LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153224
    Device Name
    VitalStim(R) Plus Electrotherapy System
    Manufacturer
    DJO, LLC
    Date Cleared
    2016-02-17

    (103 days)

    Product Code
    IPF,HCC
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K070425
    Why did this record match?
    Device Name :

    VitalStim(R) Plus Electrotherapy System

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

    For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
    Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

    Device Description

    The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/algorithm-based device. Therefore, many of the requested points, especially those related to AI system validation (e.g., sample size for test datasets, expert ground truth, MRMC studies), are not applicable to this type of submission.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device for an electrotherapy system, mainly through bench testing and technical comparisons, rather than clinical performance studies against a "ground truth" derived from expert consensus or pathology, as would be common for AI-driven diagnostic tools.

    Acceptance Criteria and Device Performance (for an Electrotherapy System)

    Since this is an electrotherapy system and not an AI/algorithm, the "acceptance criteria" are related to safety, electrical performance, and electromagnetic compatibility. The "reported device performance" demonstrates compliance with these standards.

    Table of Acceptance Criteria and Reported Device Performance

    Category / CharacteristicAcceptance Criteria (Standard / Requirement)Reported Device Performance
    Electrical SafetyIEC 60601-1 for basic safety and essential performanceComplied. The device was tested and found to comply with IEC 60601-1.
    EM CompatibilityIEC 60601-1-2 for electromagnetic compatibilityComplied. The device was tested and found to comply with IEC 60601-1-2.
    UsabilityIEC 60601-1-6 for usabilityComplied. The device was tested and found to comply with IEC 60601-1-6.
    Home HealthcareIEC 60601-1-11 for home healthcareComplied. The device was tested and found to comply with IEC 60601-1-11.
    Nerve/Muscle Stim.IEC 60601-2-10 for performance of nerve and muscle stimulatorsComplied. The device was tested and found to comply with IEC 60601-2-10.
    FCC RequirementsFCC Part 15 Subpart B:2008 Class BComplied. The device was tested to FCC requirements and found to comply with FCC Part 15 Subpart B:2008 Class B.
    FCC CFR Title 47 Part 15 Subpart CComplied. The device was tested to FCC requirements and found to comply with FCC CFR Title 47 Part 15 Subpart C.
    Software ValidationFDA's guidance document: General Principles of Software Validation, Jan 2002Verified. The device's software was verified in accordance with the requirements, and "software testing demonstrated that the software meets its design requirements."
    Wireless CoexistencePerformance in environment with other 2.4 GHz wireless devices (Bluetooth, Wi-Fi)Met all specified requirements. "The performance of VitalStim® Plus Electrotherapy System was evaluated in an environment with other VitalStim device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements."
    Patient Leakage Current
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1