(62 days)
The Vari-Lase™ procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
The Vari-Lase Console is a software controlled diode laser that provides an output wavelength of 810 nm.
The provided 510(k) summary for the Vari-Lase™ Endovenous Laser Console does not describe any acceptance criteria or a study that proves the device meets such criteria in terms of clinical performance or effectiveness.
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the device is substantially equivalent to predicate devices based on indications for use and technological characteristics.
- Non-Clinical Testing: The only testing mentioned is non-clinical, related to compliance with electrical safety standards (EN 60601 series). These are safety and performance standards for the electrical components of the device, not clinical effectiveness studies.
- Absence of Clinical Evaluations: The document explicitly states: "No clinical evaluations of this product have been conducted."
Therefore, based on the provided text, it's not possible to complete the requested table and details about acceptance criteria and a study proving their fulfillment. The device approval appears to be based on substantial equivalence and compliance with engineering safety standards, without clinical performance data in this submission.
Given this, I will answer the questions based on the absence of the requested information, which is a key finding in the provided document.
Acceptance Criteria and Device Performance
No acceptance criteria related to clinical performance or effectiveness are described in the provided document, nor is any device performance data reported from a clinical study. The document explicitly states, "No clinical evaluations of this product have been conducted."
The "Summary of Non-Clinical Testing" refers to compliance with electrical safety standards, which are not direct measures of device clinical performance against specific acceptance criteria.
Additional Study Details (Not Applicable as No Clinical Study was Conducted)
Since no clinical study demonstrating device performance against acceptance criteria was conducted or reported in this 510(k) summary, the following points are not applicable:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this device is a laser console, not an AI-assisted diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.