Mural Perinatal Surveillance

K220732 · Ge Medical Systems Information Technologies, Inc. · HGM · Jun 23, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K220732
• Device Name: Mural Perinatal Surveillance
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jun 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 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.

Device Story

Mural Perinatal Surveillance is a software-only information management system for the OB/GYN department. It collects clinical data from hospital network sources, including fetal monitors and electronic health records (EHR). The system integrates patient surveillance, alarm management, documentation, and record-keeping into a single application. It provides clinical decision support tools, including risk scores (Shoulder Dystocia, Postpartum Hemorrhage) and the Bishop Score, as well as a Fetal Waveform Assessment Tool (FWAT) for visual waveform comparison. The software is deployed on a server architecture and accessed via web browsers on hospital-supplied IT hardware. It does not control or alter connected medical devices. Healthcare providers use the output to support clinical judgment and documentation; it is not intended as the sole source for decision-making. The system benefits patients by centralizing monitoring and documentation throughout the obstetrical care journey.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities included risk analysis, requirements review, design review, software verification/validation, and usability testing. Cybersecurity and interoperability were evaluated per FDA guidance. Alarm functionality was tested per IEC 60601-1-8.

Technological Characteristics

Software-only, cloud-native application using virtualization and containerized services on a Linux operating system. Accessed via web browser (HTML5/JavaScript). Connectivity via hospital network (LAN/WAN) using HL7/ORU protocols. Software developed under GE Healthcare QMS; safety classification per IEC 62304; alarm testing per IEC 60601-1-8.

Indications for Use

Indicated for obstetric patients during and after pregnancy in clinical support settings. Intended for use by healthcare professionals (nurses, physicians) in hospital environments.

Regulatory Classification

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.

Predicate Devices

• IntelliSpace Perinatal Revision K.00 (K173941)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<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: [e-mail]<br>Ph: [phone] |
| Secondary Contact Person: | Michael Petrini<br>Regulatory Affairs Executive<br>GE Medical Systems Information Technologies, Inc.<br>Ph: [phone] |
| 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 Device<br>Philips IntelliSpace Perinatal Revision<br>K.00<br>K173941 | Subject Device<br>Mural Perinatal Surveillance<br>K220732 |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Patient Population | Hospital Based Obstetric Patients | Hospital Based Obstetric Patients |
| Environment of Use | Healthcare facility environment within<br>the Obstetrical/Gynecological<br>(OB/GYN) department | Healthcare facility environment within<br>the Obstetrical/Gynecological (OB/GYN)<br>department |
| Intended User | Bedside care team (nurses, physicians) | Bedside care team (nurses, physicians) |
| Software Level of<br>Concern | Major | Major |
| User Interface | Standard PC/Laptop<br>Web client available on mobile device<br>screens. | Standard PC/Laptop<br>Web client available on mobile device<br>screens (excluding mobile phones). |
| SW and HW<br>Components | Software only product; client server<br>architecture installed on off-the-shelf IT<br>devices. | Software only product; client server<br>architecture installed on off-the-shelf IT<br>devices. |
| Software Capabilities<br>- Clinical<br>Annotations &<br>Record Archive | Ability for users to generate annotations<br>on fetal strips and save a report to the<br>patients records for long term storage. | |
| Software Capabilities<br>– Computed Items &<br>Assessment Tools | None<br><br>Mural Perinatal Surveillance utilizes a<br>combination of standard general<br>computes widely accepted and generally<br>available along with more complex<br>computes derived directly from well-<br>established industry standards or<br>evidence-based studies and peer-<br>reviewed research journals. The basis for<br>complex computes are fully disclosed to<br>the user.<br>The complex computes include Shoulder<br>Dystocia Risk, Postpartum Hemorrhage<br>Risk Score, and Bishop Score.<br>The software provides a Fetal Waveform<br>Assessment Tool (FWAT) which acts as<br>a digital line on the screen to allow<br>clinicians to view waveforms against the<br>manually set reference line. | |
| Software Capabilities<br>-Alarms | Capable generating alarm conditions<br>within the software based on information<br>coming from fetal monitors. | |
| Connectivity | HL7 link for Admission Discharge<br>Transfer (ADT) messages and ORU.<br>Acquire physiological data from<br>compatible measuring devices.<br>WAN/LAN hospital connectivity | |
| Operating System(s) | Operating System:<br>Servers - Windows Server 2012<br>●<br>R2<br>Clients - Windows 10 LTSB<br>●<br>2016<br><br>Operating System:<br>Servers – Linux distribution with<br>●<br>container orchestration<br>Clients – WebKit based browser<br>●<br>with support for HTML5 &<br>JavaScript<br>The Mural Perinatal Surveillance system<br>is designed as a cloud-native application<br>utilizing virtualization technology on a<br>Linux operating system with<br>containerized services. The application<br>runs on premises (on prem) within a<br>hospital network. | |
| Data Sources /<br>Connectivity /<br>Outputs | Data Sources (inputs)<br>HL7, Fetal monitors (on a network),<br>Connectivity & Output<br>IntelliSpace Perinatal provides an<br>interface to launch the Philips IntelliVue<br>XDS Remote Display for remote viewing<br>and operating of compatible patient<br>monitors. Additionally, the system can<br>output reports/records.<br><br>Data Sources (inputs)<br>HL7, Fetal monitors (on a network)<br>Connectivity & Output<br>Mural Perinatal Surveillance does not<br>control other medical devices. The<br>software generates reports that can be<br>stored 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:<br>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:<br>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. | |