(107 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 600um fiber and the following accessories used to gain endovascular access: 0.035" / 150cm stainless steel guide wire 5Fr/45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle
The provided text is a 510(k) Summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit) and the FDA's clearance letter. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The reasons are as follows:
- No specific acceptance criteria are listed for device performance. The submission relies on comparing the device's characteristics and intended use to an already cleared (predicate) device.
- No detailed study is described to demonstrate performance against acceptance criteria. The "Summary of Non-Clinical Testing" mentions tests for integrity and biocompatibility of marker bands, but these are general safety and materials tests, not performance studies as typically envisioned for clinical efficacy.
- There is no mention of a test set, ground truth, experts, or adjudication methods. These are elements of a clinical trial designed to prove effectiveness, which is not the primary purpose of a 510(k) submission focused on substantial equivalence.
- No information on MRMC studies or standalone algorithm performance is present, as this device is a physical instrument, not an AI or imaging diagnostic tool.
- No sample size for training or establishment of ground truth for a training set is applicable here, again because it's not an AI or algorithm-driven device.
In summary, the provided document is a regulatory submission for substantial equivalence, not a performance study report. It shows that the device is considered safe and effective because it is very similar to other devices already on the market, not through a head-to-head performance study against derived acceptance criteria.
§ 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.