Surfacer Inside-Out Access Catheter System

The Surfacer Inside-Out Access Catheter System is designed to obtain central venous access by facilitating catheter insertion into the central venous system for patients with upper body venous occlusions or conditions that prevent conventional central venous access. The system consists of a workstation for femoral vein access, a delivery instrument with needle wire and guide, an exit target for fluoroscopic guidance, and an exit introducer that is advanced over the needle wire to achieve central venous access.

The subject device has identical indications for use, design, technological characteristics, performance specifications, and materials as the predicate device (DEN190038). The only difference is an amended warning statement in the Instructions for Use requiring that procedures be proctored by a Merit representative and performed by physicians with appropriate training in interventional procedures.

FDA guidance documents and internationally recognized standards established under Section 514 of the Food, Drug and Cosmetic Act are applicable, including standards addressing biocompatibility, sterilization, and labeling. The document does not specify individual ISO, IEC, or ASTM standard numbers.

Substantial equivalence is established because the subject device is identical to the predicate in all material respects—same indications, design, technological characteristics, performance specifications, and materials. The only modification is a labeling change (an amended warning statement) that does not alter the device's physical or functional properties or performance. Since no additional performance testing was required and the device continues to meet the same acceptance criteria as the predicate, the warning change alone does not affect substantial equivalence.