(403 days)
The "VELASI -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up. After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.
The provided document is a 510(k) premarket notification for a medical device, specifically a Medical Diode Laser System (VELAS II -15D). It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining specific performance acceptance criteria for the novel device itself.
Therefore, the document does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for the device's clinical efficacy in treating reflux of saphenous veins. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, meaning the new device should perform as safely and effectively as the predicate.
The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate adherence to relevant safety and performance standards, and a comparison presented in the "Summary of Substantial Equivalence" table.
Here's an analysis based on the information provided, though it will not contain specific performance metrics for clinical efficacy as none are present.
1. Table of Acceptance Criteria and the Reported Device Performance
As specific clinical performance acceptance criteria (e.g., success rate of vein closure, reduction in vein diameter) are not provided in this regulatory submission for the novel device, the "acceptance criteria" are inferred from the comparison to the predicate device, primarily focusing on technical specifications and safety standards.
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (VELAS II -15D) |
|---|---|
| Indications for Use | "The 'VELAS II -15D' is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities." |
| Laser Type | Diode laser |
| Wavelength | $1470nm \pm 10nm$ |
| Output power | 1-15W |
| Operation mode | CW, single pulse, repeat pulse |
| Pulse width | 10ms-2.5s |
| Pulse repetition rate | 0.2Hz-50Hz |
| Application / Light delivery system | Recommended disposable sterile fiber (K124003, MED-Fibers, Inc.), bare fiber, 3m, 600μm fiber core diameter, NA ≥0.22, SMA905 connector, single use. |
| Aiming Beam | Diode laser of 635/532nm, power max. |
§ 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.