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The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

The Novii Patch is an accessory to the Novii Pod that connects directly to the Novii Pod and contains the surface electrodes that attach to the abdomen.

The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.

The Novii Pod maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting

The Monica Novii Pod Fetal-Maternal Monitor is designed as an ambulatory device for the monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological signal to be picked up from three different positions on the maternal abdomen using the 5 electrodes on the Monica Novii Patch. The monitor filters the abdominal signals, converts the abdominal electrophysiological data into a digital format and then processes it in real time to extract the fetal heart rate, maternal heart rate and uterine activity. The result of the processing is transmitted via the Bluetooth connection to the Monica Novii CTG Interface device that is a Monica Approved accessory to the Monica Novii Pod.

Here's a breakdown of the acceptance criteria and the studies that prove the Monica Novii Wireless Patch System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for non-clinical tests (Data Transfer Validation and Data Extraction Validation).

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The Monica AN24 is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA). The AN24 acquires and displays the FHR & MHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) and maternal ECG (mECG) signal. Using the same surface electrodes, the AN24 also acquires and displays the UA tracing from the uterine electromyography (EMG) signal. The AN24 is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.

The Monica AN24™ is a small, battery-powered device for L&D surveillance of fetal well-being. The AN24™ is designed to passively monitor Fetal Heart Rate (FHR)), maternal heart rate (MHR) and Uterine Activity (UA) during pregnancy and can be used at any time from > 36 completed weeks gestation in laboring patients. The AN24™ is suitable for singleton pregnancies only.

The Monica AN24 is a small, battery powered electrophysiological monitor (specifically fetal ECG, maternal ECG and uterine EMG). The electrical signals are passively monitored on three channels using five electrodes placed on the pregnant abdomen in specific locations. From these electrical signals the Fetal Heart Rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA) are continuously extracted and displayed in the same standard format as the predicate device.

Here's an analysis of the Monica AN24 device's acceptance criteria and study, based on the provided 510(k) summary:

Monica AN24 Device Acceptance Criteria and Study Analysis

The Monica AN24 is an intrapartum maternal-fetal monitor. This 510(k) summary focuses on demonstrating the substantial equivalence of the Monica AN24's Maternal Heart Rate (MHR) monitoring capability to a predicate SPO2 pulse oximeter (Philips M1191A). The FHR and UA monitoring capabilities had previously been cleared (K101801).

1. Table of Acceptance Criteria and Reported Device Performance

The study aimed to demonstrate non-inferiority of the Monica AN24's MHR monitoring compared to the predicate SPO2 pulse oximeter.

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