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The Cross Vascular RF Generator and Footswitch (optional accessory) are to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.

The Cross Vascular RF Generator (Figure 1) is a rechargeable battery-operated device used with compatible, separately cleared RF Transseptal Needles (i.e., Cross Vascular Models RFN-XX-CX) which are connected to the RF Generator through a Cross Vascular Connection Cable. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available patient return electrode such as the Valleylabs Patient Return Electrode Model #E7507. An optional Cross Vascular Footswitch may be used with the RF Generator.

The Cross Vascular RF Transseptal Needle and Connection Cable are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The Cross Vascular RF Transseptal Needle is used in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the left atrium. The RF Transseptal Needle within a compatible transseptal introducer set (Table 4) along with radiofrequency (RF) energy from the RF Generator is used to facilitate the septal puncture. The RF Transseptal Needle delivers RF power in a monopolar mode between the device's distal electrode and a commercially available external Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2. The RF Transseptal Needle is loaded through a compatible transseptal sheath and dilator (Table 4) and is connected at its proximal end to the Cross Vascular RF Generator via the Cross Vascular Connection Cable. The distal end of the needle contains a small through hole to facilitate injection of contrast solution. The active tip is specially shaped to be atraumatic to the cardiac tissue until RF energy is applied.