(411 days)
Not Found
No
The summary describes a device for acquiring, displaying, storing, and archiving EEG signals, and for biofeedback. It explicitly states that the device does not draw any diagnostic conclusions and that data needs to be interpreted by a clinical expert. There are no mentions of AI, ML, or related concepts in the description of the device's functionality or performance studies.
Yes
The device is intended for biofeedback and relaxation purposes, and it is explicitly stated that it can be used in "medical and therapeutic practices." Additionally, the "Device Description" section outlines its functionality for EEG biofeedback (neurofeedback) and peripheral biofeedback setting, which are therapeutic modalities. While it also performs diagnostic functions (acquiring and displaying EEG/ERP signals), its intended use includes therapeutic applications.
No
The device description explicitly states: "The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings." This indicates it is a data acquisition and display device, not one that provides a diagnosis.
No
The device description explicitly states it contains hardware components: an EEG amplifier, impedance meter, and peripheral channels. It also mentions accessories like the NeuroAmp x23/x39 devices which are described as hardware front-ends.
Based on the provided information, the EEG NeuroAmp II.5s is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EEG NeuroAmp II.5s Function: The EEG NeuroAmp II.5s acquires, displays, stores, and archives electroencephalographic (EEG) signals directly from the patient's brain via electrodes placed on the head. It is a device that interacts with the patient's body to measure physiological signals.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It measures electrical activity of the patient's brain.
- Diagnostic Conclusion: The description explicitly states, "The device does not draw any diagnostic conclusion." This is a key characteristic that differentiates it from many IVD devices which are designed to provide diagnostic information based on specimen analysis.
Therefore, the EEG NeuroAmp II.5s falls under the category of a medical device that measures physiological signals in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.
The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.
The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, GWE, GWJ, OLV, HCC
Device Description
The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting.
The EEG NeuroAmp 11.5s device itself contains three function blocks:
-
- EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end
-
- Impedance meter function
-
- peripheral channels for additional sensors, ERP synchronization and biofeedback
Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting.
The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.
The cable that connects the x23/x39 devices to the EEG NeuroAmp 11.5s may be up to 3m long allowing for flexibility for the arrangement of the recording environment.
The front-connector interfaces directly with all typically available EEG cap systems. Ground, ear electrodes and two additional channels are available at the top panel of the device for convenient connection of standard electrodes.
In case of an event related potential (ERP) recording, the ERP task is presented to the client on a second monitor. The Sync-Box is connected to the second screen to record a visual signal for task presentation synchronization and to the audio output. An event button is connected to the Sync-Box to align the clients' reaction to the presented tasks.
EEG NeuroAmp II.5s 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, 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
- Stimulation interface for EEG/ERP measurements
- Optional peripheral physiological signal sensors as accessories
- Interface to an optional full 23-/39-channel digital EEG recording front-end
- Event button for the measurement of event related potentials as optional accessory (ERP Sync)
- Peripheral channels for biofeedback (Audio/Visual/Tactile feedback)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's brain obtained by placing two or more electrodes on the head.
Indicated Patient Age Range
patients of all ages but is not designed for fetal use.
Intended User / Care Setting
Used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices.
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)
Electrical Safety: The EEG NeuroAmp II.5s was tested according to IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012. Results indicate that the EEG NeuroAmp 11.5 complies with the applicable standard.
Electromagnetic Compatibility: The EEG NeuroAmp II.5s was tested according to IEC 60601-1-2: Edition 4.0; 2014-02 and IEC 60601-2-26: 2012. Results indicate that the EEG NeuroAmp II.5s complies with the applicable standards.
Performance Testing: The EEG NeuroAmp II.5s was verified for EEG hardware performance in accordance with internal requirements and the applicable clauses of IEC 62366-1: 2015, IEC 80601-2-26: 2019, and IEC 60601-2-40:2016. Results indicate that the EEG NeuroAmp II.5s complies with its predetermined specifications and the applicable standards.
The optional accessories "NeuroAmp x23", "NeuroAmp x39", "ERP Sync", "Combination Sensor" and tactile feedback device "Brumm" have been tested according to ISO 10993-1, IEC 60601-1 and IEC 60601-1-2 and have shown full compliance to these standards. ISO 10993-1 applies only to "Combination Sensor" and "Brummi".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 30, 2020
Corscience gmbH & Co. KG Stefan Bolleininger Director Regulatory Affairs Hartmannstrasse 65 Erlangen, 91052 De
Re: K193159
Trade/Device Name: EEG NeuroAmp II.5s Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GWE. GWJ. OLV. HCC Dated: November 30, 2020 Received: November 30, 2020
Dear Stefan Bolleininger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193159
Device Name EEG NeuroAmp II.5s
Indications for Use (Describe)
The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.
