Globe Introducer (601-01001)

The Globe Introducer is a single-use steerable sheath designed for percutaneous catheter introduction into blood vessels and heart chambers, including the left side of the heart through the interatrial septum. It consists of a 16 Fr steerable sheath with a hydrophilic coating, a compatible dilator, and a handle with an integrated steering knob for bidirectional deflection control.

The Globe Introducer features a steering knob that rotates in the plane of the handle with bidirectional deflection (≥90° clockwise, ≥45° counterclockwise), compared to the predicate's coaxial actuator knob with unidirectional 0°-180° deflection. It has a larger sheath (16 F inner diameter, 71 cm usable length) than the predicate (13 F, 74 cm) and includes a hydrophilic-coated PEBAX sheath with PTFE liner, sterilized by ethylene oxide.

Bench testing followed applicable principles of FDA-recognized consensus standards and guidance documents. Specific standards cited include ISO 80369 for Luer connections. Testing included biocompatibility, sterilization validation, packaging validation, shelf-life testing, and multiple mechanical performance tests (particulate, deployment-retraction force, pressure withstand, torque, lubricity, radiopacity, etc.).

Both devices share identical product code (DRA), intended use, and indications for use. Although the Globe has a larger lumen (16 F vs. 13 F) and different steering mechanism (bidirectional vs. unidirectional), these dimensional differences ensure compatibility with the prescribed catheters for the same clinical applications, and the steering design differences do not alter fundamental scientific technology or introduce new safety concerns. Comprehensive bench testing and biocompatibility/sterilization validation demonstrate equivalent performance meeting the predicate's safety and effectiveness profile.