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510(k) Data Aggregation

    K Number
    K980211
    Device Name
    MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-02-06

    (16 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K962977
    Why did this record match?
    Device Name :

    MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

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

    These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.

    The breast localization needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

    Device Description

    The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.

    The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.

    AI/ML Overview

    The provided text pertains to a 510(k) submission for various medical needles (biopsy and breast localization needles) and focuses on the "Substantial Equivalence" claim, rather than a study demonstrating performance against specific acceptance criteria for a novel device. The document identifies substantially equivalent predicate devices but does not detail a study conducted to prove the performance of the new device.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this type of performance study data. The 510(k) summary explicitly states "SUBSTANTIAL EQUIVALENCE" and lists predicate devices, indicating the regulatory pathway chosen.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for a test set or data provenance.
    3. Number of experts or their qualifications for ground truth establishment.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
    6. Stand-alone algorithm performance data.
    7. The type of ground truth used in a performance study.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.
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