(101 days)
Mural Perinatal Surveillance is a perinatal monitoring system intended for electronic collection, display, and documentation of clinical data with optional features to store, export, annotate, calculate, and retrieve clinical data. Data is acquired from medical devices, electronic health records, or other data sources on a hospital's network. This device is intended for use by healthcare professionals in clinical support settings for obstetric patients during and after pregnancy.
This product is not intended to control of the medical devices providing data across the hospital network. All information or indications provided are intended to support the judgment of medical professionals and are not intended to be the sole source of information for decision making.
Mural Perinatal Surveillance is a software only, information management system designed for the obstetrical (OB) care environment. Its use covers patients during pregnancy, labor, birth and covers newborn documentation. The software interfaces with a healthcare facility's Electronic Medical Records (EMR) and patient monitoring network to collect, display and document relevant patient data.
The software combines patient surveillance and alarm capabilities with patient documentation and record keeping into a single application to support patient care for their complete obstetrical care journey.
The provided document is a 510(k) summary for the GE Medical Systems Information Technologies, Inc. Mural Perinatal Surveillance system. This document outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical tests.
However, it does not contain information about specific acceptance criteria and the study that proves the device meets those criteria, particularly regarding algorithmic performance. The document focuses on software validation, risk analysis, cybersecurity, and interoperability, confirming that the software was developed according to GE Healthcare's Quality Management System and relevant IEC standards.
The "Mural Perinatal Surveillance" is described as a software-only information management system intended for electronic collection, display, and documentation of clinical data, with optional features to store, export, annotate, calculate, and retrieve clinical data primarily for obstetric patients. It explicitly states that it is "not intended to control or alter any of the medical devices providing data across the hospital network" and that "all information or indications provided are intended to support the judgment of medical professionals and are not intended to be the sole source of information for decision making."
This indicates that the device functions as a data management and display tool, rather than an AI-driven diagnostic or prognostic tool that would require extensive performance studies with acceptance criteria based on metrics like sensitivity, specificity, or AUC, or comparative effectiveness studies with human readers.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria in the context of AI performance, because such a study is not described in the provided document, nor would it typically be required for a device of this nature (a perinatal monitoring system for data management, not an AI for diagnosis or risk assessment). The "computed items & assessment tools" (Shoulder Dystocia Risk, Postpartum Hemorrhage Risk Score, and Bishop Score) are stated to be derived from "standard general computes widely accepted" or "well-established industry standards or evidence-based studies and peer-reviewed research journals," implying they are based on established clinical rules or formulas, not novel AI algorithms requiring new performance validation studies.
However, based on the provided text, I can infer the "acceptance criteria" related to the device's functions and the "study" (non-clinical tests) demonstrating its adherence to regulatory and quality standards.
Here's an interpretation based on the provided information, focusing on what is present in the document rather than what is absent related to AI performance:
Inferred Acceptance Criteria and Proof of Meeting Criteria for Mural Perinatal Surveillance
Given that Mural Perinatal Surveillance is a data management and display system, not a diagnostic AI, the acceptance criteria and proof of meeting them are primarily centered around its functionality, reliability, security, and adherence to quality systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Goals Implicit in Document | Reported Device Performance (Summary from document) |
|---|---|---|
| Functional Performance | - Electronic collection, display, and documentation of clinical data. | - Successfully collects, displays, and documents clinical data. - Provides optional features for storing, exporting, annotating, calculating (based on established computes), and retrieving data. - Software capabilities for clinical annotations & record archive demonstrated. - Software capabilities for alarms demonstrated (capable of generating alarm conditions within the software). |
| - Data acquisition from medical devices, EHRs, etc. | - Acquires physiological data from compatible measuring devices (HL7, fetal monitors on a network). | |
| Safety (Software & Cybersecurity) | - Software operates safely without unintended harm or error. | - Safety classification and performance testing in accordance with IEC 62304 Edition 1.1 2015 successfully completed. - Risk Analysis / Management Requirements Reviews successfully completed. - Cybersecurity evaluated as recommended in the 2014 FDA guidance document, successfully completed. |
| Effectiveness (Software & Interoperability) | - Software performs as intended and integrates effectively with hospital systems. | - Software Verification and Software Validation successfully completed, confirming that software and user requirements have been met. - Interoperability evaluated as recommended in the 2017 FDA guidance document, successfully completed. |
| Usability | - Device is user-friendly for healthcare professionals. | - Usability Testing successfully completed. |
| Quality System & Regulatory Compliance | - Developed under a robust quality management system; adheres to relevant standards. | - Developed following the GE Healthcare Quality Management System (QMS). - Design Reviews successfully completed. - Testing in accordance with IEC 60601-1-8 Edition 2.2 2020-07 for alarm functionality successfully completed. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a dataset for validating AI performance. Instead, it refers to "Non-Clinical Tests" which include software verification and validation activities. These tests typically involve:
- Unit testing: Testing individual components of the software.
