ELID (Endoscopic Less Invasive Decompression) System

The ELID System is a set of minimally invasive surgical instruments designed to perform lumbar spine decompression to treat various spinal conditions. It comprises a bone needle, flat blade dilator, dilator tubes, and rongeurs made from aluminum, Nitinol, or stainless steel, supplied non-sterile and reusable.

The subject device shares identical indications for use, materials of manufacture, and device components with predicate devices. The primary difference is that the ELID system includes a flat blade dilator and guidewire not present in the main predicate (Vertos mild Device Kit), though these components were previously cleared in separate submissions and remain unchanged.

Cleaning validation, sterilization validation, biocompatibility testing, usability testing, and particulate analysis per ASTM F1877. Materials comply with ASTM B211 (aluminum), ASTM F2063 (Nitinol), and ASTM A564 (stainless steel).

The ELID system is substantially equivalent because it has nearly identical technological characteristics to the Vertos mild Device Kit predicate, including the same indications for use, materials, and core instrument components. The minor addition of a flat blade dilator and guidewire does not raise new safety or effectiveness concerns because both components were previously cleared and remain mechanically and functionally unchanged. Non-clinical testing demonstrates the system's strength is sufficient for its intended use.