(443 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard EEG recording and display.
No
The device is described as a "Monitoring System" for measuring and recording electrical activity of the brain (EEG signals) and explicitly states it "does not provide any diagnostic conclusion about the patient's condition." Its purpose is to display acquired waveforms and processed variables for interpretation, not to treat or cure.
No
The provided text explicitly states that "The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition." It is a monitoring system that records and displays EEG signals for interpretation by a licensed professional, not a device that provides diagnoses.
No
The device description explicitly lists three main hardware components: Display Module (DM-201), Patient Module (PM-201), and EasyPrep Sensor Kit (EK-701).
Based on the provided information, the NeuroFAST Monitoring System, Model NF-201 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NeuroFAST system directly measures electrical activity from the patient's head using electrodes. It does not analyze biological specimens.
- The intended use explicitly states it measures and records electrical activity of the brain. This is a physiological measurement, not an in vitro analysis of a specimen.
- The device description confirms it records and displays EEGs obtained from noninvasive electrodes placed on the head. This reinforces that it's a direct physiological measurement device.
Therefore, the NeuroFAST Monitoring System, Model NF-201 falls under the category of a medical device that performs physiological monitoring, not an IVD device.
N/A
Intended Use / Indications for Use
The NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.
Product codes
OMC
Device Description
The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor that records and displays electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by the licensed medical professional.
The NeuroFAST Monitoring System, Model NF-201 has three main components:
- Display Module (DM-201) processes acquired digital EEG signals, displays . EEG waveforms and processed EEG variables, and archives them for later review
- Patient Module (PM-201) acquires analog EEG signals through the Patient . Cable, and converts them into digital EEG signals
- . EasyPrep Sensor Kit (EK-701) - Noninvasive, disposable, single patient electrodes for acquiring the EEG signal
The NeuroFAST NF-201 system also includes the following cables:
- Patient Cable (PC-201) connects the Patient Module to four (4) noninvasive . electrodes
- USB Data Cable (DC-201) sends acquired digital EEG signals from the . Patient Module to the Display Module
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
patient's brain (obtained by placing electrodes on the head)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical professional / OR, ICU, ER, clinical settings and for clinical research.
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)
Non-clinical Testing: Laboratory testing was performed on identical hardware to the NeuroFAST subject of this submission, demonstrating that the NeuroFAST Monitoring System, Model NF-201 meets its design and functional requirements, including IFCN Guidelines for electroencephalographs. Actual device functions and features were evaluated against the device specifications and in all instances the NeuroFAST NF-201 performed as expected and no unexpected behavior was observed. The device will meet the requirements of UL medical electrical equipment standards for safety and the IEC particular standard for electroencephalographs.
Clinical Testing: The NeuroFAST NF-201 device is an electroencephalographic device comprised of hardware that has been bench tested to assess safety and effectiveness and to establish substantial equivalence with the predicate devices. Further clinical data is not required to demonstrate performance for the NeuroFAST NF-201 for the indication for use subject to this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
510(k) #781430
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
1. Contact Details
| Applicant Name: | Neuro Wave Systems Inc.
2490 Lee Blvd., Suite 300
Cleveland Heights, OH 44118
OCT 29 2010
(216) 361-1591 (telephone)
(216) 361-1554 (fax) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tracie Capozzio,
Quality Assurance and Regulatory Compliance
tcapozzio@neurowavesystems.com |
| Date Prepared: | October 19, 2010 |
| Device Name | |
| Trade Name: | NeuroFAST Monitoring System, Model NF-201 |
| Common/Usual Name: | EEG Monitor |
| Classification Name: | Electroencephalograph |
| Product Code: | OMC |
21 CFR 882.1400 Class II Neurology
Legally Marketed Predicate Device 3.
Regulation Number:
Classification Panel:
Device Class:
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|----------------------|----------------------------------|
| K082886 | OLT | ZOOM-100DC | Brainscope Company, Inc. |
| K072382 | GWQ | Model I-2000 Monitor | Infinite Biomedical Technologies |
4. Description of Device
The NeuroFAST Monitoring System, Model NF-201, is an EEG monitor that records and displays electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by the licensed medical professional.
The NeuroFAST Monitoring System, Model NF-201 has three main components:
- Display Module (DM-201) processes acquired digital EEG signals, displays . EEG waveforms and processed EEG variables, and archives them for later review
1
- Patient Module (PM-201) acquires analog EEG signals through the Patient . Cable, and converts them into digital EEG signals
- . EasyPrep Sensor Kit (EK-701) - Noninvasive, disposable, single patient electrodes for acquiring the EEG signal
The NeuroFAST NF-201 system also includes the following cables:
- Patient Cable (PC-201) connects the Patient Module to four (4) noninvasive . electrodes
- USB Data Cable (DC-201) sends acquired digital EEG signals from the . Patient Module to the Display Module
5. Intended Use
The intended use of NeuroFAST Monitoring System, Model NF-201 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 NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for The NeuroFAST Monitor is to be used under the direction and clinical research. interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.
