BD Surgiphor™ Antimicrobial Irrigation System (910110)

The BD Surgiphor™ Antimicrobial Irrigation System is a 450 mL sterile solution containing 0.5% povidone-iodine (PVP-I) used for mechanical wound irrigation and debridement. It is supplied in a bottle with a manual screw cap and is intended to loosen and remove wound debris, foreign materials, and microorganisms through the mechanical action of fluid pressure applied to wounds.

The subject device is identical to its predicate (K221504) except for the bottle material, which changes from polypropylene to high-density polyethylene (HDPE). The solution composition, screw cap, packaging (PETG tray with Tyvek cover), bottle dimensions, sterilization method (gamma irradiation to SAL 10⁻⁶), and instructions for use remain unchanged.

Biocompatibility (ISO 10993-1:2018); Endotoxin testing (USP <85> and AAMI ST72:2019/R2010); Sterilization validation (ANSI/AAMI/ISO 13004:2022, ANSI/AAMI/ISO 11737-1:2018, ANSI/AAMI/ISO 11737-2:2019); and customized functional testing for mechanical debris removal.

The change from polypropylene to HDPE bottle material does not alter the intended use, mechanism of action, solution composition, or safety and effectiveness profile. With packaging, cap, and solution remaining unchanged, prior testing remains valid. Substantial equivalence is demonstrated through conformity to standards and design verification and validation testing of the new bottle material.