K Number

Device Name

Fetal Doppler

Manufacturer

Shenzhen Mericonn Technology Co., Ltd.

Date Cleared

2021-11-03

(124 days)

Product Code

KNG

Regulation Number

884.2660

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K153475

Reference Devices

K153475

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description outlines standard signal processing and calculation units, with no mention of AI or ML technologies. The performance studies also focus on traditional device testing.

Therapeutic

No
The device is intended to detect and display fetal heart rate and sound, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.

Diagnostic

No
The device detects and displays fetal heart rate and plays the heart sound, but it does not provide a diagnosis or interpret the significance of the findings. Its purpose is to monitor, not diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, LCD/TFT display control unit, and battery.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Fetal Doppler described here uses ultrasonic technology to detect and display the fetal heart rate and play the fetal heart sound. This is a non-invasive method that interacts directly with the patient's body (specifically, the pregnant abdomen) rather than analyzing a sample taken from the body.
Intended Use: The intended use is to detect fetal heart rate and sound, which is a physiological measurement taken directly from the fetus within the mother.

Therefore, the Fetal Doppler falls under the category of a medical device that performs a diagnostic function in vivo (within the living body), not in vitro (in glass or outside the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

KNG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Health care professionals in hospital, clinic, community and home

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

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), 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.

Key Metrics

Not Found

Predicate Device(s)

K153475

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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

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

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

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

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

Gestational Type	Singleton	Singleton	Same
Display Type	FD100,FD200,FD300:
LCD	Digital Display
LCD	Similar
	FD400: TFT
Power Supply	Two 1.5V AA
Alkaline	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
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