(101 days)
Not Found
No
The summary describes a data management and display system for perinatal care, with no mention of AI or ML capabilities. The focus is on data collection, display, documentation, and alarm functionality.
No
The device is an information management system that collects, displays, and documents clinical data. It explicitly states it is not intended to control medical devices and its purpose is to support the judgment of medical professionals, not to be the sole source of information for decision making, indicating it does not directly treat or diagnose.
No
This device is a perinatal monitoring system that collects, displays, and documents clinical data. It is intended to support the judgment of medical professionals and is explicitly stated as "not intended to be the sole source of information for decision making," which distinguishes it from a device providing diagnostic conclusions.
Yes
The device description explicitly states "Mural Perinatal Surveillance is a software only, information management system". The performance studies focus on software verification and validation, cybersecurity, and interoperability, further supporting its software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "perinatal monitoring system intended for electronic collection, display, and documentation of clinical data." It acquires data from medical devices, EHRs, and other sources. This describes a system for managing and presenting patient data, not for performing tests on biological samples to diagnose or monitor a condition.
- Device Description: The description reinforces this by calling it a "software only, information management system designed for the obstetrical (OB) care environment." It focuses on collecting, displaying, and documenting patient data and integrating with existing systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic results based on such analysis. IVDs are specifically designed for these purposes.
The device functions as a clinical information system to support healthcare professionals in managing patient data and workflow in an obstetrical setting. While it is a medical device, its function falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
HGM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in clinical support settings for obstetric patients during and after pregnancy.
Bedside care team (nurses, physicians)
Healthcare facility environment within the Obstetrical/Gynecological (OB/GYN) department
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Submission Recommendations for Interoperable Medical Devices."
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
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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3
510(k) Summary K220732
| Submitter Information | |
|---|---|
| Date Summary Prepared: | 23 June 2022 |
| Submitter: | GE Medical Systems Information Technologies, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226, USA | |
| Primary Contact Person: | Brandon O'Shea |
| Sr. Regulatory Affairs Manager | |
| GE Medical Systems Information Technologies, Inc. | |
| Email: brandon.oshea@ge.com | |
| Ph: (414) 323-3147 | |
| Secondary Contact Person: | Michael Petrini |
| Regulatory Affairs Executive | |
| GE 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 Device
Philips IntelliSpace Perinatal Revision
K.00
K173941 | Subject Device
Mural Perinatal Surveillance
K220732 |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Patient Population | Hospital Based Obstetric Patients | Hospital Based Obstetric Patients |
| Environment of Use | Healthcare facility environment within
the Obstetrical/Gynecological
(OB/GYN) department | Healthcare facility environment within
the Obstetrical/Gynecological (OB/GYN)
department |
| Intended User | Bedside care team (nurses, physicians) | Bedside care team (nurses, physicians) |
| Software Level of
Concern | Major | Major |
| User Interface | Standard PC/Laptop
Web client available on mobile device
screens. | Standard PC/Laptop
Web client available on mobile device
screens (excluding mobile phones). |
| SW and HW
Components | Software only product; client server
architecture installed on off-the-shelf IT
devices. | Software only product; client server
architecture installed on off-the-shelf IT
devices. |
| Software Capabilities
- Clinical
Annotations &
Record Archive | Ability for users to generate annotations
on fetal strips and save a report to the
patients records for long term storage. | |
| Software Capabilities
– Computed Items &
Assessment Tools | None
Mural Perinatal Surveillance utilizes a
combination of standard general
computes widely accepted and generally
available along with more complex
computes derived directly from well-
established industry standards or
evidence-based studies and peer-
reviewed research journals. The basis for
complex computes are fully disclosed to
the user.
The complex computes include Shoulder
Dystocia Risk, Postpartum Hemorrhage
Risk Score, and Bishop Score.
The software provides a Fetal Waveform
Assessment Tool (FWAT) which acts as
a digital line on the screen to allow
clinicians to view waveforms against the
manually set reference line. | |
| Software Capabilities
-Alarms | Capable generating alarm conditions
within the software based on information
coming from fetal monitors. | |
| Connectivity | HL7 link for Admission Discharge
Transfer (ADT) messages and ORU.
Acquire physiological data from
compatible measuring devices.
WAN/LAN hospital connectivity | |
| Operating System(s) | Operating System:
Servers - Windows Server 2012
●
R2
Clients - Windows 10 LTSB
●
2016
Operating System:
Servers – Linux distribution with
●
container orchestration
Clients – WebKit based browser
●
with support for HTML5 &
JavaScript
The Mural Perinatal Surveillance 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 /
Connectivity /
Outputs | Data Sources (inputs)
HL7, Fetal monitors (on a network),
Connectivity & Output
IntelliSpace Perinatal provides an
interface to launch the Philips IntelliVue
XDS Remote Display for remote viewing
and operating of compatible patient
monitors. Additionally, the system can
output reports/records.
Data Sources (inputs)
HL7, Fetal monitors (on a network)
Connectivity & Output
Mural Perinatal Surveillance does not
control other medical devices. The
software generates reports that can be
stored in a patients record. | |
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6
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 |
7
| 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. |