Fetal Doppler is intended to detect fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

Device Description

Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by used by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation. It is comprised of an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, and LCD/TFT display control unit. It has audio output and can be connected with headphones or to a recorder with audio input. The Fetal Doppler is powered by a standard 1.5 V DC alkaline battery.

AI/ML Overview

This document seems to be a 510(k) summary for a Fetal Doppler device, not a study evaluating a device's performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would. Therefore, much of the requested information regarding acceptance criteria for an AI/ML algorithm or a comparative effectiveness study is not available in the provided text.

The document instead focuses on demonstrating substantial equivalence to a predicate device through conformity with standards and basic performance tests.

Here's a breakdown of what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of an AI/ML algorithm's effectiveness. Instead, it outlines performance data provided to support substantial equivalence, primarily focusing on safety and basic operational characteristics.

Here's a summary of the performance testing conducted, which might be interpreted as meeting certain "acceptance criteria" for basic functionality:

Acceptance Criteria Category	Reported Device Performance / Evaluation Method
Biocompatibility	Met ISO 10993-1, 10993-5, 10993-10 standards. Testing included Cytotoxicity, Skin Sensitization, and Irritation.
Software Verification & Validation	Conducted and completed as per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a moderate software level of concern.
Electromagnetic Compatibility & Electrical Safety	Conformed to relevant requirements of ANSI/AAMI ES 60601-1, IEC 60601-1-2:2014, and IEC 60601-1-11 Edition 2.0 2015-01.
Basic Performance Testing	- Use Life Testing- Battery Life Testing- Battery Indicator Testing- Testing per IEC 60601-2-37 Edition 2.1 2015 (ultrasonic medical diagnostic and monitoring)- Acoustic output measurement as per FDA guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (June 27, 2019) for Track 1 devices.
FHR Measuring Range	50 – 240 BPM (Matches predicate)
FHR Accuracy	±2BPM (Matches predicate)
FHR Resolution	1BPM (Matches predicate)
Iob	<10 mW/cm² (Better than predicate's <20 mW/cm²)
Ispta	<50 mW/cm² (Better than predicate's <100 mW/cm²)
Isata	<20 mW/cm² (Matches predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance tests mentioned (biocompatibility, software V&V, electrical safety, use/battery life, acoustic output) are engineering tests, not typically clinical studies involving patient data or test sets in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The document describes testing of a medical device's physical and software components, not an AI/ML algorithm requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. As above, this document does not describe an AI/ML algorithm validation study that would involve expert adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. This document is for a Fetal Doppler, which is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The Fetal Doppler is a standalone device; the question about "algorithm only" performance applies to AI/ML devices, which this is not. The device itself performs the function of detecting and displaying FHR.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. The "ground truth" for a Fetal Doppler would be the actual fetal heart rate, which is derived directly from its acoustic processing, not from expert consensus or pathology in a diagnostic sense. The accuracy of the FHR measurement is stated as ±2BPM.

8. The sample size for the training set

This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set" with ground truth.

Summary

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November 3, 2021

Shenzhen Mericonn Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong 518067 CHINA

Re: K212084

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, 2021 Received: October 4, 2021

Dear Kevin Wang:

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 and Part 809); 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) K212084

Device Name Fetal Doppler

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary - K212084

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: November 2, 2021

1. Submission sponsor

Name: Shenzhen Mericonn Technology Co., Ltd. Address: Room 20203, Building 6, Donglongxing Kejiyuan, Huaning Road, Xinshishequ, Dalang Street, Longhua district, Shenzhen City, Guangdong, 518109 P.R. China Contact person: Jiang Chuanyuan Title: General manager E-mail: info@digitalems.net Tel: 0086 13928416535

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067 Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160

Subject Device Information
Trade/Device Name	Fetal Doppler
Common Name	Fetal Doppler
Model	FD 100, FD 200, FD 300, FD 400
Regulatory Class	II
Regulation Name:	Fetal ultrasonic monitor and accessories
Regulation Number:	21 CFR 884.2660
Product Code	KNG

3. Subiect Device Information

4. Predicate Device

EDAN Instruments, Inc, SD5 Ultrasonic Tabletop Doppler (K153475) The predicate device has not been subject to a design-related recall

5. Device Description

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It is comprised of an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, and LCD/TFT display control unit.

