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510(k) Data Aggregation

    K Number
    K110566
    Manufacturer
    Date Cleared
    2011-06-24

    (116 days)

    Product Code
    Regulation Number
    884.5960
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Viberect™ Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction and to provoke ejaculation for spinal cord injured men.

    Device Description

    The Viberect™ Penile Vibratory Stimulation Device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis, as a form of sexual aid, or for the purpose of activating several nerve reflexes that men are born with which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.

    The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating gel pads, made up of polyurethane soft pads. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating heads. Therefore, the user activates and deactivates the device by hand pressure alone (i.e., no switches need to be pushed). Vibratory stimulation for approximately 7-10 minutes is recommended. The touch pad provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Viberect™ Penile Vibratory Stimulation Device:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state specific quantifiable acceptance criteria for the Viberect™ device beyond "substantially equivalent" to predicate devices. The performance data is primarily focused on demonstrating this substantial equivalence.

    Acceptance Criteria (Implied)Reported Device Performance
    Biocompatibility: Non-toxic and no adverse reaction when implanted (for patient-contacting material).The polyurethane (patient-contacting material) was shown to be nontoxic and did not cause an adverse reaction when implanted for five days in USP In Vivo Biological Reactivity Tests (Class VI Plastics Tests), including Intracutaneous and Systemic Toxicity testing.
    Functional Equivalence: Actual penile stimulation.The Viberect™ has been shown to be substantially equivalent to the predicate device (Ferticare Personal Therapeutic Vibrator, K955589) in terms of actual penile stimulation (i.e., amount of penis actually stimulated) for spinal cord injured men.
    Safety: Benefit outweighs potential risks.A comprehensive Risk Analysis confirmed that the benefits of the Viberect™ Device outweigh all potential risks.
    Indications for Use: Ability to provoke erections and ejaculation based on predicate uses.The Viberect™ IFU encompasses those listed for the predicate devices, both provoking penile erection and ejaculation in men with erectile dysfunction and men with spinal cord injuries. The document states that "any differences in technological characteristics... do not raise issues of safety and effectiveness." This implies the device must effectively achieve these indications.

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: The document only mentions "spinal cord injured men" in the context of the performance testing but does not specify the sample size for this test.
    • Data Provenance: Not explicitly stated. Given the context of a 510(k) submission, it is likely the data was generated specifically for this application, but whether it was retrospective or prospective, or the country of origin, is not mentioned.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    This information is not provided in the document. The study's methodology for determining "actual penile stimulation" or the outcome of the risk analysis is not detailed enough to identify the involvement or qualifications of experts.

    4. Adjudication Method for the Test Set

    This information is not provided.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.

    6. Standalone (Algorithm Only) Performance Study

    No, a standalone algorithm performance study was not done. The Viberect™ is a medical device, not an AI algorithm. The performance testing described relates to the device's physical and functional capabilities.

    7. Type of Ground Truth Used

    The "ground truth" for the device's performance appears to be established through:

    • Biocompatibility testing: Laboratory assays (USP In Vivo Biological Reactivity Tests).
    • Functional performance: Comparison to a predicate device in terms of "actual penile stimulation." The method for objectively measuring this "actual penile stimulation" is not described, so the specific ground truth (e.g., physiological measurements, expert assessment) is unclear.
    • Risk Analysis: Expert assessment based on industry standards and engineering principles.

    8. Sample Size for the Training Set

    This information is not applicable/provided. The Viberect™ is a physical medical device, not an AI algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable/provided as there is no training set for a medical device in this context.

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