AdheResp Smart Breath-actuated Mesh Nebulizer

The AdheResp Smart Breath-actuated Mesh Nebulizer is a handheld device that converts liquid medications into aerosol droplets for inhalation by patients aged 5 years and older. It is designed for use in hospitals, home care, schools, and long-term care facilities, and uses a vibrating mesh membrane activated by a piezoelectric element to generate aerosol particles.

The device employs vibrating mesh nebulization technology similar to the predicate, but adds breath-actuation capability that delivers aerosol during a designated portion (40%–80%, default 60%) of the inhalation cycle rather than continuously. It includes wireless connectivity, a rechargeable battery, and an 8+ ml fill volume, with a nebulization rate exceeding 0.25 ml/min.

ISO 10993-1 (biocompatibility), ISO 18562 (biocompatibility of airway devices), and comparative aerosol performance testing at 15 and 30 liters per minute using three medications (albuterol, ipratropium, cromolyn). Testing included nebulization rate, inter- and intra-sample variability, cleaning validation, aging, and simulated life testing.

Although the predicate lacks breath-actuation and wireless connectivity, the reference device (Respironics AAD) demonstrates that breath-actuated mesh nebulizers with similar algorithms and particle size distribution are clinically acceptable. Comparative aerosol performance testing shows the subject device produces equivalent mass median aerodynamic diameter (MMAD), geometric standard deviation (GSD), and respirable dose across three drugs at both flow rates, with no new safety or effectiveness concerns raised by the differences in features.