The F2 and F3 Fetal Monitor are intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

They both provide Non-stress testing for pregnant women from the 28th week of gestation. They can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, they can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Device Description

With non-invasive ultrasound Doppler, external TOCO and direct fetal ECG technique, Fetal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. You can externally monitor the fetal heart rate using ultrasound and uterine activity via a TOCO transducer. Alternatively, you can internally monitor one of the fetal heart rate with direct fetal ECG technique and uterine activity with an Intrauterine Pressure Catheter.

The Fetal Monitor has six models: Cadence, Cadence DUAL, Cadence PRO, Cadence II, F2 and F3. The former four models Cadence, Cadence DUAL, Cadence PRO, Cadence II have already been cleared under K082369, while the other two models F2, F3 are new models of Fetal Monitor in this Traditional 510(K) application, which have the same intended use and constructions to the existing models.

The Fetal monitor can be connected with Central Monitoring System via RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System.

AI/ML Overview

The provided text describes the regulatory submission for the F2 and F3 Fetal Monitors. It outlines their intended use and states that they are substantially equivalent to previously cleared devices (Cadence series). However, the document does not contain specific acceptance criteria, performance metrics, or details of a clinical study demonstrating the device meets such criteria.

The submission focuses on establishing substantial equivalence to a predicate device (K082369) through design and technological similarity, rather than presenting a de novo clinical study with specific performance benchmarks.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis of what can be inferred or explicitly stated:

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for FHR detection) nor does it provide a table of measured performance against such criteria.
Sample sized used for the test set and the data provenance: No test set (clinical or otherwise) with specific sample sizes or data provenance is mentioned for the F2/F3 models' performance evaluation. The focus is on equivalence to an existing device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment process is described.
Adjudication method (e.g., 2+1, 3+1, none) 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. Fetal monitors are monitoring devices, not AI-assisted diagnostic tools for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a monitor, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as no AI/algorithm training is described.
How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted or inferred:

While the document doesn't present a traditional acceptance criteria table and study results, it demonstrates "acceptance" through the substantial equivalence pathway.

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

The implicit "acceptance criteria" is that the F2 and F3 Fetal Monitors perform equivalently to the predicate devices (Cadence, Cadence DUAL, Cadence PRO, Cadence II cleared under K082369) for their stated intended use. The "reported device performance" is essentially that they function in the same manner as the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit/Explicit)
Substantial Equivalence to Predicate Device K082369	"The F2, F3 fetal monitors have the same device characteristics as the predicate approved device cleared under K082369. Both models use the same technology and circuitry as the already approved device models Cadence, Cadence DUAL, Cadence PRO, Cadence II cleared under K082369. Hence the models F2, F3 above are substantially equivalent to the predicate devices cited." (Page 1) "Verification and validation testing was done on the Fetal Monitor models F2, F3. This premarket notification submission demonstrates that Fetal Monitor models F2, F3 is substantially equivalent to the predicate device." (Page 2)
Intended Use	"The F2 and F3 Fetal Monitor are intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. They both provide Non-stress testing for pregnant women from the 28th week of gestation. They can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, they can internally monitor one of the FHRs with DECG and uterine activity with an IUPC." (Page 5)
Compliance with Regulatory Standards (Implicit for 510(k) pathway)	"Software testing, Hardware testing, Safety testing, Environment test, Risk analysis, Final validation" were applied. (Page 1) This implies compliance with relevant performance and safety standards, although specific standards are not listed.
Diagnostic Ultrasound Performance (1MHz PW fetal probe)	The 1MHz PW fetal probe is intended for "Fetal" clinical application using "PW" (Pulsed Wave) mode. This is listed as "P=previously cleared by FDA", indicating its performance has already been established and accepted. (Page 6)

2. Sample sized used for the test set and the data provenance:
Not explicitly stated for the F2/F3 models' performance. The submission relies on the established performance of the predicate devices. The "Test Summary" mentions "Verification and validation testing was done on the Fetal Monitor models F2, F3" (Page 2), but does not provide details on the sample size or type of data used for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study with expert-established ground truth for F2/F3 is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.

