Cassette Autoclave (ACA5)

The Cassette Autoclave (ACA5) is a table-top steam sterilizer for sterilizing dental and medical instruments using pressurized steam at 121°C or 134°C. It features five modules: water supply, disinfection chamber, air dry, exhaust steam processing, and control system. The device is not intended for liquids, biomedical waste, or steam-incompatible materials.

The ACA5 has a 5.1L sterilization chamber (larger than predicate's 2.7L), dimensions of 650×416×200mm (larger than predicate's 561×252×162mm), weighs 43kg (heavier than predicate's ~15kg), and uses an internal water reservoir versus the predicate's external reservoir. Both operate on 110V, 60Hz power and include USB ports. Both are over-the-counter devices with the same product code (FLE) and regulatory class (II).

ANSI/AAMI ST55:2016 for table-top steam sterilizers; IEC 61010-1:2010/AMD1:2016 and IEC 61010-2-040:2020 for electrical safety; IEC 61326-1:2020 for electromagnetic compatibility; IEC 62304:2006+AMD1:2015 for software life cycle processes; and FDA guidance on software verification and validation.

The ACA5 and predicate Enbio S share identical intended uses (sterilizing dental/medical instruments via steam), same regulatory classification (Class II), same product code (FLE), and same over-the-counter use designation. Although they differ in size, weight, and chamber volume, both employ identical sterilization cycles (121°C/30min and 134°C/4min), passed the same bench tests (vacuum, temperature, pressure, moisture, biological performance), and comply with the same international standards. The nonclinical testing demonstrates equivalent safety and effectiveness despite physical differences.