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510(k) Data Aggregation

    K Number
    K961246
    Device Name
    SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Date Cleared
    1997-02-14

    (319 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K014037
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Seguin Annuloplasty Ring is indicated for use in repair of diseased or damaged mitral heart valves that are determined by the Physician to be repairable and do not require replacement. The Seguin Annuloplasty Ring provides support to the mitral heart valve restricting expansion of the annulus.

    Device Description

    The Seguin is a semi-rigid annuloplasty ring fabricated from an ultra-high molecular weight polyethylene (PE) core surrounded by a custom Dialine® polyester sewing ring. The PE core is covered with a knitted polyester material providing a means for attaching the ring to the heart annulus as well as a suitable surface for tissue ingrowth.

    AI/ML Overview

    The provided text describes the 510(k) Summary for the St. Jude Medical (SJM) Seguin Annuloplasty Ring, which is intended for use in the repair of diseased or damaged mitral heart valves. The summary aims to demonstrate substantial equivalence to the predicate device, the Carpentier-Edwards Physio™ annuloplasty ring.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it frames the "acceptance" as demonstrating substantial equivalence to the predicate device. The performance is reported by stating that the Seguin Annuloplasty Ring has similar or substantially equivalent characteristics and performance to the Physio™ annuloplasty ring.

    Characteristic / TestAcceptance Criteria (Implicit)Reported Device Performance (Seguin Annuloplasty Ring)
    Product LabelingSubstantially Equivalent to Predicate DeviceSimilar Indications for Use, contraindications, warnings, precautions, etc., as the Physio™ annuloplasty ring.
    Intended UseIdentical to Predicate DeviceIdentical to the Physio™ annuloplasty ring: repair of diseased or damaged mitral valves determined by Physician to be repairable.
    Physical CharacteristicsSubstantially Equivalent to Predicate Device (kidney-shaped, core for flexibility/rigidity, covered in polyester fabric, similar size range)Kidney-shaped, polymer core for flexibility/rigidity, covered in knitted polyester material. Available in 26mm-40mm (Physio™: 24mm-40mm). Utilizes sizing obturators.
    Anatomical SitesIdentical to Predicate DeviceIntended for use in the mitral valve, identical to the Physio™ annuloplasty ring.
    Target PopulationIdentical to Predicate DeviceIdentical to the Physio™ annuloplasty ring: patients of all ages with diseased or damaged mitral valves.
    Performance TestingSubstantially Equivalent to Predicate DeviceDemonstrated capability of adequately repairing diseased or damaged mitral valves, similar to the Physio™ annuloplasty ring.
    Safety CharacteristicsSubstantially Equivalent to Predicate DeviceCapable of withstanding stresses well beyond in-vivo experience, biocompatible, and non-toxic, similar to the Physio™ annuloplasty ring.
    Evaluation of Mitral Annulus (Deflections)Expected orifice reduction between 2.9% (rigid) and 10% (flexible) for severe cardiac cycle.Expected orifice reduction between 10% and 2.9% during severe cardiac cycle, similar to semi-rigid predicate.
    Theoretical Failure Analysis (Stress Magnitudes)Worst case physiological loads
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