The Maternal Fetal Monitoring – Central Nurse System (MFM-CNS) is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.

The MFM-CNS has display fields for the following obstetric data:

patient demographics
provider notes
FHR
uterine activity (via tocodynamometry or IUP)
maternal heart rate
SpO2
NIBP
respiratory rate
temperature
pulse rate

Device Description

MFM-CNS is a software production who runs on PC station with Microsoft Windows XP operating system. MFM-CNS by connecting one central station with some bedside fetal / maternal monitors, carries out centralized monitoring management for many beds. It can monitor a pregnant woman during the whole parturition process, and all the monitoring information can be recorded, saved and printed, and alarm when the parameter exceed the user defined limit and poor signal quality. At the same time, the old records can be searched conveniently and quickly.

Device features:

Connect maximum 32 bedside fetal / maternal monitors with Ethernet.
Display FHR, UA, Maternal HR, PR, SpO2, NIBP, RR and TEMP numerics on the screen.
The screen displays all the monitors simultaneously, or displays one monitor in full screen.
24-hour CTG, 1440-group Maternal Vital Sign data, 200-group NIBP data review.
Print CTG report, Maternal Vital Sign list, NIBP list on the paper
Audible & visible alarm when FHR or maternal vital sign exceeds the user defined limit or poor signal quality.
Patient information, CTG, Maternal Vital Sign list and NIBP list can be saved, and burned into CDs for backup.
Support user accessing control.

AI/ML Overview

This 510(k) submission for the Edan Instruments, Inc. Central Monitoring System (MFM-CNS) does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in the way a typical diagnostic or AI/ML device submission would. This is because the MFM-CNS is a "perinatal monitoring system and accessories," primarily a data management and display software for existing medical devices (bedside fetal/maternal monitors), not a device performing independent diagnostic analysis or making clinical decisions. Its "performance" is more related to its functionality, reliability, and accuracy in data handling and display, rather than diagnostic accuracy metrics like sensitivity or specificity.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, ground truth type for training set) are not applicable or not provided in the document for this type of device.

Here's an analysis of the information provided, addressing the questions where possible:

Acceptance Criteria and Device Performance Study for Edan Instruments, Inc. Central Monitoring System (MFM-CNS)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not outline specific numerical acceptance criteria (e.g., "accuracy must be >X%") or report quantitative device performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this type of device are implicitly tied to its stated functionality, safety, and substantial equivalence to a predicate device.

The "reported device performance" is essentially a confirmation that the device functions as intended and meets safety and performance requirements through various testing methods.

Acceptance Criteria (Inferred from testing types)	Reported Device Performance (Summary of Conclusion)
Functional Requirements: - Connects to max 32 bedside monitors. - Displays specified FHR, UA, Maternal HR/PR/SpO2/NIBP/RR/TEMP numerics. - Displays all monitors simultaneously or one in full screen. - Provides 24-hour CTG, 1440-group Maternal Vital Sign data, 200-group NIBP data review. - Prints CTG, Maternal Vital Sign, NIBP reports. - Provides audible/visible alarms for out-of-limit parameters or poor signal. - Saves patient info, CTG, Maternal Vital Sign, NIBP records, and can burn to CDs. - Supports user access control.	Compliance Confirmed: Verification and validation testing was done. The device demonstrated substantial equivalence to the predicate device, implying its functional, safety, and performance characteristics are comparable and acceptable for its intended use. The software performs its intended functions for data display, management, and archiving.
Software Quality: - Software testing conducted.	Compliance Confirmed: Software testing was applied to the development of the MFM-CNS.
Risk Management: - Risk analysis conducted.	Compliance Confirmed: Risk analysis was applied to the development of the MFM-CNS.
Safety: - Safety testing conducted.	Compliance Confirmed: Safety testing was applied to the development of the MFM-CNS.
Performance (General): - Performance testing conducted.	Compliance Confirmed: Performance testing was applied to the development of the MFM-CNS.

2. Sample Size Used for the Test Set and Data Provenance

The document states "Verification and validation testing was done on MFM-CNS." However, it does not specify the sample size used for the test set (e.g., number of patient records, number of monitoring sessions).

Given the nature of the device as a data management system, the "test set" would likely constitute a series of simulated or real-world data streams from connected monitors, and various user interactions. The document does not provide details on the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As a data management system, the "ground truth" for its performance would primarily involve confirming the accurate display and storage of data as received from the connected monitors, not an independent clinical diagnosis requiring expert consensus. Human experts may have been involved in verifying the UI/UX and data integrity, but their number and qualifications are not listed.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable in the context of testing a data management and display system.

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

No MRMC study was conducted or reported. This device is not an AI-assisted diagnostic tool; it is a display and management system for perinatal monitoring data. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply.

