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510(k) Data Aggregation

    K Number
    K081459
    Device Name
    CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
    Manufacturer
    INTEGRA RADIONICS, INC.
    Date Cleared
    2008-08-13

    (82 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K071669,K042277,K021989
    Why did this record match?
    Reference Devices :

    K071669, K042277, K021989

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

    The CUSA Selector™ NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

    Device Description

    The CUSA Selector NXT Ultrasonic Surgical Aspirator consists of two components: System Console and Service Module. The System Console operates the full functions of the aspirator, but does not have an on-board aspiration source. The Service Module is an add-on that provides an integrated system look with a fully independent aspiration source. The product is being updated to improve usability and control technology within the system. It will utilize the existing set of Selector handpieces.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary for a medical device (CUSA Selector NXT Ultrasonic Surgical Aspirator Module) and primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use. It does not contain details about performance studies, sample sizes, expert involvement, or adjudication methods for verification/validation.

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