AVEA disposable expiratory filter/water trap (11790)

The AVEA disposable expiratory filter/water trap is an accessory device designed exclusively for use with the AVEA Ventilator. It functions as both an expiratory filter and water trap in institutional healthcare environments (hospitals) for adult, pediatric, and neonatal patients, and must be operated by trained clinical personnel under physician direction.

The device uses filtration media with an integral water trap. It has an internal volume of 500 ml (including a 130 ml water trap), dimensions of 9.7 cm diameter by 33 cm height, and achieves performance specifications of VFE/BFE 99.999% efficiency, DOP/POA efficiency 99.97%, flow resistance less than 1 cmH2O at 60 lpm, and flow leakage less than 0.01 lpm at 140 cmH2O internal pressure.

Biocompatibility testing was performed per ISO 10993.

The subject device is identical to the predicate device (K081837) in all material respects: same product code (CBK), same regulation (21 CFR 868.5895), identical technological design (filtration media with integral water trap), identical dimensions and internal volume, and identical performance specifications. The only modification is a clarification of the indications for use to specify the device as an AVEA ventilator accessory, which does not alter the fundamental intended use or safety/effectiveness profile.