(55 days)
The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of a cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic. Accessories include a footswitch and a fiber optic pull-back device, the JouleTraker.
The provided text is for a 510(k) Premarket Notification for a laser system and explicitly states that no clinical performance data was submitted. Therefore, the device has not been "proven to meet acceptance criteria" through a study in this submission.
Based on the information provided in K062210:
1. Table of acceptance criteria and the reported device performance:
Since "No clinical performance data was submitted," there is no table of acceptance criteria and reported device performance to present. The submission relies solely on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance:
Not applicable. No clinical performance data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical performance data was submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical performance data was submitted.
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. No clinical performance data was submitted. This device is a laser system, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No clinical performance data was submitted. This device is a laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No clinical performance data was submitted.
8. The sample size for the training set:
Not applicable. No clinical performance data was submitted. This device is a laser system, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. No clinical performance data was submitted.
§ 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.