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The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.

The modified EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit (Gen2). The EpiAccess Needle component remains the same as with the predicate device. The reusable Control Unit (Gen2) has been modified for a reduction in overall size, which eliminates the need for a custom cart. The modified Control Unit component also allows for connection to an existing display monitor in the Cath Lab rather than having a dedicated touch screen LCD display monitor as with the predicate device. Both Control Unit components are for use with the cleared EpiAccess Needle component and have an input for a commercial A-Line component and video output to a display monitor. Both the modified and the predicate device use embedded, validated software with the same algorithm to provide the same pressure/frequency information to the user via the same graphical user interface screen for the same intended use. The EpiAccess System displays the pressure measurement information, which physicians may be able to use to determine needle tip location based on known anatomical pressure differences. This additional information regarding needle tip location is an added convenience feature over standard Tuohy introducer needles for epicardial access. The system does not alert the user to tip location or provide clinical decision guidance. The EpiAccess Needle is placed under visualization with fluoroscopic imaging standard for electrophysiology procedures. Both control unit components are reusable and not patient contacting. Both control units have been tested and passed for electrical safety and EMC, reliability, and transit testing.

The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.

The EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit that includes pre-programmed diagnostic computer with a touchscreen display and graphical user interface (GUI).