The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.
The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- |
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3
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
Corscience GmbH & Co. KG
510(K) SUMMARY
General Information
1 Applicant
Date: November 13, 2020
Name: Corscience GmbH & Co. KG
Hartmannstrasse 65 Address: D-91052 Erlangen Germany
Contact person in the U.S .:
Address
Telephone: E-Mail:
Beaverton, OR 97008 818-3139980
BEE SYSTEMS INC Dr. Bernhard Wandernoth 7724 SW Nimbus Ave, BLDG 10 S
Contact person in Germany: Telephone: FAX: E-Mail:
Stefan Bolleininger +49 9131 977986 – 50 +49 9131 977986 - 449 stefan.bolleininger@corscience.de
Stetson Bollinger
Signature:
2 Brand Name
EEG NeuroAmp® II (brand name EEG NeuroAmp® II.5s for differentiation to the EEG-biofeedback device EEG NeuroAmp®)
3 Common Name or Classification Name
EEG/ERP measurement & biofeedback device
Establishment Registration Number 4
3005488716
5 Facility Address
Corscience GmbH & Co. KG Hartmannstrasse 65 D-91052 Erlangen Germany
4
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
6 Device Classification
6.1. Classification
This is a class II device
6.2. Classification panel
Panel: Neurology Primary Product Code: GWQ Secondary Product Codes: GWE, GWJ, OLV, HCC
Regulation Number 6.3.
21 CFR 882.1400 -- Electroencephalograph
7 Predicate Devices Descriptions
7.1. Names
For the EEG measurement functionality Mitsar EEG - primary predicate device Natus Brain Monitor, Embla Dx series
For the EEG-biofeedback (neurofeedback) or peripheral biofeedback functionality EEG NeuroAmp II
7.2. Predicate Device Companies
Mitsar Co. Ltd, Novorossiyskaya Str. 21-2, 194021 St. Petersburg, Russian Federation Natus Medical Incorporated DBA Excel-Tech Ltd., 2568 Bristol Circle, Oakville, ON L6H5S1, Canada Corscience GmbH & Co. KG, Hartmannstrasse 65, 91052 Erlangen, Germany
7.3. Predicate Device 510(k)#
Mitsar EEG: K143233 Natus Brain Monitor, Embla Dx series: K180290 EEG NeuroAmp: K073557
5
| Title
| Premarket Notification for EEG NeuroAmp II.5s | |||
|---|---|---|---|
| Document Name | |||
| NeuroAmp II.5s_510(k).doc | Issue | ||
| 1.3 | Project | ||
| COR035 | Date | ||
| Nov 13th, 2020 | |||
| Corscience GmbH & Co. KG |
Device Description 8
The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The figures show the two different settings.
Image /page/5/Figure/3 description: The image shows a diagram of a brain-computer interface (BCI) setup. On the left side, a therapist is sitting at a desk with a computer and a screen labeled "Therapist screen". On the right side, a patient is sitting in a chair wearing a cap with electrodes, connected to an EEG NeuroAmp® X23 device. The diagram also shows connections labeled "Video", "Data", and "Audio" between the therapist's computer and the patient's setup, including a speaker and a Sync-Box.
Use of the EEG NeuroAmp II.5s and x23 in an EEG/ERP measurement setting
Image /page/5/Figure/5 description: The image shows a diagram of a neurofeedback setup. On the left side, a clinician is sitting at a desk with a computer, keyboard, and an EEG NeuroAmp with Impedance Meter. A USB cable connects the NeuroAmp to the computer, and a signal is sent from the NeuroAmp to the client. On the right side, a client is sitting in front of a screen that provides feedback based on their brain activity.
Use of the EEG NeuroAmp II.5s in an EEG biofeedback setting
6
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
The EEG NeuroAmp 11.5s device itself contains three function blocks:
-
- EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end
-
- Impedance meter function
-
- peripheral channels for additional sensors, ERP synchronization and biofeedback
Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting,
The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.
The cable that connects the x23/x39 devices to the EEG NeuroAmp 11.5s may be up to 3m long allowing for flexibility for the arrangement of the recording environment.
The front-connector interfaces directly with all typically available EEG cap systems. Ground, ear electrodes and two additional channels are available at the top panel of the device for convenient connection of standard electrodes.
In case of an event related potential (ERP) recording, the ERP task is presented to the client on a second monitor. The Sync-Box is connected to the second screen to record a visual signal for task presentation synchronization and to the audio output. An event button is connected to the Sync-Box to align the clients' reaction to the presented tasks. The following figure shows a schematic of the whole system with all connections. Please note: EEG cap, computer and speakers are not part of the device and must be purchased from external sources.
