AeroChamber2go Anti-Static Valved Holding Chamber

The AeroChamber2go Anti-Static Valved Holding Chamber is a portable holding chamber designed for patients aged 5 and older to use with pressurized Metered Dose Inhalers to administer aerosolized medication. It is a single-patient, multiple-use device intended for home use and is prescribed by physicians or licensed healthcare professionals.

The device is a valved holding chamber with a mouthpiece interface, constructed from thermoplastic polymer, thermoplastic elastomer, and silicone components. It measures 3.6 cm width × 6.2 cm length × 12.7 cm height with a chamber volume of 140 cc, and is manufactured via plastic molding and mechanical assembly with a recommended replacement interval of 12 months.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 10993-11 (systemic toxicity/pyrogen), ISO 10993-18 (chemical characterization), ISO 18562-1 (risk assessment for dry gas), ISO 18562-2 (particulate matter emissions), and ISO 18562-3 (VOC and aldehyde emissions). Testing also followed FDA/CDRH 1993 guidance for nebulizers, spacers, and actuators.

The aerosol characterization testing demonstrated that the subject device's aerodynamic particle size distributions and fine particle fractions were very closely matched to the predicate device across three formulations. Although fine particle dose was slightly lower in some cases, it remained similar or higher than the metered dose inhaler alone, making any difference not clinically significant. Mechanical testing and biocompatibility studies showed the device meets design specifications with no new safety or efficacy concerns identified.