Prelude Wave Hydrophilic Sheath Introducer

The Prelude Wave Hydrophilic Sheath Introducer is a catheter introducer device designed to provide vascular access and facilitate percutaneous introduction of diagnostic and therapeutic devices into veins and arteries, including the radial artery, while maintaining hemostasis. It consists of a sheath with an integral hemostasis valve, a compatible dilator, a hydrophilic-coated shaft, and optional components including a SnapFix securement device, available in multiple French sizes and lengths.

The subject device has the same fundamental design as the predicate Prelude IDEAL but differs in three ways: modified sheath material, a redesigned sheath/dilator tip and fit, and inclusion of an adhesive-backed fixation device (SnapFix) to maintain sheath placement during procedures. All materials meet ISO 10993 biocompatibility requirements and the device maintains the same intended use, indications, sterilization methods, and principles of operation.

ISO 10555-1:2013 (intravascular catheters general requirements), EN ISO 11070 2014/A1:2018 (sterile single-use catheter introducers), ISO 10993-1:2018 (biocompatibility evaluation), ISO 14971:2019 (risk management), and FDA guidance on biocompatibility training and toxicology profiles.

The device is substantially equivalent because it shares identical intended use, indications for use, sterilization methods, and fundamental technology with the predicate Prelude IDEAL. Although the sheath material, tip design, and fixation method differ, these modifications do not alter the core function or safety profile. Comprehensive design verification testing, design validation with clinician feedback, and full biocompatibility testing performed at baseline and shelf-life demonstrate the modified device meets performance specifications without introducing unacceptable risks.