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

Device Description

The Fetal 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.

AI/ML Overview

The provided document is a 510(k) summary for a Fetal Doppler device (Models AOJ-50A and AOJ-50B). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Here's the information about acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for the Fetal Doppler relate to its ability to measure Fetal Heart Rate (FHR) accurately. The performance reported is in comparison to the predicate device, which inherently sets the acceptance criteria through substantial equivalence.

Acceptance Criteria Item	Reported Device Performance (Subject Device)
FHR Measuring Range	50 bpm - 210 bpm
Accuracy	± 2 bpm
Resolution	1 bpm
Acoustic Output Power	3 W
Nominal Frequency	2 MHz
Working Frequency	(2.0 ± 10%) MHz
Iob	< 20 mW/cm²
pr	1 MPa
Ispta	< 100 mW/cm²
Isata	< 20 mW/cm²
Wo	50 mW
Effective Radiating Area	(157 ± 30%) mm²

Note: The document states that the "subject and predicate device have similar technological characteristics" and that the "differences in technological characteristics between the subject and predicate device do not raise different questions of safety or effectiveness." This implies that the acceptance criteria for the subject device are met if its performance matches or falls within acceptable limits established by the predicate device for these parameters.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention specific sample sizes for clinical test sets or data provenance (country of origin, retrospective/prospective clinical studies). The submission relies on non-clinical performance testing and comparison to a legally marketed predicate device.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the use of human experts to establish ground truth for a test set. This type of device (Fetal Doppler) typically relies on direct measurement accuracy against established standards or instruments rather than expert interpretation of complex medical imagery or data requiring consensus.

4. Adjudication Method for the Test Set

Since no expert panel or clinical test set requiring subjective interpretation is described, an adjudication method is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or reported as this device is a diagnostic tool primarily for objective measurement (FHR detection and display) and not one that relies on human interpretation of complex data that could be augmented by AI. The document does not describe AI assistance for human readers.

6. Standalone Performance Study (Algorithm Only)

The document focuses on the performance of the device as a whole system. It does not detail a standalone algorithm-only performance study in the context of AI or advanced algorithms. The core function is based on established Doppler ultrasound principles.

7. Type of Ground Truth Used

The ground truth for the performance parameters (like FHR measurement) would typically be established by:

Bench testing against calibrated instruments: For accuracy, range, resolution, and acoustic output parameters, precise measurements from calibrated test equipment serve as the ground truth.
Compliance with recognized standards: Adherence to standards like IEC 60601-1, IEC 60601-2-37, and NEMA UD2 ensures performance meets established safety and effectiveness benchmarks.

The document implicitly refers to these as the methods for establishing ground truth through "Non-Clinical Performance Testing" which includes "Ultrasound and Acoustic Testing."

8. Sample Size for the Training Set

The document does not describe or refer to a training set in the context of machine learning or AI models. This device is an ultrasonic monitor that relies on physical principles of Doppler shift, not on data-driven learning models with training sets.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for machine learning, the question of how its ground truth was established is not applicable.

Summary

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December 19, 2018

Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao General Manager Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming district Shenzhen, 518105 China

Re: K182190

Trade/Device Name: Fetal Doppler (Models AOJ-50A and AOJ-50B) Regulation Number: 21 CFR§ 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: November 8, 2018 Received: November 19, 2018

Dear Qihuan Zhao:

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 mav, 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 avare 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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) K182190

Device Name

Fetal Doppler (Models AOJ-50A and AOJ-50B)

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)

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510(k) Summary - K182190

1. Submitter

Name and Address	Shenzhen AOJ Medical Technology Co., Ltd.Room 202, HaoGu industry park, 2037 Guanguang road, Guangming district,518105, Shenzhen, P.R. ChinaTel.: +86 18603031299
Contact Person:	Qihuan Zhao, General Manager, Shenzhen AOJ Medical Technology Co., Ltd.
Date Prepared:	December 17, 2018

2. Device Information

Trade Name:	Fetal Doppler (Models AOJ-50A, AOJ-50B
Common Name:	Fetal doppler
Classification Name:	Fetal ultrasonic monitor and accessories
Regulation Number:	21 CFR 884.2660
Device Classification:	Class II
Product Code:	KNG (monitor, ultrasonic, fetal)
Review Panel:	Obstetrics/Gynecology

3. Predicate Device

510(k) Number:	K180419
Device Name:	YM-2T8 Ultrasonic Doppler
Manufacturer:	Shenzhen IMDK Medical Technology Co., Ltd.

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

4. Device Description

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The main unit is powered by two 1.5V AA alkaline batteries. The use-life of the device is five years.

5. Indications for Use

6. Predicate Comparison

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

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Comparison Items	Predicate Device	Subject Device	ComparisonResult
	Ultrasonic Doppler	Fetal Doppler
	Model: YM-2T8
510(k) Number	K180419	K182190	----
Manufacturer	Shenzhen IMDK MedicalTechnology Co., Ltd.	Shenzhen AOJ Medical Technology Co.,Ltd.	----
Classification Name	Fetal ultrasonic monitor andaccessories	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	The Ultrasonic Doppler usescontinuous-wave Doppler todetect fetal heart beats, displayfetal heart rate and play the fetalheart sound from early gestationthru delivery for singletonpregnancies. The UltrasonicDoppler is intended for use bytrained healthcare professionalsonly in a clinical setting.	The Ultrasonic Doppler is intended todetect fetal heart beats, display fetal heartrate and play the fetal heart sound fromearly gestation thru delivery for singletonpregnancies. The Ultrasonic Doppler isintended for use by trained healthcareprofessionals only in a clinical setting.	Same
Gestational Age	12 weeks	12 weeks	Same
Gestational Type	Singleton	Singleton	Same
Technical Characteristics			Same
Display Type	Digital Display; LCD	Digital Display; LCD	Same
Power Suppler	2* 1.5V AA Alkaline batteries	2* 1.5V AA Alkaline batteries	Same
Probe connection	Wired	Wired	Same
Acoustic OutputPower	3 W	3 W	Same
Nominal Frequency	2 MHz	2 MHz	Same
Working Frequency	(2.0 ± 10%) MHz	(2.0 ± 10%) MHz	Same
$I_{ob}$	< 20 $mW/cm^2$	< 20 $mW/cm^2$	Same
$p_r$	1 MPa	1 MPa	Same
$I_{spta}$	< 100 $mW/cm^2$	< 100 $mW/cm^2$	Same
$I_{sata}$	< 20 $mW/cm^2$	< 20 $mW/cm^2$	Same
$W_o$	50 mW	50 mW	Same
Mode of operation	Continuous Wave Doppler	Continuous Wave Doppler	Same
Effective RadiatingArea	(157±30%) mm²	(157±30%) mm²	Same
FHR MeasuringRange	50 bpm -210 bpm	50 bpm - 210 bpm	Same
Accuracy	± 2bpm	± 2bpm	Same
Resolution	1 bpm	1 bpm	Same

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As evidenced by the table above, the subject and predicate device have similar technological characteristics. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety or effectiveness.

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:

Cytotoxicity (ISO 10993-5)
Skin Sensitization (ISO 10993-10)
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:

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
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

Ultrasound and Acoustic Testing

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

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 Ultrasound Equipment

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.

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Software Verification and Validation Testing

Software verification and validation testing was conducted 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.

Conclusion 8.

Based on the comparison and analysis above, the Fetal 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).