(117 days)
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 judgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network.
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.
The provided text is a 510(k) summary for the GE Medical Systems Information Technologies, Inc. "Mural Clinical Viewer". It describes the device, its intended use, and comparison to a predicate device. However, it explicitly states that no clinical studies were required or performed to support substantial equivalence.
Therefore, I cannot provide the information requested regarding acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies. The document states:
"The similarities and differences between the subject device and the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios. Therefore, the subject of this premarket submission, Mural Clinical Viewer, did not require clinical studies to support substantial equivalence."
Instead, the submission relied on non-clinical performance testing and software evaluation:
- Summary of Non-Clinical Tests: Software was evaluated according to the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Developed following GE Healthcare Quality Management System.
- Activities successfully completed: Risk Analysis/Management, Requirements Reviews, Design Reviews, Software Verification, Software Validation, Usability Testing.
- Subject to 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 to confirm that software and user requirements have been met.
- Cybersecurity: Evaluated as recommended in the 2014 FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- Interoperability: Evaluated as recommended in the 2017 FDA guidance document "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."
Conclusion: The performance data described above demonstrates that the Mural Clinical Viewer is as safe and effective as the Mortara Monitoring Waveform Viewer and supports a determination of substantial equivalence without the need for clinical studies.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.