Fetal Doppler

K182190 · Shenzhen AOJ Medical Technology Co., Ltd. · KNG · Dec 19, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K182190
• Device Name: Fetal Doppler
• Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Dec 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Fetal Doppler is intended for use by trained healthcare professionals only in a clinical setting.

Device Story

Hand-held fetal doppler; non-invasive measurement of fetal heart rate (FHR). Input: continuous-wave ultrasound (2 MHz) reflected from fetal heart; transducer probe with two angled semi-circle crystals (one transmit, one receive). Processing: Doppler shift detection; signal conversion to FHR and audio output. Output: digital FHR display (LCD) and audible heart sounds. Used in clinical settings by trained healthcare professionals. Benefits: enables monitoring of fetal well-being during pregnancy and labor.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5, -10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and acoustic output (IEC 60601-2-37, NEMA UD2).

Technological Characteristics

Hand-held ultrasonic monitor; 2 MHz continuous-wave Doppler; wired probe with two piezoelectric crystals. Powered by 2x 1.5V AA alkaline batteries. Digital LCD display. Biocompatibility per ISO 10993. Acoustic output: Ispta < 100 mW/cm², Isata < 20 mW/cm². Software level of concern: moderate.

Indications for Use

Indicated for detection of fetal heart beats, display of fetal heart rate, and audio playback of fetal heart sounds in singleton pregnancies from 12 weeks gestation through delivery. Intended for use by trained healthcare professionals in clinical 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

• YM-2T8 Ultrasonic Doppler (K180419)

Submission Summary (Full Text)

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### December 19, 2018

Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao General Manager Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming district Shenzhen, 518105 China

Re: K182190

Trade/Device Name: Fetal Doppler (Models AOJ-50A and AOJ-50B) Regulation Number: 21 CFR§ 884.2660 Regulation Name: Fetal Ultrasonic Monitor and Accessories Regulatory Class: II Product Code: KNG Dated: November 8, 2018 Received: November 19, 2018

Dear Qihuan Zhao:

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 mav, 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 avare 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.

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.

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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.html; 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sharon M. Andrews -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K182190

Device Name

Fetal Doppler (Models AOJ-50A and AOJ-50B)

Indications for Use (Describe)

The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Fetal Doppler is intended for use by trained healthcare professionals only in a clinical setting.

Type of Use (Select one or both, as applicable)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary - K182190

#### 1. Submitter

| Name and Address | Shenzhen AOJ Medical Technology Co., Ltd.<br>Room 202, HaoGu industry park, 2037 Guanguang road, Guangming district,<br>518105, Shenzhen, P.R. China<br>Tel.: [phone] |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Qihuan Zhao, General Manager, Shenzhen AOJ Medical Technology Co., Ltd. |
| Date Prepared: | December 17, 2018 |

#### 2. Device Information

| Trade Name: | Fetal Doppler (Models AOJ-50A, AOJ-50B |
|------------------------|------------------------------------------|
| Common Name: | Fetal doppler |
| Classification Name: | Fetal ultrasonic monitor and accessories |
| Regulation Number: | 21 CFR 884.2660 |
| Device Classification: | Class II |
| Product Code: | KNG (monitor, ultrasonic, fetal) |
| Review Panel: | Obstetrics/Gynecology |

#### 3. Predicate Device

| 510(k) Number: | K180419 |
|----------------|--------------------------------------------|
| Device Name: | YM-2T8 Ultrasonic Doppler |
| Manufacturer: | Shenzhen IMDK Medical Technology Co., Ltd. |

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

#### 4. Device Description

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.

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The main unit is powered by two 1.5V AA alkaline batteries. The use-life of the device is five years.

#### 5. Indications for Use

The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Fetal Doppler is intended for use by trained healthcare professionals only in a clinical setting.

