Single-use Balloon Dilatation Catheter

The Single-use Balloon Dilatation Catheter is indicated for endoscopic dilation of gastrointestinal strictures in adult and adolescent populations, and for endoscopic dilation of the Sphincter of Oddi in adults with or without prior sphincterotomy. The device comes in three types (RX, OTW, and OTW with preloaded stainless guide wire) with multiple balloon diameter and length configurations.

The proposed device offers three catheter types (RX, OTW, OTW with stainless wire-guided) versus predicate devices offering only one or two types. It includes balloon diameters of 6–20 mm and lengths of 30, 55, or 80 mm with working lengths of 180 or 240 cm. Materials include Pebax (tip and shaft) and Nylon 12 for the balloon. The 80 mm balloon length is new compared to predicates.

ISO 10993-5, 7, 10, 11, 23; ISO 10555-1, 10555-4; ISO 20696; ISO 80369-7, 80369-20; ISO 11135:2014; ASTM F88, F640, F1886, F1929, F3172, D4169; USP <85> and <151>.

Although the proposed device includes additional catheter types and balloon configurations not present in individual predicates, each variant (RX, OTW, OTW stainless-guided) is covered by at least one predicate device. The 80 mm balloon length, though new, is supported by reference device K122924 and passed performance testing. Biocompatibility testing confirmed safety despite material differences from predicates. Nonclinical performance testing (burst pressure, compliance, kink stability, delivery force) demonstrated the device meets acceptance criteria and performs comparably to predicates, establishing safety and effectiveness for the same indications of use.