- Integration testing: Testing the interaction between different software components.
- System testing: Testing the complete integrated system.
- Regression testing: Ensuring changes don't break existing functionality.
- Usability testing: Testing with intended users to ensure ease of use.
- Cybersecurity testing: Penetration testing, vulnerability scanning.
- Interoperability testing: Testing data exchange with other systems (e.g., HL7 interfaces).
The document does not specify the "sample size" of data records or patient cases used for these non-clinical tests, nor does it mention data provenance (country of origin, retrospective/prospective). This level of detail is typically not required for the type of software validation described, which focuses on code quality, functional correctness, and adherence to software engineering best practices and relevant standards rather than a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not applicable as the document does not describe a study involving human experts establishing "ground truth" for a performance test set in the way it would be for an AI diagnostic algorithm. The acceptance criteria are based on software engineering principles, regulatory standards, and functional specifications, not on expert consensus on clinical data for diagnostic accuracy.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. There is no mention of adjudication for a clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not reported. This type of study is relevant for evaluating the impact of an AI (or other support tool) on human reader performance, typically in diagnostic imaging or similar fields. Since Mural Perinatal Surveillance is a data management and display system intended to support judgment rather than provide independent diagnostic conclusions, such a study would not be expected or relevant based on the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
The document implies that the "computed items & assessment tools" (e.g., Shoulder Dystocia Risk, Postpartum Hemorrhage Risk Score, Bishop Score) perform "standalone" calculations based on pre-defined rules/algorithms. However, these are based on "widely accepted" or "well-established industry standards," indicating they are deterministic calculations, not AI algorithms requiring standalone performance validation against ground truth data in the context of novel algorithm output. The document explicitly states the information is "not intended to be the sole source of information for decision making," meaning the system outputs are always viewed by human clinicians.
7. The type of ground truth used
For the non-clinical software verification and validation, the "ground truth" is typically defined by:
- Functional specifications: How the software is designed to behave.
- Requirements documents: What the software is supposed to do.
- Industry standards: Adherence to IEC standards (e.g., 62304 for software lifecycle, 60601-1-8 for alarms).
- Known good outputs: For calculations, the "ground truth" is the correct mathematical or rule-based output.
- Security best practices: For cybersecurity.
- Clinical workflows: For usability testing.
No "ground truth" in the sense of expert consensus, pathology, or outcomes data is described as being used for a performance study of the device's own outputs.
8. The sample size for the training set
This information is not applicable. The device is described as operating based on "standard general computes" and "complex computes derived directly from well-established industry standards or evidence-based studies and peer-reviewed research journals." This suggests rule-based or empirically derived algorithms rather than a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8. There is no mention of a machine learning training set or associated ground truth establishment process.
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June 23, 2022
GE Medical Systems Information Technologies, Inc. Brandon O'shea Regulatory Affairs Program Manager 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K220732
Trade/Device Name: Mural Perinatal Surveillance Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: II Product Code: HGM Dated: March 11, 2022 Received: March 14, 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. 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
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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-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). 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,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220732
Device Name Mural Perinatal Surveillance
Indications for Use (Describe)
Mural Perinatal Surveillance is a perinatal monitoring system intended for electronic collection, display, and documentation of clinical data with optional features to store, export, annotate, calculate, and retrieve clinical data. Data is acquired from medical devices, electronic health records, or other data sources on a hospital's network. This device is intended for use by healthcare professionals in clinical support settings for obstetric patients during and after pregnancy.
