Ambu® Virobac II® Exhalation Filter

The Ambu® Virobac II® Exhalation Filter is a standalone, non-sterile, single-patient-use viral/bacterial filter intended to prevent transmission of viruses or bacteria from patients receiving respiratory support. It connects to a resuscitator via a standard ISO conical connection and comprises a compact transparent housing with filter media.

Both devices use electrostatic filtration with polypropylene-based filter media and standard 30 mm ISO conical connectors. The applicant device uses Methyl Methacrylate Butadiene Styrene housing (enhanced clarity) versus the predicate's proprietary clear plastic. Both are non-sterile, single-patient-use devices designated MR safe. The applicant achieves ≥99.99% bacterial and viral filtration efficiency compared to the predicate's 99.96% BFE and 99.81% VFE.

ISO 23328-1 and ISO 23328-2 (resistance, duration, leak, volume), ASTM F2101 (bacterial/viral filtration efficiency), ISO 5356-1 and ISO 10651-4 (connectors), ASTM D4169 (transportation simulation), and ISO 23328-1 (NaCl filtration).

The applicant device is substantially equivalent because it performs the same clinical function (removal of microbiological and particulate matter), uses similar materials and principle of operation (electrostatic filtration), maintains identical connectors and configurations, and demonstrates equal or superior filtration efficiency to the legally marketed predicate device in the same regulatory class.