DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

K100626 · Shenzhen Biocare Electronics Co., Ltd. · KNG · May 21, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100626
• Device Name: DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
• Applicant: Shenzhen Biocare Electronics Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: May 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats. Doppler fetal heart rate detector is a portable equipment to detect the heart rate of fetus in Obstetrics & Gynecology and delivery room. It can also be used at home or in public place for prenatal diagnosis on pregnant women.

Device Story

Hand-held, battery-powered Doppler device; detects fetal heart beats. Operates via ultrasonic signal emission and reception; processes signals to calculate fetal heart rate; displays results. Used by clinicians in OB/GYN or delivery rooms; also for patient self-use at home or in public. Provides real-time heart rate data to assist in prenatal monitoring and diagnosis.

Clinical Evidence

Bench testing only. Validation and verification testing conducted to confirm device met design specifications, including electrical safety and EMC requirements. No clinical data provided.

Technological Characteristics

Hand-held, battery-powered ultrasonic Doppler device. Components include ultrasonic signal emitter/receiver, analog signal processing circuitry, fetal heart rate calculation logic, and display control. Regulatory class II, product code KNG.

Indications for Use

Indicated for the detection of fetal heart beats in pregnant women for prenatal diagnosis. Suitable for use in clinical settings (Obstetrics & Gynecology, delivery rooms) and home or public environments.

Regulatory Classification

Identification

A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Predicate Devices

• Contec Pocket Fetal Doppler (K082480)

Submission Summary (Full Text)

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Ki00626

Premarket Notification Submission for Doppler Fetal Heart Rate Detector- Section III 510(k) Summar Internal Report SN: SHA02420091202

#### 510(k) Summary Section III

### As Required by CFR 870.92

## MAY 8 1 2010

## Sponsor

## Submission Correspondent

Proposed Product Trade Name Model Product Code: Regulation Number: Device Class:

Submission Purpose:

Submission Type

Predicate Device:

Intended Use

Device Description

Shenzhen Biocare Electronics Co., Ltd 5/F, Taohuayuan High-Tech Innovation Park, Baoan Shenzhen, Guangdong, 518102, China

Mr. Hongbo Zhong Director Tel: [phone] Fax: [phone] Email: [e-mail]

Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Sute 5D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: [phone] Fax: [phone] Email: [e-mail]

Doppler Fetal Heart Rate Detector FM-200 KNG 21 CFR 884.2660 Class II

New Device

Traditional 510(k)

Contec Pocket Fetal Doppler K082480

FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.

Doppler fetal heart rate detector is a portable equipment to detect the

III-1

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heart rate of fetus in Obstetrics & Gynecology and delivery room. It can also be used at home or in public place for prenatal diagnosis on pregnant women.

Doppler fetal heart rate detector is composed of the parts used for ultrasonic signal emitting and receiving, simulating signal processing, fetal heart rate calculation and display control.

Test Conclusion

SE Determination

Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards.

The proposed device, Doppler Fetal Heart Rate Detector, is substantially equivalent (SE) to the predicate device Contec Pocket Fetal Doppler (K082480).

III-2

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAY 2 1 2010

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

Shenzhen Biocare Electronics Co., Ltd % Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suit 5D, No. 19, Lane 999, Zhongshan No.2 Road(s) Shanghai, 200030 CHINA

Re: K100626

Trade/Device Name: Doppler Fetal Heart Rate Detector Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: March 3, 2010 Received: March 5, 2010

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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.

Sincerely yours,

Donald H. Rumsfeld

Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Exhibit #A Indication for Use Form

510(k) Number: K100626 Device Name: Doppler Fetal Heart Rate Detector, FM-200

Indications for Use:

FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of in Vitro Diagnostic Device Evaluation (OIVD)

Division Sign-Off Division of Radiologic Office of In Vitro Diagnostic Device and Satet

510K k188626

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