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. 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.

AI/ML Overview

The provided document is a 510(k) summary for the Shenzhen Biocare Electronics Co., Ltd's Doppler Fetal Heart Rate Detector (Model FM-200). It focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a clinical or standalone study report would.

Based on the provided text, the device's performance was validated through laboratory testing to ensure it met "all design specifications, including electrical safety, EMC, specification." However, it does not explicitly state quantitative acceptance criteria for fetal heart rate detection accuracy or sensitivity/specificity, nor does it provide a detailed study with specific performance metrics against such criteria.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present quantitative acceptance criteria or detailed performance metrics for the FM-200 Doppler Fetal Heart Rate Detector in the typical sense of a clinical performance study (e.g., accuracy against a gold standard, sensitivity, specificity).

Instead, it states:

Acceptance Criteria Category	Reported Device Performance
Design Specifications	Met all design specifications
Electrical Safety	Compliance demonstrated
EMC (Electromagnetic Compatibility)	Compliance demonstrated
Consensus Standards	Compliance to requirements of all consensus standards (e.g., electrical safety, EMC)

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "laboratory testing" but does not detail the number of subjects or data points used to validate the device's core function of detecting fetal heart beats.
Data Provenance: Not specified. The testing described is "laboratory testing," which typically means controlled environments. It does not provide information on whether human subjects were involved, their country of origin, or if the data was retrospective or prospective.

3. Number of Experts and their Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The document refers to "design specifications" and "consensus standards" as the basis for evaluation, implying a compliance-based assessment rather than an expert-driven ground truth establishment for a diagnostic performance study.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of the testing described (compliance to electrical safety, EMC, and design specifications), a traditional adjudication method for diagnostic performance would likely not be relevant or documented in this type of submission summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed or reported in this submission summary. The device is a "Doppler Fetal Heart Rate Detector," which is typically used by a single operator to detect heartbeats. Its primary function is direct measurement/detection, not interpretation by multiple readers of complex images or signals requiring AI-assisted analysis.

6. Standalone Performance Study

Standalone Performance Study: The "laboratory testing" described is a form of standalone testing, as it evaluates the device's ability to meet its design specifications and comply with standards. However, it is not a standalone diagnostic performance study (e.g., yielding sensitivity, specificity, accuracy against a clinical gold standard) that you might find for an AI algorithm. The document emphasizes technical compliance rather than diagnostic efficacy quantified in typical clinical metrics for standalone performance.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the "laboratory testing" appears to be defined by adherence to design specifications (e.g., measuring heart rate within a certain range, performing specific functions) and consensus standards (e.g., electrical safety, EMC limits). It does not mention clinical outcomes data, pathology, or expert consensus on fetal heart rate diagnosis. The device "detects fetal heart beats," implying its 'ground truth' is the actual presence and rate of the fetal heart beat during testing, likely validated using reference measurement equipment.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This device is a traditional hardware-based Doppler fetal heart rate detector, not an AI/ML algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process.

Summary Limitations:

It is crucial to understand that the provided text is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a predicate device based on technical specifications and safety standards. It is not a detailed clinical study report and therefore does not contain the in-depth performance metrics, study designs, and ground truth methodologies typically found in submissions for AI/ML-driven devices or those requiring extensive clinical efficacy trials. The "Test Conclusion" confirms technical compliance rather than diagnostic accuracy against a clinical gold standard.

Summary

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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: +86-755-27960888 Fax: +86-755-27960643 Email: hb-zhong@tom.com

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: +86-21-64264467 Fax: 240-238-7587 Email: diana.hong@mid-link.net

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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Regulation Number and Section

§ 884.2660 Fetal ultrasonic monitor and accessories.

(a)
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.(b)
Classification. Class II (performance standards).