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

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.

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

patient demographics
provider notes
fetal heart rate (FHR)
uterine activity
fetal movement
maternal heart rate
SpO2
non-invasive blood pressure (NIBP)
respiratory rate
temperature
pulse rate

MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records.

Lite has display fields for the following obstetric data:

patient demographics
provider notes
fetal heart rate (FHR)
uterine activity
fetal movement

Device Description

The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS v3.91 additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting, processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware.

The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are intended to be used in hospital clinical areas such as monitor units, delivery room, etc. They are intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system interface. The user cannot only depend on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system to obtain monitoring data, because whether the data provided by the system are accurate depends on the stability of the operating system, the performance of PC station and the network.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Edan Instruments, Inc.'s Central Monitoring System MFM-CNS Lite v1.1 and MFM-CNS v3.91). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for the new device in the same way one might for a novel diagnostic algorithm.

Therefore, the document does not contain a table of acceptance criteria and reported device performance for the subject device, nor does it detail a clinical study proving the device meets specific performance criteria. Instead, it relies on demonstrating that the new devices (MFM-CNS v3.91 and MFM-CNS Lite v1.1) are substantially equivalent to a previously cleared predicate device (EDAN Instrument, Inc. Central Monitoring System, model MFM-CNS v3.82, K143695).

However, I can extract information related to the performance data provided to support the substantial equivalence claim.

Here's a breakdown of the available information based on your request:

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

The document does not provide a table of acceptance criteria and reported device performance for the subject device in clinical terms (e.g., sensitivity, specificity, accuracy). Instead, it states that "the non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device."

The "performance" described is in the context of software verification and validation, and compliance with standards.

Acceptance Criteria (from testing performed)	Reported Device Performance (MFM-CNS v3.91 and MFM-CNS Lite v1.1)
Risk analysis according to ISO 14971: 2007	Passed
Software life cycle management according to IEC 62304: 2006	Passed all testing
Bench testing per IEC 60601-1-8: 2006 (Medical electrical equipment 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)	All results show pass

2. Sample size 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 in the document, as it focuses on software verification and validation, not a clinical test set. The device is a "clinical data managing software application," meaning its primary function is to display and manage data from other monitors, not to make independent diagnoses or measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The "ground truth" for software validation would typically be established by comparing the software's output to the expected output according to specifications and functional requirements, rather than expert interpretation of clinical cases.

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

This information is not provided.

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

An MRMC comparative effectiveness study was not done. The device is a data management system, not an AI-assisted diagnostic tool for human readers.

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

A standalone human-in-the-loop performance study was not done. The performance described is related to the software's functionality and safety, not its diagnostic accuracy in a clinical context. The document explicitly states: "During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system interface. The user cannot only depend on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system to obtain monitoring data, because whether the data provided by the system are accurate depends on the stability of the operating system, the performance of PC station and the network." This indicates it's designed as an information display and management tool, not an independent diagnostic algorithm.

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

The concept of "ground truth" in the clinical sense (e.g., pathology, outcomes data) is not applicable to the performance data presented. The "ground truth" for the software validation would be its adherence to established software requirements and industry standards.

8. The sample size for the training set

This information is not applicable/not provided. The device is a software application for data management; it does not explicitly mention machine learning or AI models that require a training set in the conventional sense. The "training" here refers to software development and testing cycles rather than model training.

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

This information is not applicable/not provided for the reasons stated above.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 6, 2017

Edan Instruments, Inc. % Doug Worth Sr.Dir.US RA/OA Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089

Re: K171178

Trade/Device Name: Central Monitoring System MFM-CNS Lite v1.1 and MFM-CNS v3.91 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: August 4, 2017 Received: August 7, 2017

Dear Doug Worth:

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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education (DICE) 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. 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

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 Industry and Consumer Education (DICE) 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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director 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

510(k) Number (if known) K171178

Device Name

Central Monitoring System MFM-CNS v3.91

Indications for Use (Describe)
--------------------------------	--

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

□ patient demographics
□ provider notes
□ fetal heart rate (FHR)
□ uterine activity
□ fetal movement
□ maternal heart rate
SpO2
□ non-invasive blood pressure (NIBP)
□ respiratory rate
□ temperature
□ pulse rate

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)

| X | 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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Indications for Use

510(k) Number (if known) K171178

Device Name

Central Monitoring System MFM-CNS Lite v1.1

Indications for Use (Describe)

MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records.

