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510(k) Data Aggregation

    K Number
    K981506
    Device Name
    RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
    Manufacturer
    REPRO-MED SYSTEMS, INC.
    Date Cleared
    1998-06-25

    (59 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K841257,K974173,K904485
    Why did this record match?
    Reference Devices :

    K841257, K974173, K904485

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows.

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

    Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

    Device Description

    The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification summary for the RESTORE Vacuum Erection Device from 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

    Therefore, this document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document states that the RESTORE Vacuum Erection Device is "substantially equivalent" to predicate devices based on:

    • Technological Characteristics: The vacuum pump is stated to be substantially equivalent to the Erecaid System Classic (K841257) and Erecaid System / Stay Erec System (K974173). The constriction rings are identical to the Pro-Long rings (K904485).
    • Manufacturing: Repro-Med Systems, Inc. manufactured the predicate Osbon products.
    • Materials: All component materials are identical to the named predicate devices.

    The FDA's letter (K981506) confirms this finding of substantial equivalence, allowing the device to be marketed. This regulatory pathway typically relies on existing data or equivalence to devices already proven safe and effective, rather than new, independent clinical trials with explicit acceptance criteria.

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