PUREVUE™ FMS

The PUREVUE™ FMS is a dual arthroscopic pump system that provides fluid distension and irrigation of knee, shoulder, hip, elbow, ankle, and wrist joint cavities, along with fluid suction during diagnostic and operative arthroscopic procedures. It uses two independent peristaltic pump systems that can operate in single roller mode (inflow only) or dual roller mode (inflow and outflow simultaneously).

Both the PUREVUE™ FMS and predicate device (Stryker CrossFlow) are dual roller pumps using peristaltic principles with software-controlled pressure maintenance. The PUREVUE™ FMS offers slightly different pressure settings and flow rate ranges—adopting more conservative limits—and includes an integrated vacuum pump with additional suction tube set options not present in the predicate.

Electrical safety per IEC 60601-1 Edition 3.2 (2020); electromagnetic compatibility per IEC 60601-1-2 Edition 4.1 (2020); software per IEC 62304:2015; tube set sterilization per ISO 11135:2018; biocompatibility per ISO 10993-1:2018 for indirect patient contact materials; and bench performance testing per design specifications.

The PUREVUE™ FMS is substantially equivalent to the Stryker CrossFlow predicate because it has identical indications for use, the same basic dual-roller peristaltic design, and comparable technological characteristics. Minor differences in pressure settings, flow rates, and the addition of an integrated vacuum pump do not raise different safety or effectiveness questions, as the subject device uses more conservative limits and all features are verified through performance testing.