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510(k) Data Aggregation

    K Number
    DEN140020
    Device Name
    ECLIPSE SYSTEM
    Manufacturer
    PELVALON
    Date Cleared
    2015-02-12

    (233 days)

    Product Code
    PJH
    Regulation Number
    876.5930
    Type
    Direct
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.

    Device Description

    The Eclipse System is a device intended to treat women with fecal incontinence (FI), also referred to as "accidental bowel leakage", or "bowel control disorder". The Eclipse System contains the Eclipse Insert and the Pump, including Regulator. The Eclipse Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum (Figure 1). The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse Insert consists primarily of a silicone and stainless steel base with an inflatable silicone balloon. The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements.

    AI/ML Overview

    "The Eclipse System is designed to treat fecal incontinence in adult women. The acceptance criteria and the study proving the device meets these criteria are detailed below:

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Eclipse System were primarily focused on its effectiveness in reducing fecal incontinence (FI) episodes, safety, and specific bench testing parameters.

    Attribute(s)Acceptance CriteriaReported Device Performance
    Clinical EffectivenessPrimary Endpoint: ≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period compared to baseline.Primary Endpoint: 79% of subjects (ITT Cohort, n=61) reported ≥50% reduction in FI episodes (95% CI 66-88%, p
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