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510(k) Data Aggregation

    K Number
    K171921
    Device Name
    VenaCure EVLT NeverTouch Procedure Kit
    Manufacturer
    AngioDynamics, Inc.
    Date Cleared
    2017-08-24

    (58 days)

    Product Code
    GEX,CLA
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K162914
    Predicate For
    K231945
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VenaCure EVLT Tre' Sheath and 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.

    Device Description

    The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits include a variety of procedural accessories:

    • NeverTouch Fiber with Sheath-Loc Fitting
    • Tre' Sheath Introducer with Dilator
    • Teflon Coated Stainless Steel Guidewire (lengths from 70cm to 200cm)
    • 0.018 Guidewire (Lengths from 45cm to 200cm)
    • Micro Access Components:
    • 21 gauge Entry Needle
    • 5F x 10cm Sheath/Dilator
    • 0.018" x 45cm Guidewire
    • 19 gauge Entry Needle (optional)

    The VenaCure EVLT Tre' Sheath is a 4F sheath used during endovascular venous laser treatment procedures. The sheath is used as a conduit for placing a laser fiber. The product will be offered in 25, 45, 65, and 90cm lengths. The VenaCure EVLT Tre' Sheath will be provided both as a standalone product and also packaged with the various procedural accessories detailed above.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or performance efficacy study against predetermined endpoints.

    Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.

    The document primarily describes the device, its intended use, and discusses non-clinical performance and material testing (e.g., leak resistance, tensile strength, biocompatibility) to support substantial equivalence. These tests are usually for safety and basic functionality rather than effectiveness against clinical endpoints.

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