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For use with devices having a .035" guidewire compatible lumen. The Director guidewire is used to guide endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts.

The Director guidewire is constructed with three core segments that are bonded together. The proximal core is a Bisphenol A epoxy with fibers, covered with a polyethylene jacket, the mid section of the guidewire is a PTFE coated stainless steel, and the distal section is a nitinol tapered core covered with a polyester weave, polyurethane, and proprietary hydrophilic coating.

This document does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The provided text is a 510(k) summary for the Bard® Director™ Guidewire. It focuses on demonstrating substantial equivalence to predicate devices, primarily through:

• Description of the device and its intended use.
• Comparison of materials and construction with predicate devices.
• Discussion of biocompatibility testing.
• Bench testing for properties like stiffness, torque, and radiopacity to show substantial equivalence to predicate guidewires.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Information on experts, adjudication methods, or ground truth establishment.
4. Details of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for this specific information based on the provided text. This 510(k) summary is focused on regulatory clearance based on substantial equivalence rather than detailed performance study results against specific acceptance criteria.

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