(79 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.
Not Found
The provided text is a 510(k) summary letter from the FDA concerning the AngioDynamics, Inc. VenaCure EVLT™ Procedure Kit. It primarily deals with the substantial equivalence determination for this medical device.
Crucially, this document does not contain information about specific acceptance criteria, device performance metrics, or details of a study that proves the device meets acceptance criteria. It is a regulatory approval letter, not a clinical study report or a technical performance specification.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details or effect size
- Standalone algorithm performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document confirms the device's indications for use and its regulatory classification but does not delve into the detailed performance data that would typically be found in a clinical study report or a more extensive 510(k) submission summary.
§ 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.