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510(k) Data Aggregation

    K Number
    K090866
    Device Name
    NEUROCALM MODEL 1 AND 2
    Manufacturer
    NEUROMED DEVICES, INC
    Date Cleared
    2009-10-21

    (204 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K072123,K071120
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NeuroCalm Transcutaneous Electrical Nerve Stimulator Device is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

    Device Description

    The NeuroCalm device is a battery-powered portable TENS device intended for the relief of chronic intractable pain and adjunctive treatment of postsurgical or post-traumatic acute pain. The device is small, portable and lightweight. The device is available in two configurations: Model 1 and Model 2. The Model 1 configuration provides a 10-second treatment using a proprietary wave form while Model 2 provides a 35-second treatment using a slightly different waveform to alleviate pain. The NeuroCalm TENS device is powered by a 12-volt battery. The power source provides ample power for the 10-course treatment. The device has a two-year shelf life. Treatment is provided by passing AC and DC current through noble metal (gold) electrodes. Treatment cycles are controlled by software-controlled printed circuit board assemblies. Electrical output and waveforms are optimized depending on the treatment duration desired. A complete course of treatment consists of a 10 x 10-second treatment for Model 1 and a 10 x 35second treatment for Model 2. After the conclusion of the tenth treatment, the device is inoperable and may be discarded (discard as one would discard a battery).

    AI/ML Overview

    The provided text describes a Traditional 510(k) Summary for the NeuroCalm Transcutaneous Nerve Stimulator (TENS) Device. The 510(k) pathway establishes substantial equivalence to predicate devices, rather than requiring extensive clinical trials to "prove" meeting acceptance criteria in the same way a PMA (Premarket Approval) process would. Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, and ground truth establishment, as typically found in clinical performance studies, is largely not present in this type of submission.

    Here's a breakdown of what can be extracted and what is missing based on your request:

    Acceptance Criteria and Reported Device Performance

    The NeuroCalm TENS device is deemed substantially equivalent based on its intended use, design, and function being similar to predicate devices. The "acceptance criteria" here implicitly relates to proving this substantial equivalence, primarily by demonstrating similar electrical output, waveforms, and pain relief mechanisms.

    Acceptance CriteriaReported Device Performance
    Intended Use Equivalence: Symptomatic relief and management of chronic, intractable pain; Management of post-surgical pain; Management of post-traumatic pain.The NeuroCalm device is indicated for "symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain," which directly matches the intended use of predicate TENS devices.
    Design and Function Equivalence: TENS device that provides pain relief by generating small electrical currents of varying waveforms; battery-powered; software-controlled."NeuroMed Corporation's TENS device... are similar in intended use, design and function. All are TENS devices... and provide pain relief by generating small electrical currents of varying waveforms applied directly to the area experiencing pain. The proposed and predicate devices share the same regulatory classification (Class II, classification code GZJ), are battery powered, and are all software-controlled TENS units that provide the user with pain reduction."
    Regulatory Classification Equivalence: Class II, product code GZJ.The NeuroCalm device holds the same regulatory classification (Class II, product code GZJ) as the predicate devices.
    Performance (Implicit): Expected to provide pain relief similar to predicate TENS devices.The submission states that the device "provides the user with pain reduction," drawing equivalence to predicate devices which also perform this function. Specific performance metrics (e.g., pain reduction scores) are not provided as this is a 510(k) substantiation.
    Technical Specifications (Implicit): Output parameters (waveform, current, voltage) comparable to predicate devices."...generate small electrical currents of varying waveforms..." This implies technical comparison, but specific parameters, and how they meet "acceptance criteria" through a study, are not detailed in this summary. Model 1 provides a 10-second treatment with a proprietary waveform, and Model 2 provides a 35-second treatment using a slightly different waveform.

    Information Not Available in the Provided Text:

    The nature of a 510(k) summary, particularly for a TENS device, focuses on substantial equivalence rather than a full clinical trial with performance metrics against pre-defined acceptance criteria. Therefore, the following information is not present in the provided document:

    1. Sample size used for the test set and the data provenance: No clinical performance study on a "test set" is described. The basis for substantial equivalence relies on comparison to predicate devices, not new clinical data with a test set.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no described clinical test set requiring ground truth establishment by experts.
    3. Adjudication method for the test set: Not applicable for the same reason as above.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a TENS unit, not an AI-assisted diagnostic or interpretive tool.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a TENS unit, not an algorithm.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no ground truth for a clinical study is established or needed for this 510(k) submission.
    7. The sample size for the training set: Not applicable, as there is no training set mentioned in the context of a clinical study or AI model.
    8. How the ground truth for the training set was established: Not applicable for the same reason as above.

    In summary, this 510(k) application for the NeuroCalm TENS Device relies on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria, sample sizes, and ground truth establishment as would be required for novel or high-risk devices. The "study" here is primarily a technical and functional comparison to existing, cleared devices.

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