Doppler FHR Detector (BF-500D+, BF-560)

K242846 · Shenzhen Bestman Instrument Co., Ltd. · KNG · Jun 26, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K242846
• Device Name: Doppler FHR Detector (BF-500D+, BF-560)
• Applicant: Shenzhen Bestman Instrument Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Jun 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

Device Story

Hand-held Doppler ultrasound device for non-invasive fetal heart rate (FHR) monitoring. System comprises main unit (LCD, speaker, battery, electronics) and wired probe (two angled semi-circle ultrasonic crystals for continuous wave transmission/reception). Used by healthcare professionals in hospitals, clinics, community, or home settings. Device processes reflected ultrasonic signals to calculate and display FHR (bpm) and output audio. Provides real-time monitoring to assist clinicians in assessing fetal status. Benefits include non-invasive, portable fetal heart detection. BF-500D+ uses rechargeable Ni-MH battery; BF-560 uses disposable AA alkaline batteries. Both models provide visual FHR, battery status, and audio feedback.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993), electrical safety, electromagnetic compatibility, acoustic output measurement, and software verification/validation. Use life testing (609 hours) performed on n=3 samples per model using fetal heart rate simulators to validate performance and durability.

Technological Characteristics

Hand-held Doppler ultrasound monitor. Continuous wave operation. Materials: Patient-contacting components tested per ISO 10993-1. Connectivity: Wired probe. Power: 9V rechargeable (BF-500D+) or 4.5V alkaline (BF-560). Frequency: 2 MHz (BF-500D+); 2 MHz/3 MHz (BF-560). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359. Software: Moderate level of concern.

Indications for Use

Indicated for detection of fetal heart beats, display of fetal heart rate, and audio playback of fetal heart sounds in patients with singleton pregnancies after 12 weeks of gestation.

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

• BF-500B Doppler Fetal Heart Rate Detector (K090510)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 26, 2025

Shenzhen Bestman Instrument Co., Ltd.
Yong Bai
Head of Firm
8th floor, Yifang Building, No.315, Shuangming Avenue,
Dongzhou Community, Guangming Street, Guangming District
Shenzhen, GD 518107
CHINA

Re: K242846
Trade/Device Name: Doppler FHR Detector (BF-500D+, BF-560)
Regulation Number: 21 CFR 884.2660
Regulation Name: Fetal Ultrasonic Monitor and accessories
Regulatory Class: Class II
Product Code: KNG
Dated: May 23, 2025
Received: May 23, 2025

Dear Yong Bai:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive, Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
**Indications for Use** | Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below. |
| --- | --- |

510(k) Number (if known)<br/>K242846

Device Name<br/>Doppler FHR Detector (BF-500D+, BF-560)

Indications for Use (Describe)<br/>The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

Type of Use (Select one or both, as applicable)<br/>
☑ Prescription Use (Part 21 CFR 801 Subpart D)<br/>
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services<br/>Food and Drug Administration<br/>Office of Chief Information Officer<br/>Paperwork Reduction Act (PRA) Staff<br/>[e-mail]

&gt; "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]

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# 510(k) Summary

## 1. Submitter

Name and Address Shenzhen Bestman Instrument Co., Ltd.
8th floor, Yifang Building, No.315, Shuangming Avenue, Dongzhou Community, Guangming Street, Guangming District, Shenzhen, China, 518107
Tel.: [phone]

Contact Person: Bai Yong
Date Prepared: June 11, 2025

## 2. Device Information

Trade Name: Doppler FHR Detector (BF-500D+ and BF-560)
Common Name: Fetal Doppler
Regulation Number: 21 CFR 884.2660
Regulation Name: Fetal ultrasonic monitor and accessories
Product Code: KNG (Monitor, Ultrasonic, Fetal)
Device Classification: Class II
Review Panel: Obstetrics/Gynecology

## 3. Predicate Device

510(k) Number: K090510
Device Name: BF-500B Doppler Fetal Heart Rate Detector
Manufacturer: Shenzhen Bestman Instrument Co., Ltd.

The predicate device has not been subject to a design-related recall.

## 4. Device Description

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and liquid crystal display(LCD) screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at one frequency.