This product is not intended to control of the medical devices providing data across the hospital network. All information or indications provided are intended to support the judgment of medical professionals and are not intended to be the sole source of information for decision making.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K220732
| Submitter Information | |
|---|---|
| Date Summary Prepared: | 23 June 2022 |
| Submitter: | GE Medical Systems Information Technologies, Inc.9900 Innovation DriveWauwatosa, WI 53226, USA |
| Primary Contact Person: | Brandon O'SheaSr. Regulatory Affairs ManagerGE Medical Systems Information Technologies, Inc.Email: brandon.oshea@ge.comPh: (414) 323-3147 |
| Secondary Contact Person: | Michael PetriniRegulatory Affairs ExecutiveGE Medical Systems Information Technologies, Inc.Ph: (360) 294-9283 |
| Device Information | |
| Device Trade Name: | Mural Perinatal Surveillance |
| Common/Usual Name: | Perinatal monitoring system and accessories |
| Regulation Name: | Perinatal monitoring system and accessories |
| Regulation Number: | 21 CFR 884.2740 |
| Regulation Class: | Class II |
| Product Code: | HGM (System, Monitoring, Perinatal) |
| Review Panel: | Obstetrics/Gynecology |
| Predicate Device | |
| 510(k) Number: | K173941 |
| Manufacturer | Philips Medizin Systeme Boeblingen GmbH |
| Device Name | IntelliSpace Perinatal Revision K.00 |
| The predicate device has not been subject to a design-related recall. | |
| Device Description |
Device Design
Mural Perinatal Surveillance is a software only, information management system designed for the obstetrical (OB) care environment. Its use covers patients during pregnancy, labor, birth and covers newborn documentation. The software interfaces with a healthcare facility's Electronic Medical Records (EMR) and patient monitoring network to collect, display and document relevant patient data.
The software combines patient surveillance and alarm capabilities with patient documentation and record keeping into a single application to support patient care for their complete obstetrical care iourney.
Environment of Use
Mural Perinatal Surveillance is intended to be used in a healthcare facility environment within or supporting the Obstetrical/Gynecological (OB/GYN) department.
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Principle of Operation and Deployment
Mural Perinatal Surveillance software is installed on a server architecture and accessed via web browser through a credential-based log-in within a hospital supplied network. The application provides a means for obstetrical patient surveillance, alarming, investigation and patient documentation management.
The software comes with modular features to store, export, annotate, calculate and retrieve clinical data to support patient documentation and record keeping.
The product is not intended to control or alter any of the medical devices providing data across the hospital network. All information or indications provided are intended to support the judgment of medical professionals and are not intended to be the sole source of information for decision making.
Indications for Use
Mural Perinatal Surveillance is a perinatal monitoring system intended for electronic collection. display, and documentation of clinical data with optional features to store, export, annotate, calculate, and retrieve clinical data. Data is acquired from medical devices, electronic health records, or other data sources on a hospital's network. This device is intended for use by healthcare professionals in clinical support settings for obstetric patients during and after pregnancy.
This product is not intended to control or alter any of the medical devices providing data across the hospital network. All information or indications provided are intended to support the judgement of medical professionals and are not intended to be the sole source of information for decision making.
