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The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.

The provided document describes a 510(k) premarket notification for a medical device called the NovaGold™ High Performance Guidewire. This document specifically states that the submission is for establishing substantial equivalence to a predicate device, rather than a study demonstrating clinical effectiveness with acceptance criteria.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text focuses on:

• Predicate Device: K122816; Endscopic Wire Guide manufactured by Wilson-Cook Medical.
• Device Description: Steerable, metallic core with PTFE polymer coating, hydrophilic coating over the distal portion, radiopaque floppy tip.
• Intended Use: Selective cannulation of biliary ducts (common bile, pancreatic, cystic, right and left hepatic ducts) and aiding in placement of diagnostic/therapeutic devices during endoscopic procedures.
• Functional and Safety Testing: Bench testing according to applicable standards and guidances, providing assurance of safety and effectiveness, and demonstrating equivalence to the predicate.
• Comparative Technology Characteristics: Similarities to predicate in intended use, operating principle, packaging/sterilization, nominal diameter, similar lengths, Nitinol alloy core wires, distal radiopaque tip, and lubricious coatings.
• Non-Clinical Tests Submitted:
  • Biocompatibility: Cytotoxicity (L-929 MEM Elution, Colony Microassay by Elution), Guinea Pig Maximization Sensitization, Irritation (Intracutaneous Reactivity), Chemical Characterization.
  • Bench testing: Coating adherence, corrosion resistance, dimensional measurements, fracture resistance, tensile strength, torqueability.
  • Shelf Life Testing: 13-month accelerated aging.

The conclusion is that the NovaGold guidewire is equivalent to the predicate device based on equivalent intended use and no differences raising new safety/effectiveness questions. This is a common approach for 510(k) clearances for devices that do not introduce novel technology or a new intended use.

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