NEUROMARK System (NMK00301)

The NEUROMARK System is a hand-held, single-use radiofrequency (RF) device designed for otolaryngological (ENT) procedures to create lesions in nasal tissue by disrupting posterior nasal nerves in patients with chronic rhinitis. It consists of a bipolar RF device with a pre-shaped, malleable shaft and an end effector with multiple electrodes, controlled by a console that monitors tissue bioimpedance to regulate energy delivery.

The subject device maintains the same principle of operation, anatomical location of use, design configuration, functionality, energy type, materials, biocompatibility, feedback control, thermal lesion characteristics, electrical and thermal safety, and sterilization as the predicate. Minor modifications include fewer leaflets and material changes in the treatment tip, minor material and dimensional changes to the shaft, and simplification of the activation button, slider, connector, interface cable, and packaging.

Not stated in this summary.

The device has the same intended use and fundamental scientific technology as the predicate NEUROMARK System [K222032]. The modifications made (fewer tip leaflets, material changes, and component simplifications) are minor and do not raise different questions of safety and effectiveness. Performance testing including design verification, usability, biocompatibility, software, and electrical/thermal safety testing confirmed the device meets specifications and performs equivalently to the predicate.