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510(k) Data Aggregation

    K Number
    K011676
    Device Name
    VIVAWAVE MICROWAVE SYSTEM
    Manufacturer
    VIVANT MEDICAL, INC.
    Date Cleared
    2002-06-18

    (384 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K864413,K861904,K981672,K962313,K962692
    Why did this record match?
    Device Name :

    VIVAWAVE MICROWAVE SYSTEM

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

    The VivaWave™ Microwave System is intended for coagulation of soft tissue

    Device Description

    The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector.

    The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic.

    The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.

    The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The provided document is a 510(k) premarket notification letter from the FDA, a summary of the device, its intended use, and a comparison to predicate devices for substantial equivalence.

    It outlines:

    • The device name: VivaWave™ Microwave System
    • Its intended use: Coagulation of soft tissue.
    • That it consists of an external microwave generator and a probe.
    • Electrical safety, electromagnetic compatibility, and biocompatibility testing were performed to comply with standards (EN60601-1, EN60601-1-2, ISO 10993).

    However, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details on sample size, data provenance, or expert involvement in any studies.
    3. Information on adjudication methods.
    4. Data from multi-reader multi-case (MRMC) comparative effectiveness studies.
    5. Standalone algorithm performance.
    6. Specifics on ground truth establishment or training set details.

    The document primarily focuses on establishing substantial equivalence to previously marketed devices based on indications for use, basic function, manufacturing methods, and materials, rather than presenting detailed performance study results against specific acceptance criteria.

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