Image /page/6/Figure/10 description: This image shows a diagram of an ERP (Event-Related Potential) experimental setup. The diagram includes components such as a computer with EEG recording software, an EEG NeuroAmp II.5s, an ERP sync device, a computer screen for ERP task presentation, speakers, and an input device. The diagram also shows the connections between these components, including video, audio, USB, Mini-Din8, and digital connections.
Schematic of the event related potential (ERP) recording set-up
7
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
EEG NeuroAmp II.5s 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, 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
- Stimulation interface for EEG/ERP measurements
- Optional peripheral physiological signal sensors as accessories ●
- Interface to an optional full 23-/39-channel digital EEG recording front-end ●
- Event button for the measurement of event related potentials as optional accessory (ERP ● Sync)
- . Peripheral channels for biofeedback (Audio/Visual/Tactile feedback)
8
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
8.1. All accessories to be marketed for use with the subject device
| Device name | Description | 510(k) number |
|---|---|---|
| NeuroAmp x23 | 23-channel EEG recording front-end, works | |
| only with EEG NeuroAmp II.5s | No prior clearance | |
| NeuroAmp x39 | 39-channel EEG recording front-end, works | |
| only with EEG NeuroAmp II.5s | No prior clearance | |
| ERP Sync | Device to record the audio-visual stimuli and | |
| patient inputs synchronously with the EEG, | ||
| used for Event Related Potential | ||
| measurements, works only with EEG | ||
| NeuroAmp II.5s | No prior clearance | |
| Combination sensor | For measurement of heart rate, galvanic skin | |
| response (GSR) and skin temperature, works | ||
| with EEG NeuroAmp and EEG NeuroAmp | ||
| II.5s | No prior clearance | |
| Brummi | Tactile feedback device, works with EEG | |
| NeuroAmp and EEG NeuroAmp II.5s | No prior clearance | |
| pIRx3 | Temperature sensor, works with EEG | |
| NeuroAmp and EEG NeuroAmp II.5s | K073557 | |
| Software accessories | Description | 510(k) number |
| Cygnet | EEG biofeedback software, works with EEG | |
| NeuroAmp and EEG NeuroAmp II.5s | K073557 | |
| ERPrec | EEG measurement/recording functionality, | |
| works only with EEG NeuroAmp II.5s | No prior clearance | |
| BEE Lab | EEG-biofeedback functionality, works with | |
| EEG NeuroAmp and EEG NeuroAmp II.5s | No prior clearance |
9
Title
Premarket Notification for EEG NeuroAmp II.5s
| Document Name | NeuroAmp II.5s_510(k).doc |
|---|---|
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
9 Indications for Use Statement
EEG NeuroAmp® II.5s is intended to acquire, display, store and archive The the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp® II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.
The EEG NeuroAmp® 11.5s can also be used for biofeedback and relaxation purposes. For purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.
The EEG NeuroAmp® II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.
The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.
Required Components 10
For EEG measurement functionality:
- EEG NeuroAmp II (brand name EEG NeuroAmp II.5s) ●
- . Either NeuroAmp x23 or NeuroAmp x39, 23- or 39-channel EEG recording front-end
- Software ERPrec ●
- User manuals ●
Computer, monitor and electrode caps are purchased from other sources
Optional accessories - to be obtained from EEG NeuroAmp 11.5s manufacturer
- ERP Sync device to record the audio-visual stimuli and patient inputs synchronously with the ● EEG, used for Event Related Potential measurements
- . Combination sensor for measurement of heart rate, galvanic skin response (GSR) and skin temperature
For EEG-biofeedback functionality:
- EEG NeuroAmp 11.5s
- Software Cygnet (optional)
- Software BEE Lab (optional) ●
- User manuals ●
Computer, monitor and electrodes are purchased from other sources
Optional accessories - to be obtained from EEG NeuroAmp 11.5s manufacturer
- Combination sensor for measurement of heart rate, galvanic skin response (GSR) and skin ● temperature
- Tactile feedback device Brummi
10
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| ------- | ----------------------------------------------- |
| Document Name | NeuroAmp II.5s_510(k).doc |
|---|---|
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
Corscience GmbH & Co. KG
11 Summary Table of Comparisons
11.1. EEG/ERP measurement functionality
| Specification | Subject Device
EEG NeuroAmp II.5s | Primary Predicate
Device
Mitsar EEG
K143233 | Predicate Device
Natus Brain Monitor
K180290 | Discussion on safety
and effectiveness |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use (short
version) | Acquire, display, store
and archive the electro-
encephalographic (EEG)
signals from a patient's
brain obtained by placing
two or more electrodes
on the head incl.
