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510(k) Data Aggregation

    K Number
    K954272
    Device Name
    INNOVA RECTAL STIMULATON ELECTRODE
    Manufacturer
    EMPI
    Date Cleared
    1996-04-15

    (216 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K891773,K910081,K940091
    Why did this record match?
    Device Name :

    INNOVA RECTAL STIMULATON ELECTRODE

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

    The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of unnary incominence.

    Device Description

    The Innova Rectal Stimmlation Electrode assembly is a light-weight cylinder consisting of two conductive rings that are paired and isolated, physically. The cylinder is shaped with a waist and a handle for confort, positioning and ease in removing, It is watertight to allow for washing with socop and water between uses. The electrode is designed for repeated intermittent use in the home or clinic for up to one year by a single user. It does not require sterilization, but does require washing with soap and water and drying between uses.

    AI/ML Overview

    The provided text describes the "Innova Rectal Stimulation Electrode" and its performance in comparison to a predicate device, the "InCare Rectal Electrode."

    Here's an analysis of the acceptance criteria and study data based on the provided input:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance AspectInnova Rectal Electrode's Performance
    I. Product Verification and Validation:
    Leadwire placement and integrity"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Impedance"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Tensile strength"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Connection strength"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Flexion"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Label durability"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Surface integrity"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Material integrity (mechanical stability)"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Dimensions"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
    Material biocompatibility"Meets ISO 10993 and USP class VI"
    II. Clinical Performance (vs. InCare Rectal Electrode):
    Produce pelvic floor contraction equal to or greater than InCare Rectal ElectrodeAll subjects had pelvic muscle contractions using both electrodes that were of sufficient amplitude to produce an observable and measurable response at maximum comfortable intensity.
    Maximum comfortable current intensityInnova rectal electrode achieved significantly higher maximum comfortable current intensity (p
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