The Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Device Description

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

Basic parameters: FHR, TOCO, Event Mark, AFM
Optional Dual FHR monitoring
Optional Internal parameters: IUP/DECG
12 hours waveforms playback
Optional Built-in wireless module
Software for data transmission to PC
Quick printing for stored waveform
Lithium battery for 4 hours continuous working
Probe rack and wall mounting rack
Optional Fetal Stimulator
FHR limit alarm
Pulse wave Doppler waterproof transducer for FHR detection

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. The document is a 510(k) summary for the Edan Instruments Fetal & Maternal Monitor (Models F6 and F9), which outlines the device's features, comparison to predicate devices, and a general statement about verification and validation testing.

Here's a breakdown of what is and is not in the document, based on your requested information:

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

Not present. The document states: "Verification and validation testing was done on the Fetal & Maternal Monitor. This premarket notification submission demonstrates that Fetal & Maternal Monitor is substantially equivalent to the predicate device." However, it does not provide specific acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) nor detailed performance metrics from these tests.

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

Not present. The document does not mention the sample size, data provenance, or whether the tests were retrospective or prospective.

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)

Not present. The document does not describe how ground truth was established, nor does it mention any experts involved in such a process.

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

Not present. There is no information about any adjudication methods used.

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

Not present. This device is a Fetal & Maternal Monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Not applicable/Not present. As this is a medical monitoring device, not an algorithm in the sense of AI, the concept of "standalone algorithm performance" doesn't directly apply. The document implies performance of the device itself (hardware and embedded software) rather than a separate algorithm. It states "Software testing" and "Hardware testing" were performed.

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

Not present. The document does not specify the type of ground truth used for its verification and validation. Given the nature of a fetal monitor, performance would likely be assessed against established physiological measurements or another reference standard, but this is not detailed.

8. The sample size for the training set

Not present. The document does not mention any training set or its size, which is typical for traditional medical devices that do not involve machine learning or AI models requiring explicit training data.

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

Not present. As there's no mention of a training set, there's no information on how its ground truth would have been established.

In summary, the provided 510(k) document is a high-level summary demonstrating substantial equivalence to predicate devices rather than a detailed report of specific performance studies including acceptance criteria, sample sizes, expert involvement, or adjudication methods. It merely states that "Verification and validation testing was done" and led to the conclusion of substantial equivalence.

Summary

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NOV 2 6 2008 510(K)Summary of Safety and Effectiveness

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: 86-755-26882220Fax:86-755-26882223Responsible person: Jiang Yucai
Official correspondent:	William SternMultigon Industries, Inc.1 Odell PlazaYonkers, N.Y. 10701Phone: 914 376 5200 X27Fax: 914 376 6111
Date of Preparation:	Jul 17, 2008
Proprietary Name:	Fetal & Maternal Monitor (Models F6 and F9)
Classification Name:	21 CFR 884.2740 Perinatal monitoring system and accessories
Product code:	HGM
Predicate Devices:

Predicate devices	CADENCE II	Corometrics 120 seriesmaternal/ fetal monitor
Manufacturer	Edan Instruments, Inc.	GE Healthcare
K #	K073221	K991739

Device Description:

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

Basic parameters: FHR, TOCO, Event Mark, AFM
· Optional Dual FHR monitoring
· Optional Internal parameters: IUP/DECG

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Fetal & maternal monitor 510K Submission

12 hours waveforms playback
· Optional Built-in wireless module
· Software for data transmission to PC
· Quick printing for stored waveform
· Lithium battery for 4 hours continuous working
Probe rack and wall mounting rack
Optional Fetal Stimulator
FHR limit alarm
Pulse wave Doppler waterproof transducer for FHR detection

Comparison with predicate device

Monitoring Mode	Fetal & MaternalMonitor	CADENCE II	Corometrics 120 seriesmaternal/ fetal monitor
FHR/Dual FHR	yes	yes	yes
TOCO	yes	yes	yes
Fetal ECG, IUP	yes	yes	yes
Intended Use:	The Fetal & Maternal Monitor is intended for non-invasive and invasivemonitoring of fetus during antepartum examination, labor and delivery. It isintended to be used only by trained and qualified personnel in antepartumexamination rooms, labor and delivery rooms.
	Fetal & Maternal Monitor provides Non-Stress testing for pregnant womenfrom the 28th week of gestation. It can externally monitor the FHRs usingultrasound and uterine activity via a TOCO transducer. Alternatively, it caninternally monitor one of the FHRs with DECG and uterine activity with anIUPC.
Contraindications:	It is not intended for use in intensive care units, operating rooms or for homeuse.
Test Summary:	The following quality assurance measures were applied to the developmentof the Fetal & Maternal Monitor
	• Software testing
	• Hardware testing
	• Safety testing
	• Environment test
	• Risk analysis
	• Final validation
Conclusion:	Verification and validation testing was done on the Fetal & Maternal Monitor.This premarket notification submission demonstrates that Fetal & MaternalMonitor is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edan Instruments, Inc. c/o Mr. William Stern Official Correspondent Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701

NOV 2 6 2008

Rc: K082602

Trade/Device Name: Fetal and Maternal Monitor (Models F6 and F9) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: November 4, 2008 Received: November 5, 2008

Dear Mr. Stern

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Fetal and Maternal Monitor (Models F6 and F9), as described in your premarket notification:

1 MHz PW fetal probe - model F6 1 MHz PW fetal probe - model F9

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. William Stern

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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Glenn Bell, Ph.D., at (240) 276-3666.

Sincerely yours,

loquítm Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Fetal & maternal monitor 510K Submission

Indication for Use

K0826002

510(k) Number (if known):

Device Name:

Fetal & Maternal Monitor (Models F6 and F9)

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (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, Abdominal, and Radiological Devices 510(k) Number

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Diagnostic Ultrasound indications for Use Form

Fill out one form for each ultrasound system and each transducer. 1 MHz PW fetal probe- model F9

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application	Mode Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal				N
Abdominal
Intraoperative(specify)
Intraoperative Neurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other
N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E

Additional Comments: ___ The above is a 1 mHz PW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)

Imri In Whan

(Division Sign-Off) Divisior Regraductive, Abdominal, and Radiological Devic

510(k) Number

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Diagnostic Ultrasound indications for Use Form

Fill out one form for each ultrasound system and each transducer. 1 MHz PW fetal probe- model F6

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application	Mode Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal				N
Abdominal
Intraoperative(specify)
Intraoperative Neurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other
N=new indication; P=previously cleared by FDA: e=ADDED UNDER appendix E

ਦ

Additional Comments: _ The above is a 1 mHz PW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED

CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)

Irmu In Whay
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

(k) Number K082662

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).