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510(k) Data Aggregation

    K Number
    K072261
    Device Name
    FINESSE SYSTEM
    Manufacturer
    PRIMAEVA MEDICAL, INC.
    Date Cleared
    2007-12-26

    (134 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K000944,K003183,K981870,K984552
    Why did this record match?
    Device Name :

    FINESSE SYSTEM

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

    The Primaeva Medical Finesse System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

    Device Description

    The Primaeva Medical Finesse System is comprised of four primary components; an RF Generator with User Interface Software, a Cooling System Hand Piece, a Cooler Controller, and a disposable Electrode Insertion Device with an integrated cable. RF energy is delivered from the RF Generator, through the electrodes, and into the target tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs. The RF Generator, Cooler Controller, and Cooling System Hand Piece are not disposable. Each Electrode Insertion Device is supplied sterile and is for single patient use only and cannot be re-sterilized. The insertion device is a hand-held mechanical device that is used to insert the electrodes, at an acute angle, into the target tissue. The device has ten (10) electrodes arranged in a single row array. The device has a mechanism to deploy and retract the electrodes when actuated by the user. There is a cable with a connector that connects to the RF Generator. The Cooler system comprises a solid state cooling device with a feedback loop to monitor and control temperature. The cooling device is placed on the tissue surface during the treatment cycle. The RF Generator is the energy source for the system. Accessory cables and power cords are also supplied with the system.

    AI/ML Overview

    There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Primaeva Medical Finesse System, which outlines the device's description, intended use, and comparison to predicate devices for substantial equivalence. It also includes the FDA's clearance letter.

    Therefore, I cannot provide the requested table or information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for acceptance criteria.

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