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

This information is not explicitly stated in the provided text. However, as it is a "Central Monitoring System" that displays data acquired from other devices and allows for manual input and user-defined limits, its primary function inherently involves a "human-in-the-loop." It is a software application designed to provide information to clinicians, not to make autonomous diagnostic decisions. Its validation would focus on the accuracy of data acquisition, display, archiving, and alarming functions, which are analogous to "standalone" performance of the software functions themselves.

7. The Type of Ground Truth Used

For a data management and display system like the MFM-CNS, the "ground truth" would be:

Accurate input data: Ensuring the data received from bedside monitors is correctly interpreted and displayed.
Functional correctness: Verification that display fields show the correct information, alarms trigger appropriately based on predefined limits, data is stored and retrieved accurately, and printing functions work as expected.
User Interface/Experience (UI/UX) adherence: Conformance to design specifications for how information is presented.

It is not expert consensus, pathology, or outcomes data in a diagnostic sense, but rather a verification of the system's faithful handling and presentation of information.

8. The Sample Size for the Training Set

This information is not provided and is typically not relevant for a deterministic software application like this, which does not employ machine learning or AI models that require specific training data sets.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is generally not applicable as there's no indication of a "training set" in the context of an AI/ML algorithm. If the term "training set" refers to internal development and testing data, the "ground truth" would have been established through a combination of simulated data, test cases with known outputs, and direct comparison to the behavior of the predicate device or established specifications.

Summary

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510(K)Summary of Safety and Effectiveness

JAN - 6 2011

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

Submitter:	Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86755 26882220Fax:+86 755 26882223
Contact person:	Jiang yucaiEdan Instruments, Inc.
Preparing date:	2010-08-23
Proprietary Name:	Central Monitoring System (model MFM-CNS)
Classificationinformation:	21 CFR 884.2740 Perinatal monitoring system and accessoriesClass II
Product code:	HGM
Review Panel:	Obstetrics/Gynecology
Predicate Devices:	CIV-ob Obstetrical Monitoring Software Application (K051175)
Device Description:	MFM-CNS is a software production who runs on PC stationwith Microsoft Windows XP operating system. MFM-CNSby connecting one central station with some bedside fetal /maternal monitors, carries out centralized monitoringmanagement for many beds. It can monitor a pregnantwoman during the whole parturition process, and all themonitoring information can be recorded, saved and printed,and alarm when the parameter exceed the user defined limitand poor signal quality. At the same time, the old records can

Device features:

be searched conveniently and quickly.

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Connect maximum 32 bedside fetal / maternal . monitors with Ethernet.
Display FHR, UA, Maternal HR, PR, SpO2, NIBP, . RR and TEMP numerics on the screen.
The screen displays all the monitors simultaneously, . or displays one monitor in full screen.
24-hour CTG, 1440-group Maternal Vital Sign data, . 200-group NIBP data review.
. Print CTG report, Maternal Vital Sign list, NIBP list on the paper
Audible & visible alarm when FHR or maternal vital . sign exceeds the user defined limit or poor signal quality.
Patient information, CTG, Maternal Vital Sign list . and NIBP list can be saved, and burned into CDs for backup.
Support user accessing control. .

The Maternal Fetal Monitoring - Central Nurse System (MFM-CNS) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.

The MFM-CNS has display fields for the following obstetric data:

patient demographics ●
provider notes .
FHR
uterine activity (via tocodynamometry or IUP) .
maternal heart rate .
SpO2 .
NIBP
respiratory rate
temperature
pulse rate

1.2 Indications

for Use

l -2

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Test Summary:

The following quality assurance measures were applied to the development of the MFM-CNS Electrocardiograph:

Software testing .
Risk analysis .
Safety testing .
Performance test .

Conclusion:

Verification and validation testing was done on MFM-CNS. This premarket notification submission demonstrates that the subject device MFM-CNS is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

ここで

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Edan Instruments, Inc. c/o Mr. William Stern Official Correspondent Multigon Industries, Inc. l Odell Plaza YONKERS NY 10701

Re: K100358

Trade Name: MFM-CNS (Central Monitoring System) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: December 20, 2010 Received: December 23, 2010

Dear Mr. Stern:

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. 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 801); medical device reporting of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stuckert Lemieux MD

lerbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Indications for Use

K100358 510(k) Number:

JAN - 6 2011

.. :

Device Name: Central Monitoring System (model MFM-CNS)

The Maternal Fetal Monitoring – Central Nurse System (MFM-CNS) is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

The MFM-CNS has display fields for the following obstetric data:

. patient demographics
. provider notes
. FHR
uterine activity (via tocodynamometry or IUP) .
. maternal heart rate
SpO2 .
NIBP .
respiratory rate .
temperature .
pulse rate .

Prescription Use	X	Or	Over the Counter Use
(21 CFR Part 801 Subpart D)			(21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and Urological Devices

510(k) Number	K100358	1-4
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Regulation Number and Section

§ 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).