Self-Seal Sterilization Pouch and Roll

The Self-Seal Sterilization Pouch and Roll are medical packaging designed to enclose devices for sterilization via steam (132°C for 4 minutes) or ethylene oxide (EO at 50°C for 4 hours). The pouches are self-sealing; rolls require a plastic sealing machine. After sterilization, they maintain sterility of enclosed devices for up to 6 months, with a 3-year shelf life before sterilization. Built-in chemical indicators change color to visually confirm exposure to the sterilization process.

The subject device uses medical-grade paper (60g/m²) and PET/CPP film (52 μm) identical to the predicate. Key differences include: EO and steam chemical indicator colors differ (red-to-brown for EO vs. pink-to-yellow in predicate; blue-to-dark greenish black for steam vs. dark grey in predicate), sterilization cycle parameters vary slightly (695 mg/L EO at 50°C vs. 800 mg/L at 55°C), maintenance of sterility is 6 months versus 24 months, and shelf life is 3 years versus 5 years. All physical performance properties and biocompatibility are substantially equivalent.

ISO 11135:2014 (EO sterilization validation), ISO 17665-1:2006 and ISO TS 17665-2:2009 (steam sterilization), ISO 10993-5/7/10/23 (biocompatibility), ISO 11140-1:2014 (chemical indicators), ASTM F2251, F88/F88M, F1140, F1929, F2096, F1608, F1980, and ISO 1924-2 (physical performance).

The subject device is substantially equivalent because it shares the same intended use, indication for use, materials, sterilization methods, and fundamental design as the predicate K221875. All critical safety and effectiveness characteristics including seal strength, burst strength, microbial barrier, and biocompatibility are identical or equivalent. Differences in indicator color, sterilization parameters, and shelf life are non-core characteristics supported by independent validation testing that demonstrates achievement of SAL 10⁻⁶, and these differences do not alter the basic nature or intended use of the device.