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510(k) Data Aggregation
(158 days)
Novii+ Wireless Patch System
The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires 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 34 weeks and 0/7 days and greater 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 Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent 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 Novii+ Wireless Patch System (Novii+ system) is a battery-powered maternal-fetal monitoring system that measures abdominal fetal heart rate (FHR), abdominal uterine activity (UA), and abdominal maternal heart rate (MHR). The Novii+ Wireless Patch system 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 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 a Bluetooth connection to the Novii+ Interface device which is an accessory to the Novii+ Pod.
The Novii+ Pod (proposed device) is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies with cephalic fetal presentation.
Here's a breakdown of the acceptance criteria and study details for the Novii+ Wireless Patch System, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Parameter (Metric) | Acceptance Criteria (Lower limit of 95% two-sided CI) | Reported Device Performance | Outcome |
|---|---|---|---|
| FHR (PA) | >80% | 83.45% | PASS |
| MHR (PA) | >80% | 97.26% | PASS |
| UA (RI) | >80% | 100% | PASS |
| UA (PPA) | >80% | 84.67% | PASS |
| FHR Deming Slope | 0.958 - 1.042 (95% two-sided CI) | 1.02 | PASS |
| FHR Deming Intercept | -10 to 10 BPM (95% two-sided CI) | -3.18 BPM | PASS |
| MHR Deming Slope | 0.958 - 1.042 (95% two-sided CI) | 1.01 | PASS |
| MHR Deming Intercept | -10 to 10 BPM (95% two-sided CI) | -1.18 BPM | PASS |
| MHR RMSE (Novii vs. GS) |
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(146 days)
MONICA NOVII WIRELESS PATCH SYSTEM
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).
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Testing | |||
| Data Transfer Validation | Bias difference for Fetal Heart Rate (FHR) | Less than 1 BPM | Demonstrated compliance (implies bias difference was |
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