Intended Use

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.

Technology

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.

Performance

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/14/2024

    8 months
  • 2

    FDA Approval

    2/3/2025

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