(20 days)
VenaCure EVLT NeverTouch Procedure Kit: The AngioDynamics VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
VenaCure EVLT NeverTouch Direct Introducer Sheath: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature.
VenaCure EVLT NeverTouch Direct Procedure Kit: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of variose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
VenaCure EVLT NeverTouch and NeverTouch Direct Fiber Procedure Kits should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower extremity.
VenaCure EVLT NeverTouch Procedure Kit: The VenaCure EVLT Fiber Procedure Kits include single use disposable devices for use with a laser for the treatment of varicose veins. In addition, the Trè-Sheath Introducer is available both in the kits and provided individually. The main components of the NeverTouch Procedure Kit are identified below:
- 600μ VenaCure EVLT NeverTouch Fiber
- 4Fr Tre' Sheath Introducer
- 0.035" Guidewire
- 19 Gauge or 21 Gauge Entry Needle
VenaCure EVLT NeverTouch Direct Fiber Procedure Kit: The VenaCure EVLT NeverTouch Direct Procedure Kits is comprised of single use disposable devices for use with a laser for the treatment of varicose veins. The VenaCure EVLT NeverTouch Direct Fiber Procedure Kits are comprised of
- 21 Gauge Entry Needle
- 0.018" Guidewire
- Introducer Sheath/Dilator Assembly
- Fiber
This document is a 510(k) Pre-market Notification for the AngioDynamics VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits. It seeks to establish substantial equivalence to a predicate device.
Based on the provided text, the submission does not describe any new studies or performance tests as the device itself hasn't changed. The submission explicitly states:
"The proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits and the predicate VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits are identical to one another (and therefore substantially equivalent) in all aspects, not limited to design, materials, manufacturing, specifications, dimensions, and indication for use. The difference is the proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits is an update to the labeling." (Page 5, Section G)
And, "Modifications made to the VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits were limited to updating the labeling." (Page 5, Section H)
Therefore, the submission is not presenting new acceptance criteria or a study to prove the device meets new criteria. Instead, it leverages the previous testing and substantial equivalence determination for the predicate device (K171921) and reference devices (K170695 and K112600) because the changes are limited to labeling, and do not affect the device's technical characteristics, functionality, or performance.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such new study or criteria are presented in this 510(k) submission.
The document implies that the original predicate device (K171921) and reference devices (K170695 and K112600) met their acceptance criteria through non-clinical testing. However, the details of those past studies (sample size, experts, ground truth, etc.) are not included in this document.
§ 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.