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.

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
fetal heart rate (FHR)
uterine activity (via tocodynamometry or IUP)
fetal movement
maternal heart rate
SpO2
non-invasive blood pressure (NIBP)
respiratory rate
temperature
pulse

Device Description

The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application. Its function is to manage clinical data of fetal heart and maternal vital signs (CTG - Cardiotocography), which is 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. It provides electronic medical records and operates with off-the-shelf software and hardware.

The MFM-CNS is intended to be used in hospital clinical areas such as monitor units, delivery room, etc. It is 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 system interface. The user cannot only depend on the MFM-CNS system to obtain monitoring data, because whether the data provided by the system is accurate depends on the stability of the operating system, the performance of PC station and the network. Although the software has its independent alarm system, the alarm information provided by the system is just for reference.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Edan Instruments Inc. "Central Monitoring System" (MFM-CNS). It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical testing for safety and effectiveness.

However, the document explicitly states:

"Clinical test: Clinical testing is not required." (Page 8)
The non-clinical tests relate to software validation, risk analysis, usability analysis, and software life cycle management, not direct performance criteria against a ground truth.

Therefore,Based on the provided document, the following information regarding acceptance criteria and a study proving the device meets them cannot be provided:

A table of acceptance criteria and the reported device performance: The document states no clinical testing was required, and the non-clinical tests focused on software quality assurance (validation, risk, usability, lifecycle management) rather than performance metrics against specific acceptance criteria.
Sample size used for the test set and the data provenance: No clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is described as a "clinical data managing software application" for viewing perinatal monitoring data, not an AI-assisted diagnostic tool that would enhance human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no indication of an algorithm performing diagnoses or analyses independently that would require standalone performance testing against a ground truth.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth was established or used for performance evaluation since no clinical testing was deemed necessary.
The sample size for the training set: Not applicable, as there's no mention of Machine Learning/AI training in the document.
How the ground truth for the training set was established: Not applicable.

Summary from the document:

The device, MFM-CNS, is a "clinical data managing software application." Its purpose is to facilitate the management, viewing, and electronic record-keeping of perinatal monitoring data (FHR, uterine activity, maternal vital signs, etc.) acquired from bedside monitors or manual input. The substantial equivalence determination was based on non-clinical software quality assurance measures and a comparison to predicate devices, noting that the differences do not affect safety and effectiveness.

Summary

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Image /page/0/Picture/1 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 symbol of three human profiles facing 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

March 30, 2015

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

K143695 Trade/Device Name: Central Monitoring System Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: December 19, 2014 Received: January 5, 2015

Dear Doug Worth,

Re:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 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,

Joyce M. Whang -S

for

Benjamin Fisher 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) K143695

Device Name Central Monitoring System

The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual inout 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
fetal heart rate (FHR)
uterine activity (via tocodynamometry or IUP)
fetal movement
maternal heart rate
SpO2
non-invasive blood pressure (NIBP)
respiratory rate
temperature
pulse

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

1. Submitter:	Edan Instruments, Inc.3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059
Contact person:	Queena Chen
Preparing date:	March 24, 2015
2. Device name andclassification:	Device Name: Central Monitoring SystemModel: MFM-CNSClassification Name:21 CFR 884.2740 Perinatal monitoring system andaccessoriesProduct code: HGMRegulatory Class: Class IIReview Panel: Obstetrics/Gynecology
3.PremarketNotification Class IIICertification andSummary	Not applicable, the subject device is Class II.
4. Predicate Device(s):	CIV-ob Obstetrical Monitoring Software Application/K103172/ CIVNET Communication Ltd.Philips OB TraceVue Obstetrical Information ManagementSystem/K081203/ Philips Medizin System
5. Device Description:	The Maternal Fetal Monitoring – Central Nurse System(hereinafter called "MFM-CNS") is a clinical data managingsoftware application. Its function is to manage clinical dataof fetal heart and maternal vital signs (CTG -Cardiotocography), which is automatically acquired frombedside monitors, for the purpose of collecting, processingand saving the patient and/or clinical data that is normallyprovided on record papers and/or separate bedside monitors.It provides electronic medical records and operates with

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off-the-shelf software and hardware.

