CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR

K082369 · Edan Instruments, Inc. · HGM · Nov 7, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082369
• Device Name: CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
• Applicant: Edan Instruments, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

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 Story

Cadence series Fetal Monitors (Cadence, Cadence Dual, Cadence Pro, Cadence II) monitor fetal physiological parameters including Fetal Heart Rate (FHR1, FHR2), uterine activity (TOCO), fetal movement (FM), and automatic fetal movement (AFM). Device uses 1 MHz PW waterproof fetal probes to collect ultrasound signals. Data is processed and displayed on a 5.7" LCD (Cadence II) and can be printed via built-in thermal recorder. System connects to Obstetrical Central Monitoring Systems via RJ45 or wireless network modules. Insight software on a PC manages and prints collected data. Used by trained clinicians in antepartum, labor, and delivery rooms to support clinical assessment of fetal status during pregnancy and labor.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities, risk analysis, and verification/validation testing.

Technological Characteristics

System includes 1 MHz PW waterproof fetal probes. Connectivity via RJ45 interface or wireless network module (DB9). Cadence II features 5.7" LCD display and built-in thermal recorder. Data management via Insight software. Class II perinatal monitoring system.

Indications for Use

Indicated for monitoring physiological parameters of pregnant women during antepartum examination, labor, and delivery. Not for use in intensive care units, operating rooms, or home settings.

Regulatory Classification

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.

Predicate Devices

• Cadence (K040903)
• Cadence II (K073221)

Submission Summary (Full Text)

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K08 2369 p. 1 of 3

### Attachment H

B.

## 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.

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.

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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.

### Predicate Device Information C.

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

### D. Indications for Use/Intended Use

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.

### 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.

4. 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:

్ ప్రప్ర

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 [phone]. 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 [phone] or [phone] 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 [phone].

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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