Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

K220245 · Contec Medical Systems Co.,Ltd · KNG · Sep 28, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K220245
• Device Name: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
• Applicant: Contec Medical Systems Co.,Ltd
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Sep 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

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 Story

Hand-held fetal heart rate (FHR) monitor; utilizes continuous wave Doppler ultrasound to detect fetal heart rate. Device consists of main unit and probe; contains ultrasonic transmitter/receiver, analog signal processing unit, FHR calculation unit, and LCD display. CONTEC10C uses 2.0 MHz frequency (AA batteries); CONTEC10CL uses 3.0 MHz frequency (3.7V lithium battery). Operated by healthcare professionals or patients in hospitals, clinics, or homes. Provides real-time FHR measurement on LCD display; assists clinicians in monitoring fetal status. Benefits include non-invasive, portable fetal heart rate detection.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -10), electrical safety (IEC 60601-1, -1-11), EMC (IEC 60601-1-2), acoustic output (IEC 60601-2-37), and battery safety (IEC 62133-2). Performance testing included use life, battery life, and battery indicator verification.

Technological Characteristics

Hand-held Doppler ultrasound monitor. Materials: ABS, Silica, PVC. Frequencies: 2.0 MHz (CONTEC10C) or 3.0 MHz (CONTEC10CL). Power: AA batteries or 3.7V lithium battery. Standards: ISO 10993-5/10 (biocompatibility), IEC 60601-1/1-11 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound performance), IEC 62133-2 (battery).

Indications for Use

Indicated for pregnant women at or after 12 weeks gestation for the detection of fetal heart rate by healthcare professionals (nurses, midwives, technicians) in clinical or home settings.

Regulatory Classification

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.

Predicate Devices

• Fetal Doppler (K182526)

Submission Summary (Full Text)

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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.

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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/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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known) K220245

Device Name

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M5.44443 11.5556L14.2222 2.77783L13.2222 1.77783L5.44443 9.5556L2.77777 6.88896L1.77777 7.88896L5.44443 11.5556Z" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over The Counter Use (21 CFR 801 Subpart C) </span> </div> |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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
- 2. 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: [phone] Fax: [phone] Email: pms.qms(@contecmed.com

- 3. 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: [phone] Fax: [phone] Email: information(@believe-med.com

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#### 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 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.

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:

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.

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

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| Item | Subject Device | Predicate Device |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K182526 |
| Device name | Pocket Fetal Doppler | Fetal Doppler |
| Classification<br>Regulation | 21 CFR 884.2660 | 21 CFR 884.2660 |
| Classification | II | II |
| Product Code | KNG | KNG |
| Regulation<br>Name | Fetal ultrasonic monitor and<br>accessories. | Fetal ultrasonic monitor and<br>accessories. |
| Indications<br>for use | The Pocket Fetal Doppler (Models<br>CONTEC10C and CONTEC10CL) is<br>used to detect the fetal heart rate. The<br>device should be used by health care<br>professionals including nurses,<br>midwives, and specialized<br>technicians in the hospital, clinic,<br>community and home. The device is<br>intended for use at or after 12 weeks<br>gestation. | The device is used to detect the fetal<br>heart rate. The device should be used<br>by health care professionals<br>including nurses, midwives, and<br>specialized technicians in hospital,<br>clinic, community and home. |
| Intended<br>population | Women with pregnancy at or after 12 weeks | Women with pregnancy at or after 12 weeks |
| Design | A main unit and a probe. The main<br>unit can display FHR | A main unit and a probe. The main<br>unit can display FHR |
| Mode of action | Doppler ultrasound, continuous wave | Doppler ultrasound, continuous wave |
| Ultrasound<br>frequency | 2.0 MHz, 3.0 MHz | 2.0 MHz, 2.5 MHz, and 3.0 MHz |
| | -FHR Measuring Range:<br>50 BPM ~ 240 BPM | -FHR Measuring Range:<br>50-210 bpm |
| Performance | -Resolution: 1 BPM<br>Accuracy: ±2 BPM | -Resolution: 1 bpm<br>-Accuracy: ±2 bpm |
| Acoustic output<br>(statistical<br>maximum limit) | ISATA < 20 mW/cm2 | -2.0MHz – ISATA: 17.24 mW/cm2<br>-2.5MHz – ISATA: 18.57 mW/cm2<br>-3.0MHz – ISATA: 11.496 mW/cm2 |
| Patient contact<br>material | ABS, Silica, PVC | ABS, silicone, colorants |
| Biocompatibility | ISO 10993-5<br>& ISO 10993-10 | ISO 10993-5<br>& 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

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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;

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- > 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

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#### 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.