Genie MAX Large Bore Introducer Sheath

The Genie MAX is a large bore introducer sheath system designed to provide a conduit for inserting intravascular devices into blood vessels while maintaining a hemostatic seal to minimize blood loss. The system includes an introducer sheath, protector, dilator, and 3cc syringe, with sheath lengths ranging from 15 to 65 cm.

The Genie MAX uses the same fundamental technology and principles of operation as the predicate GORE DrySeal Flex Introducer Sheath. Key differences include: sheath length specifications (15-65 cm vs. 33-65 cm for predicate), different mechanisms to regulate hemostasis valve pressure, and different polymeric materials in hub and sheath components.

Not stated in this summary.

The Genie MAX is substantially equivalent to the GORE DrySeal Flex because both devices have the same intended use, medical device classification, and are based on the same basic design with similar materials and device features. The technological differences (length specifications, valve pressure mechanisms, and polymeric materials) do not raise any different safety or effectiveness questions. Comprehensive mechanical bench testing, biocompatibility testing, packaging validation, and sterilization validation support substantial equivalence.