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510(k) Data Aggregation

    K Number
    K152178
    Device Name
    StimQ Peripheral Nerve Stimulator (PNS) System
    Manufacturer
    STIMQ LLC
    Date Cleared
    2016-03-11

    (220 days)

    Product Code
    GZF
    Regulation Number
    882.5870
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K150517,K141399,K934065,K883780,K000852
    Why did this record match?
    Device Name :

    StimQ Peripheral Nerve Stimulator (PNS) System

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

    The StimQ Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

    Device Description

    The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

    AI/ML Overview

    The provided text describes the StimQ Peripheral Nerve Stimulator (PNS) System and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study results in the format requested for an AI/ML device.

    The document is a 510(k) summary for a medical device (a peripheral nerve stimulator) that does not appear to be an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to older, legally marketed predicate devices through comparisons of technological characteristics, materials, and non-clinical performance testing against established standards.

    Therefore, I cannot extract the information required in your prompt's format from this document because it is not applicable. The device described is a hardware medical device, not an AI/ML algorithm.

    If you have a document describing an AI/ML powered medical device, I would be happy to analyze it for the requested information.

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