System 9 Sterile Battery Container

The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container designed to enclose compatible Stryker sterile battery packs and maintain their sterility until use. It consists of a stainless-steel perforated lid with filter retention plate and a plastic (Radel) base, and is validated for low-temperature hydrogen peroxide sterilization cycles in hospitals, surgery centers, and healthcare facilities.

The subject device differs from the predicate (Aesculap AICON Container) in container base material (Radel PPSU vs. anodized aluminum), lid material (stainless steel vs. anodized aluminum), sterilization method scope (hydrogen peroxide only vs. multiple methods), maintenance of sterility duration (45 days vs. 365 days), and device sizes (two sizes optimized for System 9 batteries vs. multiple full/three-quarter/half sizes). Filter material, design, intended use, classification, condition of use, and operating principle remain identical.

ISO 14937:2009, ISO 22441:2022 (sterilization efficacy); ISO 10993-17 (toxicological risk); AAMI ST98:2022 (cleaning validation); AAMI ST77:2013/(R)2018 (maintenance of sterility and containment devices); ISO 17664-1:2021 and AAMI TIR 12:2020 (simulated use design validation); IEC 62366-1 Ed 1.1b 2020 (human factors); ISO 14971 (risk management).

Although the materials and sterilization scope differ from the predicate, these differences do not raise new safety or effectiveness questions because the Radel base and stainless steel lid are suitable for and validated only with hydrogen peroxide sterilization, preventing interference with wireless charging. The shorter 45-day shelf life is appropriate for the specific application. All performance testing confirmed the device maintains sterile barrier integrity, is cleanable, and withstands repeated sterilization cycles. The intended use, operating principle, patient population, and professional use context are identical to the predicate.