(128 days)
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.
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 provided document is a 510(k) summary for a Fetal Doppler device (Models AOJ-50A and AOJ-50B). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
Here's the information about acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The core performance acceptance criteria for the Fetal Doppler relate to its ability to measure Fetal Heart Rate (FHR) accurately. The performance reported is in comparison to the predicate device, which inherently sets the acceptance criteria through substantial equivalence.
| Acceptance Criteria Item | Reported Device Performance (Subject Device) |
|---|---|
| FHR Measuring Range | 50 bpm - 210 bpm |
| Accuracy | ± 2 bpm |
| Resolution | 1 bpm |
| Acoustic Output Power | 3 W |
| Nominal Frequency | 2 MHz |
| Working Frequency | (2.0 ± 10%) MHz |
| Iob |
§ 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).