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510(k) Data Aggregation

    K Number
    K023432
    Device Name
    MEDLINE ASEP PLUS SURGICAL DRAPES
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2002-11-04

    (20 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ASEP™ Plus Back Surgical Drapes are used to cover accessory tables in the operating room The fluid repellent properties of the drapes aid in the control of microbial and other contamination.

    Device Description

    Medline ASEP™ Plus Reusable Surgical Drapes (Mayo Stand Cover and Back Table Cover)

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the Medline ASEP™ Plus Reusable Surgical Drapes. This document indicates the FDA's decision that the device is "substantially equivalent" to legally marketed predicate devices.

    Crucially, this document is a regulatory approval letter and not a study report. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in your prompt. The FDA's substantial equivalence determination for this type of device (surgical drapes) typically relies on material characteristics and performance against established industry standards for barrier properties, durability, and biological safety, rather than a "study that proves the device meets the acceptance criteria" in the way one would analyze a diagnostic or AI-driven device.

    Therefore, I cannot provide the requested information from the provided text. To answer your prompt, I would need a detailed study report or technical data sheet for the Medline ASEP™ Plus Reusable Surgical Drapes.

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