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510(k) Data Aggregation

    K Number
    K190644
    Device Name
    Guide Sheath
    Manufacturer
    Surmodics, Inc.
    Date Cleared
    2019-04-18

    (36 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Guide Sheath is intended to introduce therapeutic devices into the vasculature, excluding the coronary and neuro vasculature.

    Device Description

    The Surmodics Guide Sheath is designed to perform as a guide sheath and/or introducer sheath. The sheath is braid reinforced with an embedded radiopague marker band to identify the distal tip. It also has a hydrophilic coating over the working length to provide a lubricious surface to ease insertion. The device comes packaged with a dilator, which is either .018" or .035" guidewire compatible.

    This highly flexible, braid reinforced sheath is designed to resist kinking and maximize strength while keeping a minimized profile. Incorporated in the sheath is a radiopaque marker band located approximately 5mm from the distal tip. The Guide Sheath has an atraumatic tip and has a hydrophilic coating over the working length.

    The dilator hub is designed to snap into the Guide Sheath cross cut valve cap. Additionally, the dilator shaft design allows for simultaneous movement of the sheath and dilator assembly. The dilator features an atraumatic tip, which is designed to extend beyond the sheath tip by approximately 5 cm. The dilator shaft is radiopaque.

    The Guide Sheath features a custom designed cross cut valve that is integrated into the sheath hub and includes a 3-way stopcock with sidearm extension tubing. No assembly is required.

    The sheath is packaged in a dual sterile barrier configuration. The sheath and dilator will be placed individually in high density polyethylene (HDPE) coiled hoops, which are then placed in a poly-tyvek pouch within a shelf box.

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) summary for the Surmodics Guide Sheath does not contain information related to a study proving a device meets acceptance criteria for an AI/software device.

    The document describes the acceptance criteria and performance of a physical medical device (catheter introducer) through various bench tests, packaging tests, and biocompatibility tests. It demonstrates substantial equivalence to a predicate device, as opposed to an AI or software product.

    Therefore, I cannot fulfill your request for information regarding an AI device's acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or training set details, as these concepts are not applicable to the content provided.

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