ENTire IRE System

The ENTire IRE System is an electrosurgical generator used for surgical ablation of soft tissue in otorhinolaryngology (ENT) procedures. It consists of a reusable generator activated by a foot pedal and single-use sterile handpieces with bipolar electrodes that deliver high-voltage, low-energy electrical pulses to create irreversible nanopores in cell membranes, inducing cell death and tissue reduction.

The ENTire IRE System uses irreversible electroporation (IRE), a nonthermal ablation technology operating at 200–1,000 kHz frequency with 1.3–1.5 kV voltage and 1–5 microsecond pulse widths, delivering up to 40 bursts per application with maximum output of 4.0W. This differs from the primary predicate's radiofrequency (RF) technology at 100 kHz and 340 Vrms, though the reference device also employs IRE at higher voltages (800V–15kV).

Testing was conducted per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, IEC 62304, IEEE 1016, and IEC 62366-1 for electrical safety and EMC. Biocompatibility was assessed per ISO 10993-1, and pre-clinical animal safety and performance studies were conducted in accordance with FDA guidance on electrosurgical devices.

The ENTire IRE System is substantially equivalent because it achieves the same intended use (soft tissue ablation in ENT procedures) using similar materials, packaging, and sterilization methods as the predicates. Although it employs IRE rather than the primary predicate's RF technology, performance testing demonstrated the device achieves intended tissue effects with no thermal injury beyond the target zone, supporting that it does not raise new questions of safety or effectiveness.