Fetal & Maternal Monitor (F15A, F15A Air)

The Fetal & Maternal Monitor (F15A, F15A Air) is a perinatal monitoring system for non-stress testing and fetal monitoring in pregnant women from the 28th week of gestation. It monitors multiple physiological parameters including fetal heart rate, fetal movements, maternal heart rate, maternal ECG, maternal temperature, maternal oxygen saturation (F15A only), and uterine activity, displaying and storing data for trained personnel in antepartum and labor/delivery settings.

The F15A series differs from the predicate F9 Express in power input (1.2A-0.5A vs 1.0A-0.5A), physical dimensions (389×296×82.5mm vs 347×330×126mm), weight (≤8kg vs ~6.3kg), electrical safety classification (different anti-shock degrees for certain parameters), and effective radiating ultrasound area (942mm² with 12 crystals or 550mm² with 7 crystals vs 942mm² with 12 crystals). Core measurement ranges, frequencies, and functional capabilities remain identical.

IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-8:2006/AMD1:2012/AMD2:2020, IEC 60601-2-27:2011, IEC 60601-2-37:2015, IEC 80601-2-49:2018, ISO 80601-2-56:2017+A1:2018, ISO 80601-2-61:2017-12, ANSI IEEE USEMCSC C63.27-2021, IEC 62359:2017, and ANSI AAMI EC53:2013/(R)2020.

The subject device has identical intended use and core functional parameters as the predicate F9 Express, with differences in power supply, dimensions, weight, and electrical safety classification that do not raise new safety or effectiveness questions. Bench testing demonstrates compliance with applicable consensus standards for medical electrical equipment, ultrasonic monitoring, ECG, thermometry, and pulse oximetry. Software verification/validation and cybersecurity testing were performed per FDA guidance, and all measurement ranges, ultrasound frequency, and physiological monitoring capabilities match the predicate device.