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510(k) Data Aggregation

    K Number
    K020848
    Device Name
    NAFD 100
    Manufacturer
    Date Cleared
    2002-09-23

    (192 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMATRIX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NAFD 100 (and its components) is indicated for the collection of nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells.
    Device Description
    The NAFD 100 is intended to non-invasively extract samples of breast cancer screening, providing a sample for a "Pap smear" for the breast. Virtually all breast cancers originate in the epithelial cells of fluid ducts that are present in a woman's breast. The case for routine, early breast screening is compelling. By the time a mammogram or manual clinical examination finds an abnormality, the cancerous lesion is already formed. The longer cancer has to develop in the body, it becomes stronger and more difficult to treat. A screening test using Nipple Aspirate Fluid (NAF) would be similar to a Pap smear, allowing a physician to detect abnormalities before a breast cancer is formed, or to screen for the possible presence of cancer. The routine use of the Pap smear has reduced the incidence of cervical cancer mortality by 70%, through early screening. Breast cancer screening could reasonably be expected to yield the same type of results. The NAFD 100 incorporates both hardware and disposable components, for use in a physician's office, and was developed to maximize patient comfort, and minimize risk to the patient. The system consists of three components: System console Powerhead Disposable patient interface
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