EEG NEUROAMP, MODEL CS10137

K073557 · Corscience GmbH & Co. KG · HCC · Feb 28, 2008 · Neurology

Device Facts

• Record ID: K073557
• Device Name: EEG NEUROAMP, MODEL CS10137
• Applicant: Corscience GmbH & Co. KG
• Product Code: HCC · Neurology
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software. For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices. The EEG NeuroAmp is not intended for diagnostic purposes. Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by the State in which he practices to use or order the use of the device.

Device Story

EEG NeuroAmp serves as a high-performance interface between a client and a clinician's computer for EEG and peripheral biofeedback therapy. It accepts inputs from two EEG channels and three peripheral physiology channels (e.g., GSR, temperature via thermistor or infrared probe). The device features a built-in impedance meter with LED bar display to ensure electrode contact quality and includes notch filters to cancel power line interference. It provides audio, visual, or tactile feedback signals to the user. Used in clinical office settings, the device is operated by trained professionals. The clinician monitors the output via the Cygnet software, which displays real-time biofeedback data and alerts the clinician to 60-Hz contamination or poor electrode contact. By providing feedback on electrical brain activity and peripheral physiological measures, the device assists the patient in learning to control their physiological state to promote relaxed alertness.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) confirmed. Biocompatibility testing for the pIRx3 sensor housing and elastic belt performed per ISO 10993-1; housing passed all tests, while the cotton belt passed dermal irritation and sensitization tests but is restricted to intact skin.

Technological Characteristics

Class II biofeedback device. 2-channel EEG amplifier (quasi-DC coupled, low-noise) and 3-channel peripheral sensor interface. 13-bit ADC resolution. 5th order Butterworth anti-aliasing filter. USB-powered with galvanic isolation. Impedance meter with LED bar display. Optional pIRx3 infrared temperature sensor. Connectivity via USB to PC running Cygnet software.

Indications for Use

Indicated for biofeedback and relaxation training in office settings by trained professionals. Not for diagnostic use.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

• ProComp (K903497)
• BrainMaster 2E (K990538)

Submission Summary (Full Text)

{0}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

K073557

#### 510(K) SUMMARY 5

### General Information

#### Applicant 5.1

Date: February 06, 2008

- Corscience GmbH & Co. KG Name:
- Address: Henkestr. 91 D-91052 Erlangen Germany

# Contact person in the U.S.:

Address

Telephone: FAX: E-Mail:

Contact person in Germany: Telephone: FAX: E-Mail:

Patrik R. Karem

SOMNO TECH, L.L.C. 700-706 Seco Rd. Monroeville, PA 15146 412 - 372 - 8571 412 — 372 — 8575 [e-mail]

### Christine Baumann 01149 9131 977986 – 25 01149 9131 977986 - 59 [e-mail]

Signature: C. Baumann

#### 5.2 Trade Name

EEG NeuroAmp

## 5.3 Common Name or Classification Name

Biofeedback device

#### 5.4 Establishment Registration Number

3005488716

FEB 28 2003

{1}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

#### Facility Address 5.5

Corscience GmbH & Co. KG Henkestr. 91 D-91052 Erlangen Germany

#### 5.6 Device Classification

#### 5.6.1 Classification

This is a class II device

#### 5.6.2 Classification panel

Panel: neurology Product Code HCC

#### 5.6.3 Regulation Number

882.5050

.

#### 5.7 Reason for Premarket Notification

Approval of biofeedback device and computer software. Included in this premarket notification is the peripheral temperature sensor plRx3 as optional accessory. This sensor measures forehead temperature and thus supports conventional thermal biofeedback.

The device has been exempt, but is not any longer because power supply is changed from batterysupply to supply via serial (USB-) port of the therapist computer.

#### 5.8 Predicate Devices Descriptions

Names 5.8.1

ProComp BrainMaster

#### 5.8.2 Predicate Device Companies

Thought Technology Ltd., Montreal, Canada BrainMaster Technologies, Inc., Oakwood Village, OH 44146, formerly: Cleveland, OH 44124

#### 5.8.3 Predicate Device 510(k)#

ProComp: K903497 BrainMaster: K990538

{2}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

#### Device Description 5.9

The purpose of the EEG NeuroAmp is to act as user-friendly high-performance interface between client and clinician computer for EEG biofeedback) and/or peripheral biofeedback therapy. The EEG NeuroAmp contains four function blocks:

- 1. EEG amplifier, two channels, aligned and high-resolution
- 2. Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
- 3. Peripheral sensor amplifiers, three channels, allow measurement of peripheral biofeedback signals such as GSR (Galvanic Skin Response) and temperature. The latter may be by means of a contact probe (thermistor) or non-contact infrared thermal sensor (infrared thermometer).
- 4. An output for audio/visual/tactile feedback