Substantial Equivalence Comparison 6.
The technology of the NeuroFAST NF-201 device is equivalent to other EEG monitor devices. The EEG signal is acquired in analog format, digitized, processed and presented to the user for interpretation. An EasyPrep Sensor Kit is provided for the convenience of the user in applying the monitoring electrodes. The EasyPrep Sensor Kit is made of the same materials used in the manufacture of several medical sensors listed under 510(k) #781430 (refer to section 15 for addition details).
2
| Feature | NeuroFAST Monitoring
System,
Model NF-201
(K092477) | ZOOM-100DC
(082886) | Model I-2000 Monitor
(072382) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The NeuroFAST Monitor NF-
201 is intended to be used for
measuring and recording the
electrical activity of a
patient's brain, obtained by
placing electrodes on the
head. The NeuroFAST NF-
201 is indicated for use in
acquiring
electroencephalographic
(EEG) signals in the OR, ICU,
ER, clinical settings and for
clinical research. The
NeuroFAST Monitor is to be
used under the direction and
interpretation of a licensed
medical professional. The
NeuroFAST Monitor NF-201
does not provide any
diagnostic conclusion about
the patient's condition. | The ZOOM-100DC is used
to measure and record the
electrical activity of a
patient's brain. The ZOOM-
100DC is intended to monitor
the state of the brain by
acquisition and display of
electroencephalogram (EEG)
signals and by the calculation
of standard quantitative EEG
(qEEG) parameters. | The I-2000 Monitor is
intended to be used for
measuring and recording the
electrical activity of a
patient's brain, obtained by
placing electrodes on the
head.
The I-2000 Monitor is
indicated for use in
monitoring the state of the
brain by acquisition of
electroencephalogram
(EEG) signals, in research
and clinical environments. |
| Modalities | EEG | EEG | EEG |
| Environment
of Use | Operating room, intensive
care unit, emergency room,
and clinical settings where
EEG monitoring is used. | Hospitals and Clinics | Hospitals and Clinics |
| Power Source | 120 Volt 60Hz AC power | Li Ion Battery | Battery
120 Volt 60Hz AC power |
| System
Components | Patient Module, Patient Cable,
Display Module, Data Cable
and EasyPrep Electrode Kit | ZOOM-100DC, External
Patient Interface Cable,
External Audio Cable,
Compact Flash Card, Battery
Charger | Table PC, Battery Powered
wireless headbox, headbox
charger, power conditioner |
| Sensing
Electrodes | Silver-silver chloride
disposable EEG electrodes | Standard off-the-shelf EEG
electrodes | Unknown type of EEG
electrodes |
| Feature | NeuroFAST Monitoring System, Model NF-201 (K092477) | ZOOM-100DC (082886) | Model I-2000 Monitor (072382) |
| Screen Display Details | Displays:
- Raw EEG Waveforms
- Spectral Parameters: EEG power spectrum and frequency bands, 50% 50% Median Edge Frequency (MEF), and 95% Spectral Edge Frequency (SEF) | Displays:
- Raw EEG Waveform | Displays:
- Raw EEG waveforms
- Spectral Parameters: EEG power spectrum 95% Spectral Edge Frequency (SEF) |
| Stored EEG data available | Yes - through removable storage | Yes - through Compact Flash card | Yes - through removable storage |
| EEG Channels/ Montage | 2 bilateral frontal channels viewed concurrently | Up to 5 channels viewed concurrently
8 single-ended channels corresponding to 8 electrodes placed anywhere on the head, including but not limited to, all locations defined by the International 10/20 system. (5 different channels can be viewed concurrently) | 2 channels |
| Real Time EEG Display | Yes | Yes | Yes |
| Processed EEG Bandwidth | User Selectable
Low Filter: 0.125 or 0.5 Hz
High Filter: 30 or 70 Hz | 0.5-50 Hz | Unknown |
| Automatic Artifacting | Yes | Yes | Unknown |
| Amplifier Common Mode Rejection Ration (CMRR) | ≥100 dB | ≥ 100 dB | Unknown |
| Amplifier Input Impedance | ≥50 Meg Ohm | ≥ 100 Meg Ohms | Unknown |
| Electrode Impedance Test | Yes
Continuous and on demand by | Yes | Yes |
| Feature | NeuroFAST Monitoring
System,
Model NF-201
(K092477) | ZOOM-100DC
(082886) | Model I-2000 Monitor
(072382) |
| Derived /
Processed
EEG Measures | Power spectrum parameters
derived from FFT: - Power spectrum
displayed as Density
Spectral Array (DSA) - 95% Spectral Edge
Frequency (SEF) - Median Edge Frequency
(MEF) - Spectral Powers in EEG
frequency bands
traditionally used to
quantify EEG signals ( $\alpha$ ,
$\beta$ 1, $\beta$ 2, $\delta$ , $\theta$ and $\gamma$ ) | Power spectrum parameters
derived from FFT: - Absolute Power
a. Monopolar Power
b. Bipolar Power - Relative Power
a. Relative Monopolar Power
