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510(k) Data Aggregation

    K Number
    K974768
    Device Name
    PDI STERILE LUBRICATING JELLY
    Manufacturer
    NICE-PAK PRODUCTS, INC.
    Date Cleared
    1998-01-16

    (25 days)

    Product Code
    KMJ,DAT
    Regulation Number
    880.6375
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NICE-PAK PRODUCTS, INC.

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

    PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as a catheter, enema tip, or endoscope). The device is intended for use on order of a physician.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a sterile lubricating jelly. It primarily discusses the regulatory approval of the device and its intended use.

    This document does not contain information about:

    • Acceptance criteria and reported device performance from a study.
    • Sample sizes, data provenance, or details about test sets.
    • The number of experts or their qualifications for establishing ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance studies.
    • The type of ground truth used.
    • Sample size for the training set or how its ground truth was established.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text.

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