The difference between BF-500D+ and BF-560 are shown as below:

- BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries.
- BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+.
- the two models have different probe shapes.

## 5. Indications for Use

The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

## 6. Substantial Equivalence Discussion

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The following tables compare the intended use and technological characteristics of the subject and predicate devices:

Table 6-1: Comparison between the predicate device BF-500B and the subject device BF-500D+

| Comparison Items | Predicate Device Doppler Fetal Heart Rate Detector Model: BF-500B | Subject Device Doppler FHR Detector Model: BF-500D+ | Comparison Result |
| --- | --- | --- | --- |
| 510(k) Number | K090510 | K242846 | --- |
| Manufacturer | Shenzhen Bestman Instrument Co., Ltd. | Shenzhen Bestman Instrument Co., Ltd. | --- |
| Classification Name | Fetal ultrasonic monitor and accessories | Fetal ultrasonic monitor and accessories | Same |
| Regulation Number | 844.2660 | 844.2660 | Same |
| Device Class | Class II | Class II | Same |
| Product Code | KNG | KNG | Same |
| Indications for Use | The Doppler Fetal Heart Rate Detector can be used for the detection of average fetal heartbeat rate. | The Doppler FHR Detector is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting. | Different |
| Gestational Age | 12 weeks | 12 weeks | Same |
| Gestational Type | Singleton | Singleton | Same |
| Technical Characteristics | | | Same |
| Display Type | Digital Display; LCD | Digital Display; LCD | Same |
| Power Supply | 9.6 V | 9 V | Different |
| Battery Type | Rechargeable Ni-MH battery | Rechargeable Ni-MH battery | Same |
| Probe connection | Wired | Wired | Same |
| Acoustic Output Power | Less than 1.8W | Less than 1.8 W | Same |
| Nominal Frequency | 2 MHz | 2 MHz | Same |
| Working Frequency | (2.0 ± 10%) MHz | (2.0 ± 10%) MHz | Same |
| \(I_{ob}\) | ≤ 10 mW/cm2 | ≤ 10 mW/cm2 | Same |
| \(p_r\) | 1 MPa | 1 MPa | Same |
| Ispta | < 100 mW/cm2 | < 100 mW/cm2 | Same |
| Isata | < 20 mW/cm2 | < 20 mW/cm2 | Same |
| \(W_o\) | 10 mW | 26.31 mW | Different |
| Mode of operation | Continuous Wave Doppler | Continuous Wave Doppler | Same |

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Table 6-2: Comparison between the predicate device BF-500B and the subject device BF-560

| Comparison Items | Predicate Device Doppler Fetal Heart Rate Detector Model: BF-500B | Subject Device Doppler FHR Detector Model: BF-560 | Comparison Result |
| --- | --- | --- | --- |
| 510(k) Number | K090510 | K242846 | --- |
| Manufacturer | Shenzhen Bestman Instrument Co., Ltd. | Shenzhen Bestman Instrument Co., Ltd. | --- |
| Classification Name | Fetal ultrasonic monitor and accessories | Fetal ultrasonic monitor and accessories | Same |
| Regulation Number | 844.2660 | 844.2660 | Same |
| Device Class | Class II | Class II | Same |
| Product Code | KNG | KNG | Same |
| Indications for Use | The Doppler Fetal Heart Rate Detector can be used for the detection of average fetal heartbeat rate. | The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestational. The device should only be used by a trained medical professional in a clinical setting and not intended for operated by the pregnant at home. | Different |
| Gestational Age | 12 weeks | 12 weeks | Same |
| Gestational Type | Singleton | Singleton | Same |
| Technical Characteristics | | | Same |
| Display Type | Digital Display; LCD | Digital Display; LCD | Same |
| Power Supply | 9.6 V | 4.5V | Different |

