The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

Device Description

The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a Pocket Fetal Doppler. It details the device's characteristics, indications for use, comparison to a predicate device, and results of non-clinical testing. However, it does not include information about acceptance criteria for performance metrics (beyond resolution and accuracy values), NOR does it describe a study involving human readers or experts to prove the device meets these criteria.

Therefore, many of the requested points cannot be extracted from the provided text.

Based on the information available:

1. A table of acceptance criteria and the reported device performance

The document provides performance specifications for the device and a predicate, but doesn't explicitly state "acceptance criteria" in a pass/fail sense in this section. It lists the device's performance characteristics.

Performance Parameter	Acceptance Criteria (Not explicitly stated as such, but implied by device specification)	Reported Device Performance (Subject Device)	Reported Device Performance (Predicate Device)
FHR Measuring Range	(Not stated as separate criteria, but within acceptable range for fetal heart rate)	50 BPM ~ 240 BPM	50-210 bpm
Resolution	1 BPM	1 BPM	1 bpm
Accuracy	±2 BPM	±2 BPM	±2 bpm
Acoustic Output (ISATA)	< 20 mW/cm² (FDA recommendation)	< 20 mW/cm²	2.0MHz – 17.24 mW/cm²2.5MHz – 18.57 mW/cm²3.0MHz – 11.496 mW/cm²

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

Not provided in the document. The testing described is non-clinical performance and safety testing, not human use studies with a test set of data.

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 applicable. No human experts were used for a test set in the context of device performance claims based on this document. The testing focused on device specifications and compliance with standards.

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

Not applicable. No test set involving human interpretation/adjudication was described.

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. This device is a direct measurement tool (Fetal Doppler) and does not involve AI assistance or human interpretation/improvement studies as described in the document.

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

This largely describes the type of testing performed. The device's performance (FHR range, resolution, accuracy) was tested in a standalone capacity against specifications, not as part of an algorithm's performance in image interpretation. The testing validated the device's ability to measure FHR.

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

For the device performance metrics (FHR range, resolution, accuracy), the "ground truth" would be established by calibrated measurement equipment and reference standards typically used in medical device testing, not biological ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm with training data.

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

Not applicable. No training set for an AI algorithm was described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 28, 2022

Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K220245

Trade/Device Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Regulation Number: 21 CFR$ 884,2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: August 24, 2022 Received: August 24, 2022

Dear Ray 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.

{1}------------------------------------------------

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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220245

Device Name

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

The assigned 510(k) Number: K220245

Tab #4 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: September 27, 2022
1. 510(k) Owner

Contec Medical Systems Co., Ltd.

No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE'S REPUBLIC OF CHINA.

Contact Person: Jie Xiao Position: Deputy Manager Tel: +86-335-8015490 Fax: +86-335-8015490 Email: pms.qms(@contecmed.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com

{4}------------------------------------------------

4. Identification of Subject Device

Trade Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Common Name: Fetal Doppler

Regulatory Information Regulation Name: Fetal ultrasonic monitor and accessories Regulation Number: 21 CFR 884.2660 Regulatory Class: II Product Code: KNG Review Panel: Obstetrics/Gynecology

Predicate Device 5.
510(k) Number: K182526 Product Name: Fetal Doppler Manufacturer: Vcomin Technology Limited

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

Device Description:

The CONTEC10C is powered by three AA batteries, and the ultrasonic signal is continuously transmitted at a frequency of 2.0MHz.

The CONTEC10CL is powered by a 3.7V lithium battery, and the ultrasonic signal is continuously transmitted at a frequency of 3.0MHz.

Indications for use Statement:

1. Substantial Equivalence Discussion
  The table below compares the intended use and technological characteristics of the subject and predicate device.

{5}------------------------------------------------

Item	Subject Device	Predicate Device
		K182526
Device name	Pocket Fetal Doppler	Fetal Doppler
ClassificationRegulation	21 CFR 884.2660	21 CFR 884.2660
Classification	II	II
Product Code	KNG	KNG
RegulationName	Fetal ultrasonic monitor andaccessories.	Fetal ultrasonic monitor andaccessories.
Indicationsfor use	The Pocket Fetal Doppler (ModelsCONTEC10C and CONTEC10CL) isused to detect the fetal heart rate. Thedevice should be used by health careprofessionals including nurses,midwives, and specializedtechnicians in the hospital, clinic,community and home. The device isintended for use at or after 12 weeksgestation.	The device is used to detect the fetalheart rate. The device should be usedby health care professionalsincluding nurses, midwives, andspecialized technicians in hospital,clinic, community and home.
Intendedpopulation	Women with pregnancy at or after 12 weeks	Women with pregnancy at or after 12 weeks
Design	A main unit and a probe. The mainunit can display FHR	A main unit and a probe. The mainunit can display FHR
Mode of action	Doppler ultrasound, continuous wave	Doppler ultrasound, continuous wave
Ultrasoundfrequency	2.0 MHz, 3.0 MHz	2.0 MHz, 2.5 MHz, and 3.0 MHz
	-FHR Measuring Range:50 BPM ~ 240 BPM	-FHR Measuring Range:50-210 bpm
Performance	-Resolution: 1 BPMAccuracy: ±2 BPM	-Resolution: 1 bpm-Accuracy: ±2 bpm
Acoustic output(statisticalmaximum limit)	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
Patient contactmaterial	ABS, Silica, PVC	ABS, silicone, colorants
Biocompatibility	ISO 10993-5& ISO 10993-10	ISO 10993-5& ISO 10993-10
Electrical Safety	IEC 60601-1 and IEC 60601-1-11	ANSI/AAMI ES60601-1
		and IEC 60601-1-11
EMC	IEC 60601-1-2	IEC 60601-1-2
Performance	IEC 60601-2-37	IEC 60601-2-37
Battery	EN 62133	EN 62133

Table 1 General Comparison

{6}------------------------------------------------

The subject and predicate device have similar indications for use statements and have the same intended use - to detect the fetal heart rate. The subject device and predicate device have different ultrasound frequencies, but the ultrasound frequencies of subject device (2.0 MHz) are included in the ultrasound frequencies of the predicate device (2.0 MHz, and 3.0 MHz). The subject and predicate devices have different acoustic output and FHR measuring range, but both meet FDA recommendations for acoustic output (IssTA: <20 mW/cm²). The subject and predicate devices also have different patient contacting materials; both the patient contacting materials of subject device and predicate device passed testing for the recommended biocompatibility endpoints per ISO 10993 standards (cytotoxicity, sensitization, irritation). Therefore, these differences do not raise different questions of safety and effectiveness.

7. Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the subject device met all design specifications and to support device safety and effectiveness. The test results demonstrated that the subject device complies with the following standards:

A Recommended biocompatibility endpoints per the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
A IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
A 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
IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
Acoustic output testing per the 2019 FDA guidance Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
- 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;

{7}------------------------------------------------

IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
In addition, the following performance testing was performed on the subject device:
Use Life Testing
Battery Life Testing
Battery Indicator Testing

{8}------------------------------------------------

8. Conclusion

The non-clinical performance testing described above demonstrates that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).