Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

These are steerable guidewires (five models ranging from 0.014" to 0.035" diameter) with shapeable nitinol tips for navigating neuro and peripheral blood vessels. They are used to introduce and position catheters and other interventional devices, and are explicitly not for coronary use. Each comes with an introducer, torque device, and shaping mandrel.

All subject devices are substantially identical to their predicates in design, materials (stainless steel core, nitinol tip, hydrophilic distal coating), dimensions, stiffness profiles, and sterilization method (100% ethylene oxide). The primary difference is the proximal PTFE coating formulation (described as 'proposed PTFE' versus the predicate's PTFE). Shelf life also differs: subject devices have 1-year shelf life versus 3-year for predicates.

ISO 10993 series (biocompatibility), ISO 14971:2019 (risk management), ISO 11070:2014 (sterile single-use intravascular introducers, dilators and guidewires), and the FDA 2019 guidance 'Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling.'

The only material change is the alternative PTFE proximal coating formulation. The applicant established this difference does not raise new safety or effectiveness concerns by performing biocompatibility testing (cytotoxicity, pyrogenicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility—all passing) and bench performance testing (coating integrity, corrosion resistance, agent compatibility, simulated use, and particulate—all meeting acceptance criteria). Since the proximal coating is indirect blood contact and the modified PTFE demonstrated equivalent biocompatibility and performance characteristics, the subject devices perform identically to predicates with the same indications and intended use.