LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993777
    Device Name
    DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
    Manufacturer
    R-GROUP INTL.
    Date Cleared
    2000-05-25

    (199 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that mits an electrical current used to cut away the affected tiscues following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.

    Some indications for use are:

    • a. Cervical conizations
    • b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
    • c. External Anogenital Lesions
    • d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.
    Device Description

    Disposable Ball and Loop Electrodes

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device: "Disposable Ball and Loop Electrodes". This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed studies with acceptance criteria and performance data like those you'd find for novel high-risk devices or software as a medical device (SaMD).

    Therefore, the input document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or MRMC studies.

    The clearance letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA determined it is as safe and effective as a device already on the market. This often relies on comparing the new device's design, materials, and intended use to a predicate device, rather than requiring extensive clinical trials with specific performance metrics against pre-defined acceptance criteria.

    In summary, the provided document does not contain the study details, acceptance criteria, or performance data that you've asked for due to the nature of a 510(k) substantial equivalence determination.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1