Wovyn Depth Electrode

The Wovyn Depth Electrode is a single-use, sterile, implantable depth electrode designed for temporary use (less than 30 days) in the brain. It is used by neurosurgeons to record, monitor, and stimulate electrical signals at subsurface brain levels in patients undergoing evaluation for epilepsy surgery or other neurological procedures.

The device features 4 to 16 macro electrode contacts with contact lengths of 1.5 mm to 3 mm, electrode body diameter of 0.8 mm to 2.0 mm, and overall length of 360–400 mm. The primary difference from the predicate is the use of Platinum/Iridium (Pt90/Ir10) contacts instead of stainless steel, while maintaining equivalent electrode jacket material (TPU), stimulation charge density limits (< 30 µC/cm²), and design features including a stylet for placement.

ISO 13485 (design controls, nonconforming product, corrective and preventive actions), ISO 11135 (ethylene oxide sterilization validation achieving SAL of 10⁻⁶), and biocompatibility testing per applicable standards including cytotoxicity, skin sensitization, intracutaneous, pyrogenicity, systemic toxicity, bacterial reverse mutation, chromosomal aberration, hemolysis, and brain implantation studies.

The Wovyn is substantially equivalent because it shares identical intended use (temporary subsurface brain recording, monitoring, and stimulation < 30 days in the same patient population and clinical settings) and equivalent or identical technological characteristics as the primary predicate SENSO SEEG Depth Electrode (K213170). The sole difference—Platinum/Iridium contacts instead of stainless steel—is supported by the secondary predicate (K151790) and does not raise new safety or effectiveness concerns, as confirmed by nonclinical testing demonstrating safety and performance of the Pt90/Ir10 material.