Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

The Rusch Endotracheal Tubes are sterile, single-use devices inserted into the trachea via the nose or mouth to establish a patent airway for ventilation. Three variants are cleared: Reinforced (with embedded stainless-steel spiral for kinking resistance), Safety Clear (with radiopaque line), and Safety Clear Pediatric. All are available in cuffed and uncuffed versions, with or without Murphy Eye, for pediatric and adult patients.

The subject devices are made of PVC without DEHP (unlike predicates containing DEHP), feature 15mm connectors, are sterilized via ethylene oxide at 10-6 SAL, and contain compatible cuffs, inflation lines, pilot balloons, and one-way valves. The Reinforced tube has an embedded stainless-steel spiral; Safety Clear tubes incorporate a radiopaque line for visualization. Size ranges are within or narrower than predicate ranges (Reinforced 3.5–10.0 mm vs. predicate 2.5–11.0 mm).

ISO 10993-1 Fifth Edition 2018-08 for biocompatibility testing, including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, implantation, subacute systemic toxicity, genotoxicity, chemical characterization of extractables/leachables, and inhalation risks from VOCs and particulates.

The subject devices share identical intended use (airway management), same product code (BTR), same regulation (21 CFR 868.5730), identical construction materials (PVC cuff and shaft), and identical sterilization method with predicate devices. The removal of DEHP is a material improvement rather than a safety concern. Bench testing confirms equivalent performance in all critical characteristics (bonding strength, kink resistance, cuff function, tracheal seal). The narrower or equivalent size ranges and biocompatibility data demonstrate no new safety risks relative to predicates.