#### 6. Predicate Comparison

The following table compares the Fetal Doppler to the predicate device with respect to the indications for use and technological characteristics:

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| Comparison Items | Predicate Device | Subject Device | Comparison<br>Result |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Ultrasonic Doppler | Fetal Doppler | |
| | Model: YM-2T8 | | |
| 510(k) Number | K180419 | K182190 | ---- |
| Manufacturer | Shenzhen IMDK Medical<br>Technology Co., Ltd. | Shenzhen AOJ Medical Technology Co.,<br>Ltd. | ---- |
| Classification Name | Fetal ultrasonic monitor and<br>accessories | Fetal ultrasonic monitor and accessories | Same |
| Regulation Number | 844.2660 | 844.2660 | Same |
| Device Class | Class II | Class II | Same |
| Product Code | KNG | KNG | Same |
| Indications for Use | The Ultrasonic Doppler uses<br>continuous-wave Doppler to<br>detect fetal heart beats, display<br>fetal heart rate and play the fetal<br>heart sound from early gestation<br>thru delivery for singleton<br>pregnancies. The Ultrasonic<br>Doppler is intended for use by<br>trained healthcare professionals<br>only in a clinical setting. | The Ultrasonic Doppler is intended to<br>detect fetal heart beats, display fetal heart<br>rate and play the fetal heart sound from<br>early gestation thru delivery for singleton<br>pregnancies. The Ultrasonic Doppler is<br>intended for use by trained healthcare<br>professionals only in a clinical setting. | Same |
| Gestational Age | 12 weeks | 12 weeks | Same |
| Gestational Type | Singleton | Singleton | Same |
| Technical Characteristics | | | Same |
| Display Type | Digital Display; LCD | Digital Display; LCD | Same |
| Power Suppler | 2* 1.5V AA Alkaline batteries | 2* 1.5V AA Alkaline batteries | Same |
| Probe connection | Wired | Wired | Same |
| Acoustic Output<br>Power | 3 W | 3 W | Same |
| Nominal Frequency | 2 MHz | 2 MHz | Same |
| Working Frequency | (2.0 ± 10%) MHz | (2.0 ± 10%) MHz | Same |
| $I_{ob}$ | < 20 $mW/cm^2$ | < 20 $mW/cm^2$ | Same |
| $p_r$ | 1 MPa | 1 MPa | Same |
| $I_{spta}$ | < 100 $mW/cm^2$ | < 100 $mW/cm^2$ | Same |
| $I_{sata}$ | < 20 $mW/cm^2$ | < 20 $mW/cm^2$ | Same |
| $W_o$ | 50 mW | 50 mW | Same |
| Mode of operation | Continuous Wave Doppler | Continuous Wave Doppler | Same |
| Effective Radiating<br>Area | (157±30%) mm² | (157±30%) mm² | Same |
| FHR Measuring<br>Range | 50 bpm -210 bpm | 50 bpm - 210 bpm | Same |
| Accuracy | ± 2bpm | ± 2bpm | Same |
| Resolution | 1 bpm | 1 bpm | Same |

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As evidenced by the table above, the subject and predicate device have similar technological characteristics. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety or effectiveness.

#### 7. Non-Clinical Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

### Biocompatibility

The biocompatibility evaluation was conducted in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. Patient contacting materials were subjected to testing that included the following tests:

- Cytotoxicity (ISO 10993-5)
- Skin Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10)

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted and the device was found to comply with the requirements of the following standards:

- IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance with US deviations per AAMI/ANSI ES 60601-1
- IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances- requirements and tests

### Ultrasound and Acoustic Testing

Bench testing was conducted on the Fetal Doppler and the system was found to comply with the following:

- IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- Acoustic Output testing per NEMA UD2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

The acoustic output measurement methodology as recommended in FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," dated September 9, 2008 was followed for Track 1 devices.

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### Software Verification and Validation Testing

Software verification and validation testing was conducted with no outstanding anomalies. Software documentation was provided as recommended by FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 for a moderate software level of concern.

#### Conclusion 8.

Based on the comparison and analysis above, the Fetal Doppler is substantially equivalent to the predicate device.