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510(k) Data Aggregation

    K Number
    K182049
    Device Name
    exCellerator Cervical Collection Device
    Manufacturer
    ExCell Company LLC
    Date Cleared
    2019-04-25

    (268 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    K861389
    Why did this record match?
    Applicant Name (Manufacturer) :

    ExCell Company LLC

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

    The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.

    Device Description

    The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure. Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Device: ExCellerator Cervical Collection Device
    Purpose: Cervical spatula for collecting ectocervical specimens for ThinPrep Pap test and aiding transfer of endocervical brush specimens.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document describes several types of testing with acceptance criteria.

    Biocompatibility Assessments:

    AssessmentTestAcceptance CriteriaReported Device Performance
    CytotoxicityMEM Elution Cytotoxicity Assay (ISO)Non-CytotoxicPassed (Non-Cytotoxic)
    IrritationVaginal Mucosal Irritation Test (ISO)Non-IrritantPassed (Non-Irritant)
    SensitivityGuinea Pig Maximization Test (ISO)Non-sensitizerPassed (Non-sensitizer)

    Structural Assessments:

    AssessmentTest PerformedAcceptance CriteriaControl ModeGroupReported Device Performance
    Static BendStatic Cantilever Bend7 yearsNot explicitly statedNot explicitly statedSuccessfully Assessed

    Dimensional Assessments:

    Measurement (inches)Acceptance CriteriaReported Device Performance
    Length
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