Prana System

The Prana System is a sterile, single-use bipolar electrosurgical tool designed to remove tissue and control bleeding during surgical procedures. It connects via cable to an electrosurgical generator and uses cutting and energy delivery mechanisms for tissue localization and excision.

The Prana System is bipolar with a 16 mm tip size, shaft length of 87.7–134.48 mm, maximum peak voltage of 90 Vp, and is supplied sterile for single use. Key differences from the predicate (Bipolar Micro-Coagulation Forceps K172368) include lower voltage (90 vs 300 Vp), single-use vs reusable design, and sterile vs unsterile condition, but both are bipolar electrosurgical devices meeting IEC 60601-2-2.

ISO 10993-1 (biocompatibility), IEC 60601-1 and IEC 60601-2-2 (electrical safety), ISO 13004 (sterility and bioburden), mechanical testing (compression, tensile strength, functional and simulated use), and histological analysis of thermal effects on cadaveric tissue.

The Prana System is substantially equivalent to the predicate device because both are bipolar electrosurgical cutting and coagulation devices with identical indications for use (tissue removal and hemostasis). Technological differences such as lower voltage, single-use design, and sterile packaging do not raise new safety or effectiveness questions, as demonstrated by performance testing against consensus standards and compliance with applicable IEC standards.