(16 days)
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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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.