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K Number
K020218
Device Name
SNAP EEG MONITOR
Manufacturer
NICOLET BIOMEDICAL, INC.
Date Cleared
2002-04-22

(90 days)

Product Code
OLW,OMC,ORT
Regulation Number
882.1400
Type
Abbreviated
Panel
NE
Reference & Predicate Devices
K952347,K991054
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is used under the guidance and interpretation of a licensed medical professional.

Device Description

The SNAP device records and displays a processed EEG parameter called the SNAP Index, records and displays a time based trend of the SNAP Index and displays a real time EEG signal. The SNAP system has four significant components:

  1. A Visor SNAP module, which is inserted into the springboard slot of a Handspring Visor handheld computer.
  2. A disposable, single patient use SNAP Electrode for acquiring the EEG signal.
  3. A patient cable which connects the Visor SNAP module to the patient electrode.
  4. SNAP personal computer application software, which is provided for use on personal computers operating with Microsoft Windows® operating systems.
AI/ML Overview

The provided document is a 510(k) premarket notification for the Nicolet Biomedical SNAP EEG Monitor. This type of regulatory filing is focused on demonstrating substantial equivalence to existing predicate devices, rather than establishing new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and statistical performance measures.

Therefore, the document does not contain the information requested regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance for a specific study proving it meets acceptance criteria.
  • Type of ground truth used for such a study.
  • Training set sample size or how its ground truth was established.

Instead, the document states:

  • Intended Use: The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is a prescription device used under the guidance and interpretation of a licensed medical professional. This is consistent with the classification 21 CFR 882.1400, Electroencephalograph.
  • Technological Equivalence: "The technology of the SNAP device is equivalent to other EEG monitoring devices. The EEG signal is acquired in analog format, digitized and presented to the user for interpretation. The SNAP device includes an EEG trended parameter of the power spectrum of the EEG signal, SNAP Index."
  • Conclusion of Substantial Equivalence: "The indications, intended use and technology of the SNAP device is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." The predicate devices listed are the ASPECT Medical Inc. A-1050 EEG Monitor (K952347) and the Nicolet Biomedical Bravo Endeavor Multi-Modality System (K991054).

The FDA's letter explicitly confirms "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

In summary, the provided text does not describe a study to prove acceptance criteria for device performance, but rather lays out the basis for substantial equivalence to predicates, which is the regulatory pathway taken.

§ 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).