Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

The Compressor Nebulizer (models NB-1100, NB-1101, NB-1102, NB-1103) is an air-powered jet nebulizer system that aerosolizes medications for inhalation to treat respiratory disorders. It operates on the Venturi principle, using an integral air compressor to generate high-speed airflow that atomizes liquid medication into fine mist particles. The system is designed for use with pediatric patients (ages 2 years and above) and adults in home, hospital, and sub-acute settings.

The subject device operates as a pneumatic jet nebulizer with a compressor-driven gas source (similar to predicate), generates flow rates ≥6.5 L/min (compared to 8 lpm for predicate), and has an 8 ml reservoir (versus 7 ml). It meets ANSI AAMI ES 60601-1 and IEC 60601-1-2/1-11 standards. Operating conditions are +5°C to +40°C at 15–90% RH, and storage conditions are −20°C to +55°C at 5–93% RH. The device includes optional mouthpiece and adult/child mask components similar to the predicate.

Electrical safety and EMC testing per ANSI AAMI ES60601-1:2005/(R)2012 with amendments, IEC 60601-1-2 Edition 4.1, and IEC 60601-1-11 Edition 2.1. Particle size characterization per FDA/CDRH 1993 Reviewer Guidance for Nebulizers. Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, and chemical characterization). Device life testing via simulation method.

Both devices have identical intended use, same product code (CAF), identical principle of operation (pneumatic jet nebulization), and equivalent aerosolization performance (continuous during inhalation and exhalation). Although the subject device has slightly different dimensions and weight, performance testing demonstrated that aerosol particle characteristics (MMAD, GSD, respirable dose, and respirable fraction) are comparable across three medications in both adult and pediatric configurations. The technological differences do not raise different questions of safety or effectiveness, as evidenced by biocompatibility, electrical safety, and particle characterization data meeting applicable standards.