(71 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components for signal acquisition and output, not data processing using AI/ML.
Yes
The device is intended for "biofeedback and relaxation purposes," and it serves as an "interface between client and clinician computer for EEG biofeedback) and/or peripheral biofeedback therapy," which falls under the scope of therapeutic applications.
No
The "Intended Use / Indications for Use" section explicitly states, "The EEG NeuroAmp is not intended for diagnostic purposes."
No
The device description explicitly lists hardware components such as an EEG amplifier, impedance meter, and peripheral sensor amplifiers, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for biofeedback and relaxation purposes" and "is not intended for diagnostic purposes." IVD devices are specifically designed for diagnostic purposes, analyzing samples from the human body to provide information about a person's health.
- Device Description: The device description focuses on amplifying physiological signals (EEG and peripheral) for biofeedback therapy, not for analyzing samples for diagnostic information.
- Lack of IVD Characteristics: The description does not mention any features or functions related to analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HCC
Device Description
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:
-
- EEG amplifier, two channels, aligned and high-resolution
-
- Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
-
- 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).
-
- 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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals who can ensure sound handling practices.
office
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)
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".
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.
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
§ 882.5050 Biofeedback device.
(a)
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.(b)
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.
0
| Title | Premarket Notification for EEG NeuroAmp |
|---|---|
| Document Name | NeuroAmp_510(k).doc |
| Issue | 1.1 |
| Date | Feb.06.2008 |
| Corscience GmbH & Co. KG |
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 rpkarem@somnotech.com
Christine Baumann 01149 9131 977986 – 25 01149 9131 977986 - 59 baumann@corscience.de
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:
-
- EEG amplifier, two channels, aligned and high-resolution
-
- Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
-
- 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).
-
- 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
ProComp | Predicate Device
BrainMaster 2E |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
(Cygnet).
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. | Biofeedback, relaxation
and muscle re-education
purposes. | The Brainmaster 2E is
indicated for relaxation
training using alpha EEG
Biofeedback. In the
protocol for relaxation,
Brainmaster provides a
visual and/or auditory
signal that corresponds
to the patient's increase
in alpha activity as an
indicator of achieving a
state of relaxation. |
| Power supply | Power supply via USB port
(galvanic isolation according
to IEC 60601-1) | 4 AA batteries, single-use
or rechargeable | Rechargeable batteries |
| Software | Cygnet | Biograph | BMT |
| No. of input channels | 5 | 8 | 2 |
| No. of output
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
ProComp | Predicate Device
BrainMaster 2E |
| Bandwidth (3dB) and
sample rate | EEG amplifier
(2 channels):
0.08 Hz (1st order roll-off)
...70 (5th order roll-off)
Sample rate for 50Hz line:
1000 sps
Sample rate for 60Hz line:
960 sps
Subsample rate = sample
rate / 4 (250/240)
Peripheral Amplifier
(3 channels):
DC ... 10Hz
Same sampling rate scheme | DC - 512Hz @ 2048
samples/second
DC - 64Hz @ 256
samples/second
DC - 64Hz @ 200
samples/second
DC - 8Hz @ 32
samples/second
DC - 8Hz @ 20
samples/second
(depending on channel) | 0.8 - 40 Hz
120 sps |
| Full-scale input
range, DC | $\pm$ 250 mV | 2.8V ± 1.696V | ±0.8 V |
| Overvoltage warning | yes | no | no |
| Impedance
measurement EEG
electrodes
(electrode contact
quality) | Both channels
simultaneously; displayed by
colored LED bars on device | One channel after the
other; displayed only on the
software | No impedance
measurement |
| Common-Mode
Rejection Ratio
(CMRR) - EEG
sensor only | >130 dB | > 130 dB | > 100 dB |
| Temperature
sensor (Accessory) | | | |
| Temperature range | 29°C - 43°C or 84°F - 109°F | 10°C - 45°C (50°F - 115°F) | n.a. |
| Accuracy |