SteadiSet infusion set

The SteadiSet infusion set is a sterile, single-use device for subcutaneous insulin delivery from an external pump cartridge through a soft polymer cannula with stainless-steel coil. It consists of an inserter with insertion buttons and adhesive patch, a tube set connecting the pump to the cannula, and a disconnect cover, and is sterilized with ethylene oxide.

The subject device is identical to the predicate (K242692) in product code, regulation, materials, connectors, dimensions, and sterilization method. The key difference is an extended maximum time of use from 3 days to 7 days, supported by clinical data demonstrating safety and effectiveness at the longer duration.

Not stated in this summary. The document lists performance testing categories (bench testing, biocompatibility, sterilization validation) but does not cite specific ISO, IEC, or ASTM standards.

Although the subject device differs from the predicate in maximum time of use (7 days vs. 3 days), the devices share identical intended use, materials, design, sterilization, and connectors. A clinical study of 260 subjects across 15 centers demonstrated the device is safe and effective for 7 days with no device-related serious adverse events. These different technological characteristics do not raise new questions of safety and effectiveness because the extended duration was prospectively validated clinically.