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510(k) Data Aggregation

    K Number
    K983246
    Device Name
    POS-T-VAC (IVP-600)
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1998-11-02

    (47 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POS-T-VAC (IVP-600)

    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 based on the provided text, there is no information available regarding the acceptance criteria for the POS-T-VAC (IVP-600) Vacuum Erection Device or any studies conducted to prove it meets such criteria.

    The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter primarily focuses on the regulatory authorization to market the device and its indications for use. It does not contain detailed performance data, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

    Therefore, I cannot provide the requested table or answer the specific questions about the study design, ground truth, or expert involvement based solely on this document.

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