(128 days)
Not Found
No
The summary describes a standard EEG monitoring system with software for data acquisition, display, and remote review. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic quantitative EEG metrics (SEF 95, power spectrum) which are traditional signal processing techniques.
No
This device is an electroencephalograph intended for measuring and recording the electrical activity of a patient's brain, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is an electroencephalograph intended for "measuring and recording the electrical activity of a patient's brain," and its "output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information." This indicates its use in providing data for diagnosis.
No
The device description explicitly states it includes an "EEG acquisition console with junction box" and a "Porti amplifier and power supply," which are hardware components. While it includes software, it is not solely software.
Based on the provided information, the Vigilant EEG Monitor (Vigilant 2.0) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Vigilant EEG Monitor Function: The Vigilant EEG Monitor measures and records the electrical activity of the patient's brain by applying electrodes to the head. This is a direct measurement of physiological activity within the body, not an analysis of a specimen taken from the body.
The device is an electroencephalograph, which is a type of medical device used for in vivo (within the living body) measurement.
N/A
Intended Use / Indications for Use
The Vigilant EEG Monitor (Vigilant 2.0) is an electroencephalograph that works in conjunction with Vigilant bedside monitoring and remote review software. It is intended for measuring and recording the electrical activity of a patient's brain by applying 8 electrodes on the head.
The Vigilant EEG Monitor (Vigilant 2.0) requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
Product codes (comma separated list FDA assigned to the subject device)
OLT, OMC
Device Description
The Vigilant EEG Monitor (Model Vigilant 2.0) is a multi-channel EEG monitor. It is intended for monitoring the state of the brain by applying electrodes to a patient's head. It also includes software to enable remote monitoring by a neurologist or other trained personnel. Both acquisition and review of patient data can be performed at the bedside.
The Vigilant EEG Monitor does not include a computer monitor or video camera, but these are required for system use.
The Vigilant EEG Monitor consists of an EEG acquisition console with junction box and a software CD (bedside EEG monitoring software, server software for remote telecommunications and software for remote monitoring of EEG data). The principal component of the Vigilant EEG monitor is a Porti amplifier and power supply provided by TMS International (Oldenzaal, The Netherlands). The software is designed to be loaded onto an off the shelf computer monitor that may be supplied by the user. It is also designed to interface with a video camera for real-time video monitoring concurrently with EEG monitoring. Neither the computer nor the camera is considered part of the medical device.
The EEG signal display can be configured in a reduced mode (up to 4 EEG channels plus quantitative EEG metrics for each channel) or a full mode (up to 8 EEG channels). The display modes and channel display are configurable by the user.
In the reduced mode display, the user may select to display either the spectral edge frequency (SEF 95) as a line graph, or the power spectrum (POWER) displayed as four colored line graphs, each representing the standard EEG frequency bands (delta: 0-4Hz, RED: theta: 4-8Hz, YELLOW; alpha: 8-13Hz, GREEN; beta: 13-30Hz, BLUE).
Real-time video of the patient from the system camera is displayed in a separate window from the EEG signals. This window may be hidden or resized by the user. The video is recorded in synchronization with the EEG even when it is not displayed and may be replayed during review mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain / head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
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)
Laboratory testing demonstrated that the Vigilant EEG Monitor meets its design and functional requirements. Actual device functions and features were evaluated against the device specifications and in all instances the Vigilant Monitor performed as expected and no unexpected behavior was observed. The device meets the requirements for safety of medical electrical equipment, electromagnetic compatibility, and the particular standard for electroencephalographs.
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.
EXCEL TECH. LTD.'s Xltek EP-16 headbox (K992313), EXCEL TECH. LTD.'s NeuroWorks EEG (K980214)
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
K09/963
510(k) SUMMARY
Infinite Biomedical Technologies' Vigilant 2.0 Monitor
Infinite Biomedical Technologies, LLC 3600 Clipper Mill Road, Suite 410 Baltimore, MD 21211
Phone: (410) 889-8011 Facsimile: (410) 889-8012 Contact Person: Manan Hathi Date Prepared: 21 January 2008
NOV - 6 2009
Name of Device and Name/Address of Sponsor
Vigilant 2.0 EEG Monitor
Infinite Biomedical Technologies, LLC 3600 Clipper Mill Road, Suite 410 Baltimore, MD 21211
Common or Usual Name
Electroencephalograph
Classification Name
Electroencephalograph (CFR 882.1400, Class II)
Predicate Devices
EXCEL TECH. LTD.'s Xltek EP-16 headbox (K992313) (Electroencephalograph, CFR 882.1400, GWQ)
EXCEL TECH. LTD.'s NeuroWorks EEG (K980214) (Electroencephalograph, CFR 882.1400, GWQ)
Intended Use / Indications for Use
The Vigilant EEG Monitor (Vigilant 2.0) is an electroencephalograph that works in conjunction with Vigilant bedside monitoring and remote review software. It is intended for measuring and recording the electrical activity of a patient's brain by applying 8 electrodes on the head.
