MiraChlor Antimicrobial Wound Solution

MiraChlorTM Wound Cleanser Solutions is a saline-based wound cleanser containing hypochlorous acid that cleanses, irrigates, and removes debris from various wound types. It has both prescription uses (stage I-IV pressure ulcers, diabetic ulcers, surgical wounds, burns, etc.) and over-the-counter uses (minor skin abrasions, cuts, lacerations).

The device is a topical saline-based solution containing hypochlorous acid as a preservative to inhibit microbial growth on the shelf. It creates a moist wound environment and removes slough and foreign materials through mechanical action. The technological characteristics including formulation, design, performance, route of administration, and intended use are similar to the predicate device.

Biocompatibility testing per ISO 10993-1 (Biological Evaluation of Medical Devices); USP <51> testing for preservative effectiveness against compendia organisms; USP <61>/<62> testing for bioburden evaluation; bench testing including package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC), and Raman Spectroscopy.

MiraChlorTM Wound Cleanser Solutions is substantially equivalent to the Vashe Wound Therapy Solution (K123072) predicate because both are topical saline-based wound cleansers containing hypochlorous acid with similar indications for use. Both devices have identical intended purposes, similar technological characteristics, are made of similar materials, and the testing demonstrates comparable safety, effectiveness, and performance.