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510(k) Data Aggregation

    K Number
    K970099
    Device Name
    SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
    Manufacturer
    NITINOL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-04-16

    (93 days)

    Product Code
    DTK
    Regulation Number
    870.3375
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K963014,K963016
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.

    Device Description

    The cleared SNF/SL and SNF Systems and the proposed models of the SNF/SL and SNF Systems are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When cooled, the wires can be straightened to allow delivery through a small diameter catheter. The SN Filter resumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava.

    The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava; the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed.

    NMT intends to modify the gold radiopaque marker band from one which is deposited onto the introducer sheath to one which is mechanically swaged onto the introducer sheath.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Simon Nitinol Filter™ System and Simon Nitinol Filter/Straight Line™ System, focusing on substantial equivalence to predicate devices. It describes the device's design, intended use, and a minor modification to a radiopaque marker band, but it does not detail any performance studies, clinical trials, or established acceptance metrics for device performance.

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