MFM-CMS central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include:

· Viewing patient real-time clinical data and alarms.
· Storing and reviewing patient clinical data and alarms.
· Printing real-time and history patient data.
· Configuring local settings as well as synchronizing settings to a remote device through network.
· Accessing patient clinical data between several departments.

MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.

MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.

Device Description

MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded.

AI/ML Overview

The provided text is a 510(k) summary for the Edan Instruments, Inc. MFM-CMS Central Monitoring System. It describes the device, its intended use, and a comparison to predicate devices, but does not contain information related to specific acceptance criteria, reported device performance in those criteria, sample sizes, expert qualifications, or ground truth establishment for a diagnostic AI device.

The submission is for a "Central Monitoring System" (MFM-CMS), which supports centralized management of patient clinical data from other EDAN medical devices. It is classified as an "Arrhythmia detector and alarm (including ST-segment measurement and alarm)" with product code MHX. However, the summary focuses on the system's ability to display, store, review, and print data, and manage settings, rather than its performance as an arrhythmia detector itself.

Therefore, many of the requested details cannot be extracted from this document, as they are typically found in the clinical validation studies of algorithms that perform diagnostic or interpretative tasks.

Here's an analysis based on the information available in the document:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission focuses on functional changes and comparison to predicates, not specific performance metrics like sensitivity, specificity, or accuracy for an arrhythmia detection algorithm. The "Performance" section within the comparison table refers to features like "Bi-directional Configuration" and "Data Review," not numerical performance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document states "Clinical testing: Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device." This indicates that no clinical test set was used to validate the device's performance in a diagnostic capacity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided, as no clinical test set for diagnostic accuracy was utilized.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided, as no clinical test set for diagnostic accuracy was utilized.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC study was done. The device is a "Central Monitoring System" and is not described as an AI-powered diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided, as the document does not describe the MFM-CMS as a standalone diagnostic algorithm. Its primary function is a central data management system. Although it is classified under "Arrhythmia detector and alarm," the detailed description of its updates and comparison to predicates emphasizes data handling and system functionality rather than algorithm performance for arrhythmia detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided, as no clinical validation study is described.

8. The sample size for the training set

This information is not provided. As the submission focuses on software updates and functional equivalence, details about training sets for an AI algorithm are not relevant or discussed.

9. How the ground truth for the training set was established

This information is not provided, as no clinical validation study or AI training is described.

Summary of what is available in the document:

The document describes the MFM-CMS as a central monitoring system that connects to other EDAN medical devices to manage patient clinical data. The submission is for an updated version (K232694) of an existing device (K120727), with the primary predicate being the BeneVision Central Monitoring System (K220058).

Key changes and comparisons:

The main changes to the software include:

Add distributed function.
Add license authorization.
Support department management, device management, and user management.
Support time synchronization function.
Support data automatic dump function.
Replace the software development platform.
Supports simultaneous login of multiple clients.
Support domain account to log in to the CMS client.

The comparison table highlights similarities and differences in intended use, operating system support, data review features, calculations, telemetry support, print capabilities, and network connectivity between the subject device and its predicate.

Performance Data (as per the document):
The document states:

Non-clinical test: Biocompatibility testing and Electrical safety & electromagnetic compatibility (EMC) are "Not applicable."
Software Verification and Validation Testing: Conducted in accordance with FDA guidance for software in medical devices.
Bench Testing: Functional and system-level testing was conducted to validate performance, and results "show that the subject device meets relevant consensus standards" (e.g., IEC 60601-1-8:2006 + Am1:2012 for alarm systems).
Clinical testing: "Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device."

Conclusion: The submission concludes that "The bench testing data and software verification and validation demonstrate that MFM-CMS Central Monitoring System is substantially equivalent to the predicate devices."

In essence, this FDA 510(k) summary focuses on demonstrating that the updated MFM-CMS system maintains the safety and effectiveness of its predicate devices through non-clinical testing and software verification, rather than providing a detailed performance study of a diagnostic algorithm against specific clinical acceptance criteria.

