SteadiSet Infusion Set

The SteadiSet Infusion Set is a sterile, single-use device for subcutaneous insulin infusion administered by an external pump. It consists of an inserter with a soft polymer cannula over a stainless-steel coil, a tube set connecting the hub to the pump cartridge, and a disconnect cover. The device is sterilized by ethylene oxide and indicated for 3 days of use.

The subject device differs from the predicate (AutoSoft 30) in cannula material—using polyether amide TPE with stainless-steel coil instead of Teflon—and offers additional tube length options (5, 23, 32, and 43 inches versus 23 and 43 inches). The distal connector is a rotational hub connector rather than a click-in needle connector. Both devices share the same intended use, sterilization method, compatible pump system, and physical dimensions (0.38mm ID, 1.50mm OD, 13mm cannula length).

Not stated in this summary.

Although the devices have different technological characteristics—particularly cannula material and connector design—the differences do not raise new safety or effectiveness questions because both devices perform the same subcutaneous insulin infusion function with identical intended use, sterilization, and compatibility requirements. The non-clinical testing program (bench testing, biocompatibility, functional performance, and human factors validation) demonstrates that the SteadiSet design changes are safe and effective within the established performance envelope of predicate infusion sets.