(56 days)
The Vari-Lase Endovenous Laser Console is indicated for use in 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 Endovenous Laser Console is a software controlled diode laser that provides an output wavelength of 810 nm and operates at a maximum output of 15 W.
The provided text is a 510(k) Premarket Notification for the Vari-Lase Endovenous Laser Console. This document focuses on establishing substantial equivalence to existing predicate devices due to technological characteristics and intended use, rather than presenting a performance study with acceptance criteria and detailed clinical trial results. Therefore, much of the requested information regarding such a study is not available in the provided text.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are presented in this 510(k) notification. The document aims to demonstrate substantial equivalence to predicate devices, implying that its performance is expected to be similar or equivalent, but no specific performance data is reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a performance study with a test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a performance study with a test set.
5. 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 for treating varicose veins, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a laser console, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a performance study that would require establishing a ground truth for a test set.
8. The sample size for the training set
Not applicable. The document does not describe a performance study involving a training set.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a performance study involving a training set.
Summary of available information:
The 510(k) submission for the Vari-Lase Endovenous Laser Console focuses on establishing substantial equivalence to previously cleared predicate devices (K062822, Vari-Lase Endovenous Laser Console; K051996, Diomed Delta 15 Laser Console). This is based on comparisons of:
- Device classifications: Laser instrument, surgical, powered (21 CFR 878.4810; Product code GEX).
- Technological characteristics: The device is a software-controlled diode laser with an output wavelength of 810 nm and operates at a maximum output of 15 W.
- Indications for Use: 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 document does not detail a separate clinical or performance study with defined acceptance criteria and performance metrics for the Vari-Lase Endovenous Laser Console itself. The underlying assumption of a 510(k) substantial equivalence submission is that the new device performs as safely and effectively as the predicate devices, for which safety and effectiveness have already been established.
§ 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.