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The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.

The Roadrunner® PC Wire Guides, subject of this submission, have been modified from the predicate device, Roadrunner Wire Guide (K920891), to include additional lengths ranging from 80, 145, 180, and 260 centimeters. The modifications to the Roadrunner® PC Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures. The Roadrunner® PC Wire Guides are packaged, sterile devices intended for single patient use. There are no prior submissions for the subject device.

The Roadrunner® PC Wire Guide is constructed with a nitinol mandril secured with a solder connection to platinum coils at the distal tip. The device has an outer polyurethane jacket that spans the entire device. The length of the device is coated with a hydrophilic coating except the proximal 6 centimeters of the device. The device is available with an angled or straight distal tip. The wire guide is available in a 0.035 inch or 0.038 inch diameter and lengths of 80, 145, 180, and 260 centimeters. The subject device will be provided sterile and intended for single patient use. An Olcott Torque Device and a Wire Guide Inserter are provided with each subject device configuration.

I am sorry, but the provided text does not contain information about acceptance criteria and study details for a device that meets those criteria. The document is a 510(k) premarket notification for a medical device (Roadrunner PC Wire Guide), primarily focusing on demonstrating substantial equivalence to a predicate device.

While it mentions that various tests were performed and all pre-determined acceptance criteria were met, it does not specify:

• The actual acceptance criteria themselves (e.g., specific thresholds for performance metrics).
• The reported device performance against those criteria.
• Any details about sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance studies, or ground truth types for any of the mentioned tests.
• Training set details.

The text only lists the types of tests conducted (e.g., Biocompatibility Testing, Corrosion Testing, Simulated Use Testing) and states that acceptance criteria for these tests were met to support substantial equivalence.

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