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510(k) Data Aggregation

    K Number
    K182369
    Device Name
    gammaCore Sapphire
    Manufacturer
    Electrocore, Inc.
    Date Cleared
    2018-11-27

    (88 days)

    Product Code
    PKR,QAK
    Regulation Number
    882.5892
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K173442,K180538
    Predicate For
    K191830
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

    • · Adjunctive use for the preventive treatment of cluster headache in adult patients.
    • · The acute treatment of pain associated with episodic cluster headache in adult patients.
    • · The acute treatment of pain associated with migraine headache in adult patients.
    Device Description

    The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).

    The gammaCore Sapphire:

    • . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
    • . Provides visible (light and display) and audible (beep) feedback regarding device and stimulation status.
    • . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
    • . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
    • Indicates on the display the number of remaining doses available in a 24-hour period. ●
    AI/ML Overview

    The provided documentation describes the gammaCore Sapphire (non-invasive vagus nerve stimulator), which is indicated for:

    • Adjunctive use for the preventive treatment of cluster headache in adult patients.
    • The acute treatment of pain associated with episodic cluster headache in adult patients.
    • The acute treatment of pain associated with migraine headache in adult patients.

    The information primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance benchmarks against a gold standard for a diagnostic AI device. However, based on the clinical study presented, we can infer a primary efficacy outcome as an "acceptance criteria" and the reported device performance from that study.

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred from Primary Endpoint)Reported Device Performance (SoC + nVNS group vs. Control)
    Significantly greater reduction in the mean number of Cluster Headache (CH) attacks per week.Study Outcome: Mean reduction of 5.9 CH attacks per week for SoC + nVNS vs. 2.1 for Control.
    Therapeutic Gain: 3.9 fewer attacks per week (95% CI: 0.5, 7.2; P=0.02).
    Higher 50% responder rates (proportion of subjects with ≥50% reduction in CH attacks).Study Outcome: 40% responder rate for SoC + nVNS vs. 8.3% for Control (P
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