PV01 PVDF Effort Sensor

The PV01 PVDF Effort Sensor is a respiratory monitoring accessory used during sleep studies to measure chest and abdominal wall movement. It consists of a piezoelectric PVDF sensing element housed in plastic enclosures connected by a silicone-laminated film, paired with an elastic belt that wraps around the patient's chest or abdomen. The device outputs voltage signals proportional to breathing effort for analysis by sleep clinicians to diagnose sleep disorders, and is intended for use in hospitals, sleep labs, clinics, nursing homes, or home environments under medical professional direction.

The Subject Device uses piezoelectric PVDF sensing technology, whereas the Predicate Device (RIP01) uses respiratory inductance plethysmography (RIP) technology. However, both measure the same physiological parameter (respiratory effort), produce identical output signal ranges (0–1000 µV peak-to-peak, 0.1–15 Hz), offer the same connector options (1.5 mm DIN or keyhole), rely on the host system for patient isolation, and do not require power from the host. The Subject Device has a reusable sensor module with a single-use belt, whereas the Predicate Device has both reusable components.

UL 60601-1:2003 Ed.1 + R:26 Apr 2006 (dielectric strength, ingress of liquids, patient leads sections).

Although the Subject and Predicate Devices employ different sensing technologies (PVDF versus RIP), they share substantially equivalent intended use, target population (adults and children), environments of use, contraindications, and functional outputs. The Subject Device demonstrated equivalent performance to a reference device using the same PVDF technology in a comparative breathing simulation test, and all safety tests passed UL standards. The use of established low-risk materials identical to or derived from predicate and reference devices with long clinical histories, combined with minimal skin contact and comprehensive validation testing showing safe and effective performance, establishes substantial equivalence despite the technological difference.