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510(k) Data Aggregation

    K Number
    K973022
    Device Name
    ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
    Manufacturer
    ISLAND BIOSURGICAL, INC.
    Date Cleared
    1997-10-20

    (67 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Island Biosurgical, Inc. Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.

    Device Description

    A surgical kit including disposable surgical suture carriers and catheter stylet, implantable polypropylene mesh bolsters, a urethral Malecot catheter, surgical drapes, with bone anchors (Kit #2) or without bone anchors (Kit #1).

    AI/ML Overview

    This document is a 510(k) Summary for the Island Biosurgical Bladder Neck Suspension Kit from 1997. It explicitly states:

    "Performance testing: Performance testing was not included in this 510 (k)."

    Therefore, based on the provided text, the device did not undergo performance testing to establish acceptance criteria or to prove that the device meets such criteria. Consequently, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth can be extracted from this document.

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