Aesculap Aicon® Series Container System

The Aesculap Aicon® Container System is a reusable rigid sterilization container designed to enclose medical instruments for sterilization and maintain sterility during transport and storage. It is compatible with multiple sterilization modalities including ethylene oxide, STERIS V-PRO systems, STERRAD systems, STERIZONE VP4, and PreVac Steam in various load configurations.

The subject device uses anodized aluminum construction for the container and lid with silicone gaskets, single-use polypropylene filters, and comes in standard or enhanced drying system (EDS) variants in three sizes (Full, Three-Quarter, Half). It is substantially identical in materials, design, accessories, and sterility shelf life (365 days) to the predicate device K214041.

Testing was performed in accordance with AAMI ST-77 (sterilization validation), EN868-8, EN 285, ISO 10993-5:2009 (cytotoxicity), ISO 11167-1 (sterility maintenance), TIR30 (cleaning validation), and TIR17 (material compatibility).

The subject device demonstrates substantial equivalence through identical intended use, materials of construction, overall design, and sterilization modalities as the predicate K214041. The key differences—expanded indications to allow silicone instrument organization systems for certain VHP modalities and stainless steel IOS for previously cleared modalities, along with reduced lumen size specifications for silicone IOS compatibility—are supported by identical performance testing across sterilization efficacy, dry time, microbial barrier, cytotoxicity, simulated use, cleaning, material compatibility, and sterility maintenance. These changes represent extensions of already-cleared functionality rather than fundamental design alterations.