(128 days)
No
The device description and performance studies focus on standard Doppler ultrasound technology and signal processing, with no mention of AI/ML algorithms or training/test data.
No
The device is intended to detect, display, and play fetal heart sounds, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device is intended to detect, display, and play fetal heart sounds, which is a monitoring function. While it provides a measurement (fetal heart rate), it is not described as diagnosing a disease, condition, or state of health.
No
The device description explicitly states it is a hand-held device consisting of a main unit (containing a main board, power module, battery, speaker, and screen) and a wired probe with ultrasonic crystals, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fetal Doppler described is a non-invasive device that uses ultrasound to detect and display the fetal heart rate and sound. It does not analyze samples taken from the body.
- Intended Use: The intended use is to detect fetal heart beats and display heart rate, which is a direct measurement from the body, not an analysis of a sample.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KNG
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.
The main unit is powered by two 1.5V AA alkaline batteries. The use-life of the device is five years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
Fetal heart
Indicated Patient Age Range
Not Found
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. Patient contacting materials underwent Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) testing.
- Electrical safety and electromagnetic compatibility (EMC): Complied with IEC 60601-1 and IEC 60601-1-2.
- Ultrasound and Acoustic Testing: Complied with IEC 60601-2-37 and NEMA UD2. Acoustic output measurement followed FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," dated September 9, 2008 for Track 1 devices.
- Software Verification and Validation Testing: Conducted with no outstanding anomalies. Software documentation provided as recommended by FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 for a moderate software level of concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
FHR Measuring Range: 50 bpm - 210 bpm
Accuracy: ± 2bpm
Resolution: 1 bpm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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 (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) 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| 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.
Room 202, HaoGu industry park, 2037 Guanguang road, Guangming district,
518105, Shenzhen, P.R. China
Tel.: +86 18603031299 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
4
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
Result |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Ultrasonic Doppler | Fetal Doppler | |
| | Model: YM-2T8 | | |
| 510(k) Number | K180419 | K182190 | ---- |
| Manufacturer | Shenzhen IMDK Medical
Technology Co., Ltd. | Shenzhen AOJ Medical Technology Co.,
Ltd. | ---- |
| Classification Name | Fetal ultrasonic monitor and
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
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 Ultrasonic 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 Ultrasonic Doppler is
intended for use by trained healthcare
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
Power | 3 W | 3 W | Same |
| Nominal Frequency | 2 MHz | 2 MHz | Same |
| Working Frequency | (2.0 ± 10%) MHz | (2.0 ± 10%) MHz | Same |
| $I_{ob}$ |