Type 5 Integrating Indicator for Steam (CSPN-15)

The Type 5 Integrating Indicator for Steam (CSPN-15) is a chemical indicator strip designed to monitor steam sterilization processes. It chemically reacts to critical sterilization parameters (time, temperature, and steam) and changes color from pink to dark brown/black when exposed to specified steam cycles, signaling that sterilization conditions have been achieved. The indicator is placed inside individual packs or containers to independently verify that sterilization has occurred.

The subject device consists of a paper substrate with pink water-based chemical indicator ink (ISPN-01) and a clear polyester laminate overcoat with acrylic adhesive. It uses a sulfide-based chemical indicator that transitions to dark brown/black at endpoint, matching the predicate's endpoint color. The shelf life is 48 months compared to the predicate's 60 months, and end-point stability is 6 months for both devices. Both use similar sulfide-based chemistry and polyester laminate design but differ in initial ink color (pink vs. yellow).

Testing followed ISO 11140-1:2014 (Sterilization of health care products – Chemical indicators, Part 1: General requirements for Type 5 Integrators for Steam) and FDA Guidance for Industry and FDA Staff on Chemical Indicator Premarket Notification [510(k)] Submissions. Additional tests included Steam Resistometer testing, Hospital Steam Sterilizer testing, Dry Heat testing, End Point Stability evaluation, Side-by-Side Biological Indicator testing, and Offset/Transference testing.

The subject device is substantially equivalent because it shares identical intended use, product code (JOJ), and regulatory classification (21 CFR 880.2800) with the predicate. Both devices employ sulfide-based chemistry to monitor identical steam sterilization cycles and achieve identical endpoint color specifications (dark brown/black) with identical 6-month post-exposure stability. Performance testing demonstrated the subject device passes all critical parameter thresholds at claimed temperatures with correlation coefficients >0.9 to biological indicators, and side-by-side testing confirmed it does not reach endpoint before biological indicators are inactivated, matching or exceeding predicate performance across all validated sterilization cycles.