AllNEB

AllNEB is a pneumatic jet nebulizer for administering aerosolized medications to adults and pediatric patients over 5 years old in home, hospital, and clinical settings. The device operates with compressed air or oxygen and produces aerosol only during patient inspiration, reducing environmental emissions. It features both breath-actuated and continuous delivery modes with a maximum 6ml fill volume.

AllNEB operates at 5-8 liters per minute (compared to predicate's 2.75-8 lpm), uses pneumatic jet nebulization with built-in breath-actuated or continuous mode selection, accommodates 6ml maximum fill volume, accepts compressed air or oxygen, and includes mouthpiece and oxygen tubing. The subject device specifies a patient age range (5+ years) while the predicate does not explicitly state one.

ISO 10993-1 and ISO 18562-1 for biocompatibility evaluation covering surface contact, mucosal and externally communicating tissue contact with permanent duration.

The subject device demonstrates substantial equivalence through comparative performance testing showing similar aerosol characteristics (MMAD, GSD, total dose delivered, respirable dose, and particle size distribution) across multiple test medications (albuterol sulfate, ipratropium bromide, cromolyn sodium) in both breath-actuated and constant-output modes at adult and pediatric settings. Identical design principles (pneumatic jet nebulization with breath actuation capability), materials biocompatibility, intended use (aerosolized medication administration in home/hospital/clinic settings), and patient population (prescription-only, single-patient use) establish substantial equivalence to the AeroEclipse II predicate device.