It has audio output and can be connected with headphones or to a recorder with audio input. The Fetal Doppler is powered by a standard 1.5 V DC alkaline battery.

6. Indication for use

Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

Comparison to the Predicate Device 7.

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

Device & Predicate Device(s):	K212084	K153475	Comment
Device Name	Fetal Doppler, Model:FD 100, FD 200, FD300, FD 400	SD5 UltrasonicTableTopDoppler	-
Manufacturer	Shenzhen MericonnTechnology Co., Ltd.	EDANInstruments	-
Classification name	Fetal ultrasonicmonitor andaccessories	Fetal ultrasonicmonitor andaccessories	Same
Regulation Number	844.2660	844.2660	Same
Device Class	Class II	Class II	Same
Product Code	KNG	KNG	Same
Indications for Use	Fetal Doppler isintended to detectfetal heart beats,display fetal heartrate, and play the fetalheart sound. FetalDoppler is indicatedfor use by medicalprofessionals inclinical or home caresettings for singleton	The SD5UltrasonicTableTopDoppler(hereinaftercalled "SD5")and SD6UltrasonicTableTopDoppler(hereinafter	Similar
	pregnancies from 12weeks gestation.	called “SD6”)are intended tobe used byhealth careprofessionalsincludingregisterednurses,practicalnurses,midwives,ultrasoundtechnicians,and physicianassistants, byprescriptionfrom licensedphysicians inhospitals,clinics, andprivate offices.The 2 MHzand/or 3 MHzobstetricalprobes areindicated forthe detection offetal heart ratefrom earlygestation thrudelivery and asa generalindication offetal wellbeing.They can alsobe used toverify fetalheart viability.
Gestational Age	12 weeks	12 weeks	Same

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Gestational Type	Singleton	Singleton	Same
Display Type	FD100,FD200,FD300:LCD	Digital DisplayLCD	Similar
	FD400: TFT
Power Supply	Two 1.5V AAAlkaline	100V-240V,50Hz/60Hz	Different
Probe Connection	Wired	Wired	Same
Nominal Frequency	2.5 MHz	2 MHz	Similar
Working Frequency	2.5 MHz ±10%	(2.0±10%)MHz	Similar
Iob	<10 mW/cm²	<20 mW/cm²	Different
Ispta	<50 mW/cm²	<100 mW/cm²	Different
Isata	<20 mW/cm²	<20 mW/cm²	Same
Mode of Operation	Continuous Doppler	ContinuousDoppler	Same
Effective Radiating Area	208mm² ±15%	245mm² ±15%	Different
FHR Measuring Range	50 – 240 BPM	50 – 240 BPM	Same
Accuracy	±2BPM	±2BPM	Same
Resolution	1BPM	1BPM	Same

The subject and predicate device have the same intended use (i.e., to detect the fetal heart beat). The Fetal Doppler and SD5 Ultrasonic TableTop Doppler have different technological characteristics, including different battery/power supply, and ultrasound performance (Iob, Ispta, Isata). The differences in technological characteristics do not raise new questions of safety and effectiveness.

8. Performance Data

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

Biocompatibility testing

The biocompatibility evaluation was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard 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:

Cytotoxicity (ISO 10993-5:2019) ●

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Skin Sensitization (ISO 10993-10:2010)
Irritation (ISO 10993-10:2010)

Software Verification and Validation Testing

Software verification and validation testing was conducted and completed and 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.

Electromagnetic Compatibility and Electrical Safety

The subject device models were assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and ● A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
IEC 60601-1-11 Edition 2.0 2015-01 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

Performance Testing

The following testing is provided to support the safety and performance of the subject device:

Use Life Testing
Battery Life Testing
Battery Indicator Testing
Testing per IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
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 nonclinical 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).