6. Indications for Use: 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.

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

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

7. Predicate Device Comparison

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Item	CIV-obTM (plus)	MFM-CNS 3.82	SE
Manufacturer/K#	CIVNET CommunicationLtd./ K103172	EDAN Instruments/N/A
Classification
Classified as perFDA regulation	Class II	Class II	Same
Network and Hardware
Hardware	Off-the-shelf computersand accessories	Off-the-shelf computersand accessories	Same
Networkconnecting tobedside monitor	Ethernet	Ethernet	Same
Software
Display	Fetal heart rate, TOCO,maternal vital signs,patient demography data,and notes.Providing the means todisplay multiple bedssimultaneously.	Fetal heart rate, TOCO,maternal vital signs,patient demography data,and notes.Providing the means todisplay multiple bedssimultaneously.	Same
Print	Print (locally orremotely) CTG, patientrecords, and CIV-obTM(plus) data base definition(e.g. item names).	Print (locally orremotely) CTG andpatient records.	Different
Archive	CTG and maternal vitalsigns.Providing the ability toarchive files to asecondary or tertiarystorage medium (i.e.optical disk).Providing automaticarchiving of the data.	CTG and maternal vitalsigns.Providing the ability toarchive files to asecondary or tertiarystorage medium (i.e.optical disk).Saving dataautomatically.	Same
Alarm	Visual alerts offetal/maternal monitorsuch as out-of-limit heartrate or poor signalquality.	Visual alerts offetal/maternal monitorsuch as out-of-limit heartrate or poor signalquality.	Same
Electronicpatient record.	Easy interfacing with anyIT patient record systemfor data acquisition,viewing and storage of	Easy interfacing withany IT patient recordsystem for dataacquisition, viewing and	Same

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	electronic patient record.	storage of electronic patient record.
Notes	Providing the user the ability to enter comments and specific data.	Providing the user the ability to enter comments and specific data.	Same

Remote Access	Review fetal/maternal monitor data remotely over the TCP/IP.	Review fetal/maternal monitor data remotely over the TCP/IP.	Same

Standards compliance
Detail	IEC 62304IEC 62366	IEC 62304IEC 62366	Same
Intended Use
Intended use	The CIVNET CIV- ob TM(plus) is a clinical data managing software application and is indicated for antepartumn and intrapartumn monitoring of pregnant women in a healthcare setting	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.	Same







	The CIVNET CIV- ob TM(plus) is indented to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record.The CIYNET CIV ob TM(plus) has display fields for the following obstetric data: patient demographics, provider notes, fetal heart rate	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:

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(FHR), uterine activity(via tocodynamometry orIUP), etc.	patient demographics,provider notes, fetalheart rate (FHR), uterineactivity (viatocodynamometry orIUP), etc.
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Item	The Philips OB TraceVueObstetrical InformationManagement System	MFM-CNS	SE
Manufacturer/K#	Philips MedizinSystem/K081203	EDAN Instruments/None
	Classification
Classified as perFDA regulation	Class II	Class II	Same
	Software
CTG	The Philips OB TraceVueObstetrical InformationManagement System cananalyze signal loss,contractions, basal heartrate, accelerations,decelerations, short termvariation, long termvariation and otherparameters.	The MFM-CNS cananalyze signal loss,contractions, basal heartrate, accelerations,decelerations, short termvariation, long termvariation and otherparameters.	Same
NICHD	The Philips OB TraceVueObstetrical InformationManagement System cananalyze FHR baseline andits scope, FHR baselinevariation and its scope,accelerated number, earlydeceleration, latedeceleration, variabledeceleration, prolongeddeceleration, sine curve andother parameters.	The MFM-CNS cananalyze FHR baseline andits scope, FHR baselinevariation and its scope,accelerated number, earlydeceleration, latedeceleration, variabledeceleration, prolongeddeceleration, sine curveand other parameters.	Same

The subject device shares the same characteristics in most items with the predicate device except in the following one aspect: The predicate device prints the CIV ob ™ (plus) data base definition (e.g. item names) but the subject device does not. MFM-CNS only prints fetal and/or maternal reports such as fetal monitoring graphs or maternal trend lists.

The comparison above shows that the differences do not affect the safety and

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effectiveness of the MFM-CNS and there are no safety and effectiveness issues relating to the MFM-CNS.

8. Effectiveness and Safety Considerations:

Clinical test:

Clinical testing is not required.

Non-clinical test:

Since the subject is a software only product, EMC and Electrical Safety Evaluation are not required. But the following quality assurance measures were applied to the development of the MFM-CNS to ensure its safety and effectiveness:

Software testing according to FDA Guidance General Principles of Software Validation dated on Jan. 11, 2002.
Risk analysis according to ISO 14971: 2007
Usability analysis according to IEC 62366: 2007
Software life cycle management according to IEC 62304: 2006

The subject device passed all testing. The tests and analysis were all conducted to ensure the safety and effectiveness, and results show substantial equivalence between the subject device and the predicates.

9. Substantially Equivalent Determination

Verification and validation testing was done on the MFM-CNS and all testing passed pre-specified criteria. Since the testing passed, this premarket notification submission demonstrates that the subject device MFM-CNS is 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).