Puracyn® Plus Antimicrobial Irrigation Solution

Puracyn® Plus Antimicrobial Irrigation Solution is a sterile wound irrigation formula containing hypochlorous acid that provides mechanical cleansing and removal of debris, dirt, and microorganisms from wounds. It is supplied in 1000 mL and 3000 mL flexible plastic bags and is intended for use with irrigation systems including jet lavage devices.

The subject device is identical to the predicate in composition (purified water, hypochlorous acid, sodium phosphates), description (clear, colorless solution in flexible plastic bags), volume (1000 mL and 3000 mL), antimicrobial preservative (hypochlorous acid), biocompatibility, packaging material, manufacturing practice (aseptic techniques), and intended use (multiple use within a single patient). The subject device adds explicit mention of hydrodynamic shear mechanism and has been tested for compatibility with InterPulse®, Pulsavac®, and MicroAire® jet lavage systems.

ISO 10993-1 (biocompatibility), ISO 11607-1 and ISO 11607-2 (packaging testing), ISO 11737-1 and ISO 11737-2 (sterilization validation), ICH Q1A(R2) (stability studies), USP <51> (preservative antimicrobial effectiveness), USP <71> (sterility testing), USP <85> (endotoxin testing), USP <61> and USP <62> (bioburden testing).

The subject device is substantially equivalent because all materials, manufacturing methods, and performance characteristics are identical to the predicate device (K232080). The device raises no new safety or effectiveness questions, and compatibility testing demonstrates successful performance with three major jet lavage systems. All supporting data from stability, biocompatibility, packaging, sterilization, endotoxin, preservative effectiveness, sterility, and bioburden testing were leveraged from the predicate.