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The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coagulation and ablation of soft tissue. The SIRATM RFA Electrosurgical Device is to be used in conjunction with a radiofrequency (RF) electrosurgical generator for use in open abdominal surgical procedures. The device is not intended for contraceptive tubal coaqulation (permanent female sterilization).

The SIRA™ RFA Electrosurgical Device, model number SIRA-1000, is a sterile, single-use electrosurgical device, which is for use in the intraoperative coagulation and ablation of soft tissue. The SIRA-1000 is supplied STERILE using an ethylene oxide (EO) process. The device is a single-use device that can be used for multiple applications in one operative site. The SIRA-1000 is to be used in conjunction with a bipolar electrosurgical generator (e.g., Medtronic ForceTriad Generator). The SIRA-1000 is a prescription Class II device. The SIRA-1000, shown in Figure 1 below, consists of an electrode array with an internal irrigation chamber, a cable assembly, and an integrated switch and timer.

The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coaqulation and ablation of soft tissue. The SIRA™ RFA Device is to be used in conjunction with a radiofrequency (RF) electrosurgical generator for use in open abdominal surgical procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The SIRA™ RFA Electrosurqical Device is used for the simultaneous administration of RF energy and saline for the coagulation and ablation of soft tissue in open intraoperative procedures. The SIRA™ RFA Electrosurgical Device is comprised of a 4cm diameter electrode array, a handle (shaft), a co-extruded cable, an integrated electrical RF switch and timer, a main cable, and a fluid administration set.