Arthrex Spine Endoscope

The Arthrex Spine Endoscope is a rigid endoscope with a rod lens system and optical fibers that provides visualization and illumination during spinal endoscopic procedures and minimally invasive surgery. It is available in multiple configurations (15° or 30° viewing angles, 6.3–10 mm diameter, 130–181 mm length) and is designed for reusable, multi-patient use when connected to compatible Arthrex light guides and camera systems.

The Arthrex Spine Endoscope and its predicate device (K130778 RZ Medizintechnik Cervical Endoscopes) share the same intended use, indications for use, design principles, materials, manufacturing processes, and cleaning/disinfection requirements. Both are rigid endoscopes with rod lens systems intended for spinal visualization during minimally invasive procedures.

Not stated in this summary. The document references non-clinical bench testing including biocompatibility testing, cleaning/disinfection and reprocessing validation, design verification, and electrical, mechanical, and thermal (EMT) safety evaluation, but does not cite specific ISO, IEC, or ASTM standards.

Substantial equivalence is supported by technological equivalence: the devices have identical intended use, indications, design, materials, operation principles, manufacturing and packaging processes, and cleaning/reprocessing requirements. Non-clinical bench testing confirmed the subject device meets the same product requirements and specifications as the predicate, using comparable testing methods and acceptance criteria. No animal or human clinical studies were required because any differences between devices are considered minor and do not raise different safety or effectiveness questions.