FETAL DOPPLER

K112911 · Beijing Choice Electronic Technololgy Co., Ltd. · KNG · Oct 27, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K112911
• Device Name: FETAL DOPPLER
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Oct 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Indications for Use

The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

Device Story

Hand-held, battery-powered device; utilizes 2MHz ultrasound probe to detect fetal heart beats via ultrasound shift principle. Components include power supply, user interface, signal collection/processing module, and control module. Used in hospital or homecare settings by clinicians or patients. Device converts ultrasound signals into audible output for fetal heart beat monitoring; assists in confirming fetal viability.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 61266 (ultrasonic performance), and ISO 10993 (biocompatibility) verified design specifications.

Technological Characteristics

Hand-held, battery-powered; 2MHz ultrasound probe; signal collection and processing module; control module. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61266, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for detection of fetal heart beats in pregnant women starting at 12 weeks gestation. Intended for use in hospital or homecare 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

• Doppler Fetal Heart Rate Detector (K100626)

Submission Summary (Full Text)

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K112911

Project #:M0242011Bc Premarket Notification 510(k) Submission Section 111 510(k) Summary

## Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: _

- 1. Date of Submission: Sep 26, 2011
- 2. Sponsor

Beijing Choice Electronic Technology Co., Ltd No.9 Shuangyuan Road, Badachu Hi-Tich Zone, Shijingshan District, Beijing, China, 100041 Establishment Registration Number: 3005569927 Contact Person: Lei Chen Position: Quality Director Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- Proposed Device Identification 4.

Proposed Device Name: Fetal Doppler Proposed Device Model: MD800 Classification: II Product Code: KNG Regulation Number: 21 CFR 884.2660 Review Panel: Obstetrics/ Gynecology Intended Use Statement:

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The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

- ર Predicate Device Identification
510(k) Number: K100626 Product Name: Doppler Fetal Heart Rate Detector Manufacturer: Shenzhen Biocare Electronics Co., Ltd

- 6. Device Description
The Fetal Doppler is a hand-held, battery powered audio Doppler device integrated with 2MHz probe for detecting fetal heart beat. The device is normally applied to pregnancy as early as 12 weeks through the principle of ultrasound shift in hospital or homecare environment.

The Fetal Doppler includes the following components: Power supply module, User interface, Signal collection and process module and Control module

- 7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1 2005+ CORR.1 (2006) + CORR.2 (2007), Medical Electrical Equipment – Part 1: General Requirements for Safety.

IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests

IEC 61266:1994 Ultrasonic~ Hand-held probe Doppler fetal heartbeat detectors- Performance requirements and methods of measurement and reporting.

ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity,

ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivitv

- 8. Substantially Equivalent Conclusion
The proposed device, Fetal Doppler, is determined to be Substantially Equivalent (SE) to the predicate device, Doppler Fetal Heart Rate Detector, K100626, in respect of safety and effectiveness.

III-2

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

Beijing Choice Electronic Technology Co., Ltd. Ms. Diana Hong General Manager MID-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai, 200237 CHINA .

OCT 2 7 2011

Re: K112911

Trade/Device Name: Fetal Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: September 30, 2011 Received: October 3, 2011

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.

Mary Patel

Mary S. Pastel, Sc.D. 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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## Project #: M0242011Bc

## Section II Indications for Use

510(k) Number: Device Name: Fetal Doppler

Indications for Use:

The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) ■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 Device Evaluation (ODE)

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Mary Pastel

Divis of Radiologics Office of In Vitro Diagnostic ice Evaluation and Safety

510K K112911