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510(k) Data Aggregation

    K Number
    K012662
    Device Name
    SE-100 VACUUM ERECTION DEVICE
    Manufacturer
    VTS, INC.
    Date Cleared
    2001-11-09

    (88 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    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 intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "SE-100 Vacuum Erection Device."
    This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details would typically be found in the 510(k) submission itself, not in the clearance letter.

    Therefore, I cannot provide the requested information based on the given text.

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