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

K232893 · Contec Medical Systems Co.,Ltd · KNG · Jun 14, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K232893
• Device Name: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
• Applicant: Contec Medical Systems Co.,Ltd
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Jun 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

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 Story

Hand-held fetal Doppler; detects fetal heart rate (FHR) via pulsed-wave ultrasound. Input: 2.5MHz ultrasonic signal transmitted/received by probe. Processing: analog signal processing unit, FHR calculating unit. Output: numerical FHR value on LCD display. Used by healthcare professionals (nurses, midwives, technicians) in hospitals, clinics, or home settings. Benefits: non-invasive, real-time FHR monitoring for clinical assessment.

Clinical Evidence

Bench testing only. No clinical data. Compliance verified with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, and IEC 62133-2. Biocompatibility confirmed per ISO 10993-1 (Attachment G). Performance testing included use life, battery life, and battery indicator verification.

Technological Characteristics

Hand-held fetal monitor; ABS plastic housing/probe cap. Pulsed-wave Doppler ultrasound at 2.5MHz. Powered by 3.7V lithium battery (10D) or 2x 1.5V AA batteries (10E/10F). LCD display. Standards: AAMI/ANSI/ES 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, IEC 62133-2. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for detection of fetal heart rate in pregnant women at or after 12 weeks gestation. For use by healthcare professionals including nurses, midwives, and specialized technicians in hospital, clinic, community, 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

• Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (K220245)

Reference Devices

• Handheld fetal doppler (K172780)

Submission Summary (Full Text)

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

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.

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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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
- 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: [e-mail]

- 4. 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

- 5. 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.

- 7. 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.

- 8. 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<br>(CONTEC 10D), Pocket<br>Fetal Doppler (CONTEC<br>10E), Pocket Fetal Doppler<br>(CONTEC 10F | Pocket Fetal Doppler | / |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Model | CONTEC 10D; CONTEC<br>10E; CONTEC 10F | CONTEC10C and<br>CONTEC10CL | / |
| Classification<br>Regulation | 21 CFR 884.2660 | 21 CFR 884.2660 | Same |
| Classification | II | II | Same |
| Product Code | KNG | KNG | Same |
| Regulation<br>Name | Fetal ultrasonic monitor and<br>accessories. | Fetal ultrasonic monitor and<br>accessories. | Same |
| Indications<br>for use | The Pocket Fetal Doppler<br>(Models CONTEC 10D,<br>CONTEC 10E and<br>CONTEC10F) is used to<br>detect the fetal heart rate.<br>The device should be used<br>by health care professionals<br>including nurses, midwives,<br>and specialized technicians<br>in the hospital, clinic,<br>community and home. The<br>device is intended for use at<br>or after 12 weeks gestation. | The Pocket Fetal Doppler<br>(Models CONTEC10C and<br>CONTEC10CL) is used to<br>detect the fetal heart rate.<br>The device should be used<br>by health care professionals<br>including nurses, midwives,<br>and specialized technicians<br>in the hospital, clinic,<br>community and home. The<br>device is intended for use at<br>or after 12 weeks gestation. | Same |
| Intended<br>population | Women with pregnancy at<br>or after 12 weeks | Women with pregnancy at or<br>after 12 weeks | Same |
| Design | A main unit and a probe.<br>The main unit can display a<br>numerical FHR value | A main unit and a probe.<br>The main unit can display a<br>numerical FHR value | Same |
| Mode of<br>action | Doppler ultrasound, pulsed<br>wave | Doppler ultrasound,<br>continuous wave | Different |
| Ultrasound<br>frequency | 2.5MHz<br>Pulse repetition frequency:<br>5556Hz (CONTEC 10D)<br>5560Hz (CONTEC 10E/F) | 2.0 MHz, 3.0 MHz | Different |
| Performance | -FHR Measuring Range:<br>50 BPM ~ 240 BPM<br>-Resolution: 1 BPM<br>Accuracy: ±2 BPM | -FHR Measuring Range:<br>50 BPM ~ 240 BPM<br>-Resolution: 1 BPM<br>Accuracy: ±2 BPM | Same |
| Acoustic<br>output<br>(statistical<br>maximum<br>limit) | CONTEC 10D: ISATA < 10<br>mW/cm²<br>CONTEC 10E: ISATA < 20<br>mW/cm²<br>CONTEC 10F: ISATA < 20<br>mW/cm² | ISATA < 20 mW/cm² | Different |
| Patient<br>contact<br>material | ABS | ABS, Silica, PVC | Different |
| Biocompatibility | Meets Attachment G<br>recommendations (FDA<br>Guidance document "Use<br>of International Standard<br>ISO 10993-1, "Biological<br>evaluation of medical<br>devices - Part 1: Evaluation<br>and testing within a risk<br>management process"<br>(issued September 2023)) | No cytotoxicity,<br>sensitization or irritation<br>(ISO 10993-5<br>& ISO 10993-10) | Same |
| Electrical<br>Safety | IEC 60601-1 and IEC<br>60601-1-11 | IEC 60601-1 and IEC<br>60601-1-11 | 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
- 10. 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.