OTTO™ Disinfecting Cap

The OTTO™ Disinfecting Cap is a sterile, disposable cap designed to disinfect swabbable needlefree connectors on intravenous catheters using 70% isopropyl alcohol. It functions as both a physical barrier to contamination and a disinfecting cleaner, achieving disinfection in 30 seconds and maintaining a disinfected surface for up to 7 days if not removed.

The device uses a polyurethane-based foam sponge (versus predicate's compressed cellulose foam), has a pink Santoprene cap (versus orange), is sealed on a foil strip for multiple caps (versus individual sealing), and has a 1-year shelf life (versus predicate's 2 years). All other core components—the 70% IPA solution, cap structure, and sterilization method—remain the same.

ISO 10993-1 (biocompatibility), ISO 13485 (quality management), ISO 80369-7 (needlefree connector compatibility), USP <788> (particulate contamination), and FDA's 2023 Guidance on ISO 10993-1 biological evaluation.

OTTO is substantially equivalent to the predicate SwabCap™ because both devices share the same intended use, regulatory classification, and functional specifications for disinfecting needlefree connectors. The reduction in disinfection time from 5 minutes to 30 seconds was validated through antimicrobial efficacy testing showing ≥4 log₁₀ reduction, and material changes (sponge composition and cap color) were tested for safety and biocompatibility without raising new safety or effectiveness concerns.