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510(k) Data Aggregation

    K Number
    K050272
    Device Name
    CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
    Manufacturer
    CRYOMEDICAL INSTRUMENTS, LTD.
    Date Cleared
    2005-03-24

    (48 days)

    Product Code
    GXH
    Regulation Number
    882.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRYOMEDICAL INSTRUMENTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cryo-PaC™ systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.
    Device Description
    The Cryo-PaCTM systems comprise a choice of three versions of a cryoanalgesia console: the base model Cryo-PaCTM, and the Cryo-PaCTM Plus and Cryo-PaCTM Ultra; all based on the same control module but providing a range of features for the control of the cryogen gas. The consoles are complemented by a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. The Cryo-PaC™ console is used to control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable. In the Cryo-PaC™ systems, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the Joule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freczing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the Cryo-PaC™ consoles facilitate the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain. The Cryo-PaC™ consoles have been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. In the Cryo-PaCTM Plus and Ultra models the console includes a pedestal that provides a convenient small footprint mobile base for the system, and houses the gas tanks. A simple footswitch completes the system.
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