AeroJet Ventilation Catheter

The Aero Jet Ventilation Catheter is a sterile, single-use tracheal tube designed for jet ventilation—delivering oxygen and air to a patient's lungs during anesthesia. It is inserted orally and placed subglottic, with a nominal length of 23 cm and outer diameter of 3.85 mm. The device enables monitoring of pressure and end-tidal CO2.

The subject device features three internal lumens (versus two in the predicate) to separately monitor gas and pressure without requiring a stopcock. It includes color-coded markers and depth markings for identification. The shaft extends through the basket with a molded distal tip rather than a cinched design. It lacks the predicate's internal stainless-steel wire. Both devices use PTFE shafts, PEBAX centering baskets, and stainless-steel stylets.

ISO 10993 (biocompatibility), ISO 18562-1 (breathing gas pathways), ISO 11990-1 (laser testing), ISO 80369-20 (small bore connector leakage/cracking), and ISO 11990:2018 (laser resistance).

The subject device performs the same intended function—jet ventilation during anesthesia—with identical insertion site, placement location, duration of use, and patient population as the predicate. Design differences (three versus two lumens, color markers, absence of internal wire, modified tip configuration) are minor variations that improve usability without affecting safety or effectiveness. Testing demonstrates comparable biocompatibility, functional performance, and laser resistance, establishing that the device operates as safely and effectively as the predicate.