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510(k) Data Aggregation

    K Number
    K993868
    Device Name
    THE SOUNDVASER DISSECTION SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    1999-12-21

    (36 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K990430,K983316,K971302,K962584
    Why did this record match?
    Device Name :

    THE SOUNDVASER DISSECTION SYSTEM

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

    The SoundVASER Dissection System (Dissection Tips and Handpiece for The SoundVaser System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal injury.

    Device Description

    The SoundVASER Dissection System is comprised of an ultrasonic surgical handpiece and associated dissection tips. The ultrasonic surgical handpiece converts electrical energy supplied by the SoundVASER ultrasonic generator into vibratory motion. The vibratory motion is applied to the dissection tip that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip cuts and coagulates contacted soft tissues.

    AI/ML Overview

    This document describes a 510(k) submission for the SoundVASER Dissection System. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require clinical studies with acceptance criteria in the way a PMA (Premarket Approval) submission would.

    Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

    Instead, the document focuses on:

    • Predicate Devices: Identifying existing devices with similar technical design and operation that have already been cleared by the FDA.
    • Device Description: Explaining how the SoundVASER Dissection System works (ultrasonic surgical handpiece and dissection tips for cutting and coagulation of soft tissues).
    • Intended Use: Stating the purpose of the device.
    • Summary of Technological Characteristics: Arguing that the device is substantially equivalent to predicate devices based on design, operation, materials, sterilization, and intended use, thus creating no new safety or efficacy issues.

    In summary, this document is a substantial equivalence claim, not a report of a study designed to meet specific performance acceptance criteria.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study outcomes because that information is not present in the provided text.

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