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| Battery Type | Rechargeable Ni-MH battery | Alkaline battery | |
| --- | --- | --- | --- |
| Probe connection | Wired | Wired | Same |
| Acoustic Output Power | Less than 1.8W | Less than 1.5 W | Different |
| Nominal Frequency | 2 MHz | 2 MHz, 3MHz | Same |
| Working Frequency | (2.0 ± 10%) MHz | (2.0 ± 10%) MHz
(3.0 ± 10%) MHz | Different |
| $I_{ob}$ | ≤ 10 mW/cm² | ≤ 10 mW/cm² | Same |
| $p_r$ | 1 MPa | 1 MPa | Same |
| $I_{spta}$ | < 100 mW/cm² | < 100 mW/cm² | Same |
| $I_{sata}$ | < 20 mW/cm² | < 20 mW/cm² | Same |
| $W_o$ | 10 mW | 21.54 mW (for 2 MHz probe)
22.49 mW (for 3 MHz probe) | Different |
| Mode of operation | Continuous Wave Doppler | Continuous Wave Doppler | Same |
| Coupling Medium Impedance | 1.5-1.6 (10⁵g/cm².s) | 1.5-1.6 (10⁵g/cm².s) | Same |
| Effective Radiating Area | (6±0.5) cm² | (1.57±5%) cm² | Different |
| FHR Measuring Range | 50 bpm ~ 210 bpm | 65 bpm ~ 210 bpm | |
| Accuracy | ± 2bpm | ± 2bpm | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| Working Time | ≥5 hours | ≥2 hours | Different |
| Working Environment | Temperature: +5°C ~ +40 °C
Humidity: ≤ 80%
Atmospheric pressure: 86kPa ~ 106kPa | Temperature: +5 °C ~ +40 °C
Humidity: ≤ 80%
Atmospheric pressure: 86kPa ~ 106kPa | Same |
| Transport and Storage Environment | Temperature: -10 °C ~ +40 °C
Humidity: ≤ 80% | Temperature: -10 °C ~ +40 °C
Humidity: ≤ 80% | Same |

The subject and predicate devices have similar indications for use statements and have the same intended use – to detect the fetal heart rate.

The subject and predicate devices have different technological characteristics, including different ultrasound frequency, output power, effective area and measuring range, power supply, and working time. These differences in technology do not raise different questions of safety or effectiveness and can be evaluated through performance testing.

## 7. Non-Clinical Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

### Biocompatibility

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The biocompatibility evaluation was conducted in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process. Patient contacting materials were subjected to testing that included the following tests:

i. Cytotoxicity (ISO 10993-5)
ii. Skin Sensitization (ISO 10993-10)
iii. Irritation (ISO 10993-10)

These tests were selected based on the nature and duration of patient contact, as outlined in Attachment G of the FDA guidance.

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted and the device was found to comply with the requirements of the following standards:

i. IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance with US deviations per AAMI/ANSI ES 60601-1
ii. IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances– requirements and tests

## Ultrasound and Acoustic Testing

Bench testing was conducted on the Fetal Doppler and the system was found to comply with the following:

i. IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ii. Acoustic Output testing per IEC 62359:2017, Guidance for Industry and Food and Drug Administration Staff:2019, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

The acoustic output measurement methodology as recommended in FDA guidance document “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff,” dated June 27, 2019 was followed for Track 1 devices.

## Software Verification and Validation Testing

Software verification and validation testing was conducted and completed with no outstanding anomalies. Software documentation was provided as recommended by FDA guidance document “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” dated May 11, 2005 for a moderate software level of concern.

## Use Life

Use life testing to validate the device performance and durability over the proposed service life of 609 hours was conducted. Testing was conducted on three samples (n=3) for each device model, in compliance with FDA recommendations for adequate sample sizes in medical device testing.

The use life testing protocol encompassed the following key elements:

i. Continuous device operation for the entire 609-hour service life period.
ii. Simulated cleaning and disinfection processes, replicating expected maintenance procedures over the device's lifespan.
iii. Battery cycling for rechargeable batteries and key-fatigue testing of device buttons to assess long-

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term durability of these components.

iv. Utilization of a fetal heart rate simulator to evaluate device performance under worst-case operational scenarios.

The device successfully passed all aspects of the use life testing, including cpontinous operation, sinluated maintenance, and stress testing under various conditions.

8. Conclusion

The results of the testing described above demonstrate that the Doppler FHR Detector (BF-500D+ and BF-560) is safe and effective as the predicate device and supports a determination of the substantial equivalence.

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