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510(k) Data Aggregation

    K Number
    K980948
    Device Name
    VED VALU- VACUUM ERECTION DEVICE
    Manufacturer
    MISSION PHARMACAL COMP
    Date Cleared
    1998-06-25

    (104 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 VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.

    Vacuum Pump - used to create an erection in men with erectlie dysfunction by means of an applied vacuum to the penis, which draws blood into the penlle corpora cavernosa causing the penis to become erect and rigid.

    Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the ald of a vacuum pump.

    VED VALU and VED VALU ULTRA are designed to help you create an erection sufficient to penetrate the vagina and have sexual intercourse. They are intented for use by men who have full or parlal impotence. NOTE: Neither the VED VALU nor the VED VALU ULTRA is a contraceptive.

    Device Description

    The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding two vacuum erection devices, VED® VALU™ (Manual Pump) and VED® VALU™ (Electric Pump). This document primarily establishes that the devices are substantially equivalent to previously marketed devices and permits them to be marketed.

    It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter and the accompanying "Indications For Use" form do not detail performance metrics, sample sizes for testing, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

    Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance studies based on the provided text. The document is a regulatory approval letter, not a performance study report.

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