(154 days)
Not Found
No
The device description and performance studies focus on standard Doppler technology and electrical/acoustic safety, with no mention of AI/ML algorithms or related training/testing data.
No
The device is used to detect and play the fetal heart sound, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
The device is intended to detect and play fetal heart sounds, which is a monitoring function, not a diagnostic one. It does not provide information to diagnose a condition or disease.
No
The device description explicitly states it consists of two main hardware components: a main unit (containing a main board, power module, battery, speaker, and screen) and a wired probe (containing a transducer and ultrasonic crystals). This indicates it is a physical hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Ultrasonic Doppler described here uses ultrasound to detect and play the fetal heart sound. It does not analyze any biological specimens taken from the body. It is a non-invasive device that interacts directly with the patient's body (via ultrasound waves) to gather information.
Therefore, based on the provided information, the Ultrasonic Doppler is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (Continuous-Wave Doppler)
Anatomical Site
Not Found
Indicated Patient Age Range
from early gestation thru delivery
Intended User / Care Setting
trained healthcare professionals only in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Biocompatibility: Evaluation conducted in accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), and Irritation (ISO 10993-10).
- Electrical safety and electromagnetic compatibility (EMC): Device complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
- Ultrasound and Acoustic Testing: Device complies with IEC 60601-2-37 and NEMA UD2. Acoustic output measurement followed FDA guidance for Track 1 devices.
- Software Verification and Validation Testing: Conducted and completed with no outstanding anomalies. Software documentation provided as recommended by FDA guidance for a moderate software level of concern.
Clinical Performance Testing: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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
1
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
2
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) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)□ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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.
4
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
Ultrasonic Doppler
Model: YM-2T8 | Predicate Device
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
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. | The SD5 Ultrasonic TableTop Doppler
(hereinafter called "SD5") and SD6
Ultrasonic TableTop Doppler (hereinafter
called "SD6") are intended to be used by
health care professionals including
registered nurses, practical nurses,
midwives, ultrasound technicians, and
physician assistants, by prescription from
licensed physicians in hospitals, clinics and
private offices.
The 2 MHz and/or 3 MHz obstetrical probes
are indicated for the detection of fetal heart
rate from early gestation thru delivery and
as a general indication of fetal well being.
They can also be used to verify fetal heart
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
7.2 V/2000 mAh (Ni-MH Battery) |
| Probe connection | Wired | Wired |
| Acoustic Output
Power | 3 W | 3 W |
| Nominal Frequency | 2 MHz | 2 MHz |
| Working Frequency | (2.0 ± 10%) MHz | (2.0 ± 10%) MHz |
| Iob | pr | 1 MPa | 1 MPa |
| Ispta | Isata |