VENACURE EVLT NEVERTOUCH PROCEDURE KIT

• K Number: K130671
• Device Name: VENACURE EVLT NEVERTOUCH PROCEDURE KIT
• Manufacturer: ANGIODYNAMICS, INC.
• Date Cleared: 2013-03-26 ( 14 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Special
• Panel: SU
• Reference & Predicate Devices: K112600
• Predicate For: N/A

Intended Use

The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kit is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Device Description

AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kits are offered with the following components:

• 600um Fiber with markings on the fiber to aid in withdrawal
• Introducer Sheath and Dilator
• Entry Needle
• Guidewire

AI/ML Overview

The provided text describes the AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kit and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria for a study and the device performance against those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed results from a clinical or performance study with defined acceptance criteria and statistical analysis.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria or Reported Performance: The document states that the device is substantially equivalent based on "non-clinical performance testing in accordance with ISO 10993 and in-house test criteria," which included a list of tests (Fiber to Tip Tensile, Fiber to SMA Tensile, Fiber output Testing, Surface Visual, Depth Marks, Simulated Use Testing, Biocompatibility per ISO 10993-1). However, it does not list specific acceptance criteria for these tests nor does it report the quantitative or qualitative results of these tests against any such criteria.
• No Study Details: The document mentions "non-clinical performance testing," but it does not describe a "study" in the sense of a clinical trial or a statistically designed performance evaluation with sample sizes, ground truth establishment, expert involvement, or adjudication methods.
• No Information on AI/Algorithm Performance: The device described is a medical kit for a surgical procedure (laser treatment for varicose veins). There is no mention of an AI or algorithm in its function, so questions related to standalone algorithm performance, MRMC studies, or human reader improvement with AI assistance are not applicable.

In summary, the provided text only states that non-clinical testing was performed and supports substantial equivalence, but it lacks the detailed performance data and study design information you've requested.

Regulation Number and Section

§ 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.