PAL Sterilization Case

The PAL Sterilization Case is a reusable stainless-steel container designed to hold a PAL handpiece, cable, and up to four cannulas during steam sterilization, storage, and transport in hospital settings. It maintains sterility of enclosed components during autoclave sterilization when used with FDA-cleared sterilization wraps and is only validated for non-stacked configurations.

The subject device is constructed of 304L and 304 stainless steel with medical-grade silicone mounts, measuring 15.91" x 6.55" x 2.42" with a maximum load of 5.582 lbs. It differs from the predicate (which uses polyphenylsulfone and stainless steel, measuring 8.5" x 11.0" x 3.0" with <1800g capacity) in materials, dimensions, and enclosed instruments, but shares the same sterilization case design, steam sterilization methods, and non-stacking requirement.

ANSI/AAMI ST77:2013/(R)2018, AAMI TIR12:2020, ISO 17665:2024, AAMI ST98:2022, and FDA Reprocessing Medical Devices in Health Care Settings guidance. Testing validated gravity sterilization at 121°C for 30 minutes and pre-vacuum sterilization at 132°C for 4 minutes, both achieving SAL 10⁻⁶.

Both the subject and predicate devices serve the identical regulatory purpose as Class II sterilization wrap containers (Product Code KCT), are used with FDA-cleared sterilization wraps, employ the same steam sterilization methodology (pre-vacuum and gravity cycles), and share similar design principles with silicone mounting systems and perforated enclosures for steam penetration. Although they contain different instrument sets and have different dimensions and materials, these differences are device-specific customizations that do not alter the fundamental function of containing reusable surgical instruments during autoclave sterilization while maintaining sterility.