Sterilization Pouches and Reels

The Sterilization Pouches and Reels are medical packaging made of medical-grade paper and medical compound film designed to contain medical devices during steam or ethylene oxide sterilization. They maintain sterility of enclosed devices for up to 12 months post-sterilization and have a 5-year pre-sterilization shelf life. Chemical indicators on the pouches change color to show exposure to sterilization but do not guarantee sterilization occurred.

The subject device offers 72 size variants compared to the predicate's 32 sizes, with maximum validated loads of 1.87 lbs for both pouches and reels. Key differences include chemical indicator color schemes (subject: Pink-to-Cocoa for steam, Blue-to-Golden Brown for EO; predicate: Blue-to-Dark Grey for steam, Pink-to-Yellow for EO) and reduced sterility maintenance period (12 months vs. predicate's 24 months). Material composition and sterilization cycles are substantially similar.

ASTM F88/F88M-2015 (seal strength), ASTM F1929-2015 (seal leak detection), ASTM F2096-2011 (gross leak detection), ISO 1924-2:2008 (tensile properties), ASTM F2251-13 (thickness), ISO 11140-1:2014 (chemical indicators), ISO 10993 series (biocompatibility), ISO 11135:2014 (EO sterilization validation), ISO 17665-1:2006 (moist heat sterilization), and DIN 58953-6-2010 (microbial barrier testing).

The subject device is substantially equivalent because it uses identical materials (medical-grade paper and compound film), identical sterilization cycles (132°C steam for 4 minutes; 800 mg/L EO at 55°C for 6 hours), and meets all critical performance standards (seal strength, leak tests, microbial barrier, biocompatibility) at equivalent or superior levels to the predicate. Although it maintains sterility for 12 months rather than 24 months and uses different chemical indicator color schemes, these differences do not affect the fundamental safety or effectiveness of the device's sterilization containment function, and the shorter sterility window was validated through testing.