Cadence series Fetal monitor is intended for monitoring physiological parameters of pregnant women 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. It is not intended for use in intensive care units, operating rooms or for home use.

Device Description

There are four models included in Cadence series Fetal monitor: Cadence, Cadence Dual, Cadence Pro and Cadence II.

The Fetal Monitor can provide different configurations according to different user requirements, FHR1 (Fetal Heart Rate 1), FHR2 (Fetal Heart Rate 2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), FS (fetal stimulator, optional). The user can select the monitors according to requirements.

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.

Cadence II adopts 5.7"LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

The data collected and stored by Fetal Monitor can be real-time transferred to PC or Obstetrical Central Monitoring System and can be managed and printed by the Insight software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments Fetal Monitor:

Based on the provided text, the submission is a 510(k) premarket notification for a Fetal Monitor, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through rigorous clinical studies for a new technology. Therefore, many of the typical acceptance criteria and study elements you've requested are not explicitly detailed in this type of submission.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily based on equivalence to the predicate devices in terms of intended use, design, principle of operations, performance, and fundamental scientific technology. There are no explicit quantitative performance metrics or acceptance criteria stated in the document in the format of a clinical study endpoint.

Acceptance Criterion (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred)
Intended Use Equivalence: Monitoring physiological parameters of pregnant women during antepartum examination, labor, and delivery.	"YES - The intended use for the Fetal Monitor is equivalent to that for the predicate device."
Technological Equivalence: No new types of safety or effectiveness questions raised by technological characteristics.	"NO - The technological characteristics of the Fetal Monitor raise no new types of safety or effectiveness questions."
Design, Principle of Operations, Performance, and Fundamental Scientific Technology Equivalence: The device maintains equivalence to predicate devices.	"All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified Fetal Monitor is substantially equivalent in intended use, design, principle of operations, performance, and contains the same fundamental scientific technology as the predicate device listed above."
Fetal Heart Rate Detection: Functionality for 1 MHz PW transducer for fetal heart rate detection.	The device includes a "1 MHz PW waterproof fetal probe" with the intended use of "Diagnostic ultrasound imaging or fluid flow analysis of the human body" specifically for "Fetal" clinical application under "PWD" (Pulsed Wave Doppler) mode.

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

The document does not describe a clinical "test set" in the context of a performance study to establish new acceptance criteria. The activities mentioned are "verification and validation activities" related to design control, which are typically engineering and functional tests rather than human-subject clinical trials for performance endpoints.

Sample Size for Test Set: Not applicable/Not specified in the provided text, as this is a substantial equivalence submission, not a de novo performance study.
Data Provenance: Not applicable/Not specified.

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

Not applicable. The document does not describe a clinical study that involved experts establishing ground truth for a test set. This type of submission relies on established safety and efficacy of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical study for performance evaluation involving adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The Fetal Monitor is a monitoring device, not an interpretative AI algorithm for image analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a traditional fetal monitor, not an AI algorithm. Its function is to collect and display physiological data, not to perform standalone diagnostic interpretations without human involvement.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. The "ground truth" here is effectively the accepted performance and safety of the legally marketed predicate devices to which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The device described is a hardware medical device (Fetal Monitor) and does not inherently involve machine learning algorithms that require a "training set" in the conventional sense.

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

Not applicable. See #8.

Summary of Device and Regulatory Context:

The submission for the Edan Instruments Fetal Monitor (models Cadence, Cadence Dual, Cadence Pro, Cadence II) is a 510(k) premarket notification. This regulatory pathway means the manufacturer is claiming that their new device is "substantially equivalent" to one or more legally marketed predicate devices and therefore does not require a new premarket approval (PMA) application, which would necessitate extensive clinical trials to establish de novo safety and effectiveness.

