FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

These are four related disposable pressure transducer sensors (FloTrac, FloTrac Jr, Acumen IQ, and VolumeView) that convert mechanical pressure signals to electrical signals for intravascular pressure monitoring and cardiac output measurement. FloTrac and Acumen IQ are for adults; FloTrac Jr is for pediatric patients ≥12 years; VolumeView is for intravascular pressure monitoring. All sensors are constructed with a pressure-sensitive silicon chip, polycarbonate housing with integral stopcock and flush device, and connect via cable to a patient monitor.

The subject devices are identical to predicate devices in intended use, indications, and technological characteristics, with the exception of changed pressure tubing and IV set component materials. The core sensor design—silicon chip with electrodes, polycarbonate housing, stopcock, and flush mechanism—remains unchanged from the predicates.

Biocompatibility testing per ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) and FDA guidance issued September 4, 2020. Performance verification per Edwards' current design requirements; shelf-life and sterilization validations per existing specifications.

The devices meet substantial equivalence because the only material differences from predicates are the pressure tubing and IV set components, which do not raise new safety or effectiveness concerns. Risk analysis and performance verification testing confirmed the devices meet established acceptance criteria and perform equivalently to their predicates (K152980 and K231248) despite these component material changes.