Mural Clinical Viewer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 21, 2022 GE Medical Systems Information Technologies, Inc. Brandon O'shea Sr. Regulatory Affairs Manager 9900 Innovation Drive Wauwatosa, Wisconsin 53226 ### Re: K222586 Trade/Device Name: Mural Clinical Viewer Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: November 22, 2022 Received: November 22, 2022 Dear Brandon O'Shea: 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. {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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). 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, Shruti N. Mistry -S for Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222586 Device Name Mural Clinical Viewer #### Indications for Use (Describe) Mural Clinical Viewer is a patient monitoring software application intended for the electronic collection, display, trending, annotation, measurement and export of clinical data. Data is acquired from medical devices. Electronic Health Records (EHRs) and other data sources on a hospital's network. The application is designed to accept a patient selection from a host Electronic Health Record (EHR) program and then display that patient's data and waveforms within the EHR. The device is intended to be used by healthcare professionals in general hospital (including ICU) or remote clinical support settings while operating within a single patient's EHR. This product does not control or alter any of the medical devices providing data across the hospital network. All information, alerts or visual indications provided are intended to support the judgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 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. 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. 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/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the outside of the circle. The logo is simple and recognizable. # 510(k) Summary | In accordance with 21 CFR 807.92 the following summary of information is provided: | | | |------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | | | | 807.92(a)(1) – Submitter Information | | | | Date | 26 August 2022 | | | Submitter | GE Medical Systems Information Technologies, Inc.<br>9900 Innovation Drive<br>Wauwatosa, WI 53226, USA | | | Primary Contact Person | Brandon O'Shea<br>Sr. Regulatory Affairs Manager<br>GE Medical Systems Information Technologies, Inc.<br>Email: brandon.oshea@ge.com<br>Ph: (414) 323-3147 | | | Secondary Contact Person | Michael Petrini<br>Regulatory Affairs Executive<br>GE Medical Systems Information Technologies, Inc.<br>Ph: (360) 294-9283 | | | 807.92(a)(2) – Device Information | | | | Device Trade Name | Mural Clinical Viewer | | | Common/Usual Name | Monitor, Physiological, Patient (with arrhythmia detection or alarms) | | | Regulation Name | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | | | Regulation Number | 21 CFR 870.1025 | | | Regulation Class | Class II | | | Product Code | MHX | | | Review Panel | Cardiovascular | | | 807.92(a)(3) – Predicate Device | | | | 510(k) Number | K141811 | | | Manufacturer | Mortara Instruments, Inc. | | | Predicate Device(s) | Mortara Monitoring Waveform Viewer | | | The predicate device has not been subject to a design-related recall | | | | 807.92(a)(4) – Device Description | | | ## Device Design Mural Clinical Viewer is a software only, information management system designed to enable viewing of patient's monitoring data. The system is accessible from the Electronic Health Record (EHR) application. Its use covers near real time and retrospective display of patient vitals, waveforms and events. The system also covers documentation of patient vitals including discrete values and waveform strips. The software is integrated with a healthcare facility's Electronic Health Records (EHR) and Medical Gateway Interface (MGI) for electronic collection, display, trending, annotation, measurement and export of clinical data. The software accessed as an integral part of the host EHR application, provides a single place to view patient monitoring data and to record documentation in EHR system without having to switch between multiple different applications and devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has a stylized design with wave-like elements around the perimeter, giving it a dynamic and recognizable appearance. ## Environment of Use Mural Clinical Viewer is intended to be used in a healthcare facility environment within a host EHR application. # Principle of Operation and Deployment Mural Clinical Viewer software is a cloud-based application with client-server architecture, accessed on web browser embedded within a host EHR system. Mural Clinical Viewer application is accessed via the EHR application within a hospital network. EHR application manages user authentication with credential-based log-in within a hospital supplied network. The application provides a means for viewing and documenting patient monitoring data including vitals, waveforms and alarms/events as supplied by a Medical Gateway Interface (MGI), supporting clinicians in investigation and patient documentation management. The software comes with features to view, annotate, measure, save and retrieve clinical data to support patient documentation and record keeping. This product does not control or alter any of the medical devices providing data across the hospital network. All information, alerts or visual indications provided are intended to support the judgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network. ## 807.92(a)(5) - Indications for Use Mural Clinical Viewer is a patient monitoring software application intended for the electronic collection, display, trending, annotation, measurement and export of clinical data. Data is acquired from medical devices, Electronic Health Records (EHRs) and other data sources on a hospital's network. The application is designed to accept a patient selection from a host Electronic Health Record (EHR) program and then display that particular patient's data and waveforms within the EHR. The device is intended to be used by healthcare professionals in general hospital (including ICU) or remote clinical support settings while operating within a single patient's EHR. This product does not control or alter any of the medical devices providing data across the hospital network. All information, alerts or visual indications provided are intended to support the iudgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network. 