The "study" that proves the device meets the "acceptance criteria" (which are fundamentally criteria for substantial equivalence) consisted of:

Verification and validation activities related to design control and risk analysis. These are typically engineering tests to ensure the device performs according to its specifications and is safe.
Demonstrating equivalence in intended use, technological characteristics (no new safety/effectiveness questions), design, principle of operations, performance, and fundamental scientific technology to the predicate devices (Cadence [K040903] and Cadence II [K073221]).

The FDA's letter states that "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the device met the criteria for substantial equivalence based on the provided information, rather than specific performance metrics from a large-scale clinical study.

Summary

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K08 2369 p. 1 of 3

Attachment H

NOV - 7 2008

510(K) SUMMARY

Submitter's Information A.

Name:	Edan Instruments, Inc
Address:	3/F - B, Nanshan Medical
	Equipments Park, Nanhai Rd 1019#,
	shekou, Nanshan Shenzhen,
	518067 P.R. China
Phone:	0086-755-26892220
Fax:	0086-755-26882223
Contact Person:	Jiang Yucai
Official Correspondent:	William Stern
Date Summary Prepared:	Jul 13, 2008
Device Information
Trade/Device Name:	Fetal Monitor
Regulation Number:	884.2740
Classification Name:	System, Monitoring, Perinatal

Classification Name:	System, Monitoring, Pe
Regulation Class:	Class II
Product Code:	HGM
Classification Panel:	Obstetrics/Gynecology

Description of Device

There are four models included in Cadence series Fetal monitor: Cadence, Cadence Dual, Cadence Pro and Cadence II.

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Cadence II adopts 5.7"LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

The data collected and stored by Fetal Monitor can be real-time transferred to PC or Obstetrical Central Monitoring System and can be managed and printed by the Insight software.

Predicate Device Information C.

Cadence	[K040903] [09/02/2004]
Cadence II	[K073221] [12/28/2007]

D. Indications for Use/Intended Use

Substantial Equivalence E.

Is the product a device? 1. YES-The Fetal Monitor is a device.

Does the new device have the same intended use? 2. YES-The intended use for the Fetal Monitor is equivalent to that for the predicate device.

Does the device have technological characteristics the raise new types of 3. safety or effectiveness questions?

NO- The technological characteristics of the Fetal Monitor raise no new types of safety or effectiveness questions.

Does descriptive or performance information demonstrate equivalence? YES- Edan Instruments, Inc. believes that the information provided in this submission clearly describes the Fetal Monitor and demonstrates that it is substantially equivalent to the predicate device.

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K082369 p. 3of3

207

Safety Summary F.

Edan Instruments, Inc. made several modifications to the Cadence cleared under K040903 and Cadence II cleared under K073221. All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified Fetal Monitor is substantially equivalent in intended use, design, principle of operations, performance, and contains the same fundamental scientific technology as the predicate device listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

NOV - 7 2008

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

Re: K082369

Trade/Device Name: Fetal Monitors, Models: Cadence, Cadence Dual, Cadence Pro and Cadence II Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Codes: HGM and HEL Dated: October 10, 2008 Received: October 10, 2008

Dear Mr. Stern:

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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 Cadence Series Fetal Monitors, as described in your premarket notification:

Transducer Model Number

1 MHz PW waterproof fetal probe

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 Ms. Kathryn Daws-Kopp at (240) 276-3666.

Sincerely yours,

lope In 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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Attachment C

Indications for Use Statement

Fetal Monitor Device Name

Cadence series Fetal monitor is intended for monitoring physiological Indications parameters of pregnant women during antepartum examination, labor for Use and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. It is not intended for use in intensive care units, operating rooms or for home use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use YES (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use

Amir M. Waly

(Division Sign-Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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Attachment D

Diagnostic Ultrasound indications for Use Form

Fill out one form for each ultrasound system and each transducer. 1 MHz PW waterproof fetal probe- model: Cadence, Cadence Dual, Cadence Pro, Cadence II

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.

CONCURRENCE OF cdrb, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Arne M Whay

(Divis Reproductive, Abdominal, Division and Radiological Devi 510(k) Number

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).