EDEN ControlCath

The EDEN ControlCath is a sterile, single-use epidural catheter consisting of a flexible catheter, steering handle, and infusion port. It is used to deliver drugs indicated for the epidural space in patients 18 years and older.

The device features a steerable catheter with outer diameter of 1.73 mm or 2.1 mm and length of 300 mm. It includes a trocar, catheter sheath, and guide wire, is compatible with 10 cc syringes, and uses one infusion port. Raw materials include ABS, silicone, PVC, PE, PA, SUS 304, PEEK, and titanium dioxide. It is sterilized using ethylene oxide gas, unlike the predicate device which uses gamma sterilization.

ISO 10993 series (parts 1, 5, 10, 11, 23) for biocompatibility; ISO 10555-1 for intravascular catheter general requirements; ISO 80369-7 and 80369-20 for small-bore connectors; ISO 11135 for ethylene oxide sterilization; ASTM F88, F1929, and F1980 for seal strength, leak detection, and accelerated aging.

The EDEN ControlCath is substantially equivalent to the predicate SPINAUT-E/SPINAUT-I (K150789) because both devices share identical intended use for epidural drug delivery, same product code (BSO), equivalent key performance specifications across catheter, trocar, sheath, and guide wire components, same infusion port design and syringe compatibility, and equivalent biocompatibility per ISO 10993 standards. Although the candidate uses different raw materials and ethylene oxide sterilization rather than gamma, bench testing demonstrates these differences do not affect substantial equivalence, and the devices are functionally equivalent for their intended epidural application.