The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) 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 fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. 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. This device can detect a fetal heart rate value at or after twelve weeks gestation.

The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

AI/ML Overview

The FDA 510(k) summary for the Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) does not contain the level of detail typically found in a clinical study report for device acceptance criteria and performance, especially for AI/ML-based devices. This is a traditional medical device (fetal Doppler) and not an AI/ML device, hence some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or training set details) is not applicable or provided in this document.

However, based on the provided text, here's an attempt to extract the relevant information regarding performance and acceptance, and clarify what is not applicable or available:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on its ability to accurately measure fetal heart rate (FHR) within specified ranges and its compliance with relevant electrical safety, EMC, and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria (from testing standards/specifications)	Reported Device Performance
FHR Measuring Range	50 BPM ~ 240 BPM	50 BPM ~ 240 BPM
FHR Resolution	1 BPM	1 BPM
FHR Accuracy	±2 BPM	±2 BPM
Acoustic Output (ISATA)	< 20 mW/cm² (FDA guidance)	CONTEC 10D: < 10 mW/cm²CONTEC 10E/F: < 20 mW/cm²
Biocompatibility	Meets FDA Guidance "Use of International Standard ISO 10993-1..." recommendations (Attachment G)	Device considered biocompatible (passed testing per ISO 10993 standards)
Electrical Safety	Complies with IEC 60601-1 and IEC 60601-1-11	Complies with IEC 60601-1 and IEC 60601-1-11
EMC	Complies with IEC 60601-1-2	Complies with IEC 60601-1-2
Performance (Ultrasonic)	Complies with IEC 60601-2-37	Complies with IEC 60601-2-37
Battery Safety	Complies with EN 62133	Complies with EN 62133
Use Life	Met design specifications	Passed Use Life testing
Battery Life	Met design specifications	Passed Battery life testing
Battery Indicator Performance	Met design specifications	Passed Battery indicator testing
Software Verification & Validation	Consistent with Basic level per 2023 FDA guidance "Content of Premarket Submissions for Device Software Functions"	Documentation consistent with Basic level

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

The document describes non-clinical testing to verify design specifications and compliance with standards. It does not mention a "test set" in the context of patient data or clinical trials with a specific sample size. The performance metrics (FHR range, resolution, accuracy) are likely derived from bench testing using simulators or controlled inputs, and not from a dataset of patient recordings.

Sample Size: Not specified as it's non-clinical, likely involves a series of tests on manufactured units.
Data Provenance: Not applicable in the context of patient data. The tests are performed on the device itself.

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

Not applicable. This is a hardware device measuring a physiological parameter. The "ground truth" for its performance is established by reference to calibrated measurement equipment and standardized test protocols, not by expert human interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. There is no human interpretation or "test set" for adjudication, as it's a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic aids where the impact on human reader performance is evaluated. This device is a direct measurement tool for FHR, not an interpretive aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, the performance characteristics (FHR measuring range, resolution, accuracy, acoustic output) are essentially standalone performance metrics of the device as an instrument, independent of human interpretation during a diagnostic process. The stated performance data (e.g., FHR accuracy ±2 BPM) represents the device's inherent capability.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests is based on technical specifications and adherence to international and national standards. For example:

FHR accuracy would be verified against a precisely known or simulated fetal heart rate signal.
Acoustic output would be measured using specialized acoustic measurement equipment.
Biocompatibility is determined by laboratory testing against ISO 10993 standards.

8. The Sample Size for the Training Set:

Not applicable. This device does not employ machine learning or AI that would require a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this traditional medical device.

Summary

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June 14, 2024

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: K232893

Trade/Device Name: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal Ultrasonic Monitor And Accessories Regulatory Class: II Product Code: KNG Dated: May 11, 2024 Received: May 13, 2024

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 (the 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 available 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

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Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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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-comprehensiveregulatory-assistance/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 -S

Monica D. Garcia, PhD 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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K232893

Device Name

Pocket Fetal Doppler (CONTEC 10D); Pocket Fetal Doppler (CONTEC 10E); Pocket Fetal Doppler (CONTEC 10F)

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)

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."

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The assigned 510(k) Number: _ K232893

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: June 14, 2024
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

1. Identification of Subject Device
  Trade Name: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) Common Name: Fetal Doppler

Regulatory Information Regulation Name: Fetal ultrasonic monitor and accessories Regulation Number: 21 CFR 884.2660

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Regulatory Class: II Product Code: KNG (Monitor, Ultrasonic, Fetal) Review Panel: Obstetrics/Gynecology

1. Predicate Device

Predicate Device:

510(k) Number: K220245 Product Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Manufacturer: Contec Medical Systems Co., Ltd.

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

Device Description: 6.
The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. 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. This device can detect a fetal heart rate value at or after twelve weeks gestation.

The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

1. Indications for use Statement:
  The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) 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.
1. Substantial Equivalence Discussion The following table compares the intended use and technological characteristics of the subject and predicate device.

