The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

Device Description

The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0, 2.5, or 3.0 MHz, depending on the probe settings selected.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Shenzhen Taikang Medical Equipment Co., Ltd. Fetal Doppler. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vcomin Technology Limited Company Fetal Doppler, Model: FD-200D). The performance data provided is largely in the form of testing against applicable standards and showing similarity/equivalence to the predicate device, rather than explicit acceptance criteria and reported performance in a quantitative table for each functional aspect of the device in a clinical study.

However, based on the provided text, we can infer some key performance aspects and their reported outcomes:

Acceptance Criteria (Inferred from Predicate Equivalence & Standards)	Reported Device Performance
Indications for Use: Detect fetal heart rate in hospital, clinic, community, and home, used by healthcare professionals at or after 16 weeks gestation.	Same as predicate. The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.
Design: Hand-held, battery-powered audio Doppler device; main unit displays FHR.	Same as predicate. A main unit and a probe. The main unit displays FHR.
Mode of Action: Doppler ultrasound, continuous wave.	Same as predicate. Doppler ultrasound, continuous wave.
Ultrasound Frequency: 2.0 MHz, 2.5 MHz, and 3.0 MHz.	Same as predicate. 2.0 MHz, 2.5 MHz, and 3.0 MHz.
FHR Measuring Range: 50-210 bpm.	Same as predicate. 50-210 bpm.
FHR Accuracy: ±2 bpm.	Same as predicate. ±2 bpm.
FHR Resolution: 1 bpm.	Same as predicate. 1 bpm.
Biocompatibility: Non-cytotoxic, non-irritating, non-sensitizing for patient-contacting components.	Demonstrated conformity. Testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization), and ISO 10993-10:2010 (irritation) showed the materials were non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety & EMC: Compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2).	Demonstrated conformity. Testing successfully completed against IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133 (for batteries).
Software Verification & Validation: Compliance with FDA guidance for moderate software level of concern.	Demonstrated conformity. Software verification and validation conducted and documentation provided in accordance with FDA guidance "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: Adequate operational lifespan.	Testing completed. Use-Life Testing was performed. Specific duration/results not detailed in this summary.
Fetal Heart Rate Accuracy: Accurate detection of FHR.	Testing completed. Fetal Heart Rate Accuracy Testing was performed. Specific performance data (e.g., mean absolute error) is not detailed in this summary, but the device meets the ±2 bpm accuracy specification which is "Same" as the predicate.
Acoustic Output: Within safe limits according to standards.	Testing completed. Acoustic output testing per NEMA UD 2-2004(R2009) and FDA guidance for Track 1 devices. The subject device's ISATA values (e.g., 2.0MHz - ISATA: 6.01mW/cm²) are different (lower for 2MHz, 2.5MHz, and 3.0MHz) than the predicate, but this difference does not raise new questions of safety and effectiveness, implying they are within safe and acceptable limits.

Study Details:

The provided text from the 510(k) summary does not describe a clinical study with human subjects, a test set, expert readers, or ground truth establishment in the manner typically associated with AI/ML device evaluations. This submission is for a traditional medical device (Fetal Doppler) where substantial equivalence is demonstrated through engineering and performance testing against standards, and comparison to a predicate device.

Therefore, the following points are not applicable or not detailed in this specific 510(k) summary, as it's not a submission for an AI/ML-based device:

Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set for AI/ML. The performance testing was likely conducted in a lab environment using appropriate phantoms, simulators, or controlled setups as per the referenced standards (e.g., IEC 60601-2-37 for ultrasonic medical diagnostic equipment).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a Fetal Doppler's accuracy would be established through calibrated instruments or reference measurements, not expert consensus on images.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. The device is a diagnostic tool, not an AI assistance system for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "standalone" hardware device, not an algorithm. Its performance is evaluated intrinsically.
The type of ground truth used: For FHR accuracy, the ground truth would be precise, known heart rate simulations from equipment or calibrated reference measurements. For biocompatibility, it's lab test results comparing to established biological responses. For electrical safety, it's compliance with specified measurement limits.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, for this Fetal Doppler (K211940), substantial equivalence was demonstrated primarily through:

Comparison to a predicate device (K182526) showing sameness in intended use, design, mode of action, and core FHR specifications.
Non-clinical performance testing against recognized international and national standards for biocompatibility (ISO 10993), electrical safety and electromagnetic compatibility (IEC 60601 series), battery safety (IEC 62133), software verification (FDA guidance), use-life, FHR accuracy (IEC 60601-2-37), and acoustic output (NEMA UD 2 and FDA guidance).

The documentation asserts that any differences in technological characteristics (like acoustic output) do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence determination.

