(158 days)
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) |
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).