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The AngioDynamics, Inc. NeverTouch 600μm Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

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This document is a 510(k) clearance letter for a medical device, the AngioDynamics, Inc. NeverTouch 600um Fiber. It does not contain the detailed study information about acceptance criteria or device performance that you requested.

The letter confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not provide the specific performance data, study design, or ground truth establishment that would be required to answer your questions.

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