Lite has display fields for the following obstetric data:

□ patient demographics

□ provider notes
□ fetal heart rate (FHR)
□ uterine activity
□ fetal movement

Type of Use (Select one or both, as applicable)

|X 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.

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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510(K) Summary

Prepared in accordance with the content and format regulatory 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) 26858736Fax: +1 (408) 418-4059
Contact person:Preparing date:	Alice YangApril 19, 2017
2. Device name andclassification:	Device Name: Central Monitoring SystemModel: MFM-CNS v3.91, MFM-CNS Lite v1.1Classification Name/ Product code:884.2740 Perinatal monitoring system and accessories / HGMRegulatory Class: Class II
3. Predicate Device(s):	1. EDAN Instrument, Inc. Central Monitoring System, modelMFM-CNS v3.82, K143695. The predicate device was not the subjectof a recall and no reference devices were used in this submission.
4. Device Description:	MFM-CNS v3.91 and MFM-CNS Lite v1.1The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are clinical datamanaging software applications. Both applications manage clinicaldata of fetal monitoring and uterine activity, and the MFM-CNS v3.91additional monitors maternal vital signs. Data are automaticallyacquired from bedside monitors, for the purpose of collecting,processing and saving the patient and/or clinical data that is normallyprovided on record papers and/or separate bedside monitors. Theyprovide electronic medical records and operate with off-the-shelf

software and hardware.

The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are intended to be

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used in hospital clinical areas such as monitor units, delivery room, etc. They are intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system interface. The user cannot only depend on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system to obtain monitoring data, because whether the data provided by the system are accurate depends on the stability of the operating system, the performance of PC station and the network.

5. Indications for Use MFM-CNS v3.91:

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

MFM-CNS has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement maternal heart rate SpO2 non-invasive blood pressure (NIBP) respiratory rate temperature pulse rate

MFM-CNS Lite v1.1:

MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.

Lite is intended to manage antepartum-monitoring data acquired from

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bedside monitors and produce electronic medical records. Lite has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement

6. Predicate Device Comparison

The subject device shares the same characteristics in most items with the predicate device except in the following aspects:

Item	MFM-CNSv3.82	MFM-CNS v3.91	MFM-CNS Lite v1.1
Manufacturer/K#	EDANInstruments/K143695	EDANInstruments/N/A	EDANInstruments/N/A	SE
	Indication for Use
	MFM-CNSv3.82	MFM-CNS v3.91	MFM-CNS Lite v1.1
Indication for Use	The MaternalFetal Monitoring– Central NurseSystem(hereinaftercalled"MFM-CNS") isa clinical datamanagingsoftwareapplication and isindicated forantepartum andintrapartummonitoring ofpregnant womenin a healthcare	The Maternal FetalMonitoring –Central NurseSystem (hereinaftercalled"MFM-CNS") is aclinical datamanaging softwareapplication and isindicated forantepartum andintrapartummonitoring ofpregnant women ina healthcare setting.The MFM-CNS isintended to manageperinatal	MFM-CNS Lite(hereinafter called"Lite") is a clinicaldata managingsoftware applicationand is indicated forantepartum monitoringof pregnant women ina healthcare setting.MFM-CNS Lite isintended to manageantepartum-monitoringdata acquired frombedside monitors andproduce electronicmedical records.The MFM-CNS Litehas display fields for	Different

	setting.	monitoring data	the following obstetric
	The MFM-CNS	acquired from	data:
	is intended to	bedside monitors or	Patient demographics,
	manage perinatal	manual input for	provider notes, fetal
	monitoring data	viewing at the	heart rate (FHR),uterine activity, fetal
	acquired from	central nursing	movement.
	bedside monitors	station. The system
	or manual input	also produces an
	for viewing at the	electronic medical
	central nursing	record.
	station. The	The MFM-CNS has
		display fields for
	system also	the following
	produces an	obstetric data:
	electronic	patient
	medical record.	demographics,
	The MFM-CNS	provider notes, fetalheart rate (FHR),
	has display fields	uterine activity, etc.
	for the following
	obstetric data:
	patientdemographics,
	provider notes,
	fetal heart rate
	(FHR), uterine
	activity (via
	tocodynamometry
	or IUP), etc.
		Classification
Classified as per
FDA regulation	Class II	Class II	Class II	Same
		Network and Hardware
	Off-the-shelf	Off-the-shelf	Off-the-shelf
Hardware	computers and	computers and	computers and	Same
	accessories	accessories	accessories
Network
connecting to	Ethernet	Ethernet	Ethernet	Same
bedside monitor