Summary

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February 5, 2024

Edan Instruments, Inc. Tracy Yue Regulatory Engineer 15 Jinhui Road, Jinsha Community, Kengzi Sub-district, Pingshan District Shenzhen, 518122 China

Re: K232694

Trade/Device Name: Central Monitoring System (MFM-CMS) 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: January 5, 2024 Received: January 5, 2024

Dear Tracy Yue:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jennifer W. Shih -S

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices

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Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232694

Device Name

Central Monitoring System (MFM-CMS)

Indications for Use (Describe)

· Viewing patient real-time clinical data and alarms.
· Storing and reviewing patient clinical data and alarms.
· Printing real-time and history patient data.
· Configuring local settings as well as synchronizing settings to a remote device through network.
· Accessing patient clinical data between several departments.

MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.

MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.

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)

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."

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Prepared in accordance with the requirements of 21 CFR Part 807.92
1. Submitter:	Edan Instruments, Inc.#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel: +86(0755) 84513592Fax: +86(0755) 26882223
2. Contact person:Preparing date:	Tracy YueSep. 4, 2023
3. Device name andclassification:	Trade name: Central Monitoring System, model: MFM-CMSClassification Name/ Product code:21 CFR 870.1025 Monitor, Physiological, Patient(With Arrhythmia DetectionOr Alarms)MHXRegulatory Class: Class II
4. Predicate Device(s):	1) Shenzhen Mindray Bio-Medical Electronics Co., LTD, BeneVision CentralMonitoring System, cleared under K220058 (Primary)2) Edan Instruments, MFM-CMS Central Monitoring System, cleared underK120727 (Reference)
5. Reason forSubmission	By submission of the Traditional 510(k), Edan Instruments is requestingclearance for an updated version of the MFM-CMS Central Monitoring System(K120727).
6. Device Description:	MFM-CMS is a central monitoring system product, which can connect andmanage information from EDAN medical devices. MFM-CMS offers centralmanagement for monitoring information from the medical devices. All thesecollected information can be displayed, printed, alarmed and recorded.Modifications:The following are the main changes to the software which is the subject of this

510(k) Summary

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1. Add distributed function.
1. Add license authorization.
1. Support department management, device management and user management.
1. Support time synchronization function.
1. Support data automatic dump function.
1. Replace the software development platform.
1. Supports simultaneous login of multiple clients.
1. Support domain account to log in to the CMS client.
1. Indication for Use MFM-CMS central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include:
- . Viewing patient real-time clinical data and alarms.
- Storing and reviewing patient clinical data and alarms. .
- . Printing real-time and history patient data.
- Configuring local settings as well as synchronizing settings to a remote . device through network.
- Accessing patient clinical data between several departments. .

MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.

MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.

9. Predicate Device Comparison

The subject device is technologically equivalent to predicate devices. Any differences are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness. The table below compares the intended use and technological characteristics of the subject and primary predicate device:

