LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120587
    Device Name
    AMT T-FASTENER ANCHOR KIT
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2012-05-25

    (88 days)

    Product Code
    KGC
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device (AMT T-Fastener Anchor Kit), which indicates the device is substantially equivalent to legally marketed predicate devices.

    While it mentions the device and its intended use, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).

    This type of information is typically found in the scientific and clinical sections of a 510(k) submission, which are not provided in this document. The letter itself is a regulatory outcome, not the study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1