External Evaluation Plan: User Evaluation of the Next Generation CardioLab EP Recording System with the Prucka 3 Digital EP Amplifier

The current CardioLab system is cleared by the FDA for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab can be used in a variety of hospital and clinical settings to record cardiac data and measurements. The next generation CardioLab system is a pre-market (investigational) device in the stage of development where feedback from users is important to gauge the system’s commercial readiness, ensuring optimal functionality in a real-world clinical setting. The results of this study are intended primarily for use to review and consider improvements to the existing device.