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:

A Visor SNAP module, which is inserted into the springboard slot of a Handspring Visor handheld computer.
A disposable, single patient use SNAP Electrode for acquiring the EEG signal.
A patient cable which connects the Visor SNAP module to the patient electrode.
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.

Summary

{0}------------------------------------------------

K0202-18

APR 2 2 2002

Summary of Safety and Effectiveness

Company Name:	Nicolet Biomedical5225 Verona RoadMadison, WI 53711
Contact:Phone:Fax:	Glen Hermanson, Manager of Standards and Compliance608 441-2065608 441-2007
Summary Date:	January 17, 2002
Trade Name:	SNAP
Common Name:	EEG Monitor
Classification Name:	21 CFR 882.1400; Product Code: OLW, OMC, ORT
Predicate Device(s):
	510(k) Number: K952347
	Manufacture: ASPECT Medical Inc.
	Trade Name: A-1050 EEG Monitor
	510(k) Number: K991054
	Manufacture: Nicolet Biomedical
	Trade Name: Bravo Endeavor Multi-Modality System

Description of Device 1.0

1. A Visor SNAP module, which is inserted into the springboard slot of a Handspring Visor handheld computer.
A disposable, single patient use SNAP Electrode for acquiring the EEG signal. 2.
1. A patient cable which connects the Visor SNAP module to the patient electrode.

...

Page 46

{1}------------------------------------------------

1. SNAP personal computer application software, which is provided for use on personal computers operating with Microsoft Windows® operating systems.

2.0 Intended Use

The intended use of the SNAP device is consistent with the classification 21 CFR 882.1400, Electroencephalograph:

"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."

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.

3.0 Technological

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.

The SNAP device is incorporated with a handheld computer, the Visor. A custom SNAP Electrode is provided for the convenience of the user in applying three monitoring electrodes.

4.0 Conclusions

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

Page

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Nicolet Biomedical, Inc. c/o Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K020218

Trade/Device Name: SNAP Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): January 21, 2002 Received (Date on orig SE ltr): January 22, 2002 APR - 9 2012

Dear Mr. Syring:

This letter corrects our substantially equivalent letter of April 22, 2002.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Gary Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1_of _1

0202 510(k) Number (if known):

Device Name: SNAP

Indications For Use:

(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Mark M. Mckenna

on of General, Restorative Neurological Devices

510(k) Number K020218

Page

Regulation Number and Section

§ 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).