Summary

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January 7, 2022

Shenzhen Taikang Medical Equipment Co., Ltd. Shigui Du General Manager 3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park, Pingshan District Shenzhen, Guangdong 518015 CHINA

Re: K211940

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: December 6, 2021 Received: December 6, 2021

Dear Shigui Du:

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. 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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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, 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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Indications for Use

510(k) Number (if known) K211940

Device Name Fetal Doppler

Indications for Use (Describe)

The Fetal Doppler is used to detect the feal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

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)

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510(k) Summary K211940

Prepared in accordance with the requirements of SMDA and 21 CFR §807.92

1.0 Information of Submitter and Correspondent

Submitter's information:

Company Name: Shenzhen Taikang Medical Equipment Co., Ltd.

Street Address:	3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park,Pingshan District
City:	Shenzhen
State/ Province:	Guangdong
Country:	China
Telephone:	+86(755)-89664986
Fax:	+86(755)-89664986
Contact Person:	Shigui Du
Contact Title:	General Manager
Contact Email:	dushigui@taikang-medical.com

Submission correspondent's information:

Name:	Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address:	Room 2012#, Gebu Commercial Building, Hongxing CommunitySonggang Street, Baoan District, Shenzhen 518000, China
Contact Person:	Reanny Wang
E-mail:	reanny@reanny.com

Date Summary Prepared: January 5, 2022

2.0 Device Information

Trade/Device Name	Fetal Doppler
Model:	TK-T802CR
Regulation Name:	Fetal ultrasonic monitor and accessories
Requlation Number:	21 CFR 884.2660
Common Name:	Fetal Doppler
Product Code:	KNG (monitor, ultrasonic, fetal)
Regulatory Class:	Class II
Review Panel:	Obstetrics/Gynecology

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3.0 Predicate Device Information

Sponsor:	Vcomin Technology Limited Company
Device:	Fetal Doppler, Model: FD-200D
510(K) Number:	K182526
	The predicate device has not been subject to a design-related recall.

4.0 Device Description

5.0 Indications for Use

6.0 Comparison to the Predicate Device

The following table compares the subject device to the predicate device with respect to the intended use and technological characteristics:

Device & PredicateDevice(s):	Subject Device	Predicate Device	Comparison
	K211940	K182526
	Fetal DopplerModel: TK-T802CR	Fetal DopplerModel: FD-200D
Indications for Use	The Fetal Doppler is used todetect the fetal heart rate. Thedevice should be used by healthcare professionals includingnurses, midwives, andspecialized technicians inhospital, clinic, community andhome. The device is intended foruse at or after 16 weeksgestation.	The device is used to detect thefetal heart rate. The deviceshould be used by health careprofessionals including nurses,midwives, and specializedtechnicians in hospital, clinic,community and home.	Same
Design	A main unit and a probe. Themain unit displays FHR	A main unit and a probe. Themain unit displays FHR	Same
Mode of action	Doppler ultrasound, continuouswave	Doppler ultrasound, continuouswave	Same
Ultrasoundfrequency	2.0 MHz, 2.5 MHz, and 3.0 MHz	2.0 MHz, 2.5 MHz, and 3.0 MHz	Same

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	FHR Measuring Range: 50-210 bpm	FHR Measuring Range: 50-210 bpm	Same
	Accuracy: ±2 bpm	Accuracy: ±2 bpm
	Resolution: 1 bpm	Resolution: 1 bpm

Acoustic output	2.0MHz - ISATA: 6.01mW/cm²	2.0MHz - ISATA: 17.24 mW/cm²	Different
	2.5MHz - ISATA: 6.67mW/cm²	2.5MHz - ISATA: 18.57 mW/cm²
	3.0MHz - ISATA: 6.87mW/cm²	3.0MHz - ISATA: 11.496 mW/cm²
Material - PatientContactingComponents	ABS	ABS, Silicone, Colorants	Same

The subject and predicate device have the same intended use (i.e., to detect the fetal heartbeat). The subject and predicate device have different technological characteristics, including different acoustic output specifications, physical dimensions, and weight. The differences in technological characteristics do not raise new questions of safety and effectiveness.

7.0 Performance Summary

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

a. Biocompatibility
Biocompatibility testing on the patient-contacting components of the subject device in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: ● Tests for in vitro cytotoxicity
. Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Irritation per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: ● Tests for irritation and skin sensitization

The patient-contacting materials were shown to be non-cytotoxic, non-irritating, and nonsensitizing.

b. Electrical Safety, Electromagnetic Compatibility, and Wireless Technology
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical . equipment - Part 1: General requirements for basic safety, and essential performance with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- . IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- IEC 62133:2012 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
c. Software Verification

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Software verification and validation was conducted and software documentation was provided in accordance with the 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.

d. Performance Testing
The following testing was provided to support the safety and effectiveness of the subject device:
i. Use-Life Testing
ii. Fetal Heart Rate Accuracy Testing
Testing per IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment Part iii. 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
iv. Acoustic output testing per NEMA UD 2-2004(R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and the acoustic output measurement methodology as recommended in FDA guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019 was followed for Track 1 devices.

9. Conclusion

The non-clinical performance data described above demonstrate that the Fetal Doppler is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).