PeriCross™ Epicardial Access Kit

The PeriCross™ Epicardial Access Kit is a sterile medical device designed to provide safe access to the epicardial surface of the heart via a subxiphoid approach. It is intended to facilitate electrophysiology studies in adult patients by delivering a 0.018" guidewire to the pericardial space using a tunneler assembly, access device with integrated needle, and coaxial introducer.

The PeriCross uses a blunt obturator-equipped tunneler assembly to reach the pericardium, then deploys a specialized access device with deployable tines to retract pericardial tissue and an integrated 21-gauge needle. This differs from the predicate's 17-gauge Touhy needle approach. The subject device uses a smaller 0.018" guidewire (versus predicate's 0.032") and a 5F×18cm coaxial introducer (versus predicate's 13F×40cm deflectable introducer).

ISO 10993-1 (biocompatibility), ASTM F1980 (shelf-life), ISTA 3A (transit), ISO 11135 (sterilization), and ISO 14155 (clinical study protocol). Mechanical testing covered dimension, tensile, stiffness, breakage, corrosion, insertion, and puncture characteristics.

Although the PeriCross differs technologically from the St. Jude Agilis predicate—particularly in its use of pericardial retraction tines and a smaller integrated needle—the reference device (Epi-Ease K233959) demonstrates that pericardial retraction is an acceptable design feature for this application using identical bench testing methods. Both devices share the same intended use (subxiphoid epicardial access for EP studies), the same principles (access via pericardial puncture and guidewire delivery), and the clinical study showed 100% success in achieving guidewire access with acceptable safety (three cardiac perforations, none requiring surgery). Thus, technological differences do not raise new safety or effectiveness questions.