BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)

The BD Surgiphor™ 1000 mL Antimicrobial Irrigation System is a sterile aqueous solution containing 0.5% povidone-iodine in phosphate-buffered saline, intended to mechanically loosen and remove debris, foreign materials, and microorganisms from wounds. It can be used via manual squeeze irrigation with a screw cap or connected to a powered lavage device using an adaptor and optional Y-connector.

The subject device increases bottle size from 450 mL to 1000 mL and adds powered lavage capability through a new adaptor and Y-connector, while maintaining the identical Surgiphor solution composition (0.5% povidone-iodine plus vitamin E TPGS in 0.9% saline) and manual screw-cap option from the predicate. Packaging material changed from PETG to HDPE, and new components were included to support both irrigation modes.

Testing standards include ISO 10993-1 (biocompatibility), USP <85> and AAMI ST72 (endotoxin/pyrogens), ANSI/AAMI/ISO 11137 series (sterilization validation), ISO 11607 series (packaging), ASTM F1980/F2096/D4169/F2825/F88 (packaging integrity and shipping), and ISO 18250-1 (connectors) plus customized mechanical action tests.

Substantial equivalence is established because the subject device is unchanged in intended use, solution composition, and primary mechanism of action compared to predicate K221504. The mechanical fluid action that removes debris remains the same, and the manual screw cap and solution are identical to the predicate, so prior testing remains valid. The addition of powered lavage capability does not raise new safety or effectiveness concerns, supported by conformity to applicable standards and new design verification/validation testing for the new components and packaging.