Item	Subject Device	Predicate Device	Remark
	K232893	K220245

Table 1 General Comparison

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Device name	Pocket Fetal Doppler(CONTEC 10D), PocketFetal Doppler (CONTEC10E), Pocket Fetal Doppler(CONTEC 10F	Pocket Fetal Doppler	/
Model	CONTEC 10D; CONTEC10E; CONTEC 10F	CONTEC10C andCONTEC10CL	/
ClassificationRegulation	21 CFR 884.2660	21 CFR 884.2660	Same
Classification	II	II	Same
Product Code	KNG	KNG	Same
RegulationName	Fetal ultrasonic monitor andaccessories.	Fetal ultrasonic monitor andaccessories.	Same
Indicationsfor use	The Pocket Fetal Doppler(Models CONTEC 10D,CONTEC 10E andCONTEC10F) is used todetect the fetal heart rate.The device should be usedby health care professionalsincluding nurses, midwives,and specialized techniciansin the hospital, clinic,community and home. Thedevice is intended for use ator after 12 weeks gestation.	The Pocket Fetal Doppler(Models CONTEC10C andCONTEC10CL) is used todetect the fetal heart rate.The device should be usedby health care professionalsincluding nurses, midwives,and specialized techniciansin the hospital, clinic,community and home. Thedevice is intended for use ator after 12 weeks gestation.	Same
Intendedpopulation	Women with pregnancy ator after 12 weeks	Women with pregnancy at orafter 12 weeks	Same
Design	A main unit and a probe.The main unit can display anumerical FHR value	A main unit and a probe.The main unit can display anumerical FHR value	Same
Mode ofaction	Doppler ultrasound, pulsedwave	Doppler ultrasound,continuous wave	Different
Ultrasoundfrequency	2.5MHzPulse repetition frequency:5556Hz (CONTEC 10D)5560Hz (CONTEC 10E/F)	2.0 MHz, 3.0 MHz	Different
Performance	-FHR Measuring Range:50 BPM ~ 240 BPM-Resolution: 1 BPMAccuracy: ±2 BPM	-FHR Measuring Range:50 BPM ~ 240 BPM-Resolution: 1 BPMAccuracy: ±2 BPM	Same
Acousticoutput(statisticalmaximumlimit)	CONTEC 10D: ISATA < 10mW/cm²CONTEC 10E: ISATA < 20mW/cm²CONTEC 10F: ISATA < 20mW/cm²	ISATA < 20 mW/cm²	Different
Patientcontactmaterial	ABS	ABS, Silica, PVC	Different
Biocompatibility	Meets Attachment Grecommendations (FDAGuidance document "Useof International StandardISO 10993-1, "Biologicalevaluation of medicaldevices - Part 1: Evaluationand testing within a riskmanagement process"(issued September 2023))	No cytotoxicity,sensitization or irritation(ISO 10993-5& ISO 10993-10)	Same
ElectricalSafety	IEC 60601-1 and IEC60601-1-11	IEC 60601-1 and IEC60601-1-11	Same
EMC	IEC 60601-1-2	IEC 60601-1-2	Same
Performance	IEC 60601-2-37	IEC 60601-2-37	Same
Battery	EN 62133	EN 62133	Same

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The subject and predicate devices have same indications for use statements and have the same intended use - to detect the fetal heart rate.

The subject device and predicate device have different mode of action, but they both utilize doppler ultrasound. The subject device has the same mode of action (pulsed-wave Doppler) as another cleared handheld fetal doppler (K172780) and passed the same performance testing as the predicate device.

The subject device and predicate device have different ultrasound frequencies, but the ultrasound frequencies of subject device (2.5MHz) are included in the scope ultrasound frequencies of the predicate device (2.0 MHz and 3.0 MHz).

The subject and predicate device have different acoustic output and FHR measuring range, but both meet FDA recommendations for acoustic output (IsATA: <20 mW/cm2).

The subject and predicate device also have different patient contacting materials; the patient

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contacting materials of the predicate device passed testing for the recommended biocompatibility endpoints per ISO 10993 standards (cytotoxicity, sensitization) and the subject device met Attachment G recommendations per the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023).

The technological differences do not raise different questions of safety and effectiveness.

9. 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:

AAMI/ANSI/ES 60601-1: 2012 Medical electrical equipment Part 1: General requirements A 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 disturbances -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;
IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other A 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
This device meets the recommendations of Attachment G of the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023). Therefore, this device is considered biocompatible.
IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
A Software verification and validation documentation consistent with a Basic level of documentation per the 2023 FDA guidance Content of Premarket Submissions for Device Software Functions (fda.gov)

In addition, the following performance testing was performed on the subject device:

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Use Life testing >
Battery life testing >
ア Battery indicator testing
1. Conclusion

The non-clinical performance testing described above demonstrates that the device is as safe and effective as the predicate device (K220245) 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).