Ultrasonic Doppler (Model YM-2T8)
Device Facts
| Record ID | K180419 |
|---|---|
| Device Name | Ultrasonic Doppler (Model YM-2T8) |
| Applicant | Shenzhen Imdk Medical Technology Co., Ltd. |
| Product Code | KNG · Obstetrics/Gynecology |
| Decision Date | Jul 19, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2660 |
| Device Class | Class 2 |
Indications for Use
The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.
Device Story
Hand-held device for non-invasive fetal heart rate monitoring; utilizes continuous-wave Doppler ultrasound. System comprises main unit (display, speaker, battery) and wired probe (transducer with two angled semi-circle crystals). Probe transmits 2 MHz ultrasonic signal; receives reflected continuous wave signal; detects Doppler shift. Main unit processes signal to display fetal heart rate on OLED screen and output audio via speaker. Used by trained healthcare professionals in clinical settings. Provides real-time fetal heart rate data to assist clinicians in monitoring fetal well-being.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1, -5, -10), electrical safety (IEC 60601-1, -1-2, -1-11), and acoustic output measurement (IEC 60601-2-37, NEMA UD2).
Technological Characteristics
Hand-held fetal monitor; 2 MHz continuous-wave Doppler; wired probe with two semi-circle crystals. Power: 2x 1.5V AA alkaline batteries. Display: OLED. Acoustic output: <20 mW/cm² (Isata), <100 mW/cm² (Ispta), 1 MPa (pr). Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-37, NEMA UD2.
Indications for Use
Indicated for detection of fetal heart rate and fetal heart sounds in singleton pregnancies from early gestation (12 weeks) 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
- SD5 Ultrasonic Tabletop Doppler (K153475)
Submission Summary (Full Text)
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July 19, 2018
Shenzhen IMDK Medical Technology Co., Ltd. Yuan Xia Administrative Director C Zone, 10F, Building16, Yuanshan Industrial B Area Gongming Street, Guangming District Shenzhen, 518106 CHINA
Re: K180419
> Trade/Device Name: Ultrasonic Doppler (Model YM-2T8) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: Class II Product Code: KNG Dated: June 8, 2018 Received: June 21, 2018
Dear Yuan Xia:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K180419
Device Name Ultrasonic Doppler Model YM-2T8
### Indications for Use (Describe)
The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.
| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span style="font-size:16px;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><span style="font-size:16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size:16px;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size:16px;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| <span style="font-size:16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |
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# 510(k) Summary K180419
#### 1. Submitter
| Name and Address: | Shenzhen IMDK Medical Technology Co., Ltd. | |
|-------------------|------------------------------------------------------------------------|--|
| | C Zone, 10F, Building 16, Yuanshan Industrial B Area, Gongming Street, | |
| | Guangming District, 518106, P.R. China | |
| | Telephone: +86 13662694320 | |
| Contact Person: | Yuan Xia | |
| Date Prepared: | July 5, 2018 | |
#### 2. Device Information
| Trade Name: | Ultrasonic Doppler |
|------------------------|------------------------------------------|
| Model: | YM-2T8 |
| Classification Name: | Fetal ultrasonic monitor and accessories |
| Regulation Number: | 21 CFR 884.2660 |
| Device Classification: | Class II |
| Product Code: | KNG |
| Review Panel: | Obstetrics/Gynecology |
#### 3. Predicate Device
| 510(k) Number: | K153475 |
|----------------|---------------------------------|
| Device Name: | SD5 Ultrasonic Tabletop Doppler |
| Manufacturer: | Edan Instruments, Inc. |
The predicate device has not been subject to a design-related recall.
#### 4. Device Description
The Ultrasonic 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.
The main unit is powered by two 1.5V AA alkaline batteries.
#### ട്. Indications for Use
The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.
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#### Predicate Comparison 6.
The following table compares the Ultrasonic Doppler to the predicate device with respect to the indications for use and technological characteristics:
| Device | Subject Device<br>Ultrasonic Doppler<br>Model: YM-2T8 | Predicate Device<br>SD5 Ultrasonic Tabletop Doppler |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K180419 | K153475 |
| Manufacturer | Shenzhen IMDK Medical Technology Co., Ltd. | EDAN Instruments, Inc. |
| Classification Name | Fetal ultrasonic monitor and accessories | Fetal ultrasonic monitor and accessories |
| Regulation Number | 844.2660 | 844.2660 |
| Device Class | Class II | Class II |
| Product Code | KNG | KNG |
| Indications for Use | The Ultrasonic Doppler uses<br>continuous-wave Doppler to detect<br>fetal heart beats, display fetal heart<br>rate and play the fetal heart sound<br>from early gestation thru delivery for<br>singleton pregnancies. The Ultrasonic<br>Doppler is intended for use by trained<br>healthcare professionals only in a<br>clinical setting. | The SD5 Ultrasonic TableTop Doppler<br>(hereinafter called "SD5") and SD6<br>Ultrasonic TableTop Doppler (hereinafter<br>called "SD6") are intended to be used by<br>health care professionals including<br>registered nurses, practical nurses,<br>midwives, ultrasound technicians, and<br>physician assistants, by prescription from<br>licensed physicians in hospitals, clinics and<br>private offices.<br><br>The 2 MHz and/or 3 MHz obstetrical probes<br>are indicated for the detection of fetal heart<br>rate from early gestation thru delivery and<br>as a general indication of fetal well being.<br>They can also be used to verify fetal heart<br>viability. |
| Gestational Age | 12 weeks | 12 weeks |
| Gestational Type | Singleton | Singleton |
| Technical Characteristics | | |
| Display Type | Digital Display; LCD | Digital Display; LCD |
| Power Suppler | Two 1.5V AA Alkaline Batteries | 100 V - 240 V~, 50 Hz/60 Hz or<br>7.2 V/2000 mAh (Ni-MH Battery) |
| Probe connection | Wired | Wired |
| Acoustic Output<br>Power | 3 W | 3 W |
| Nominal Frequency | 2 MHz | 2 MHz |
| Working Frequency | (2.0 ± 10%) MHz | (2.0 ± 10%) MHz |
| <i>Iob</i> | < 20 mW/cm² | < 20 mW/cm² |
| <i>pr</i> | 1 MPa | 1 MPa |
| <i>Ispta</i> | < 100 mW/cm² | < 100 mW/cm² |
| <i>Isata</i> | < 20 mW/cm² | < 20 mW/cm² |
| Wo | 50 mW | 50 mW |
| Mode of operation | Continuous Wave Doppler | Continuous Wave Doppler |
| Effective Radiating Area | (157 $\pm$ 30%) mm² | (245 $\pm$ 15%) mm² |
| FHR Measuring Range | 50 bpm ~ 210 bpm | 50 bpm ~ 240 bpm |
| Accuracy | $\pm$ 2bpm | $\pm$ 2bpm |
| Resolution | 1 bpm | 1 bpm |
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#### 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:
- i. Cytotoxicity (ISO 10993-5)
- ii. Skin Sensitization (ISO 10993-10)
- iii. 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:
- i. 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
- ii. 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
- iii. IEC 60601-1-11, 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
# Ultrasound and Acoustic Testing
Bench testing was conducted on the Ultrasonic Doppler and the system was found to comply with the following:
- i. 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 ii. Ultrasound Equipment
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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.
# Software Verification and Validation Testing
Software verification and validation testing was conducted and completed 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.
#### 8. Clinical Performance Testing
Not Applicable
#### 9. Conclusion
Based on the comparison and analysis above, the Ultrasonic Doppler is substantially equivalent to the predicate device.
