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510(k) Data Aggregation

    K Number
    K180211
    Device Name
    Freezpoint
    Manufacturer
    Bovie Medical Corp.
    Date Cleared
    2018-03-21

    (55 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K102006
    Why did this record match?
    Device Name :

    Freezpoint

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

    The Freezpoint device is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.

    The List below shows examples of the types of lesions that may be treated:

    • Molluscum Contagiosum
    • · Skin Tags
    • Actinic Keratosis
    • · Lentigo
    • Verruca Plana
    • · Verruca Vulgaris
    • Verruca Plantaris
    • · Genital Lesions
    • · Seborrheic Keratosis
    Device Description

    The Freezpoint device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses an 8g or 16g cartridge of nitrous oxide. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N20 (-89ºC).

    AI/ML Overview

    The Freezpoint device is a cryosurgical unit that uses liquid nitrous oxide to destroy tissue by applying cryogenic gases at extremely low temperatures. The following information outlines the acceptance criteria and the study conducted to prove the device meets these criteria, as derived from the provided 510(k) summary.

    I. Acceptance Criteria and Reported Device Performance

    The primary acceptance criteria for the Freezpoint device, based on its comparison to the predicate device CryOmega, revolved around demonstrating equivalent performance in key functional aspects: the amount of cryogen dispensed and the temperature achieved.

    Acceptance CriteriaReported Device Performance (Freezpoint)Predicate Device Performance (CryOmega)
    Amount of gas dispensed per unit of timeCalculated as
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