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510(k) Data Aggregation

    K Number
    K981428
    Device Name
    ANU ICE
    Manufacturer
    CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC.
    Date Cleared
    1998-07-07

    (78 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC.

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

    The device use is the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal Tissues. By applying cold to the tissue, the INFLAMMATION IS REDUCED -THE CAP SECTION IS USED FOR THE TREATMENT OF EXTERNAL HEMORRHOIDS AND THE TUBE SECTION FOR THE TREATMENT OF INTERNAL HEMORRHOIDS. THE LUBRICANT IS USED TO EASE THE INTRODUCTION. OF THE TUBE INTO THE RECTUM.

    Device Description

    ANUICE -COLD PACK, PLASTIC APPLICATO MEDICAL GRADE - NON-CHOMICA

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "ANUICE -COLD PACK, PLASTIC APPLICATOR, MEDICAL GRADE - NON-CHEMICAL". It details the regulatory approval process but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes and data provenance for the test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance study details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is a regulatory approval notice, not a study report.

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