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. This device is a monitor, 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:
No. The device is a physical monitor with associated transducers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for this submission in terms of a new clinical study. The FDA's clearance is based on the "substantial equivalence" of the device's technology and intended use to a previously cleared device. The performance of the predicate device would have been established at its time of clearance using appropriate methods (which are not detailed in this document).

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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F2, F3 Fetal Monitors TRADITIONAL 510(K) SUBMISSION

Section 1

510(k) Summary of Safety and Effectiveness

JAN 1 3 201

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

Submitter: Edan Instruments, Inc 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China Tel: 86-755-26882220. . . . . . . . . . . . . Fax:86-755-26882223 Contact person: Yue Qiuhong Official correspondent: William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 Fax: 914 376 6111 Date of Preparation: 2010-7-22 Proprietary Name: F2, F3 Fetal Monitor (Models: F2, F3) Classification Name: System, Monitoring, Perinatal Product code: HGM, HGL Predicate Devices:

Predicate devices	CADENCE, CADENCE DUAL,CADENCE II FETAL MONITOR
Manufacturer	Edan Instruments, Inc
K #	K082369

Device Description:

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F2, F3 Fetal Monitors TRADITIONAL 510(K) SUBMISSION ·

Section 1

Comparison with predicate device .

The F2, F3 fetal monitors have the same device characteristics as the predicate approved device cleared under K082369. Both models use the same technology and circuitry as the already approved device models Cadence, Cadence DUAL, Cadence PRO, Cadence II cleared under K082369. Hence the models F2, F3 above are substantially equivalent to the predicate devices cited.

Intended Use

The F2, F3 Fetal Monitor are intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Contraindications:

It is not intended for use in intensive care units, operating rooms or for home use.

Test Summary:

The following quality assurance measures were applied to the development of the F2, F3 Fetal Monitors.

· Software testing
· Hardware testing
· Safety testing
· Environment test
· Risk analysis · · ..
· Final validation

Conclusion:

Verification and validation testing was done on the Fetal Monitor models F2, F3. This premarket notification submission demonstrates

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, KIDZL 40 , કર્ભ રે page

F2, F3 Fetal Monitors TRADITIONAL 510(K) SUBMISSION

Section 1

that Fetal Monitor models F2, F3 is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.

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

Mr. Yue Qiuhong Certification Engineer Edan Instruments, Inc. 3/F-B, Nanshan Medical Equipment Park Nanhai Road 1019# Shenzhen, Guangdong, 518067 CHINA

APR 2 6 2012

K102140 Re:

Trade/Device Name: Fetal Monitor model F2 and F3 Regulation Number: 21 CFR § 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, HGL Dated: December 20, 2010 Received: December 27, 2010

Dear Mr. Oiuhong:

This letter corrects our substantially equivalent letter of January 13, 2011.

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 Monitor model F2 and F3, as described in your premarket notification:

MS3-109301

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

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Page 2 - Mr. Yue Oiuhong

in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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 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.

If you have any questions regarding the content of this letter, please contact Ms. Kathryn Daws- Kopp at (301) 796-6535. は

Sincerely yours,

Herbert Hoover

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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F2, F3 Fetal Monitors TRADITIONAL 510(K) SUBMISSION

Section 1

Indication for Use

510(k) Number (if.known):

K102140

Device Name: F2, F3 Fetal Monitors (Models: F2, F3)

× 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 Device Evaluation (ODE)

ivision Sign

of Reproductive. Gastro-R

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Diagnostic Ultrasound indications for Use Form Fill out one form for each ultrasound system and each transducer. 1MHz PW fetal probe

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				P
Abdominal
Intraoperative(specify)
Intraoperative Neurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other

ndication; P=previously cleared by FDA; e=ADDED UNDER appendix E Additional Comments: _________________________________________________________________________________________________________________________________________________________

The above is a 1MHz PW transducer for the fetal heart rate detection

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

Tracy

r. 13, 2012

Section 1

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).