Abstract

Our lab is developing a novel device, the convection-enhanced thermo-chemotherapy catheter system (CETCS), to improve drug dispersal around a glioblastoma. To help prepare the device for clinical trials, we were advised to first prepare and receive 510(k)-clearance. The 510(k)-clearance process includes proving the novel device is substantially equivalent to a previously cleared predicate device. For the CETCS device, we have identified the Cleveland Multiport Catheter (CMC) as our predicate device. In this work, we test infusion pump flow rate, high-pressure flow rate, and microneedle tip deflection; each with respect to infusion and aspiration. The CMC’s 510(k) summary sheet provided guidelines for the test protocols to follow. If the CMC’s 510(k) summary did not state a metric, we set the metric based on the CETCS device specifications. Replicating or exceeding the threshold passing criteria set by the CMC device or the CETCS specifications demonstrates that CETCS is substantially equivalent to the predicate device for those specific metrics.

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