Item	MFM-CMS Central Monitoring System	BeneVision Central Monitoring System(K220058)	ComparisonResult
Intended Use
Intended use	MFM-CMS central monitoring system(hereinafter referred to as MFM-CMS)supports centralized management of patients'	The indications for use of the BeneVisionCentral Monitoring System include:• Real time viewing of patient clinical data and	Different
Item	MFM-CMS Central Monitoring System	BeneVision Central Monitoring System(K220058)	ComparisonResult
	clinical data provided by EDAN medicaldevices. Clinicians can obtain patient clinicaldata via MFM-CMS. The indications for useof the MFM-CMS central monitoring systeminclude:■ Viewing patient real-time clinical dataand alarms.■ Storing and reviewing patient clinicaldata and alarms.■ Printing real-time and history patientdata.■ Configuring local settings as well assynchronizing settings to a remotedevice through network.■ Accessing patient clinical data betweenseveral departments.	alarms■ Storage and historical review of patientclinical data and alarms■ Printing of real time and historical patientdata■ Configuration of local settings as well assynchronizing settings across the network to aremote device■ Transfer of patient clinical data and settingsbetween several Central Stations■ Provides a Resting 12 Lead interpretation ofpreviously stored dataThe BeneVision Central Monitoring System isa networked patient monitoring systemintended for use in a fixed location, installed inprofessional healthcare facilities to provideclinicians remote patient monitoring. Thenetwork connections between the variousdevices can be any combination of Ethernet(Wired), Wireless WIFI (WLAN), andWireless WMTS.The BeneVision Central Monitoring Systemsupports one or more Mindray compatiblephysiological monitors and will display, store,print, and transfer information received fromthe compatible monitors; The BeneVisionCentral Monitoring System supportsbi-directional configuration of the compatiblemonitors.The telemetry monitoring systems are designedto acquire and monitor physiological data forambulating patients within a defined coveragearea. The BeneVision Central MonitoringSystem supports Telemetry Systems:TMS-6016, Telepack-608, TMS60, TM80, andTM70.■ The TMS-6016 transmitter is intended foruse on Adult and Pediatric patients to monitor
	MFM-CMS is intended to be used only inclinical or hospital environment bywell-trained healthcare professionals.MFM-CMS is indicated for use whenmonitoring adult and/or pediatric and/orneonate patients as indicated by labeling ofthe medical device providing the data.
Item	MFM-CMS Central Monitoring System	BeneVision Central Monitoring System(K220058)	ComparisonResult
		ECG and SpO2 physiological data.■ The Panorama Telepack-608 transmitter isintended for use on Adult patients to monitorECG and SpO2 physiological data.■ The TMS60 transmitter is intended for use onAdult and Pediatric patients over three yearsold to monitor ECG, SpO2, NIBP and Respphysiological data. The physiological data canbe reviewed locally on the display of thetransmitter. The Central Station will supportECG, Heart Rate, SpO2, NIBP, Resp, PulseRate, Arrhythmia analysis, QT monitoring, andST Segment Analysis for the TMS60.■ The TM80/TM70 telemetry monitor isintended for use on Adult and Pediatric patientsover three years old to monitor ECG, SpO2,NIBP and Resp physiological data. Thephysiological data can be analyzed, alarmed,stored, reviewed locally on the display of themonitor, and the Central Station can configureand display the physiological parameters fromthe TM80/TM70.The BeneVision Central Monitoring System isintended for use in professional healthcarefacilities under the direct supervision of alicensed healthcare practitioner.
	Technical
Operation System	Support Windows 10 Pro 32/64 bit,Windows 11 Pro 64 bit, Server 2012, Server2016	Support Microsoft Windows 8/10, Server2012/Server 2016/ Server 2019	Different
	Performance
Bi-directionalConfiguration	Support	Support	Same
Data Review	Short trends for all parameters; trend graphand trend table for all parameters; fulldisclosure waveforms and ECG compressedwaveforms: physiological alarm events.	Trend data, events review, dynamic short trend,C.O. measurements, ST segments,full-disclosure waveforms and compressedwaveforms. NIBP measurements. 12-lead	Different
Item	MFM-CMS Central Monitoring System	BeneVision Central Monitoring System(K220058)	ComparisonResult
nurse call events, and patient call events;12-lead analysis results; NIBP measurementdata; C.O. measurement results; score trendreview.	analysis results, 12 analysis waveforms foreach analysis result
Calculations	MFM-CMS provides functions includingdrug calculation and titration table,hemodynamic calculation, oxygenationcalculation, renal function calculation andventilation calculation.	BeneVision provides functions including drugcalculation and titration table, hemodynamiccalculation, oxygenation calculation, renalfunction calculation and ventilation calculation.	Same
Telemetry	Support	Support	Same
Print	Patient information, Real-time monitoringdata, Alarm list or waveform, Waveformreview, Trend table/graph, NIBP review,12-lead analysis result, C.O. review, Scoretrend, ECG, NIBP, Nursing report,Calculation result	Patient information, Real-time waveform,Real-time alarm, Alarm Settings, Multi-leadECG Report, CSA Report, Waveform review,Arrhythmia Statistic Result, Trend Review,C.O. measurement, events, 12-lead Review, STreview, QT View Report, Drug calculations,Hemodynamics calculations, Oxygenationcalculations, Ventilation calculations, Renalcalculations, ICG hemodynamic parameter,CCO hemodynamic parameter, SvO2/ScvO2oxygenation parameters	Different
Network Connect	Support wired and wireless network.	Support wired and wireless network.	Same
Patient Monitor Numbers–Number Supported	1. Support 64 monitors running asapplication2. Running as Monitoring Stationup to 128 monitors with nopatient display, the display is provided byViewer Stations	1. Support 64 monitors running as application2. Running as serviceUp to 128 monitors with no patient display, thedisplay is provided by Work Stations	Similar

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10. Performance Data:

Non-clinical test:

Biocompatibility Testing

Not applicable.

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Electrical safety and electromagnetic compatibility (EMC)

Not applicable.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Bench Testing:

Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets relevant consensus standards.

. IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Clinical testing:

Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device.

11. Conclusion

The bench testing data and software verification and validation demonstrate that MFM-CMS Central Monitoring System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.