The Sonicaid Team3 is a fetal monitoring system designed for non-invasive and invasive monitoring of fetal and maternal physiological parameters during pregnancy. It helps clinicians assess fetal well-being through ultrasound, fetal heart rate monitoring, and includes the Dawes-Redman CTG analysis software to evaluate cardiotocographs, aiding in the identification of abnormal or reassuring fetal heart patterns.
The Team3 fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy, from 28 weeks gestation through to term and delivery in clinical and hospital-type facilities.
Sonicaid Team3 includes fetal ultrasound channels, fetal ECG, external and internal uterine activity monitoring, maternal heart rate monitoring, pulse oximetry and non-invasive blood pressure measurement. It incorporates the Dawes-Redman CTG Analysis software embedded in the device firmware for analysis of cardiotocograph traces.
Software verification and validation testing, as well as cybersecurity testing following FDA guidance, were conducted to ensure the safety and effectiveness of Sonicaid Team3, with the device considered as having a major level of concern for software. Testing demonstrates the device to be as safe and effective as the predicate.
No predicate devices specified
Submission
5/14/2024
FDA Approval
2/3/2025
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