K Number
K162681
Device Name
Enobio Wireless EEG
Date Cleared
2017-06-02

(249 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
Device Description
The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology. Enobio is a wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designed for use in a clinical environment or hospital.. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording. ENOBIO WIRELESS EEG, consists of three models designated as the 8, 20 and 32 channels. ENOBIO WIRELESS EEG has a sampling rate of 500 SPS, it works in a bandwidth from 0 to 125Hz (DC coupled) and it provides a resolution of 24 bits - 0.05μV. Enobio is capable of acquiring a variety of electrophysiological signals. These signals include EEG, EOG, ECG and EMG. The Enobio system is primarily made up of the following three items: - Necbox (amplifier, transmitter and control box), - the neoprene cap with the electrodes and - the NIC software. The Necbox, which has a data amplifier, connects directly via Wi-Fi to the Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG data is streamed through the standard Wi-Fi band, and the standard Wi-Fi operating distance range is 10 meters. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.
More Information

Not Found

No
The summary describes a standard EEG acquisition and transmission system. There is no mention of AI/ML algorithms being used for data analysis, interpretation, or any other function. The focus is on signal acquisition, storage, and transmission.

No.
The device is clearly stated to be an "EEG portable monitoring device" intended to "acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics," not for therapeutic purposes.

Yes

The "Intended Use / Indications for Use" section states: "The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics."

No

The device description explicitly states that the system is primarily made up of three items: the Necbox (amplifier, transmitter, and control box), the neoprene cap with electrodes, and the NIC software. This indicates the device includes significant hardware components beyond just software.

Based on the provided information, the ENOBIO device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The ENOBIO device acquires electrophysiological signals (EEG, EOG, ECG, EMG) directly from the patient's body using electrodes placed on the skin. This is an in vivo measurement, not an in vitro analysis of a sample.
  • The intended use is for clinical patient monitoring and aiding in diagnostics by acquiring, storing, transmitting, and displaying electrophysiological signals. This is consistent with a device that measures physiological activity directly from the body.
  • The device description details the hardware (amplifier, electrodes, software) used to acquire and process these signals. This aligns with a device that interacts directly with the patient's body to obtain data.

Therefore, the ENOBIO device falls under the category of a medical device that performs physiological measurements in vivo, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments.

The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

Product codes (comma separated list FDA assigned to the subject device)

GWQ, GWL

Device Description

The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology.

Enobio is a wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designed for use in a clinical environment or hospital.. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording.

ENOBIO WIRELESS EEG, consists of three models designated as the 8, 20 and 32 channels. ENOBIO WIRELESS EEG has a sampling rate of 500 SPS, it works in a bandwidth from 0 to 125Hz (DC coupled) and it provides a resolution of 24 bits - 0.05μV. Enobio is capable of acquiring a variety of electrophysiological signals. These signals include EEG, EOG, ECG and EMG.

The Enobio system is primarily made up of the following three items:

  • Necbox (amplifier, transmitter and control box),
  • the neoprene cap with the electrodes and
  • the NIC software.

The Necbox, which has a data amplifier, connects directly via Wi-Fi to the Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG data is streamed through the standard Wi-Fi band, and the standard Wi-Fi operating distance range is 10 meters. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Worn on the head via a headcap or headband

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained health-care personnel. It is restricted to sale by or on order of a physician.
Clinical environment or hospital.

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 performance tests were conducted to demonstrate safety and effectiveness and substantial equivalence. These included biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10), electrical performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-11, IEC 61000-4-3), software verification and validation (IEC 62304 and FDA Guidance), disinfection testing, compatibility of electrodes, and product specification compliance tests (Bandwidth, Sampling Rate, Input Referred Noise, Dynamic Range, Operating Hours, Resolution, Input Impedance). All applicable requirements were met.
No human clinical testing was required.

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.

K103140

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).

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

June 2, 2017

Neuroelectrics Barcelona S.L.U. % Deirdre Barrow Senior Consultant, Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin. Texas 78746

Re: K162681

Trade/Device Name: Enobio Wireless EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GWL Dated: April 21, 2017 Received: April 27, 2017

Dear Deirdre Barrow:

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. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS 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) K162681

Device Name Enobio Wireless EEG

Indications for Use (Describe)

ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments.

