(29 days)
The AngioDynamics, Inc. 600um 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.
Not Found
This document describes an FDA 510(k) clearance for the AngioDynamics, Inc. 600μm Fiber and Venacure Procedure Kit. The clearance letter states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance, a study, or any of the detailed data provenance, expert qualifications, or ground truth methodologies requested in your prompt.
The document is a regulatory clearance letter, not a study report or clinical trial summary. It confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to existing devices based on the information provided by AngioDynamics, Inc.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the provided text. This information would typically be found in a separate clinical study report or a detailed section of the 510(k) submission, neither of which is present here.
§ 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.