Life Saving Tourniquet

The Life Saving Tourniquet (LST) is a manual junctional hemorrhage control device designed for battlefield and trauma situations. It applies localized pressure to control severe bleeding in the inguinal (groin) and axilla (armpit) areas by positioning a pressure pin on the main artery and tightening a strap with a buckle mechanism.

The LST uses a manual, non-pneumatic pressure pin mechanism with a buckle-secured strap and manual handle-winding system to apply pressure. The predicate (SAM Junctional Tourniquet) uses a manual pneumatic mechanism with a hand pump to inflate a tourniquet control device (TCD). Both are non-sterile, single-use devices intended for adult trauma patients in Rx-only applications.

The document references ISO 13485 quality management system requirements and ISO 10993-1 biocompatibility evaluation standards. Non-clinical validation testing included usability, pressure retention testing, and effectiveness during evacuation assessments.

The LST is substantially equivalent to the SAM Junctional Tourniquet because both devices share identical product codes (DXC), regulatory classification (Class II), indications for junctional bleeding control in inguinal and axilla areas, target population (adults), and intended use environment (battlefield/trauma). Although the subject device uses a mechanical pressure pin versus the predicate's pneumatic mechanism, both employ manual pressure-point systems with buckle-secured fastening, making them functionally equivalent.