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510(k) Data Aggregation

    K Number
    K082750
    Device Name
    ENTACT SEPTAL STAPLER, MODEL 610-00100
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Date Cleared
    2009-01-06

    (109 days)

    Product Code
    OLL
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.

    Device Description

    The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.

    AI/ML Overview

    I am sorry, but the provided text does not contain specific information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for the ENTact™ Septal Stapler, detailing its classification, predicate devices, description, and indications for use. It also includes the FDA's letter of substantial equivalence determination.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information based on the given text.

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