The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.

Device Description

The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D). The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.

AI/ML Overview

The provided text is a 510(k) summary for a Fetal Doppler device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria based on clinical performance with a test set, ground truth, or expert involvement.

The summary focuses on non-clinical performance testing and substantial equivalence.

Here's a breakdown of the requested information based on the provided document, highlighting what is not available:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (from predicate)	Reported Device Performance (Subject Device)
FHR Measuring Range: 50-230 bpm	FHR Measuring Range: 50-210 bpm
Resolution: 1 bpm	Resolution: 1 bpm
Accuracy: ±2 bpm	Accuracy: ±2 bpm
ISATA: <20 mW/cm²	2.0MHz - ISATA: 17.24 mW/cm²
	2.5MHz - ISATA: 18.57 mW/cm²
	3.0MHz - ISATA: 11.496 mW/cm²

Note: The document states that the FHR measuring range of the subject device is 50-210 bpm, while the predicate device is 50-230 bpm. This is a difference, but the document concludes it "does not raise different questions of safety and effectiveness."

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

Not available. The document describes non-clinical performance testing, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "Use-life testing" involved evaluating "pressing-key performance and FHR measurement accuracy" under "simulated repeated use conditions," but this is not a clinical test set.

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)

Not available. No clinical test set with expert-established ground truth is mentioned.

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

Not available. No clinical test set with adjudication is mentioned.

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

Not applicable / Not available. This device is a Fetal Doppler, which directly measures FHR. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.

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

Not applicable / Not available. This is a hardware device for FHR detection. The "Performance" section lists device specifications for FHR measuring range, resolution, and accuracy, which are standalone device performance metrics. However, these are not the result of an "algorithm only" study in the context of AI/ML, but rather the intrinsic performance of the sensing and processing hardware.

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

For the FHR accuracy claim (±2 bpm), the ground truth would typically be established by a highly accurate reference standard for heart rate measurement. The document implies this was evaluated during "Use-life testing" under "simulated repeated use conditions," but does not explicitly state the ground truth methodology. It would likely involve a calibrated signal generator or a highly precise alternative FHR measurement system. It does not involve expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is a Fetal Doppler, not an AI/ML device that requires a "training set" for an algorithm.

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

Not applicable. As above, there is no mention of a training set as this is not an AI/ML device.

Summary

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May 29, 2019

Vcomin Technology Limited % Lucy Yan Consult Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center 55 Shizhou Zhong Road, Nanshan District Shenzhen, Guangdong 518100 China

Re: K182526

Trade/Device Name: Fetal Doppler ((Models: FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B,and FD-591D) Regulation Number: 21 CFR§ 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: April 15, 2019 Received: April 29, 2019

Dear Lucy Yan:

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.

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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); 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.htm); 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 medical devices and radiation-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

Sharon M. Andrews Assistant Division 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) K182526

Device Name

Fetal Doppler (Models: FD-231B, FD-231D, FD-640D, FD-200B, FD-200D, FD-591B,and FD-591D)

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 K182526

1. Submitter Information

Manufacturer information	Company Name: Vcomin Technology LimitedCompany address:2&3 Fl., No.1, Kangzheng Rd., Buji Town, Shenzhen,Guangdong 518110, P. R. ChinaContact person: Han JieLinPhone: +86-755-33826016Fax: +86-755-61658248E-mail: info@vcomin.com
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.Address: Room 1122, International MayorsCommunication Centre, 55 Shizhou Zhong Rd.,Nanshan District, Shenzhen, Guangdong 518000, P. R. ChinaContact person: Ms. Lucy Yan; Mr. Field FuE-Mail: lucy@cefda.com; field@cefda.com

2. Date Prepared: May 29, 2019

3. Device Identification

Trade Name	Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
Common Name	Fetal Doppler
Regulation name	Fetal Ultrasonic Monitor and Accessories
Regulation Number	21 CFR 884.2660
Product Code	KNG (Monitor, Ultrasonic, Fetal)
Regulatory Class	II

4. Predicate Device

Fetal Doppler (K131457) manufactured by Shenzhen Jumper Medical Equipment Co., Ltd. This predicate has not been subject to any design related recalls.

5. Device Description

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The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.

6. Indications for Use

Devices	Subject devices (K182526)	Predicate device (K131457)
Indications for Use	The device is used to detect the fetalheart rate. The device should be usedby health care professionals includingnurses, midwives, and specializedtechnicians in hospital, clinic,community and home.	The fetal doppler JPD-100B is a hand-held, battery powered audio dopplerdevice used for detecting fetal heart beats.
Intended population	Same as the predicate device	Women with pregnancy at or after 12weeks
Design	Same as the predicate device	A main unit and a probe. The main unitcan display FHR
Mode of action	Same as the predicate device	Doppler ultrasound, continuous wave
Ultrasound frequency	2.0 MHz, 2.5 MHz, and 3.0 MHz	2.5 MHz
Performance	- FHR Measuring Range: 50-210 bpm- Resolution: 1 bpm- Accuracy: ±2 bpm	- FHR Measuring Range: 50-230 bpm- Resolution: 1 bpm- Accuracy: ±2 bpm
Acoustic output (statisticalmaximum limit)	- 2.0MHz - ISATA: 17.24 mW/cm²- 2.5MHz - ISATA: 18.57 mW/cm²- 3.0MHz - ISATA: 11.496 mW/cm²	ISATA: <20 mW/cm²
Patient contact material	ABS, silicone, colorants	ABS, polypropylene (PP)

7. Substantial Equivalence Discussion

Both subject and predicate devices are indicated for detection of fetal heart rate. They also have the same intended patient population. Therefore, the subject and predicate devices have the same intended use.

The subject and predicate devices have the same design and mode of action. They have different acoustic output, but both meet FDA recommendations (IsaTA: <20 mW/cm²). They also have different ultrasound frequency. FHR measuring range, and patient contacting materials. These differences do not raise different questions of safety and effectiveness.

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8. Summary of Non-Clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate devices:

Biocompatibility: .
- Cytotoxicity Test per ISO 10995-5:2009 *
- - Skin Irritation Test per ISO 10993-10:2010
- - Guinea Piq Maximization Sensitization Test per ISO 10993-10:2010
Cleaning and disinfection validation testing in accordance with FDA guidance . "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015
Software verification and validation testing in accordance with FDA guidance . "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005
Electrical safety testing per ANSI/AAMI ES60601-1:2005(R)2012 + A1:2012 and . IEC 60601-1-11:2015
. Electromagnetic compatibility (EMC) testing per IEC 60601-1-2:2014
Ultrasound testing per IEC 60601-2-37:2015 .
. Battery testing per EN 62133:2013
Acoustic output testing FDA guidance "Information for Manufacturers Seeking . Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008
. Use-life testing:

In this study, the devices under simulated repeated use conditions were evaluated for pressing-key performance and FHR measurement accuracy. The results demonstrated that the subject device can be used for three years under normal use conditions.

9. Conclusion

The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device 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).