Sonicaid Team3

The Sonicaid Team3 is a perinatal monitoring system for non-invasive and invasive monitoring of pregnant women and fetuses from 28 weeks gestation through delivery. It monitors fetal heart rate, uterine activity, fetal movement, and maternal vital signs (heart rate, oxygen saturation, blood pressure) in clinical and hospital settings during antepartum and intrapartum periods.

The subject device is identical to the predicate (K200975) in all hardware specifications including ultrasound channels, tocodynamometer, fetal ECG, external/internal uterine activity sensors, maternal monitoring modules, display, printer, and power systems. The primary difference is the addition of embedded Dawes-Redman CTG Analysis software, which was previously cleared as a standalone algorithm (K992607) and provides automated assessment of cardiotocograph traces.

Software verification and validation testing per FDA Guidance for Industry and FDA Staff 'Guidance for the Content for the Premarket Submissions for Software Contained in Medical Devices' (major level of concern). Cybersecurity risk management per FDA Guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'. EMC and electrical safety compliance with IEC 60601-1-2 and IEC 60601-1.

The subject device has identical intended use and technological characteristics to the predicate device. The only difference—embedding the Dawes-Redman CTG Analysis software that was previously cleared as K992607—does not raise different questions of safety and effectiveness because this analysis function was already cleared in isolation. The addition of this software feature to the existing hardware platform merely integrates a previously validated algorithm into the device without changing the underlying monitoring capabilities or introducing new risks.