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    K Number
    K171446
    Device Name
    Cefaly Acute
    Manufacturer
    CEFALY Technology
    Date Cleared
    2017-09-15

    (122 days)

    Product Code
    PCC
    Regulation Number
    882.5891
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K160237
    Why did this record match?
    Device Name :

    Cefaly Acute

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

    Cefaly® Acute is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.

    Device Description

    The Cefaly® Acute device is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Cefaly® Acute is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 60 minutes.

    AI/ML Overview

    This document describes the Cefaly® Acute device and its substantial equivalence to a predicate device (Cefaly®). It includes a summary of a clinical trial used to support its safety and efficacy.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" for the device's performance in a table format with specific numerical targets. However, the primary outcome of the clinical study serves as the de-facto performance measure demonstrating efficacy. The performance of the Cefaly® Acute is compared against a sham group.

    Acceptance Criteria (Implied)Reported Device Performance (Cefaly® Acute)Reported Device Performance (Sham Group)Statistical Significance
    Reduction in pain score from baseline to 1 hourMean change in VAS pain score: -3.46 ± 2.32Mean change in VAS pain score: -1.78 ± 1.89Statistically significant (p
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