network bandwidth while the full quality image is loaded in the background. The use of a secure data transmission protocol and data encryption ensure high data security for data management via the internet. MediOMx tracks user activity via audit trails and stores the audit data on the centralized server. ### Indications For Use 5. MediOMx is a software-based viewer intended to be used with off-the-shelf hardware for the display of DICOM data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, and display of image data. MediOMx allows users to perform image manipulations, including window/level, pan, zoom, and rotation. MediOMx provides 2D display, Multi-planar Reformatting of medical image data. MediOMx is not intended for primary mammography interpretation Mobile usage is for reference and referral only. ### Substantial Equivalence 6. | | Proposed Device<br>MediOMx | Predicate Device:<br>MD.ai Viewer (K223425) | Substantially<br>Equivalent | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Indications<br>for Use | MediOMx is a software-based<br>viewer intended to be used with<br>off-the-shelf hardware for the<br>display of DICOM data to aid in<br>diagnosis for healthcare<br>professionals. It performs<br>operations relating to the transfer,<br>storage, and display of image<br>data. MediOMx allows users to | MD.ai Viewer is a software-based<br>viewer intended to be used with<br>off-the-shelf hardware for the<br>display of DICOM and<br>non-DICOM medical images and<br>other healthcare data to aid in<br>diagnosis for healthcare<br>professionals. It performs<br>operations relating to the transfer,<br>storage, display, and | Yes | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHNX" written with colorful lines. The lines are mostly blue, green, and red. The lines are arranged to form the shape of the letters. The letters are all uppercase. | Proposed Device | Predicate Device: | Substantially | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | MediOMx | MD.ai Viewer (K223425) | Equivalent | | perform image manipulations,<br>including window/level, pan,<br>zoom, and rotation. MediOMx<br>provides 2D display, Multi-planar<br>Reformatting of medical image<br>data. MediOMx is not intended<br>for primary mammography<br>interpretation<br><br>Mobile usage is for reference and<br>referral only. | measurement of image data.<br>MD.ai Viewer allows users to<br>perform image manipulations,<br>including window/level, rotation,<br>measurement and markup. MD.ai<br>Viewer provides 2D display,<br>Multi-Planar Reformatting and<br>3D visualization of medical<br>image data. Mobile usage is for<br>reference and referral only. MD.ai<br>Viewer is not intended for<br>primary mammography<br>interpretation. | | | Feature/<br>Function | Proposed Device<br>MediOMx | Predicate Device:<br>MD.ai Viewer (K223425) | Substantially<br>Equivalent | |---------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------|-----------------------------| | User Install<br>Requirements | Thin Client - no install, runs<br>within browser | Thin Client - no install, runs<br>within browser | Yes | | Communication | DICOM, non-DICOM | DICOM, non-DICOM | Yes | | Modalities | CT, MR, X-ray, US | CR, CT, DX, IVOCT, MR,<br>MG, NM, OCT, OT, PT, RF,<br>SC, US, XA | Yes | | Window Level,<br>Rotate/Pan/Zoom,<br>Reset, Presets,<br>Invert | Yes | Yes | Yes | | Multi-study<br>viewing, Image<br>Export, Image<br>Sharing compliant | Yes | Yes | Yes | | Metadata<br>Display/Hide | Yes | Yes | Yes | | Orientation Labels | Yes | Yes | Yes | | Keyboard Shortcuts | No | Yes | Yes | | Feature/<br>Function | Proposed Device<br>MediOMx | Predicate Device:<br>MD.ai Viewer (K223425) | Substantially<br>Equivalent | | Measurements,<br>Annotations | No | Yes | Yes | | Full Screen Mode | Yes | Yes | Yes | | Multi-monitor,<br>Layouts | No | Yes | Yes | | Linking Series | No | Yes | Yes | | Image Scrolling,<br>Linked Scrolling,<br>Reference Lines | Yes | Yes | Yes | | GSPS, KIN | No | No | Yes | | Multiplanar<br>reformat (MPR) | Yes | Yes | Yes | | Maximum Intensity<br>Projection (MIP) | Yes | Yes | Yes | | Oblique, Volume<br>Rendering, Opacity<br>Presets, Scalpel<br>tool, bone removal | No | No | Yes | | Sharpen, blur,<br>emboss, edge<br>filters | No | Yes | Yes | | Histogram<br>Equalization filter | No | Yes | Yes | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHRX" written with a series of colorful lines. The lines are mostly blue and green, with some red and yellow. The lines are arranged to form the letters of the word, and they appear to be flowing or moving. The background is white. The subject device and predicate device have substantially equivalent indications for use and technological characteristics. The minor differences do not raise questions of safety or effectiveness as the underlying technology is similar and risks associated with these differences are mitigated with similar general and special controls. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the letters "PMX" formed by a dense network of colorful lines. The lines vary in color from blue to green to red, suggesting a gradient or a range of values. The letters are well-defined, with the lines closely packed together to create the shapes. ### Performance Data 7. Safety and performance of the PMX MediOMx device has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification,validation,standalone and clinical performance testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/41:2016 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 "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". ### 8. Conclusion Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the MediOMx raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.