AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)

The AVENTIX™ PFX System is an electrosurgical generator that produces pulsed field energy (PFE) for delivery through the NOVOCLEAR™ Device, a single-use handheld applicator with a dome-like electrode tip. The system is indicated for use in ENT surgery to destroy soft tissue in the nasal airway, including the posterior nasal nerve distribution, in patients with chronic rhinitis. It is intended for use in small clinics, offices, and hospital environments.

The subject device uses radiofrequency-based pulsed field energy to produce a non-thermal tissue effect, whereas the predicate device (RhinAer® Stylus) produces a thermal tissue effect. The NOVOCLEAR™ Device has smaller shaft diameters (0.079 inches proximal, 0.059 inches distal vs. 0.12 and 0.083 inches) and a 60-degree dome-like tip angle compared to the predicate's 10-degree tilt, designed to improve access to targeted nasal tissue. Power output is 2–4W, comparable to the predicate's 4W.

ISO 13485 design controls, ISO 13484 nonconforming product handling, and ISO 13485 corrective/preventative action requirements. Biocompatibility testing per ISO standards for cytotoxicity, sensitization, and irritation. Sterilization validation demonstrating Sterility Assurance Level (SAL) of 10⁻⁶ using E-beam radiation.

The AVENTIX™ PFX System and NOVOCLEAR™ Device are substantially equivalent to the predicate devices based on identical intended use, indications for use, and patient population (chronic rhinitis patients). Although the technology differs (non-thermal PFE vs. thermal RF), the differences do not raise new safety or effectiveness concerns, as demonstrated by non-clinical testing including system design verification, design validation with surgeons, software validation, usability testing, preclinical animal studies showing comparable lesion characteristics, and biocompatibility and sterilization validation.