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510(k) Data Aggregation

    K Number
    K031660
    Device Name
    FERRIS POLYMEM STERILE BREAST PAD
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    2005-02-22

    (636 days)

    Product Code
    NTX
    Regulation Number
    880.5630
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    NTX

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

    Over the Counter Use: To be worn inside the bra to:

    • Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding .
    • Absorb milk leakage .
    • Protect the nipple from abrasion and friction damage caused by bra or clothing .
    • Help alleviate discomfort .
    • Protect clothing from milk leakage .
    Device Description

    FERRIS PolyMem® STERILE BREAST PAD

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Ferris PolyMem® STERILE BREAST PAD". It does not describe acceptance criteria, a study proving device performance, or any of the other information requested in the prompt related to an AI/algorithm-based device.

    Therefore, I cannot provide the requested information from the given text.

    The document is a regulatory approval for a physical medical device (breast pad), not a software or AI-driven device that would involve performance metrics like accuracy, sensitivity, specificity, or studies with test sets, ground truth, or expert adjudications.

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