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510(k) Data Aggregation

    K Number
    K012639
    Device Name
    SE-300 VACUUM THERAPY SYSTEM
    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

    SE-300 Vacuum Therapy System

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a medical device (SE-300 Vacuum Therapy System) and an "Indications for Use" statement. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    However, this document does not contain any information about acceptance criteria, study details, device performance data (beyond its intended use), sample sizes, ground truth establishment, or expert qualifications that would be necessary to fulfill your request. The letter is purely an administrative clearance, not a clinical study report.

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