Fetal Doppler

K212084 · Shenzhen Mericonn Technology Co., Ltd. · KNG · Nov 3, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K212084
• Device Name: Fetal Doppler
• Applicant: Shenzhen Mericonn Technology Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Nov 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

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 Story

Fetal Doppler uses ultrasonic signal transmitter/receiver to detect fetal heart beats; analog signal processing unit and FHR calculating unit transform signals into heart rate data; LCD/TFT display shows rate; audio output allows playback via headphones or recorder. Device powered by 1.5V DC alkaline batteries. Used by healthcare professionals in hospitals, clinics, community, or home settings. Output provides real-time fetal heart rate and audible heart sounds to assist clinicians in monitoring fetal wellbeing and viability. Benefits include non-invasive, portable fetal heart rate monitoring.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, -10), electrical safety (ANSI/AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment safety (IEC 60601-1-11), and acoustic output measurement (IEC 60601-2-37).

Technological Characteristics

Ultrasonic fetal monitor; 2.5 MHz nominal frequency; continuous Doppler mode. Powered by 1.5V AA alkaline batteries. Wired probe connection. LCD (FD100-300) or TFT (FD400) display. Biocompatible patient-contacting materials per ISO 10993-1. Software level of concern: moderate.

Indications for Use

Indicated for singleton pregnancies after 12 weeks gestation for the detection of fetal heart rate and fetal heart sounds. For use by healthcare professionals in hospital, clinic, community, and home settings.

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

• SD5 Ultrasonic Tabletop Doppler (K153475)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or [phone]).

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)

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.

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: [e-mail] Tel: [phone]

#### 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: [phone]

| 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

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.

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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:<br>FD 100, FD 200, FD<br>300, FD 400 | SD5 Ultrasonic<br>TableTop<br>Doppler | - |
| Manufacturer | Shenzhen Mericonn<br>Technology Co., Ltd. | EDAN<br>Instruments | - |
| Classification name | Fetal ultrasonic<br>monitor and<br>accessories | Fetal ultrasonic<br>monitor and<br>accessories | 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 is<br>intended to detect<br>fetal heart beats,<br>display fetal heart<br>rate, and play the fetal<br>heart sound. Fetal<br>Doppler is indicated<br>for use by medical<br>professionals in<br>clinical or home care<br>settings for singleton | The SD5<br>Ultrasonic<br>TableTop<br>Doppler<br>(hereinafter<br>called "SD5")<br>and SD6<br>Ultrasonic<br>TableTop<br>Doppler<br>(hereinafter | Similar |
| | pregnancies from 12<br>weeks gestation. | called “SD6”)<br>are intended to<br>be used by<br>health care<br>professionals<br>including<br>registered<br>nurses,<br>practical<br>nurses,<br>midwives,<br>ultrasound<br>technicians,<br>and physician<br>assistants, by<br>prescription<br>from licensed<br>physicians in<br>hospitals,<br>clinics, and<br>private offices.<br>The 2 MHz<br>and/or 3 MHz<br>obstetrical<br>probes are<br>indicated for<br>the detection of<br>fetal heart rate<br>from early<br>gestation thru<br>delivery and as<br>a general<br>indication of<br>fetal wellbeing.<br>They can also<br>be used to<br>verify fetal<br>heart viability. | |
| Gestational Age | 12 weeks | 12 weeks | Same |

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| Gestational Type | Singleton | Singleton | Same |
|--------------------------|---------------------------|-------------------------|-----------|
| Display Type | FD100,FD200,FD300:<br>LCD | Digital Display<br>LCD | Similar |
| | FD400: TFT | | |
| Power Supply | Two 1.5V AA<br>Alkaline | 100V-240V,<br>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 | Continuous<br>Doppler | 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.