(270 days)
The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.
The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. This device can detect a fetal heart rate value at or after twelve weeks gestation.
The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
The FDA 510(k) summary for the Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) does not contain the level of detail typically found in a clinical study report for device acceptance criteria and performance, especially for AI/ML-based devices. This is a traditional medical device (fetal Doppler) and not an AI/ML device, hence some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or training set details) is not applicable or provided in this document.
However, based on the provided text, here's an attempt to extract the relevant information regarding performance and acceptance, and clarify what is not applicable or available:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on its ability to accurately measure fetal heart rate (FHR) within specified ranges and its compliance with relevant electrical safety, EMC, and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (from testing standards/specifications) | Reported Device Performance |
|---|---|---|
| FHR Measuring Range | 50 BPM ~ 240 BPM | 50 BPM ~ 240 BPM |
| FHR Resolution | 1 BPM | 1 BPM |
| FHR Accuracy | ±2 BPM | ±2 BPM |
| Acoustic Output (ISATA) |
§ 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).