b. Relative Biopolar Power - Mean frequency variables
(univariate and multivariate)
a. Monopolar Mean
Frequency
b. Biopolar Mean Frequency - Coherence
a. Monopolar Coherence
b. Bipolar Coherence - Asymmetry
a. Monopolar Asymmetry
b. Bipolar Asymmetry | Power spectrum parameters
derived from FFT: - Power spectrum
displayed as a line
graph for each of the
four frequency bands
traditionally used to
quantify EEG signals
[Delta (0-4 Hz), Theta
(4-8Hz), Alpha (8-
13Hz) and Beta (13-30
Hz)] - 95% spectral edge
frequency (SEF) |
| Contains
patient
isolation | Yes - Patient module
(analog-to digital converter)
provides 6kV electrical
isolation of the patient from
the monitor | Battery powered, thus no
connection between patient
and mains | Yes - Wireless Bluetooth
communication provides
electrical isolation of the
patient from the monitor |
| Display
Screen | Yes - High-resolution, color,
graphical user interface and
touch screen | Yes | Yes - Graphical user
interface and touch screen
tablet PC |
| Event Markers | Yes, user selectable | Unknown | Yes |
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4
Non-clinical Testing 7.
Laboratory testing, performed on identical hardware to the NeuroFAST subject of this submission, demonstrated that the NeuroFAST Monitoring System, Model NF-201 meets its design and functional requirements, including IFCN Guidelines for electroencephalographs. Actual device functions and features were evaluated against the device specifications and in all instances the NeuroFAST NF-201 performed as expected and no unexpected behavior was observed. The device will meet the requirements of UL medical electrical equipment standards for safety and the IEC particular standard for electroencephalographs.
To ensure safety, the NeuroFAST Monitoring System, Model NF-201 will comply with all applicable requirements of IEC60601-1 and IEC60601-1-4, and will also comply
5
with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.
To ensure electromagnetic compatibility, the NeuroFAST NF-201 will comply with all applicable requirements of IEC60601-1-2, and will also comply with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.
8. Clinical Testing
The NeuroFAST NF-201 device is an electroencephalographic device comprised of hardware that has been bench tested to assess safety and effectiveness and to establish substantial equivalence with the predicate devices. We believe further clinical data is not required to demonstrate performance for the NeuroFAST NF-201 for the indication for use subject to this submission.
9. Conclusion
The NeuroFAST NF-201, when compared to its predicate devices, has the same intended use and similar technological characteristics and principles of operation. The nonclinical tests demonstrate that the device is safe, as effective, and performs at least as safely and effectively as the legally marketed devices. Thus, in indications, intended use and technology, the NeuroFAST NF-201 is substantially equivalent to the predicated devices. Minor technological difference as documented in the Substantial Equivalence Comparison table above, raise no new questions of safety or effectiveness.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus. The caduceus is depicted with a simple, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NeuroWave Systems, Inc. c/o Ms. Tracie Capozzio Quality Assurance and Regulatory Compliance 2490 Lee Blvd., Suite 300 Cleveland Heights, Ohio 44118
OCT 2 9 2010
Re: K092477
Trade/Device Name: NeuroWave NeuroFAST Monitoring System, Model NF-201 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph (EEG) Regulatory Class: Class II Product Code: OMC Dated: October 19, 2010 Received: October 20, 2010
Dear Ms. Capozzio:
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.
7
Page 2 - Ms. Tracie Capozzio
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 vours.
In A. Ramm
Melvin R. Felder, M.D.
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
8
INDICATIONS FOR USE
510(k) Number (if known): K092477
OCT 2 9 2010
Device Name: NeuroFAST Monitoring System, Model NF-201
Indications For Use:
The NeuroFAST Monitoring System, Model NF-201 is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The NeuroFAST NF-201 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and for clinical research. The NeuroFAST Monitor is to be used under the direction and interpretation of a licensed medical professional. The NeuroFAST Monitoring System, Model NF-201 does not provide any diagnostic conclusion about the patient's condition.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092477