ANNE Maternal

ANNE Maternal is a perinatal monitoring software platform that continuously collects, displays, and stores physiological data from compatible medical devices in clinical labor and delivery settings. It monitors maternal vital signs (heart rate, respiratory rate, oxygen saturation, blood pressure, temperature) and fetal parameters (heart rate, uterine contractions), provides visual and audio alarms, and integrates a Modified Early Obstetric Warning System (MEOWS) tool to signal need for clinical evaluation while supporting—not replacing—healthcare professional judgment.

Both ANNE Maternal and the predicate Sonicaid Team3 are Class II perinatal monitoring systems that collect and display maternal and fetal physiological parameters with alarms and clinical decision-support features for use in healthcare settings. The primary distinction is ANNE Maternal's integrated electronic MEOWS tool, which provides adjunctive early warning notifications based on collected vital signs; however, this software-based decision-support feature does not alter the fundamental monitoring function or clinical purpose and is similar to algorithm-based features in other legally marketed perinatal systems.

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-27 (ECG monitoring), IEC 60601-1-8:2020 (alarms), ISO 80601-2-61 (pulse oximetry), ISO 80601-2-56 (thermometers), IEC 60601-2-37 (ultrasonic equipment), ISO 15223-1 (labeling symbols), IEC 60601-1-6 (usability), IEC 62366-1:2020 (human factors), IEC 62304:2015 (software validation), and FDA cybersecurity guidance.

ANNE Maternal is substantially equivalent to Sonicaid Team3 because both devices share the same general intended use (continuous acquisition and display of maternal-fetal physiological data by qualified healthcare professionals in clinical settings to support decision-making), the same fundamental technology (data aggregation and display from compatible monitors with alarms), and perform similar functions. The integrated MEOWS tool does not change the intended use, does not replace clinician judgment, and represents an adjunctive software-based early warning feature comparable to other legally marketed perinatal monitoring systems, thus raising no different safety or effectiveness questions.