FC 700 FETAL MONITOR

K043597 · Bionet Co., Ltd. · HGM · Dec 16, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K043597
• Device Name: FC 700 FETAL MONITOR
• Applicant: Bionet Co., Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus. It intended to be used by trained healthcare personnel. It is not intended for home use.

Device Story

FC-700 fetal monitor; measures fetal heart rate (FHR) and uterine contraction (UC). Inputs: ultrasound waves directed at maternal abdomen; Doppler frequency signals reflected from fetal heart; pressure sensor data for uterine contractions. Processing: signal analysis of Doppler and pressure inputs; conversion to numerical values and graphical printouts. Outputs: LED numerical display of FHR and UC; audible fetal heart sounds; graphical printout of monitoring results. Used in clinical settings by trained healthcare personnel. Provides real-time monitoring data to aid clinicians in assessing fetal well-being.

Clinical Evidence

Bench testing only. Evidence includes electrical safety testing per IEC60601-1, electromagnetic compatibility testing per IEC60601-1-2, and biocompatibility evaluation per ISO10993.

Technological Characteristics

Materials: Biocompatible per ISO10993. Sensing: Ultrasound Doppler for FHR, pressure sensors for UC. Connectivity: RS232 interface. Safety: IEC60601-1, IEC60601-1-2. Output: LED display and graphical printer.

Indications for Use

Indicated for the monitoring of single fetus in pregnant women. Intended for use by trained healthcare personnel in clinical settings; not for home use.

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

• COROMETRICS MODEL 171 AND 172 FETAL MONITOR (K991905)

Submission Summary (Full Text)

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DEC 1 6 2005

# K043597

<

### 510(k) Summary

(As required by 21 CFR 807.92(c))

| SUBMITTER BY | BIONET CO., LTD. | | |
|-------------------|--------------------------|-------------------------------------------------|--|
| | 401 Kikox Venture Tower | | |
| | 188-5 Guro-Dong, Guro-Gu | | |
| | Seoul, REPUBLIC OF KOREA | | |
| | (PHONE) | 82-2-6300-6410 | |
| | (FAX) | 82-2-6300-6425 | |
| CONTACT PERSON | (NAME) | Hyun-Joo Kwon | |
| | (TITLE) | Regulatory Affairs Engineer | |
| | (PHONE) | 82-2-6300-6433 | |
| | (FAX) | 82-2-6300-6425 | |
| US AGENT | (NAME) | Mr. Steven Minn | |
| | (ADDRESS) | BIONET AMERICA, INC. | |
| | | 3345 Wilshire Blvd., Suite 811 | |
| | | Los Angeles, CA 90010 | |
| | (PHONE) | 888-292-6060 | |
| | (FAX) | 213-389-0036 | |
| DATE OF SUMMARY | December 24, 2004 | | |
| DEVICE NAME | (Proprietary Name) | FC-700 | |
| | (Common Name) | FC-700 | |
| | (Classification Name) | Perinatal monitoring system and accessories | |
| | (Regulation Number) | 21 CFR §884.2740 | |
| | (Regulatory Class) | II | |
| | (Product Code) | HGM | |
| PREDICATE DEVICES | (510(k) Number) | K991905 | |
| | (Device Name) | COROMETRICS MODEL 171 AND 172 | |
| | | FETAL MONITOR | |
| | (Submitter by) | GENERAL ELECTRIC MEDICAL<br>SYSTEMS INFORMATION | |

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#### FC-700 is the fetal monitor that measures the fetal heart rate and DEVICE DESCRIPTION uterine contraction. FC-700 irradiates ultrasound wave to the abdomen of a pregnant woman and detects the Doppler frequency signal reflected from the heart of the fetus. FC-700 analyzes detected signal and displays the numerical values of the fetal heart rate by LED. FC-700 measures the uterine contraction values of a pregnant woman by pressure sensors, analyzes measured value and displays the numerical values of the uterine contraction by LED. FC-700 provides the sound from the heart of fetus. I C-700 prints graphically the heart rate of the fetus and the values of uterine contraction. FC-700 is the fetal monitor that measures, displays numerical value of

INTENDED USE measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.

It intended to be used by trained healthcare personnel. It is not intended for home use.

#### COMPARISION OF TECHNOLOGICAL CHARACTERISTICS

| Comparison Areas | FC-700 | Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Indications for use | FC-700 is the fetal monitor that measures,<br>displays numerical value of measured<br>results by LED, prints graphically the fetal<br>heart rate and uterine contraction of a<br>pregnant woman, and also provides fetal<br>movement detection and fetal heart sound. It<br>is intended to aid comprehensive assessment<br>for the well being of single fetus. | Identical |
| Where used | Used by trained healthcare personnel. It is<br>not intended for home use. | Identical |
| Performance | Fetal Heart Rate (FHR)<br>Uterine Contraction (UC)<br>Fetal Movement Detection<br>High/Low Heart Rate Alarm<br>Printing Monitoring Results<br>Interface through RS232 | Similar |
| Standard met | -Electrical safety: IEC60601-1<br>-EMC: IEC60601-1-2) so on.<br>-Biocompatibility: ISO10993 | Similar |

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It has tested for electrical safety according to IEC60601-1, NONCLINICAL TESTS It has tested for croomatibility according to IEC60601-1-2 and eiectromagnetic compansions e with the guidelines of International Drocompationity in accordantion: Biological Evaluation of Medical Devices.

FC-700 is substantial equivalent to predicated device COROMETRICS CONCLUSION I C-700 is substantial equivalen MONITOR(K991905) of GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioNet/BioNet America, Inc. % Mr. Sun-Young Jeong Regulatory Affairs Engineer Research Institute for Medical Instruments Medical Industry Techno Tower R205, 1272 Maeji Heungup Wonju, Kwangwon-Do Republic of Korea

Re: K043597

DEC 1 6 2005

Trade/Device Name: FC 700 Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: November 22, 2005 Received: November 22, 2005

Dear Mr. Jeong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your becalent of t (-) personalially equivalent (for the indications for use stated in above and nave decommissarketed predicate devices marketed in interstate commerce prior to the cherosure for regary manteese production Device Amendments, or to devices that have been reay 20, 1770, the charminenth the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accordance approval application (PMA). You may, therefore, market the do not require approvation of a provisions of the Act. The general controls provisions of the Act device, subject to the general registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is classified (500 such additional controls. Existing major regulations affecting your Apploval), it the you 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 I Toast be devisou that reize complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I caran statues are regulating, 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) (21 CFR Part 801), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
. This letter will anow you to ocgin marketing your and equivalence of your device to a legally marketed notification. The FDA Inding of Sabstanning of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our bers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitle, "Ansolution on your responsibilities under the Act from the 807.97). You may obtain other general information of the years at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

BIONET CO., LTD. APPLICANT

K043597 510(k) NUMBER

FC-700 DEVICE NAME

### INDICATIONS FOR USE

.

FC-700 is the fetal monitor that measures, displays numerical value of measured results by I C 700 is the count and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.

for the world bealthcare personnel. It is not intended for home use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

______________________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use _ | OR | Over-The-Counter Use _ |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

Nancy C. Bogdon

minal,

K04 3597