NEURENT MEDICAL LIMITED 010-00043-000 NEUROMARK™ Radiofrequency Generator

The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator via a flexible cable. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities. The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile cart for ease of use. The mobile cart includes a handle and basket. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.