Sterile Water USP and Sterile 0.9% Normal Saline USP

Sterile Water USP and Sterile 0.9% Normal Saline USP are colorless, transparent solutions packaged in polypropylene bottles for external wound irrigation and debridement. Over-the-counter use includes moistening wound dressings and cleaning minor cuts, burns, and abrasions. Prescription use extends to acute and chronic dermal lesions including pressure ulcers, diabetic ulcers, and post-surgical wounds. The device is single-use and operates via mechanical action—applying and moving fluid across wound surfaces to facilitate moisturizing, debridement, and irrigation.

The device contains either sterile water or 0.9% saline meeting USP monograph standards with no preservatives or antimicrobial agents. It is packaged in polypropylene bottles with screw caps and induction seals, available in 100 mL, 250 mL, 500 mL, and 1000 mL sizes. The proposed device differs from the predicate in packaging material (PP versus HDPE), sterilization method (terminal steam versus gamma), and shelf life (2 years versus 1 year). Chemical composition, design function, and indications for use remain identical to the predicate.

Biocompatibility testing per ANSI/AAMI/ISO 10993-1:2018 and constituent parts including ISO 10993-5:2009 (cytotoxicity), ISO 10993-23:2021 (intracutaneous reactivity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-11:2017 (systemic toxicity). Packaging and transportation testing per ANSI Z 1.4, ASTM F1929-23, ASTM D3078-02, ASTM F1140, ASTM D5276-19, and ASTM D642. Non-clinical performance per USP monographs for sterility, bacterial endotoxins, conductivity, and chemical composition.

Substantial equivalence is established because both devices contain identical chemical compositions (sterile water or 0.9% saline per USP standards) with identical indications for use, identical single-use design, and identical mechanical mode of action for wound irrigation and debridement. Although the proposed device differs in packaging material, sterilization method, and shelf life, biocompatibility and performance testing demonstrate the product meets all safety and effectiveness criteria. The differences in manufacturing attributes do not alter the fundamental technological characteristics or clinical function compared to the predicate device.