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The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.

LRM produces quidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission. These devices are commonly known as quides, quidewires, or spring quidewires.

This document is a 510(k) premarket notification for a guidewire. It describes the device, its intended use, and its classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, or any of the other study-related details requested in your prompt.

Therefore, I cannot provide the requested table or answer the specific questions about the device's performance study based on the provided text. The document focuses solely on the regulatory classification and identification of the device itself, not on data demonstrating its efficacy or safety.

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