AIM (N/A)

AIM is a single-use, non-sterile bite block with integrated oxygen delivery tubing and CO2 sampling line for patients 18 years and older undergoing procedures requiring supplemental oxygen and expired gas monitoring. When paired with an oxygen supply and capnography monitor, it delivers oxygen to the oropharynx and samples exhaled CO2, but is not indicated for deep sedation procedures.

AIM delivers oxygen and samples CO2 exclusively through the oral cavity via multiple sampling ports, unlike the predicate DualGuard which samples both nasally and orally. AIM is positioned on either side of the mouth and secured with tape, whereas DualGuard is centered and secured with an elastic headband. Both devices are single-use, disposable bite blocks that connect to standard oxygen sources and capnography machines.

ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, ISO 18562-2:2017, ISO 18562-3:2017, ISO 80369-2, ISO 594-2, ISO 11607-1, ISTA 3A. Performance testing included FiO2 and EtCO2 measurements across varying respiratory rates, tidal volumes, and oxygen flow settings, plus mechanical testing (bite force, dislodgement force, axial separation force) and accelerated aging.

AIM and DualGuard share the same fundamental intended use—delivering supplemental oxygen and monitoring CO2 in sedated procedural patients—and neither is life-supporting. Although AIM samples CO2 only orally while DualGuard samples both nasally and orally, comparative testing demonstrated that AIM achieved equivalent FiO2 delivery, EtCO2 measurement accuracy, and CO2 waveform capture across all simulated respiratory conditions. The design differences in positioning and securement method do not raise new safety or effectiveness questions, as both devices perform the core oxygen delivery and CO2 sampling functions comparably.