The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.

Device Description

The Ultrasonic Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an 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 organic light-emitting diode 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 a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.

The main unit is powered by two 1.5V AA alkaline batteries.

AI/ML Overview

The provided S510(k) summary for the Ultrasonic Doppler (Model YM-2T8) does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based diagnostic device.

The document describes a fetal ultrasonic monitor and accessories which uses continuous-wave Doppler technology to detect fetal heart rate. This is not an AI/algorithm-based diagnostic device in the sense of image interpretation or complex pattern recognition. Instead, it's a hardware device that measures a physiological parameter.

Therefore, the requested information, which is highly relevant for AI/algorithm-based medical devices (like those in radiology or pathology where performance metrics, ground truth establishment, and human reader studies are crucial), is not found in this submission.

This S510(k) focuses on:

Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device (K153475 - SD5 Ultrasonic Tabletop Doppler).
Performance Testing: Primarily non-clinical testing related to:
- Biocompatibility (ISO 10993-1, 5, 10)
- Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, 1-2, 1-11)
- Ultrasound and Acoustic Testing (IEC 60601-2-37, NEMA UD2)
- Software Verification and Validation (adhering to FDA guidance for moderate software level of concern)

The document explicitly states "8. Clinical Performance Testing: Not Applicable" (page 6), further indicating that the type of study you're asking for, which involves human readers, AI assistance comparison, or complex ground truth establishment on a test set, was not performed or deemed necessary for this specific device.

If this were an AI medical device, the information would likely be found under "Clinical Performance Testing" or a similar section dedicated to the algorithm's diagnostic accuracy.

In summary, none of the requested information (acceptance criteria table, sample size, expert number/qualifications, adjudication, MRMC, standalone performance, ground truth type, training set details) is present because this is a hardware device for physiological measurement, not an AI diagnostic algorithm.

Summary

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July 19, 2018

Shenzhen IMDK Medical Technology Co., Ltd. Yuan Xia Administrative Director C Zone, 10F, Building16, Yuanshan Industrial B Area Gongming Street, Guangming District Shenzhen, 518106 CHINA

Re: K180419

Trade/Device Name: Ultrasonic Doppler (Model YM-2T8) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: Class II Product Code: KNG Dated: June 8, 2018 Received: June 21, 2018

Dear Yuan Xia:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180419

Device Name Ultrasonic Doppler Model YM-2T8

Indications for Use (Describe)

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K180419

1. Submitter

Name and Address:	Shenzhen IMDK Medical Technology Co., Ltd.
	C Zone, 10F, Building 16, Yuanshan Industrial B Area, Gongming Street,
	Guangming District, 518106, P.R. China
	Telephone: +86 13662694320
Contact Person:	Yuan Xia
Date Prepared:	July 5, 2018

2. Device Information

Trade Name:	Ultrasonic Doppler
Model:	YM-2T8
Classification Name:	Fetal ultrasonic monitor and accessories
Regulation Number:	21 CFR 884.2660
Device Classification:	Class II
Product Code:	KNG
Review Panel:	Obstetrics/Gynecology

3. Predicate Device

510(k) Number:	K153475
Device Name:	SD5 Ultrasonic Tabletop Doppler
Manufacturer:	Edan Instruments, Inc.

The predicate device has not been subject to a design-related recall.

4. Device Description

The main unit is powered by two 1.5V AA alkaline batteries.

ട്. Indications for Use

The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.

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Predicate Comparison 6.

The following table compares the Ultrasonic Doppler to the predicate device with respect to the indications for use and technological characteristics:

Device	Subject DeviceUltrasonic DopplerModel: YM-2T8	Predicate DeviceSD5 Ultrasonic Tabletop Doppler
510(k) Number	K180419	K153475
Manufacturer	Shenzhen IMDK Medical Technology Co., Ltd.	EDAN Instruments, Inc.
Classification Name	Fetal ultrasonic monitor and accessories	Fetal ultrasonic monitor and accessories
Regulation Number	844.2660	844.2660
Device Class	Class II	Class II
Product Code	KNG	KNG
Indications for Use	The Ultrasonic Doppler usescontinuous-wave Doppler to detectfetal heart beats, display fetal heartrate and play the fetal heart soundfrom early gestation thru delivery forsingleton pregnancies. The UltrasonicDoppler is intended for use by trainedhealthcare professionals only in aclinical setting.	The SD5 Ultrasonic TableTop Doppler(hereinafter called "SD5") and SD6Ultrasonic TableTop Doppler (hereinaftercalled "SD6") are intended to be used byhealth care professionals includingregistered nurses, practical nurses,midwives, ultrasound technicians, andphysician assistants, by prescription fromlicensed physicians in hospitals, clinics andprivate offices.The 2 MHz and/or 3 MHz obstetrical probesare indicated for the detection of fetal heartrate from early gestation thru delivery andas a general indication of fetal well being.They can also be used to verify fetal heartviability.
Gestational Age	12 weeks	12 weeks
Gestational Type	Singleton	Singleton
Technical Characteristics
Display Type	Digital Display; LCD	Digital Display; LCD
Power Suppler	Two 1.5V AA Alkaline Batteries	100 V - 240 V~, 50 Hz/60 Hz or7.2 V/2000 mAh (Ni-MH Battery)
Probe connection	Wired	Wired
Acoustic OutputPower	3 W	3 W
Nominal Frequency	2 MHz	2 MHz
Working Frequency	(2.0 ± 10%) MHz	(2.0 ± 10%) MHz
Iob	< 20 mW/cm²	< 20 mW/cm²
pr	1 MPa	1 MPa
Ispta	< 100 mW/cm²	< 100 mW/cm²
Isata	< 20 mW/cm²	< 20 mW/cm²
Wo	50 mW	50 mW
Mode of operation	Continuous Wave Doppler	Continuous Wave Doppler
Effective Radiating Area	(157 $\pm$ 30%) mm²	(245 $\pm$ 15%) mm²
FHR Measuring Range	50 bpm ~ 210 bpm	50 bpm ~ 240 bpm
Accuracy	$\pm$ 2bpm	$\pm$ 2bpm
Resolution	1 bpm	1 bpm

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7. Non-Clinical Performance Testing

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

Biocompatibility

The biocompatibility evaluation was conducted in accordance with 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:

i. Cytotoxicity (ISO 10993-5)
ii. Skin Sensitization (ISO 10993-10)
iii. Irritation (ISO 10993-10)

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted and the device was found to comply with the requirements of the following standards:

i. IEC 60601-1. Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance with US deviations per AAMI/ANSI ES 60601-1
ii. IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - requirements and tests
iii. IEC 60601-1-11, 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

Ultrasound and Acoustic Testing

Bench testing was conducted on the Ultrasonic Doppler and the system was found to comply with the following:

i. IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Acoustic Output testing per NEMA UD2, Acoustic Output Measurement Standard for Diagnostic ii. Ultrasound Equipment

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The acoustic output measurement methodology as recommended in FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," dated September 9, 2008 was followed for Track 1 devices.

Software Verification and Validation Testing

Software verification and validation testing was conducted and completed with no outstanding anomalies. 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.

8. Clinical Performance Testing

Not Applicable

9. Conclusion

Based on the comparison and analysis above, the Ultrasonic Doppler is substantially equivalent to the predicate device.

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).