(279 days)
Not Found
No.
The device description and performance studies do not mention any AI models, machine learning, or deep neural networks. Its function is based on standard Doppler ultrasound technology.
No.
The device is intended to detect, display and play fetal heart sounds, which is for diagnostic and monitoring purposes, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound." These functions involve gathering information about the fetal heart, which is a diagnostic purpose. Furthermore, the "Summary of Performance Studies" references "ultrasonic medical diagnostic and monitoring equipment" and "Diagnostic Ultrasound Systems," explicitly categorizing its use as diagnostic.
No
The device description clearly outlines hardware components such as a main unit, probe, LCD screen, speaker, batteries, and transducers. The performance studies also include biocompatibility, electrical safety, ultrasound and acoustic testing, and use life testing, all of which are typical for physical hardware medical devices, not solely software. While software verification and validation are mentioned, it's for software "contained in" the device, not the device itself being purely software.
No.
Reasoning: The device performs non-invasive measurement of fetal heart rate using Doppler ultrasound and is used by healthcare professionals. It does not analyze biological samples taken from the human body.
N/A
Intended Use / 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.
Product codes
KNG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals in a hospital, clinic, community, and home setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Non-Clinical Performance Testing
Sample Size: Not specified for all tests; 3 samples (n=3) for each device model for Use Life testing.
Key Results:
- Biocompatibility: Evaluation conducted in accordance with ISO 10993-1. Patient contacting materials were subjected to Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) tests.
- Electrical Safety and Electromagnetic Compatibility (EMC): Complied with IEC 60601-1 and IEC 60601-1-2.
- Ultrasound and Acoustic Testing: Complied with IEC 60601-2-37 and Acoustic Output testing per IEC 62359:2017 following FDA guidance.
- Software Verification and Validation Testing: Completed with no outstanding anomalies, following FDA guidance for a moderate software level of concern.
- Use Life: Device successfully passed all aspects of testing for a proposed service life of 609 hours, including continuous operation, simulated maintenance, battery cycling, key-fatigue testing, and evaluation with a fetal heart rate simulator under worst-case operational scenarios.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter - Doppler FHR Detector
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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"
Page 2
K242846 - Yong Bai Page 2
(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
Page 3
K242846 - Yong Bai Page 3
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K242846
Device Name
Doppler FHR Detector (BF-500D+, BF-560)
Indications for Use (Describe)
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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/23) Page 1 of 1
Page 5
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.: 86 755-26713784
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
K242846
Page 1 of 6
Page 6
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 |
| Iob | ≤ 10 mW/cm² | ≤ 10 mW/cm² | Same |
| pr | 1 MPa | 1 MPa | Same |
| Ispta |