eRapid with eTrack System

The eRapid with eTrack Nebulizer System is a portable, handheld electronic nebulizer for adult and pediatric patients age 4 and older prescribed inhaled medications. It uses micro-perforated vibrating membrane (eFlow) technology to aerosolize liquid medications and is intended for use in hospitals, nursing homes, sub-acute facilities, and home environments.

The device uses identical eFlow mesh technology and handset design as the predicate eRapid NCP, with the same aerosol performance and breath-enhanced two-way valve system. Key differences are: the eTrack controller adds built-in Wi-Fi and Bluetooth wireless connectivity; the polypropylene handset material comes from a different manufacturer (Bormed); and the adhesive bonding the piezo to the substrate was changed to Delo Monopox.

ANSI/AAMI ES60601-1:2005/(R)2012; IEC 60601-1-2:2014; IEC 60601-1-6:2010; IEC 60601-1-11:2015; IEC 62304; ISO 10993-1. Testing included biocompatibility, EMC, electrical safety, software validation (moderate level of concern, Class B), aerosol performance, simulated use, cleaning/disinfection validation, cybersecurity risk assessment, and wireless coexistence.

The eRapid with eTrack is substantially equivalent because it maintains identical intended use, regulatory classification, operating technology, and aerosol performance as the predicate eRapid NCP. Differences (wireless connectivity, material supplier change, adhesive formulation) do not alter the fundamental mechanism of action or safety/effectiveness profile. Performance testing confirmed aerosol output, particle size, and electrical characteristics remain within acceptable tolerances identical to the predicate.