Medicom Sterilization Pouch and Reel

The Medicom Sterilization Pouch and Reel are paper-based medical device packaging intended to enclose medical devices for sterilization using steam or ethylene oxide (EO) gas. The pouches maintain sterility of enclosed devices for up to one year post-sterilization and feature dual chemical indicators that change color (Red/Pink to Cocoa for steam; Blue to Golden Yellow/Brown for EO) to visually demonstrate exposure to sterilization processes.

The proposed device is composed of medical-grade paper (60g or 70g) laminated with plastic film (44μm or 52μm thickness) with PU adhesive, chemical indicators, and print ink—identical materials to the predicate. It offers three thickness combinations and comes in self-seal pouches, heat-seal pouches, and flat reels, available in multiple dimensions. The chemical indicator color-change design differs from the predicate (Red/Pink-to-Cocoa vs. green-to-purple for steam) but serves the same function.

Testing followed ANSI/AAMI/ISO 17665 (sterilization validation), ISO 11135 (EO sterilization), ISO 10993 series (biocompatibility), ASTM F88, F1140, F1929, F2096, F1608 (package integrity), ASTM F1886, F1980 (durability and aging), and AAMI/ANSI/ISO 11140-1 (chemical indicator efficacy). All tests confirmed SAL 10⁻⁶ achievement, burst strength ≥8.0 in. H₂O for pouches, seal peel strength ≥1.5 N/15mm post-sterilization, and chemical indicator stability for three years shelf life.

The proposed device shares identical intended use, materials (medical-grade paper, CPP, PET, PU adhesive), sterilization methods, and performance characteristics with the predicate K153540. Both are used to enclose devices for steam or EO sterilization and maintain sterility until opening. Comprehensive testing demonstrates the proposed device meets or exceeds the same performance standards—including sterilant penetration (SAL 10⁻⁶), package integrity, biocompatibility, and chemical indicator functionality. Minor differences (thickness options, different CI color transitions, slightly different steam cycle parameters) represent incremental design variations that do not affect safety or effectiveness, as evidenced by equivalent performance test results.