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K Number
K222450
Device Name
LVIS NeuroMatch
Manufacturer
LVIS Corporation
Date Cleared
2023-06-09

(298 days)

Product Code
OMB,OLT,OLX,OMA
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

  1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. 2. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, Autocorrelation Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

  2. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKC) if it is provided in the EEG recording.

  3. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain.

  4. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements in EEG signals from the International Standard 10-20 placement. AR does not remove the entifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms.

  5. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Description

Not Found

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) clearance letter from the FDA for the LVIS NeuroMatch® device, outlining its indications for use and regulatory compliance.

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).