The Vigilant EEG Monitor (Vigilant 2.0) requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
1
Technological Characteristics
The Vigilant EEG Monitor (Model Vigilant 2.0) is a multi-channel EEG monitor. It is intended for monitoring the state of the brain by applying electrodes to a patient's head. It also includes software to enable remote monitoring by a neurologist or other trained personnel. Both acquisition and review of patient data can be performed at the bedside.
The Vigilant EEG Monitor does not include a computer monitor or video camera, but these are required for system use.
The Vigilant EEG Monitor consists of an EEG acquisition console with junction box and a software CD (bedside EEG monitoring software, server software for remote telecommunications and software for remote monitoring of EEG data). The principal component of the Vigilant EEG monitor is a Porti amplifier and power supply provided by TMS International (Oldenzaal, The Netherlands). The software is designed to be loaded onto an off the shelf computer monitor that may be supplied by the user. It is also designed to interface with a video camera for real-time video monitoring concurrently with EEG monitoring. Neither the computer nor the camera is considered part of the medical device.
The EEG signal display can be configured in a reduced mode (up to 4 EEG channels plus quantitative EEG metrics for each channel) or a full mode (up to 8 EEG channels). The display modes and channel display are configurable by the user.
In the reduced mode display, the user may select to display either the spectral edge frequency (SEF 95) as a line graph, or the power spectrum (POWER) displayed as four colored line graphs, each representing the standard EEG frequency bands (delta: 0-4Hz, RED: theta: 4-8Hz, YELLOW; alpha: 8-13Hz, GREEN; beta: 13-30Hz, BLUE).
Real-time video of the patient from the system camera is displayed in a separate window from the EEG signals. This window may be hidden or resized by the user. The video is recorded in synchronization with the EEG even when it is not displayed and may be replayed during review mode.
Performance Data
Laboratory testing demonstrated that the Vigilant EEG Monitor meets its design and functional requirements. Actual device functions and features were evaluated against the device specifications and in all instances the Vigilant Monitor performed as expected and no unexpected behavior was observed. The device meets the requirements for safety of medical electrical equipment, electromagnetic compatibility, and the particular standard for electroencephalographs.
2
Substantial Equivalence
The Vigilant Monitor is as safe and effective as the Xltek EP-16 headbox and the Natus/XItek NeuroWorks software. The Vigilant EEG Monitor has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Vigilant EEG Monitor and its predicate devices raise no new issues of safety or effectiveness. Thus, the Vigilant 2.0 Monitor is substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized lines representing the wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Infinite Biomedical Technologies, LLC c/o Mr. Manan Hathi 3600 Clipper Mill Road, Suite 410 Baltimore, Maryland 21211
NOV - 6 2009
Re: K091963
Trade/Device Name: Vigilant EEG Monitor, Vigilant 2.0 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OMC Dated: October 23, 2009 Received: October 26, 2009
Dear Mr. Hathi:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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.
4
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/CDRHQffices/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,
M.B. Eglehus. us
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K091963
Device Name: Vigilant 2.0 EEG Monitoring System
Indications for Use:
í
The Vigilant EEG Monitor (Vigilant 2.0) is an electroencephalograph that works in conjunction with Vigilant bedside monitoring and remote review software. It is intended for measuring and recording the electrical activity of a patient's brain by applying 8 electrodes on the head.
The Vigilant EEG Monitor (Vigilant 2.0) requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR -
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic, Neurologica: and Ear, | |
| Nose and Throat-Devices | |
| 510(k) Number | K091963 |
| 2 Page |