Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

The Shogun Axis Fascial Closure System is a sterile, single-use laparoscopic access and port-site closure device intended for use in minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments. It consists of a cannula assembly with integrated valve and insufflation port, an obturator for establishing abdominal access, and an integrated fascial closure feature that uses a single-use suture passer for controlled suture placement.

The device is provided in two obturator configurations (optical and bladeless) and three cannula sizes (10 mm, 12 mm, 15 mm). The primary difference from the predicate is integration of a single-use suture passer within the sterile pack, whereas the primary predicate device uses a separately provided reusable suture passer. Both devices share the same stainless steel obturator shaft, polycarbonate distal tip, transparent cannula, and suture passage mechanisms through distal channels.

Testing conducted per ISO 80369-7 (luer lock performance), ISO 13485 clauses for design controls and quality management, ISO 10993 series for biocompatibility, ISO 11607 for packaging integrity, ASTM F1980-21 for accelerated aging, IEC 62366-1 for human factors engineering, and FDA guidance on human factors and usability engineering for medical devices.

The Shogun Axis has the same indications for use as the primary predicate (VersaOne Fascial Closure System K163654) for minimally invasive procedures. Both devices share identical principles of operation, configurations, core structures, materials, and system-level performance including access, sealing, fixation, and visualization. Bench testing and engineering analysis confirmed that differences in the suture passer integration do not raise new safety or effectiveness questions and demonstrate the subject device is as safe and effective as the predicate devices.