(266 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data acquisition, storage, and viewing, with no mention of automated analysis or interpretation using AI/ML.
No
The device is described as measuring and recording electrical activity of the brain, acquiring EEG signals, and storing data for retrieval and review. It explicitly states that it "does not provide any diagnostic conclusion about the subject's condition." These functions are for data acquisition and monitoring, not for treating or preventing disease.
No
The text explicitly states: "The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition."
No
The device description explicitly lists hardware components (Acquisition Module, Memory Module, Disposable Electrode Array) in addition to the software.
Based on the provided information, the DiscoverEEG System, Model DE-401 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The DiscoverEEG System measures electrical activity on the surface of the head using non-invasive electrodes. It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use is for measuring and recording electrical activity. While this data is used for clinical purposes, the device itself is acquiring a physiological signal directly from the body, not analyzing a sample taken from the body.
- The device description focuses on acquiring and storing EEG waveforms. This is consistent with a device that measures a physiological signal.
- There is no mention of analyzing biological specimens.
Therefore, the DiscoverEEG System, Model DE-401 falls under the category of a medical device that measures a physiological signal, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject's brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.
Product codes
OLT, OMC
Device Description
The DiscoverEEG System, Model DE-401, is a wearable, medical-grade EEG device that acquires and stores up to four electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a subject's head. The acquired EEG waveforms, as well as, processed EEG spectral variables are continuously stored by the system for later retrieval. The data can be transferred from the DiscoverEEG hardware to a computer for review.
The DiscoverEEG System, Model DE-401 has four main components:
- . Acquisition Module: contains the circuitry for acquisition of the EEG signals through connections to the electrodes placed on the subject's head. The acquired signals are digitized and then passed to the Memory Module, for signal processing and storage.
- . Memory Module: provides power to the system and contains memory and EEG processing circuitry (impedance check, lead off check, pre-processing incl. artifact removal, processed spectral variables). Includes LED indicators for assurance of proper operation and other user interface elements. May contain a wireless option for data transfer to Data Viewer Software in realtime.
- . Disposable Electrode Array: contains noninvasive, disposable, single patient electrodes (5 electrodes, 4 EEG channels) and skin preparation materials. The packaging will guide the user on how to prepare the subject's skin and how to place the electrodes.
- . Data Viewer Software: PC based software used for retrieving and reviewing acquired raw EEG waveforms (as well as processed data) from the DiscoverEEG hardware. This software will also be capable of converting the retrieved EEG data files to standard formats (i.e. EDF+, tab-delimited). Such converted data files can then be reviewed using off-the-shelf bio-signal review software that accepts the converted format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical professional, OR, ICU, ER, clinical settings and at home
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
The DiscoverEEG, Model DE-401 meets its design and functional requirements. Actual device functions and features were evaluated against the device specifications and in all instances the DiscoverEEG, Model DE-401 performed as expected and no unexpected behavior was observed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
NeuroWave Systems Inc. Tatjana Zikov President 2490 Lee Blvd., Suite 300 Cleveland Heights, OH 44118
Re: K142834
Trade/Device Name: DiscoverEEG System, Model DE-401 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OMC Dated: May 10, 2015 Received: May 11, 2015
Dear Tatjana Zikov:
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. Isting 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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Felipe Aguel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142834
Device Name DiscoverEEG System, DE-401
Indications for Use (Describe)
The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject's brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Contact Details 1.
| Applicant Name: | NeuroWave Systems Inc.
2490 Lee Blvd., Suite 300
Cleveland Heights, OH 44118
(216) 361-1591 (telephone)
(216) 361-1554 (fax) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tatjana Zikov,
President
tzikov@neurowavesystems.com |
| Date Prepared: | September 29, 2014 |
2. Device Name
| Trade Name: | DiscoverEEG System, Model DE-401 |
|---|---|
| Common/Usual Name: | EEG Monitor |
| Classification Name: | Electroencephalograph |
| Product Code: | OMC |
| Regulation Number: | 21 CFR 882.1400 |
| Device Class: | Class II |
| Classification Panel: | Neurology |
Legally Marketed Predicate Device 3.
