Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)

The Verrix EVA STEAM Biological Indicator (BI) Model 1200 is a single-use sterilization monitoring device containing Geobacillus stearothermophilus spores on a carrier with germinant. When used with the Verrix EVA Auto-Reader Model 1100, it provides steam sterilization confirmation within 7 minutes for 270°F (4 min) and 275°F (3 min) dynamic air removal cycles. The Verrix EVA STEAM Process Challenge Device (PCD) Model 1300 contains the BI plus a chemical integrator for routine monitoring of the same steam sterilization cycles.

The subject device uses ultraviolet light detection of dipicolinic acid (DPA) released from germinating spores, whereas the predicate uses fluorescence of exogenous sensor protein. Both use identical Geobacillus stearothermophilus indicator organism and 60±2°C incubation temperature. The subject device has ≥10⁵ spores per carrier compared to predicate's 10⁶ spores, but both meet minimum acceptable criteria. Subject device achieves 7-minute readout versus predicate's 7 seconds, and has 9-month shelf-life versus predicate's 18 months. The PCD designs differ but both demonstrate equivalent resistance to the AAMI 16-Towel Process Challenge Device.

ISO 11138-1:2017 (Biological Indicators—General Requirements), ISO 11138-3:2017 (Biological Indicators for Moist Heat Sterilization), ISO 11140-1:2014 (Chemical Indicators), ANSI/AAMI ST79:2017 (Sterile Processing and Sterilization), FDA Guidance for Industry on Biological Indicator Premarket Notification [510(k)] Submissions (October 4, 2007).