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 DevicePhilips IntelliSpace Perinatal RevisionK.00K173941 | Subject DeviceMural Perinatal SurveillanceK220732 |
|---|---|---|
| Patient Population | Hospital Based Obstetric Patients | Hospital Based Obstetric Patients |
| Environment of Use | Healthcare facility environment withinthe Obstetrical/Gynecological(OB/GYN) department | Healthcare facility environment withinthe Obstetrical/Gynecological (OB/GYN)department |
| Intended User | Bedside care team (nurses, physicians) | Bedside care team (nurses, physicians) |
| Software Level ofConcern | Major | Major |
| User Interface | Standard PC/LaptopWeb client available on mobile devicescreens. | Standard PC/LaptopWeb client available on mobile devicescreens (excluding mobile phones). |
| SW and HWComponents | Software only product; client serverarchitecture installed on off-the-shelf ITdevices. | Software only product; client serverarchitecture installed on off-the-shelf ITdevices. |
| Software Capabilities- ClinicalAnnotations &Record Archive | Ability for users to generate annotationson fetal strips and save a report to thepatients records for long term storage. | |
| Software Capabilities– Computed Items &Assessment Tools | NoneMural Perinatal Surveillance utilizes acombination of standard generalcomputes widely accepted and generallyavailable along with more complexcomputes derived directly from well-established industry standards orevidence-based studies and peer-reviewed research journals. The basis forcomplex computes are fully disclosed tothe user.The complex computes include ShoulderDystocia Risk, Postpartum HemorrhageRisk Score, and Bishop Score.The software provides a Fetal WaveformAssessment Tool (FWAT) which acts asa digital line on the screen to allowclinicians to view waveforms against themanually set reference line. | |
| Software Capabilities-Alarms | Capable generating alarm conditionswithin the software based on informationcoming from fetal monitors. | |
| Connectivity | HL7 link for Admission DischargeTransfer (ADT) messages and ORU.Acquire physiological data fromcompatible measuring devices.WAN/LAN hospital connectivity | |
| Operating System(s) | Operating System:Servers - Windows Server 2012●R2Clients - Windows 10 LTSB●2016Operating System:Servers – Linux distribution with●container orchestrationClients – WebKit based browser●with support for HTML5 &JavaScriptThe Mural Perinatal Surveillance systemis designed as a cloud-native applicationutilizing virtualization technology on aLinux operating system withcontainerized services. The applicationruns on premises (on prem) within ahospital network. | |
| Data Sources /Connectivity /Outputs | Data Sources (inputs)HL7, Fetal monitors (on a network),Connectivity & OutputIntelliSpace Perinatal provides aninterface to launch the Philips IntelliVueXDS Remote Display for remote viewingand operating of compatible patientmonitors. Additionally, the system canoutput reports/records.Data Sources (inputs)HL7, Fetal monitors (on a network)Connectivity & OutputMural Perinatal Surveillance does notcontrol other medical devices. Thesoftware generates reports that can bestored in a patients record. |
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Mural Perinatal Surveillance and Philips IntelliSpace Perinatal Revision K.00 (K173941) are software-only clinical information systems that have the same intended use - for the monitoring, analysis and documentation of fetal waveforms for obstetric patients during and after pregnancy.
The Mural Perinatal Surveillance software employs the same fundamental scientific technology as its predicate device. Both Mural Perinatal Surveillance and Philips IntelliSpace Perinatal Revision K.00 both operate off a client server architecture installed on off-the-shelf client servers utilizing standard communication languages such as HL7 and ORU. The Mural Perinatal Surveillance and Philips IntelliSpace Perinatal Revision K.00 software both include clinical decision support, annotation and alarm functionality. The subject device has different technological features, including different user interfaces, software capabilities (computed items and assessment tools), and operating systems. However, the different technological characteristics do not raise different questions of safety and effectiveness.
| 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 Perinatal Surveillance software was developed following the GE Healthcare Quality Management System (QMS). The following activities were successfully completed:Risk Analysis / Management Requirements Reviews Design Reviews Software Verification Software Validation Usability Testing |
| Mural Perinatal Surveillance 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 | |
| Successful completion of design verification and validation testing was performed to confirms that software and user requirements have been met. | |
| Cybersecurity was evaluated as recommended in the 2014 FDA guidance document “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” | |
| Interoperability was evaluated as recommended in the 2017 FDA guidance document “Design Considerations and Pre-market |
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| Submission Recommendations for Interoperable Medical Devices." | |
|---|---|
| Conclusion | |
| The performance data described above demonstrate that the Mural Perinatal Surveillance is as safe | |
| and effective as the IntelliSpace Perinatal Revision K.00 and supports a determination of | |
| substantial equivalence. |
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).