Laboratorios Biogalenic Sterile Water for Inhalation, USP

Laboratorios Biogalenic Sterile Water for Inhalation, USP is a sterile, single-use medical device supplied in polypropylene bottles (1000 mL or 500 mL) prefilled with sterile water. It is intended to supply sterile water to unfilled respiratory humidifier chambers in institutional and non-institutional care settings. The water is transferred to humidifier chambers where it is heated to produce vapor that humidifies medical gases or air delivered to patients.

The subject device is packaged in durable polypropylene bottles with either a bromobutyl stopper with aluminum seal (spike access) or a PP/PET aluminum induction seal with PP screw cap and tamper-evident shrink wrap. The predicate device uses LDPE bottles with a rubber disc. Both share the same active ingredient (sterile water USP), mechanism of action, indications for use, regulatory classification (Class II, BTT product code), and single-use design. Key differences include packaging material (PP vs. LDPE) and sterilization temperature (steam-air vs. moist heat), which testing demonstrated do not pose significant issues.

Testing performed per USP methods and ISO standards including ISO 10993-1:2018 (biocompatibility evaluation), ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-12:2021 (irritation), ISO 10993-11:2017 (systemic toxicity), ISO 10993-18:2020 (extractable/leachable), ISO 10993-17:2023 (toxicological risk assessment), and ISO 17665 (sterilization validation). Packaging tested per ASTM D3078-02 (leakage), ASTM F1929-23 (hermeticity), ASTM F1140/F1140M (pressure resistance), ASTM D642 (rupture resistance), and ISO 15747:2018 (drop testing).

Both devices provide sterile water for the identical indication of humidifying respiratory therapy, share the same BTT classification under 21 CFR 868.5450, are manufactured from sterile water as the primary material in disposable plastic containers, and function identically. Although packaging material differs (polypropylene vs. LDPE) and sterilization temperatures vary (121–122°C steam-air vs. moist heat), comprehensive physicochemical, performance, and biological testing demonstrated these differences do not affect device performance or safety. All test results confirmed the subject device meets intended specifications and functions equivalently to the predicate device.