Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

The Turbett Surgical Instrument Pod is a rigid stainless steel sterilization container designed to hold multiple unwrapped surgical instrument trays during steam sterilization in healthcare facilities. It maintains sterility of enclosed materials for up to 30 days post-sterilization and comes in three sizes (TS1500, TS1200, TS1000) with maximum load capacities of 375 lbs, 300 lbs, and 100 lbs respectively.

The subject device expands the indications compared to the predicate by specifying sterilization of thinner and longer lumens (0.7 mm × 500 mm and 1.0 mm × 850 mm rigid and flexible) versus the predicate's 1 mm × 500 mm lumens. The TS1200 model capacity increased from 120 lbs (predicate) to 300 lbs (subject). All other characteristics—materials (stainless steel and aluminum), sterilization parameters (270°F/132°C for 4 minutes), deployment mechanism, and 30-day storage—remain identical.

ANSI/AAMI ST77:2013 (containment devices for sterilization efficacy, thermal profile, shelf-life, microbial aerosol challenge); ANSI/AAMI ST79:2007 (dry time validation); TIR 30:2011 (cleaning validation); ANSI/AAMI HE75:2013 (usability/human factors).

The subject device is substantially equivalent because it uses identical materials, design, and sterilization methodology as the predicate. The expanded lumen size range and increased TS1200 load capacity represent performance enhancements rather than fundamental design changes, supported by comprehensive validation testing demonstrating sterilization efficacy (10⁻⁶ SAL), proper thermal penetration, drying capability, shelf-life maintenance, and usability. All tests passed using the same standards applicable to the predicate device.