807.92(a)(6) - Comparison of Intended Use and Technological Characteristics The table below compares the intended use and technological characteristics of the subject and predicate device. | Specification | Predicate Device<br>Mortara Monitoring Waveform Viewer<br>K141811 | Subject Device<br>Mural Clinical Viewer<br>K[TBD] | |--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient Population | Hospital Based Patients of any age<br>connected to a hospital monitor, network<br>and host application | Hospital Based Patients of any age<br>connected to a hospital monitor, network<br>and host application | | Environment of Use | Hospital Environment and securely<br>networked clinics or offices | Hospital Environment and securely<br>networked clinics or offices | | | This product is not for home monitoring use | This product is not for home monitoring use | | Intended User | Licensed Healthcare Providers | Licensed Healthcare Providers (nurses, physicians, tele-technicians) | | Software Level of Concern | Unknown (assumed to be Major) | Major | | User Interface | Standard PC/Laptop<br>Client application embedded in a host application | Standard PC/Laptop<br>Web client application embedded in a host application<br>NOTE: This application is not intended for use on tablets or mobile phones | | SW and HW Components | Software only product; utilizing off-the-shelf IT devices. | Software only product; utilizing off-the-shelf IT devices. | | Software Capabilities -<br>Patient Data and Information | Clinical Data Display (Detailed Bedside View + Vital Signs) + Alerts/Alarms | Clinical Data Display (Detailed Bedside View + Vital Signs) + Alerts/Alarms | | Software Capabilities -<br>Caliper Tool | The application can perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waveform Viewer displays still waveforms | The application allows user to perform caliper measurements (horizontal measurements only) using the electronic Caliper tool on ECG waveforms to assess the patient's cardiac rhythm. The Caliper tool can be activated from the Create Strip report panel window when user documents a selected strip | | Software Capabilities - Annotations | (Unknown) Not available from the 510K Summary Document | The application allows the clinician to capture and save their annotation for a selected strip on the Full disclosure.<br>These saved strips on the worklist can be viewed on the Mural Clinical Viewer and in the EHR as a PDF file. | | Software Capabilities - Alarms | Capable of receiving data from external systems for the display of alarm states.<br>Not capable of generating unique alarms or influencing external systems. | Capable of receiving data from external systems for the display of alarm states.<br>Not capable of generating unique alarms or influencing external systems. | | Connectivity | Acquire physiological data provided by the connected application provider | Acquire physiological data from MDI/MGI provided by EHR application provider | | | WAN/LAN hospital connectivity | WAN/LAN hospital connectivity | | Operating System(s) | Operating System:<br>• Windows 10 (64-bit) | Operating System:<br>• Servers – Linux distribution with container orchestration<br>• Clients – WebKit based browser with support for HTML5 & JavaScript<br>The Mural Clinical Viewer system is designed as a cloud-native application utilizing virtualization technology on a Linux operating system with containerized services. The application runs on premises (on prem) within a hospital network. | | Data Sources /<br>Connectivity / Outputs | Data Sources (inputs)<br>Patient monitoring systems | Data Sources (inputs)<br>MDI/MGI interface provided by EHR application provider | | Connectivity & Output | Connectivity & Output | | | Send data to host EHR application for<br>documentation purposes with no ability to<br>influence the original monitoring system | Send data to the host application for<br>documentation purposes with no ability to<br>influence the original monitoring system | | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The color of the logo is a light blue. The logo is simple and recognizable. Mural Clinical Viewer and the Mortara Monitoring Waveform Viewer (K141811) are softwareonly clinical information systems for monitoring analysis and documentation of patient waveforms within a hospital environment or clinical support setting. The Mural Clinical Viewer software employs the same fundamental scientific technology as its predicate device. Both Mural Clinical Viewer and the Mortara Monitoring Waveform Viewer both operate off a client server architecture installed on off-the-shelf client servers utilizing standard communication languages. The Mural Clinical Viewer and Mortara Monitoring Waveform Viewer both include waveform review, caliper and transmitted alarm display functionality. The subject device has different technological features including different user interfaces and operating systems. However, the different technological characteristics do not raise different questions of safety and effectiveness. | 807.92(b)(1) - Performance Testing | | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Non-Clinical Tests | Software was evaluated as recommended in the 2005 FDA guidance document “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” The Mural Clinical Viewer software was developed following the GE Healthcare Quality Management System. The following activities were successfully completed: Risk Analysis / Management Requirements Reviews Design Reviews Software Verification Software Validation Usability Testing | | | Mural Clinical Viewer has also been subject to the following non-clinical V&V activities: Safety classification and Performance testing in accordance with IEC 62304 Edition 1.1 2015 Testing in accordance with IEC 60601-1-8 Edition 2.2 2020-07 for alarm functionality Testing in accordance with IEC 60601-2-25 Edition 2.0 for basic safety and essential performance of electrocardiographs | | | Successful completion of design verification and validation testing was performed to confirm that software and user requirements have been met. | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. Three swirling shapes surround the letters, adding a dynamic element to the design. | Cybersecurity was evaluated as recommended in the 2014 FDA<br>guidance document “Content of Premarket Submissions for<br>Management of Cybersecurity in Medical Devices.” | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Interoperability was evaluated as recommended in the 2017 FDA<br>guidance document “Design Considerations and Pre-market<br>Submission Recommendations for Interoperable Medical<br>Devices.” | | | 807.92(b)(2) – Summary of Clinical Tests | | | Summary of Clinical Tests | The similarities and differences between the subject device and<br>the predicate device, were determined not to have a significant<br>impact on the device's performance, the clinical performance, and<br>the actual use scenarios.<br><br>Therefore, the subject of this premarket submission, Mural<br>Clinical Viewer, did not require clinical studies to support<br>substantial equivalence. | | 807.92(b)(3) - Conclusion | | | The performance data described above demonstrate that the Mural Clinical Viewer is as safe and<br>effective as the Mortara Monitoring Waveform Viewer and supports a determination of | |