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|----------------------------------------------|--------------------------------------------|
| K092477 | OMC | NeuroFAST Monitoring
System, Model NF-201 | NeuroWave Systems, Inc. |
| K101830 | OLV,
OMC | Zmachine | Consolidated Research of
Richmond, Inc. |
4. Description of Device
The DiscoverEEG System, Model DE-401, is a wearable, medical-grade EEG device that acquires and stores up to four electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a subject's head. The acquired EEG waveforms, as well as, processed EEG spectral variables are continuously stored by the system for later retrieval. The data can be transferred from the DiscoverEEG hardware to a computer for review.
The DiscoverEEG System, Model DE-401 has four main components:
4
- . Acquisition Module: contains the circuitry for acquisition of the EEG signals through connections to the electrodes placed on the subject's head. The acquired signals are digitized and then passed to the Memory Module, for signal processing and storage.
- . Memory Module: provides power to the system and contains memory and EEG processing circuitry (impedance check, lead off check, pre-processing incl. artifact removal, processed spectral variables). Includes LED indicators for assurance of proper operation and other user interface elements. May contain a wireless option for data transfer to Data Viewer Software in realtime.
- . Disposable Electrode Array: contains noninvasive, disposable, single patient electrodes (5 electrodes, 4 EEG channels) and skin preparation materials. The packaging will guide the user on how to prepare the subject's skin and how to place the electrodes.
- . Data Viewer Software: PC based software used for retrieving and reviewing acquired raw EEG waveforms (as well as processed data) from the DiscoverEEG hardware. This software will also be capable of converting the retrieved EEG data files to standard formats (i.e. EDF+, tab-delimited). Such converted data files can then be reviewed using off-the-shelf bio-signal review software that accepts the converted format.
5. Intended Use
The intended use of DiscoverEEG System, Model DE-401 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 DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject's brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.
6. Substantial Equivalence Comparison
The technology of the DiscoverEEG DE-401 device is equivalent to other EEG monitor devices. The EEG signal is acquired in analog format, digitized, processed and saved for later user interpretation. An Electrode (Sensor) Array is provided with the system for the convenience of the user in applying the acquisition electrodes. The Electrode Array is made of the materials that have been shown to pass cytotoxicity, primary skin irritation and sensitization as required (refer to section 15 for addition details).
5
| Feature | DiscoverEEG System, Model
DE-401 | NeuroFAST Monitoring
System,
Model NF-201
(092477) | Zmachine
(101830) |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The DiscoverEEG System,
Model DE-401 is intended to
be used for measuring and
recording the electrical
activity of a subject's brain,
obtained by placing non-
invasive electrodes on the
head. The DiscoverEEG, DE-
401 is indicated for use in
acquiring
electroencephalographic
(EEG) signals in the OR, ICU,
ER, clinical settings and at
home and for clinical research.
The medical use of data
acquired by the DiscoverEEG
is to be performed under the
direction and interpretation of
a licensed medical
professional. The
DiscoverEEG, Model DE-401
does not provide any
diagnostic conclusion about
the subject's condition. | 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 CR1 Zrnachine is a
single-channel EEG
acquisition and analysis
system, designed for use in
the home or clinical
environments. This device
is intended to be used by
qualified healthcare
practitioners to monitor the
wake and sleep states of
adult patients and as an
adjunct to their diagnosis
of sleep disorders. |
| Modalities | EEG | EEG | EEG |
| Environment
of Use | Operating room, intensive care
unit, emergency room, clinical
settings and At Home where
EEG monitoring is used. | Operating room, intensive
care unit, emergency room,
and clinical settings where
EEG monitoring is used. | In the home or clinical
environment |
| Power Source | Battery | 120 Volt 60Hz AC power | Li Ion Battery |
| System
Components | Electrode (Sensor) Array,
Acquisition and Memory
Modules, Data Viewer
Software | Patient Module, Patient Cable,
Display Module, Data Cable
and EasyPrep Electrode Kit | Zmachine device, EEG
sensors, Sensor cable, wall
charger |
