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    K Number
    K021051
    Device Name
    ANNULOFLO SYSTEM, MITRAL MODEL AR700
    Manufacturer
    SULZER CARBOMEDICS, INC.
    Date Cleared
    2002-04-23

    (22 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANNULOFLO SYSTEM, MITRAL MODEL AR700

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AnnuloFlo® System is intended for use in the repair of the human cardiac valve.

    The AnnuloFlo® annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

    Device Description

    The AnnuloFlo® System consists of an annuloplasty ring, and a prosthesis of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while retaining the native valve apparatus.

    The AnnuloFlo® annuloplasty ring employs materials with a long and satisfactory history of use in cardiovascular applications. All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI). The annuloplasty ring consists of a titanium stiffener ring enclosed in a sewing ring of silicone and knitted polyester fabric.

    The mitral AnnuloFlo® annuloplasty ring is kidney shaped. The curved posterior segment of the ring corresponds to the native posterior leaflet. The open segment of the ring corresponds to the anterior leaflet.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The text is a 510(k) summary and an FDA clearance letter for the AnnuloFlo® Annuloplasty System. It focuses on the device's description, intended use, indications for use, and a comparison to a predicate device for the purpose of demonstrating substantial equivalence for FDA clearance.

    The document does not contain details regarding:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for training sets.
    • How ground truth for training data was established.

    Therefore, I cannot fulfill your request with the given input.

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