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510(k) Data Aggregation

    K Number
    K102756
    Device Name
    SURECORE BIOPSY DEVICE
    Manufacturer
    CHEST INNOVATIONS INC
    Date Cleared
    2011-11-29

    (432 days)

    Product Code
    KNW,GEI
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K050737,K101832
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

    The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

    Device Description

    The SureCore™ Biopsy Device is an electrosurgical breast tissue biopsy device that is shipped sterile and intended for single use.

    AI/ML Overview

    The provided text describes a 510(k) summary for the SureCore™ Biopsy Device. It does not include information about acceptance criteria or a study that specifically addresses acceptance criteria for AI/ML device performance. This document is for a medical device (a biopsy instrument), not an AI/ML device.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and the reported device performance.
    • Sample size used for the test set and the data provenance.
    • Number of experts used to establish the ground truth.
    • Adjudication method.
    • Multi-reader multi-case (MRMC) comparative effectiveness study information.
    • Standalone performance information.
    • Type of ground truth used.
    • Sample size for the training set.
    • How the ground truth for the training set was established.

    This document focuses on substantiating equivalence to predicate devices through comparisons of intended use, technological characteristics, and non-clinical performance studies (device tensile strength, in-vitro device performance, electrical safety, electromagnetic compatibility, electrical safety for endoscopic equipment, sterility testing, shelf life testing, biocompatibility, and in-vivo animal device performance).

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