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510(k) Data Aggregation

    K Number
    K973565
    Device Name
    QUICK-CARE BIOPSY NEEDLE
    Manufacturer
    COOK, INC.
    Date Cleared
    1997-11-03

    (45 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUICK-CARE BIOPSY NEEDLE

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

    Used for soft tissue biopsy. Supplied sterile in peel-open packages. Intended for single procedure use.

    Device Description

    The Quick-Core™ Biopsy Needle is used for soft tissue biopsy procedures. The device will be constructed of stainless steel and polycarbonate in 14, 15, 16, 18, 19 and 20 gauge and 6, 9, 15, 20 and 48 cm lengths. It will be supplied sterile, intended for onetime use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a biopsy needle and provides general regulatory information from the FDA. It does not contain information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

    Therefore, I cannot fulfill your request for:

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

    The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics, rather than presenting a detailed performance study against defined acceptance criteria.

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