The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

Type of Use (Select one or both, as applicable)
---------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K162681

1. Submission Sponsor

Neuroelectrics Barcelona SLU

Avenida Tibidabo 47 bis

08035 Barcelona

SPAIN

Phone number: + 34 932540370

Contact: Ana Maiques

Title: CEO

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Cell Phone: +353 86 8733815

Office Phone: (512) 327.9997

Contact: Deirdre Barrow, Senior Consultant, RA

Email: project.management@emergogroup.com

3. Date Prepared

September 21, 2016

4. Device Identification

Trade/Proprietary Name:ENOBIO WIRELESS EEG
Common/Usual Name:Electroencephalograph
Classification Name:Full-Montage Standard Electroencephalograph
Regulation Number:882.1400 & 882.1835

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| Product Code: | GWQ, Full-Montage Standard Electroencephalograph &
GWL, Amplifier, Physiological Signal |
|-----------------------|--------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Classification Panel: | Neurology |

5. Legally Marketed Predicate Device

| Device
Name | 510(k)
No. | Product Code | Classification
Regulation | Sponsor |
|----------------------------|---------------|--------------|--------------------------------------|----------------------|
| Nicolet
Wireless
EEG | K103140 | GWL & GWQ | 21 CFR 882.1835 &
21 CFR 882.1400 | Carefusion 209, Inc. |

6. Indication for Use Statement

ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments.

The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

7. Device Description

The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology.

Enobio is a wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designed for use in a clinical environment or hospital.. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording.

ENOBIO WIRELESS EEG, consists of three models designated as the 8, 20 and 32 channels. ENOBIO WIRELESS EEG has a sampling rate of 500 SPS, it works in a bandwidth from 0 to 125Hz (DC coupled) and it provides a resolution of 24 bits - 0.05μV. Enobio is capable of acquiring a variety of electrophysiological signals. These signals include EEG, EOG, ECG and EMG.

The Enobio system is primarily made up of the following three items:

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  • Necbox (amplifier, transmitter and control box),
  • the neoprene cap with the electrodes and
  • the NIC software.

The Necbox, which has a data amplifier, connects directly via Wi-Fi to the Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG data is streamed through the standard Wi-Fi band, and the standard Wi-Fi operating distance range is 10 meters. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.

8. Substantial Equivalence Discussion

The following table compares the ENOBIO WIRELESS EEG to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

ManufacturerNeuroelectricsCarefusionSignificant Differences
Trade NameENOBIO WIRELESS EEGNicolet Wireless EEG
510(k) NumberK162681K103140 (predicate)n/a
Product CodeGWL & GWQGWL & GWQSame
Regulation
Number882.1835 & 882.1400882.1835 & 882.1400Same
Regulation NameAmplifier, Physiological
Signal & Full-Montage
Standard
ElectroencephalographAmplifier, Physiological
Signal & Full-Montage
Standard
ElectroencephalographSame
Indications for UseENOBIO is an EEG
portable monitoring
device of 8, 20, 32
channels intended for
the use in clinical patient
monitoring for use in
hospitals and other
medical environments.
The Enobio is intended to
acquire, store, transmitThe Nicolet Wireless
EEG Amplifier is
intended to be used as a
front end amplifier to
acquire, store, and
transmit
electrophysiological
signals in a wired or
wireless mode for the
Nicolet NeurodiagnosticNo significant difference as
each device acquires,
stores, amplifies and
transmits EEG signals to
host software for
neurological applications.
ManufacturerNeuroelectricsCarefusionSignificant Differences
Trade NameENOBIO WIRELESS EEG
and display
electrophysiological
signals in wireless mode
as an aid in diagnostics.
The system digitizes
analogue EEG signals
collected by a cap with
electrodes, amplifies
them, and uses WiFi
connectivity to transmit
the EEG data to a
dedicated host computer
with the software.
This device is intended to
be used by trained
health-care personnel. It
is restricted to sale by or
on order of a physicianNicolet Wireless EEG
system.
Mechanism of ActionThe Enobio Wireless EEG
is a wireless and
wearable
electrophysiology sensor
system for the recording
of electroencephalogram
(EEG) measurementsThe device is intended
to be used as a front end
Nicolet
EEGwireless32/64
amplifier with the
Nicolet Neurodiagnostic
system to record,
measure, store, analyze
and display cerebral and
extra cerebral
physiologic data for EEG
and Sleep studies with
or without synchronous
digital video. The device
is wearable on the torso
or headNo Significant Difference; the differences between them are:

● The Enobio Wireless EEG is only available in a wireless assembly whilst the Nicolet Wireless EEG is available in a wired and wireless assembly.

