Sterilization Pouch and Roll

The Sterilization Pouch and Roll is a medical device intended to enclose surgical instruments and other medical devices for steam sterilization in healthcare settings. It consists of medical grade paper and medical compound film with a chemical indicator that changes color from blue to dark grey when exposed to steam, maintaining sterility of enclosed devices for up to 6 months post-sterilization at the recommended cycle of 4 minutes at 132°C with 30 minutes dry time.

The subject device uses medical grade paper (60g/m²) and medical compound film (52μm) with the same basic five design types (self-sealing pouches, flat pouches, gusseted pouches, flat rolls, and gusseted rolls) as the predicate. Both devices employ heat-sealing and contain chemical indicators that change color upon steam exposure. The primary difference is the subject device is optimized for pre-vacuum steam sterilization only, whereas the predicate supports both steam and ethylene oxide sterilization methods.

ISO 17665-1:2006 and ISO 17665-2:2009 for sterilant penetration; ISO 10993-5, ISO 10993-23, and ISO 10993-10 for biocompatibility; ASTM F2251, ASTM F1140, ASTM F88, ASTM D3078, ASTM F1929, and ASTM F1980 for package integrity and material properties; ISO 11140-1:2014 for chemical indicator testing; DIN 58953-6 for microbial barrier testing.

The subject device demonstrates substantial equivalence through identical intended use, same regulatory classification (Class II under 21 CFR 880.6850), and matching material composition and design types as the predicate (K180661). Although sterilization parameters differ (4 minutes at 132°C versus 30 minutes at 121°C), the subject device's validation testing fully meets ISO 17665-1 requirements for sterilant penetration and achieves SAL 10⁻⁶, demonstrating equivalent safety and effectiveness. All performance tests—package integrity, seal strength, biocompatibility, and chemical indicator functionality—passed the same acceptance criteria as the predicate, confirming equivalent performance characteristics.