(90 days)
Not Found
No
The summary describes a device that processes EEG signals to derive an index, but there is no mention of AI or ML algorithms being used for this processing or for any other function of the device. The description focuses on hardware components and basic signal processing.
No.
The device is intended to monitor EEG and measure brain activity, providing information to a medical professional. It does not exert any direct therapeutic effect on the patient.
Yes
The SNAP device is intended to monitor a patient's EEG and provides the SNAP Index, which indicates brain activity level. This information is used by a licensed medical professional to assess a patient's physiological state, which falls under the definition of diagnosis.
No
The device description clearly lists multiple hardware components: a Visor SNAP module, a disposable electrode, and a patient cable, in addition to the software.
Based on the provided information, the SNAP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor a patient's EEG" and provide a "derived EEG measure, the SNAP Index, indicates the patient's brain activity level." This is a direct measurement of a physiological signal from the patient's body.
- Device Description: The device components are designed to acquire and process an electrical signal from the patient's head (EEG).
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. The SNAP device is directly monitoring a signal from the patient's body.
Therefore, the SNAP device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OLW, OMC, ORT
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. 2.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K0202-18
APR 2 2 2002
Summary of Safety and Effectiveness
| Company Name: | Nicolet Biomedical
5225 Verona Road
Madison, WI 53711 |
|----------------------------|-------------------------------------------------------------------------------------|
| Contact:
Phone:
Fax: | Glen Hermanson, Manager of Standards and Compliance
608 441-2065
608 441-2007 |
| 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
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. 2.
-
- A patient cable which connects the Visor SNAP module to the patient electrode.
...
Page 46
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
or
Enclosure
4
Page 1_of _1
0202 510(k) Number (if known):
Device Name: SNAP
Indications For 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.
(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