● The associated software systems are obviously proprietary and are therefore different but the fundamental technology of acquiring, storing, amplifying and transmitting EEG signals to host software is very similar between the two |
| Manufacturer | Neuroelectrics | Carefusion | Significant Differences |
| Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | |
| Technology
Overview | System components:
• cap with electrodes
• control box
(amplifier,
transmitter)
• software for PC | System components:
• patient cable
• amplifier, CPU and
display monitor,
telemetry unit
• access point
Interface to amplifier:
Wired Ethernet
(10/100baseT)or
Wireless
Ethernet (802.11b/g) | devices
• The Enobio Wireless EEG
is only available in a
battery operated
configuration whereas
the predicate device,
Nicolet Wireless EEG,
can be battery or AC
powered.
No significant difference as
each device consists of a
method of capturing the
signal, storing, amplifying
and transmitting the signal
No significant difference as
the predicate device,
Nicolet Wireless EEG offers
wired or wireless signal
transmission to the host
computer used to display
and manage acquired data.
The proposed device,
Enobio Wireless EEG, offers
wireless signal transmission
only. |
| | A/D conversion:
24 bits | A/D conversion:
24 bits | Same |
| | Sampling rate:
500 Hz | Sampling rate:
125, 250, 500, ... 48000
Hz | No significant difference as
the predicate device,
Nicolet Wireless EEG offers
the user a choice of
sampling rates that the user
may select. The proposed
device, Enobio Wireless |
| Manufacturer | Neuroelectrics | Carefusion | Significant Differences |
| Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | EEG, provides a fixed
sampling rate of 500 Hz
included within the range
offered by the predicate
device. |
| Anatomical
Location | Worn on the head via a
headcap or headband | Worn on the torso
and/or via a headcap | No significant difference as
the only option available for
the proposed device, Enobio
Wireless EEG, is a headcap
or headband which is
included with the options
available with the Nicolet
Wireless EEG |
| Material | ABS 40%c, ABS, gel ,
neoprene | Not specified | No significant difference as
while a potential difference
exists between the devices
in terms of patient
contacting materials,
appropriate
biocompatibility testing has
been conducted on the
proposed device. |
| Number of
Channels | 8, 20, 32 channels | 32 or 64 channel | No significant difference as
the number of channels
reflects the simpler nature
of the Enobio device.
Testing has been conducted
to ensure each model
performs in accordance
with the intended use. |
| Temperature
Control Range | Use Temperature Range:
+5 to 45 °C
Storage in Box
Temperature Range: -25
to +70 °C | Not defined but as the
use has been confined
to research institutions,
clinic, hospital,
operating room and
epilepsy evaluation | No significant difference as
the operating environment
is very similar to that of the
proposed device therefore
the operating range in |
| Manufacturer | Neuroelectrics | Carefusion | Significant Differences |
| Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | |
| Pressure Range | Atmospheric Pressure:
700 - 1.000 hPa | environments it would
be expected to be within
the same range as that
of the proposed device | terms of temperature,
pressure and humidity
would be expected to have
similar parameters. |
| Humidity Range | 15 - 93 % | | |
| Sterile | no | no | Same |
| Single-Use | no | no | Same |
| Shelf Life | 5 years | Unknown | Unknown; predicate device
shelf life is not available |
| Software
Microprocessor | ATSAM4SD32CGWL | Unknown | N/A |
| Battery Operated | yes | yes | Same |
| AC Powered | no | yes | No significant difference:
The Enobio Wireless EEG is
only available in a battery
operated configuration
whereas the predicate
device, Nicolet Wireless
EEG, can be battery or AC
powered |
| Complies with ISO
10993-1 | yes | yes | Same |
| Electrical Safety
Testing Passed | yes | yes | Same |

Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Enobio Wireless EEG and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Neuroelectrics completed a number of non-clinical performance tests. The Enobio Wireless EEG meets all the requirements for overall design, biocompatibility, and electrical safety, confirming that the design output meets the design inputs and specifications for the device.

The Enobio Wireless EEG passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

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  • Biocompatibility; ●
    • ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing o
    • O ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Test for In Vitro Cytotoxicity
    • ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation O and Delayed-Type Hypersensitivity
    • . Electrical Performance;
      • o IEC 60601-1: 2005 + CORR. 1 (2006) + CORR 2 (2007), Medical Electrical Equipment -Part 1 General Requirements for Basic Safety and Essential Performance
      • o IEC 60601-1-2:2007 (Third Edition), Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))
      • IEC 60601-2-26:2012, Medical electrical equipment Part 2-26: Particular requirements o for the basic safety and essential performance of electroencephalographs
      • o IEC 60601-1-11: 2010, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests; all applicable requirements were met
      • o IEC 61000-4-3, Radiated, radio-frequency, electromagnetic field immunity test
    • . Software verification and validation testing per IEC 62304 and FDA Guidance
    • . Disinfection testing
    • Compatibility of electrodes with Enobio Wireless EEG ●
    • . Product specification compliance tests:
      • Bandwidth O
      • O Sampling Rate
      • Input Referred Noise O
      • O Dynamic Range
      • O Operating Hours
      • o Resolution
      • Input Impedance o

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be

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demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The Enobio Wireless EEG, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device, Nicolet Wireless EEG.