(46 days)
The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.
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I am sorry, but the provided text is a 510(k) clearance letter for a medical device (AngioDynamics, Inc. VenaCure Procedure Kit). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/ML device validation.
The letter simply states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also specifies the indications for use of the VenaCure Procedure Kit.
Therefore, I cannot fulfill your request for the detailed breakdown of acceptance criteria and study information because that data is not present in the provided document.
§ 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.