EEG NeuroAmp provides the following characteristics:

- . Easy to use
- Power supply via serial PC-port .
- Impedance Meter: .
- Wide impedance range
- Cancellation of electrode galvanic voltages
- Cancellation of power line pick-up (notch filters)
- Bright easy-to-read LED bar display
- Balance display for optimum EEG signal noise reduction
- EEG Amplifier .
- Low-noise, quasi DC coupled
- Fast settling time
- High-performance filters for optimum anti-aliasing
- Peripheral Sensor Interface .
- Supply of power for active sensors
- High performance filters for optimum noise suppression
- . Optional peripheral temperature sensor pIRx3 as accessory
- . Audio/Visual/Tactile Output
- DC -2.5 to +2.5V
- AC 1 ... 250Hz, max 5Vss

User manuals with detailed descriptions of NeuroAmp, computer software Cygnet, and optional accessory plRx3 are submitted in section 13 "Proposed Labeling".

{3}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

## 5.10 Intended Use Statement

The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.

For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback.

The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.

The EEG NeuroAmp is not intended for diagnostic purposes.

### 5.11 Required Components

- EEG NeuroAmp .
- Software Cygnet .
- . User manuals

### Optional accessory

- Passive infrared temperature sensor pIRx3 .
- . User manual for plRx3

{4}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

# 5.12 Summary Table of Comparisons

| Parameter | EEG NeuroAmp | Predicate Device<br>ProComp | Predicate Device<br>BrainMaster 2E |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The EEG NeuroAmp is<br>intended for biofeedback and<br>relaxation purposes. To<br>perform its intended function<br>it must be used in<br>combination with a computer<br>and appropriate software<br>(Cygnet).<br>For purposes of this training<br>task, information for<br>feedback may be derived<br>from one or two channels of<br>EEG and from as many as<br>three channels of peripheral<br>physiology measures such<br>as are conventionally used in<br>biofeedback.<br>The EEG NeuroAmp is<br>intended to be used in the<br>office by trained<br>professionals who can<br>ensure sound handling<br>practices.<br>The EEG NeuroAmp is not<br>intended for diagnostic<br>purposes. | Biofeedback, relaxation<br>and muscle re-education<br>purposes. | The Brainmaster 2E is<br>indicated for relaxation<br>training using alpha EEG<br>Biofeedback. In the<br>protocol for relaxation,<br>Brainmaster provides a<br>visual and/or auditory<br>signal that corresponds<br>to the patient's increase<br>in alpha activity as an<br>indicator of achieving a<br>state of relaxation. |
| Power supply | Power supply via USB port<br>(galvanic isolation according<br>to IEC 60601-1) | 4 AA batteries, single-use<br>or rechargeable | Rechargeable batteries |
| Software | Cygnet | Biograph | BMT |
| No. of input channels | 5 | 8 | 2 |
| No. of output<br>channels | 1 | 0 | 0 |
| ADC resolution | 13 bit | 14 bit | 8 bit |
| Anti-aliasing filter | 5th order Butterworth | 5th order Butterworth | none |
| DC gain accuracy | ±1% | ±0.5% | ±5% |
| DC offset | +1 LSB | +3 LSB | +4 LSB |
| Parameter | EEG NeuroAmp | Predicate Device<br>ProComp | Predicate Device<br>BrainMaster 2E |
| Bandwidth (3dB) and<br>sample rate | EEG amplifier<br>(2 channels):<br>0.08 Hz (1st order roll-off)<br>...70 (5th order roll-off)<br>Sample rate for 50Hz line:<br>1000 sps<br>Sample rate for 60Hz line:<br>960 sps<br>Subsample rate = sample<br>rate / 4 (250/240)<br>Peripheral Amplifier<br>(3 channels):<br>DC ... 10Hz<br>Same sampling rate scheme | DC - 512Hz @ 2048<br>samples/second<br>DC - 64Hz @ 256<br>samples/second<br>DC - 64Hz @ 200<br>samples/second<br>DC - 8Hz @ 32<br>samples/second<br>DC - 8Hz @ 20<br>samples/second<br>(depending on channel) | 0.8 - 40 Hz<br>120 sps |
| Full-scale input<br>range, DC | $\pm$ 250 mV | 2.8V ± 1.696V | ±0.8 V |
| Overvoltage warning | yes | no | no |
| Impedance<br>measurement EEG<br>electrodes<br>(electrode contact<br>quality) | Both channels<br>simultaneously; displayed by<br>colored LED bars on device | One channel after the<br>other; displayed only on the<br>software | No impedance<br>measurement |
| Common-Mode<br>Rejection Ratio<br>(CMRR) - EEG<br>sensor only | >130 dB | > 130 dB | > 100 dB |
| Temperature<br>sensor (Accessory) | | | |
| Temperature range | 29°C - 43°C or 84°F - 109°F | 10°C - 45°C (50°F - 115°F) | n.a. |
| Accuracy | < 1°K | ±1.0°C (±1.8°F) at<br>20°C - 40°C (68°F - 104°F) | n.a. |