| Sensing
Electrodes | Silver-silver chloride
disposable EEG electrodes | Silver-silver chloride
disposable EEG electrodes | Silver-silver chloride
disposable electrodes |
| Feature | DiscoverEEG System, Model
DE-401 | NeuroFAST Monitoring
System,
Model NF-201
(092477) | Zmachine
(101830) |
| Screen
Display
Details | Data Viewer Software:
- Raw EEG Waveforms
- Signal Quality
information: Channel
Connection flags,
Impedance values,
Artifact Detection flags,
Noise Level - Spectral Parameters: EEG
power spectrum and
frequency bands, 50%
50% Median Edge
Frequency (MEF), and
95% Spectral Edge
Frequency (SEF) | Displays: - Raw EEG Waveforms
- Signal Quality
information: Channel
Connection flags,
Impedance values,
Artifact Detection flags,
Noise Level - Spectral Parameters: EEG
power spectrum and
frequency bands, 50%
50% Median Edge
Frequency (MEF), and
95% Spectral Edge
Frequency (SEF) | Displays:
Sleep/Wake Statistics |
| Stored EEG
data available | Yes - SD Card | Yes – through removable
storage | Yes - microSD |
| EEG
Channels/
Montage | Up to 4 channels (2 fronto-
temporal channels, and 2
temporal channels) | 2 bilateral fronto-temporal
channels viewed concurrently | 1 channel, differential
mastoid |
| Real Time
EEG Display | Yes, if wireless option is
present | Yes | No |
| Processed
EEG
Bandwidth | User Selectable in Data
Viewer software
Low Filter: 0.125 or 0.5 Hz
High Filter: 30 or 70 Hz | User Selectable
Low Filter: 0.125 or 0.5 Hz
High Filter: 30 or 70 Hz | 0.5-380 Hz |
| Automatic
Artifacting | Yes | Yes | Unknown |
| Amplifier
Common
Mode
Rejection
Ration
(CMRR) | ≥110 dB | ≥100 dB | Unknown |
| Amplifier
Input
Impedance | ≥100 Meg Ohm | ≥50 Meg Ohm | 10 Gig Ohms |
| Electrode
Impedance
Test | Yes | Yes
Continuous and on demand by
the user | Yes |
| Feature | DiscoverEEG System, Model
DE-401 | NeuroFAST Monitoring
System,
Model NF-201
(092477) | Zmachine
(101830) |
| Derived /
Processed
EEG Measures | Power spectrum parameters
derived from FFT: | Power spectrum parameters
derived from FFT: | Wake/Sleep Determination |
| | 1) Power spectrum displayed
as Density Spectral Array
(DSA) | 1) Power spectrum
displayed as Density
Spectral Array (DSA) | |
| | 2) 95% Spectral Edge
Frequency (SEF) | 2) 95% Spectral Edge
Frequency (SEF) | |
| | 3) Median Edge Frequency
(MEF) | 3) Median Edge Frequency
(MEF) | |
| | 4) Spectral Powers in EEG
frequency bands
traditionally used to
quantify EEG signals (α,
β1, β2, δ, θ and γ) | 4) Spectral Powers in EEG
frequency bands
traditionally used to
quantify EEG signals (α,
β1, β2, δ, θ and γ) | |
| | Signal Quality information
(Channel connection flags,
Impedance values, Artifact
Detection flags, Noise Level) | Signal Quality information
(Channel connection flags,
Impedance values, Artifact
Detection flags, Noise Level) | |
| Contains
patient
isolation | Battery powered, thus no
connection between patient
and mains | 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 |
| Display
Interface | Yes, LEDs to ensure proper
system connection and
operation. | Yes - High-resolution, color,
graphical user interface and
touch screen | Yes, To ensure proper
system connection and
operation. |
| Event Markers | Yes, artifact detection and
signal quality events
User selectable events
included in Data Viewer
software | Yes, user selectable | Yes, Sleep/Wake Events |
6
7
Non-clinical Testing 7.
Laboratory testing, performed on identical hardware to the DiscoverEEG subject of this submission, demonstrated that the DiscoverEEG, Model DE-401 meets its design and functional requirements. Actual device functions and features were evaluated against the device specifications and in all instances the DiscoverEEG, Model DE-401 performed as expected and no unexpected behavior was observed.
Prior to commercial introduction, the device will meet the requirements of UL medical electrical equipment standards for safety and the IEC particular standard for electroencephalographs.
8
To ensure safety, the DiscoverEEG, Model DE-401 will comply with all applicable requirements of IEC60601-1 and IEC60601-1-11, and will also comply with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.
To ensure electromagnetic compatibility, the DiscoverEEG, Model DE-401 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 DiscoverEEG, Model DE-401 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 DiscoverEEG, Model DE-401 for the indication for use subject to this submission.
9. Conclusion
The DiscoverEEG, Model DE-401, when compared to its predicate devices, has the similar intended use and 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 DiscoverEEG, Model DE-401 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.