iSLEEVE Introducer Set

The iSLEEVE Introducer Set is a sterile, single-use catheter introducer designed to provide percutaneous access to the femoral artery for introduction and removal of cardiovascular devices. It features a passively expandable distal sheath with radial compliance and a hydrophilic coating to reduce vessel trauma and delivery time. The device is intended for use in vessels ≥5.5 mm diameter.

The modified device adds an Expansion Tool component to the predicate iSLEEVE Introducer Set. The technological characteristics—including performance, materials, design, sterilization, biocompatibility, and packaging—remain equivalent to the predicate. The intended purpose and principles of operation are unchanged.

Not stated in this summary. The document references only generic testing categories (Luer Connections, Simulated Use Testing, Dimensional Requirements, Tensile Testing, Packaging Testing, Radiopacity, Sterilization, Usability) without citing specific ISO, IEC, or ASTM standards.

Substantial equivalence is supported because the modification involves only an additional accessory component (Expansion Tool) with no other design changes. Testing confirmed the new component meets previously established acceptance criteria across all functional and performance domains. Since the intended use, technological characteristics, and performance remain equivalent to the predicate, and no new safety or effectiveness issues emerged, the modified device is substantially equivalent.