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	Software
User Access /Authentication	16 client	32 client	1 client	Different
Display	Fetal heart rate,TOCO, maternalvital signs,patientdemography data,and notes.Providing themeans to displaymultiple bedssimultaneously.	Fetal heart rate,TOCO, maternalvital signs, patientdemography data,and notes.Providing themeans to displaymultiple bedssimultaneously.	Fetal heart rate,TOCO, patientdemography data, andnotes.Providing the means todisplay multiple bedssimultaneously.	Different
Supporting beds	32	128	6	Different
Print	Print (locally orremotely) CTGand patientrecords.	Print (locally orremotely) CTG andpatient records.	Print (locally) CTGand patient records.	Different
Archive	CTG andmaternal vitalsigns.Providing theability to archivefiles to asecondary ortertiary storagemedium (i.e.optical disk).Saving dataautomatically.	CTG and maternalvital signs.Providing theability to archivefiles to a secondaryor tertiary storagemedium (i.e. opticaldisk).Saving dataautomatically.	CTG.Providing the ability toarchive files to asecondary or tertiarystorage medium (i.e.optical disk).Saving dataautomatically.	Different
Alarm	Visual alerts offetal/maternalmonitor such asout-of-limit heartrate or poorsignal quality.	Visual alerts offetal/maternalmonitor such asout-of-limit heartrate or poor signalquality.	Visual alerts of fetalmonitor such as poorsignal quality.	Different
Electronic patientrecord	Interfaces withHL7 patientrecord systemsfor data	Interfaces with HL7 patient recordsystems for dataacquisition	Interfaces with theGerätedatenträger-Transfer (GDT)patient record systems	Different
	acquisition,viewing andstorage ofelectronic patientrecord.	viewing and storageof electronic patientrecord.	for data acquisition,viewing and storage ofelectronic patientrecord.
Notes	Providing theuser the ability toenter commentsand specific data.	Providing the userthe ability to entercomments andspecific data.	Providing the user theability to entercomments and specificdata.	Same
CTG	The MFM-CNScan analyzesignal loss,contractions,basal heart rate,accelerations,decelerations,short termvariation, longterm variationand otherparameters.	The MFM-CNS cananalyze signal loss,contractions, basalheart rate,accelerations,decelerations, shortterm variation, longterm variation andother parameters.	The MFM-CNS Litecan analyze signalloss, contractions,basal heart rate,accelerations,decelerations, shortterm variation, longterm variation andother parameters.	Same
NICHD	The MFM-CNScan analyze FHRbaseline and itsscope, FHRbaseline variationand its scope,accelerationnumber, earlydeceleration, latedeceleration,variabledeceleration,prolongeddeceleration, sinecurve and otherparameters.	The MFM-CNS cananalyze FHRbaseline and itsscope, FHRbaseline variationand its scope,accelerationnumber, earlydeceleration, latedeceleration,variabledeceleration,prolongeddeceleration, sinecurve and otherparameters.	The MFM-CNS Litecan analyze FHRbaseline and its scope,FHR baseline variationand its scope,acceleration number,early deceleration, latedeceleration, variabledeceleration,prolongeddeceleration, sinecurve and otherparameters.	Same
Remote Access	Reviewfetal/maternalmonitor data	Reviewfetal/maternal	Local Access	Different
		TCP/IP.	TCP/IP.
Storage capacity		100 thousandrecords	Capacity dependson the size of thehard disk	Capacity depends onthe size of the harddisk	Different
Windows OSSupport		XP、Win7、Win8.1	XP、Win7、Win8.1、Win10	XP、Win7、Win8.1、Win10	Different
	Standards compliance
		IEC 62304	IEC 62304	IEC 62304
Detail		IEC 62366	IEC 62366	IEC 62366	Same

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As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

7. Performance Data:

Non-clinical data:

Since the subject is a software only product, the following quality assurance measures were applied to the development of the MFM-CNS v3.91 and MFM-CNS Lite v1.1 to evaluate safety and effectiveness: 1. Risk analysis according to ISO 14971: 2007

Software life cycle management according to IEC 62304: 2006. The subject device passed all testing.
Bench testing was conducted per IEC 60601-1-8: 2006 (Medical electrical equipment 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), and all the results show pass.

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." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient or operator.

Summarv

The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.

8. Conclusion

The non-clinical data and software verification and validation demonstrate that MFM-CNS v3.91 and MFM-CNS Lite v1.1 are substantially equivalent to the predicate device

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).