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510(k) Data Aggregation

    K Number
    K100862
    Device Name
    BODYFLOW P2CH
    Manufacturer
    PHYSIOMED ELEKTROMEDIZIN AG
    Date Cleared
    2011-04-21

    (388 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K003896
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bodyflow -P2CH is a powered muscle stimulator intended for

    • Increased local blood circulation
    • · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    Device Description

    The Bodyflow®-P2CH is a device which delivers muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by permanently installed, rechargeable batteries.

    AI/ML Overview

    This document describes the 510(k) premarket notification for the Bodyflow-P2CH, a powered muscle stimulator. The information provided heavily focuses on the device's regulatory classification, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Electrical Safety (IEC 60601-1): No specific quantitative criteria listed, but general safety related to electrical leakage current, electrode and lead wire safety, output current, and power density.The Bodyflow-P2CH "passed all of the applicable test" for electrical leakage current, electrode and lead wire safety, output current, and power density.
    Electromagnetic Compatibility (IEC 60601-1-2): No specific quantitative criteria listed.The Bodyflow-P2CH "passed all of the applicable test".
    Safety of Nerve and Muscle Stimulators (IEC 60601-2-10): No specific quantitative criteria listed.The Bodyflow-P2CH "passed all of the applicable test".
    Output Specifications, Device Design, Waveforms, and Programmability (for substantial equivalence to predicate device)Demonstrated to be "substantially equivalent" to predicate device (Physiomed's LymphaVision, K003896). The specific parameters of equivalence are not itemized.

    2. Sample Size Used for the Test Set and Data Provenance:

    The document does not describe a study involving human or animal subjects that would typically have a test set with a sample size. The performance testing appears to be limited to bench testing for electrical and safety standards. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

    This information is not provided as the submission describes bench testing for safety and electrical standards, not a diagnostic or treatment effectiveness study requiring expert-established ground truth.

    4. Adjudication Method for the Test Set:

    This information is not applicable as the document describes bench testing, not a study requiring adjudication of expert interpretations.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on regulatory compliance through bench testing and substantial equivalence.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    No, a standalone performance study in the context of an algorithm or AI is not applicable to this device. The Bodyflow-P2CH is a physical medical device (powered muscle stimulator), not an AI/algorithm-driven system.

    7. The Type of Ground Truth Used:

    The "ground truth" for the performance testing described is derived from compliance with international electrical and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical performance evaluation.

    8. The Sample Size for the Training Set:

    This information is not applicable. The device is a powered muscle stimulator, not an AI or machine learning model that requires a training set.

    9. How the Ground Truth for the Training Set Was Established:

    This information is not applicable for the same reasons as #8.

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