{5}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

All three devices are intended for EEG biofeedback (neurofeedback). EEG biofeedback is a process that is intended to help the client to control his own state through shaping electrical brain activity in a manner that promotes a state of relaxed alertness. The NeuroAmp and the predicate device Procomp can also be used with other conventional biofeedback sensors. ProComp can be operated with a wider range of sensors than the NeuroAmp, e.g. with sensors intended for performing muscle reeducation. Therefore, the intended use of the NeuroAmp does not include biofeedback for the purpose of muscle reeducation, as that term is conventionally understood (application to spinal cord injury, etc). On the other hand, simply training the person toward a relaxed and alert state also has implications for regulation of the motor system. A trainee is likely to also feel motorically calmed.

The differences in technological characteristics between EEG NeuroAmp and the predicate devices ProComp and Brainmaster can be summarized as follows:

- Power supply via USB-port (5V) instead of battery supply (in the case of the Procomp) .

{6}------------------------------------------------

| Title | Premarket Notification for EEG NeuroAmp |
|---------------|-----------------------------------------|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| | Corscience GmbH & Co. KG |

- Results of electrode contact measurement (impedance check) are displayed directly on the . device
- The impedance measurement needs to be engaged explicitly, and is disabled during EEG . neurofeedback. This feature differentiates the EEG NeuroAmp from the current Brainmaster, where the impedance measurement is continuous throughout.
- . The device monitors galvanic voltages throughout the training process.
- The bandwidth extends to lower EEG frequencies. .
- The temperature range of the pIRx3 is narrower than that of the Procomp temperature sensor, . but is totally sufficient for measuring forehead temperature.

The fact that the EEG NeuroAmp is powered via the serial port of the therapist computer does not affect safety or effectiveness because the device is galvanically isolated from the computer by means of a medical grade isolating transformer and has shown full compliance to IEC 60601-1.

Since qood electrode contact quality is essential for effective EEG-biofeedback therapy, the easy-touse impedance measurement function of the NeuroAmp contributes to clinical success.

The software provides for continuous monitoring of any 60-Hz contamination of the EEG, as an index to contact quality throughout the biofeedback process. The clinician is alerted on screen whenever criteria are violated.

The NeuroAmp extends the bandwidth to lower frequencies than typical EEG amplifiers because these have turned out to be of biological interest as well.

### 5.13 Summary of Device Testing

The EEG NeuroAmp and its optional accessory plRx3 have been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and have shown full compliance to these standards and the other standards listed in chapter 9 of this 510(k).

The software was tested as described in section 16 "Software".

The optional accessory "passive infrared temperature sensor plRx3" has been tested according to ISO 10993-1 by an FDA recognized testing laboratory according to GLP standards. The housing material and the elastic belt that fastens the device to the head have both been tested.

The elastic belt conforms to the German "Oko-Tex-Standard" which is a quality mark for clothing regarding certain residues. The belt is made of cotton and therefore did not pass the test for cytotoxicity. Due to this effect the belt is suitable for use on intact skin only. It did pass the tests for dermal irritation and sensitization. Normally, there is hair between the blient's skin, unless the client is bald.

The housing material has passed all tests. It shows full compliance to the standard 10993-1. See also section 15 "Biocompatibility".

### 5.14 Conclusions

Based on the above, Corscience GmbH & Co. KG concludes, that EEG NeuroAmp is substantially equivalent to legally marketed predicate devices and iffective for its intended use, and performs as well as or better than the predicate devices.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

Public Health Service

FEB 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Corscience GmbH & Co. KG % Ms. Christine Baumann Henkestrasse 91 91052 Erlangen GERMANY

Re: K073557

Trade/Device Name: EEG NeuroAmp Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC Dated: December 12, 2007 Received: December 19, 2007

Dear Ms. Baumann:

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 such 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); 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.

{8}------------------------------------------------

Page 2 – Ms. Christine Baumann

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | CENTER FOR DEVICES AND RADIOLOGICAL HEALTH<br>1 Page ODRH Home Page Search CDRH A-Z Index Con |
|----------------------------|-------------------------------------------------------------------------------------------------------|
| | Indications for Use |
| <10/1) Number (if Imaism). | |

EEG NeuroAmp Device Name:

Indications for Use:

The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.

For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback.

The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.

The EEG NeuroAmp is not intended for diagnostic purposes.

"Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by the State in which he practices to use or order the use of the device."

Yes Prescription Use (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 General, Restorative, and Neurological Devices

http://www.fda.gov/odrh/ode/indicate.html

510(k) Number