ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

The ProVu Single Use Video Stylet with Reinforced ET Tube is a sterile, single-use intubation system combining a video-enabled stylet with an endotracheal tube in four sizes (6.5–8.0 mm ID). It is intended as a temporary artificial airway for adults requiring mechanical ventilation via oral or nasal intubation, and provides real-time video visualization during both routine and difficult intubation procedures to verify proper tube placement.

The device features a colored real-time video camera with Motion JPEG format output displayed via cable connection to an 8-inch monitor, compared to the predicate's Composite Video Baseband Signal and 7-inch monitor. The ProVu offers four tube sizes (ID 6.5, 7.0, 7.5, 8.0 mm) versus the predicate's three sizes, and has a shorter shelf life (0.5 year vs. 3 years). Both use PVC and polypropylene materials, high-volume low-pressure cuffs, EtO sterilization, and are packaged in similar formats; the bevel design is similar with the camera positioned centrally within the lumen.

ISO 5356-1 (conical connectors), ISO 5361 (tracheal tubes), ISO 14971 (risk management), ISO 11135 (sterilization validation), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (medical device safety standard), ISO 10993-1 (biocompatibility), and ISO 18562 series (breathing gas pathway biocompatibility and emissions testing).

The ProVu is substantially equivalent because it shares the same indications for use, regulatory classification (Class II, BTR/BSR product codes), basic structure as a standard ETT with integrated video camera, and fundamental materials as the VIVASIGHT-SL predicate. Both devices provide real-time video for intubation guidance in adult hospital settings with identical cuff design, sterilization method, and duration of use. Although the ProVu adds a smaller 6.5 mm size option and uses MJPEG instead of composite video, these are design refinements that do not alter the device's fundamental intended function or safety profile; all performance and biocompatibility testing demonstrates equivalence to the predicate.