(145 days)
The AngioDynamics, Inc. VenaCure NeverTouch Direct Procedure Kit is indicated for the treatment 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 other superficial veins of the lower extremity.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to AngioDynamics, Inc. It confirms that their "VenaCure NeverTouch Direct Procedure Kit" has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain specific information about acceptance criteria, device performance results, sample sizes for testing, expert qualifications, adjudication methods, or details about standalone or MRMC studies that would describe how the device met acceptance criteria. It primarily focuses on the regulatory approval and indications for use.
Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a clinical study report or performance evaluation.
§ 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.