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510(k) Data Aggregation

    K Number
    K201244
    Device Name
    Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
    Manufacturer
    TransMed7, LLC
    Date Cleared
    2020-08-07

    (91 days)

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

    The Concorde Models Concorde ST Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.

    The Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including brostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissologic examination, with partial or complete removal of the imaged abnormality.

    The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. 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

    Not Found

    AI/ML Overview

    The provided text describes the FDA's 510(k) clearance for the TransMed7, LLC Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices. It focuses on regulatory and intended use information but does not contain any data or details regarding acceptance criteria, device performance, study design, or ground truth establishment for a medical device that utilizes artificial intelligence or machine learning.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the necessary information is completely absent from the provided text.

    The document is a standard FDA 510(k) clearance letter for a physical medical device (biopsy instruments), not an AI/ML-powered device. Information about acceptance criteria, performance studies, sample sizes, expert ground truth, or MRMC studies would typically be found in detailed premarket submission documents or clinical trial reports, which are not included here.

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