(33 days)
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25 or 45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit
This document is a 510(k) premarket notification for a medical device. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, study performance, or ground truth as requested in the prompt.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device (a laser procedure kit for treating varicose veins) and details its substantial equivalence to a previously marketed device, not the performance of an AI model.
The sections for AI/ML device evaluation within your prompt (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to the content of this 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.