stimulation and recording
of visual and auditory
evoked response
potentials. | Acquire, display
and store the
electrical activity of
a patient's brain
obtained by placing
two or more
electrodes on the
head to aid in
diagnosis. | Acquire, display, store
and archive
electrophysiological
signals. Scalp and
Intracranial EEG as
well as
polysomnographic
signals. | Both predicates also offer
the capability of
stimulation and recording
of visual and auditory
evoked response
potentials. |
| Common name,
Product code,
Regulation
number | EEG/ERP measurement
& biofeedback device,
GWQ, GWE, GWJ, OLV
& HCC
21 CFR 882.1400, 21
CFR 882.5050, 21 CFR
882.1890 & 21 CFR
882.1900 | Electroencephalogr
aph
GWQ 21 CFR
882.1400 | Electroencephalograph
GWQ & OLV 21 CFR
882.1400 | Codes GWE, GWJ not
listed in product 510k of
predicate Mitsar EEG but
the product fulfills the
equal functionality.
Thererore, the additional
codes are applicable. |
| Power supply | Power supply via USB
port (galvanic isolation
according to IEC 60601-
-
| Power supply via
USB port | USB port | USB port is the only
power source, i.e. as for
predicate device no other
safety-relevant power
sources are to be
considered. The galvanic
insulation of USB data
and power conforms to
IEC 60601-1.
→ Same or better
safety |
| Software | ERPrec | EEG Studio | Natus NeuroWorks™/
SleepWorks. Data
stored in 16-bit
resolution only | The ERPrec software
stores the data in full
resolution without loss. It
is better than the
predicate devices
→ Same or better
effectiveness |
| Windows 10 and
7 compatible | Yes | Windows 7,
perhaps also
Windows 10 | Yes | Software is fully qualified
on actual Windows
systems and covers
same or more operating
systems as predicate
device
→ Same or better
effectiveness |
| EEG channels | up to 41 plus 8
peripheral channels | 21 + 4
active/reference
pairs, one auxiliary
channel | 40 | More channels
→ Same or better
effectiveness |
| Resolution EEG
channels | 24 bit, stored loss-free
24bit and full sampling
rate | 16 bit | 24 bit (16 bit stored) | Same or higher digital
resolution, better
resolution in stored data
→ Better
effectiveness |
| Sampling
frequency | 1Msample/second gross
sampling rate, down
sampled to 250 or 500
sps. synchronous
sampling over all EEG-
and peripheral channels | 500 Hz per
channel,
multiplexed | 256, 512, 1024, 2048,
4096
256, 512Hz (Embla
SDx) | Gross sampling rate much
higher than predicate
device -> improved anti-
aliasing performance. Net
sampling rate sufficient for
given bandwidth
→ Better
effectiveness |
| Common-Mode
Rejection Ratio
(CMRR) | >130 dB | at least 100 dB at
10 Hz | >106db@60Hz | The CMRR of the subject
device is much better than
the predicate device.
Better CMRR results in
better signal quality and
immunity against noise.
→ Better
effectiveness |
| Notch filter | 1000 MOhm | > 200 MΩ | >1000 MOhm | High impedance important
for proper recording. Same
or better performance as
predicate device.
→ Same or better
effectiveness |
| Bandwidth (3dB)
and
sample rate | DC ... 100Hz/160Hz | 0.16 – 70 Hz | 0.1 Hz – 100 Hz | Subject device has full DC
coupling, which allows for
recording of slow cortical
potentials.
→ Better
effectiveness |
| Impedance
measurement
EEG electrodes
(electrode
contact quality) | Yes
0 ... 140kΩ | Yes
5kΩ – 40kΩ | Yes
2.5kΩ, 5kΩ, 10kΩ,
25kΩ | Wider range as predicate
device. With that, better
guidance for technician
when mounting the
electrodes.
→ Better
effectiveness |
| Input Noise | Better
effectiveness |
| Maximum
Operational DC
input voltage
electrode offset | ±550mV | ±350 mV (Offset
tolerance) | ±300mV | Input offset range of
subject device is much
higher than predicate
device. A large offset
range is important to cover
offset voltages by
electrodes.
-> Better
effectiveness |
| ERP
measurement:
synchronization
mechanism and
precision in ms | Active audio and video
synchronization with
Sync device; Event
button, 24 bit trigger..
Accuracy/jitter:
±1ms/ Better
effectiveness and
safety |
| Visual and
auditory stimuli
for ERP
measurement | Stimulus presentation
software incorporated in
software ERPrec Audio
and video sensors for
continuous calibration
and selftest of the
system initial to each
recording. | Stimulus
presentation
software
incorporated in
software EEG
Studio. Audio and
video sensors for
initial calibration. | no data | Same or better
effectiveness |
| Measurement of
physiological
data | Combination sensor,
applied to the finger, for
heart rate and galvanic
skin response (GSR).
Skin temperature of the
finger can be measured,
not absolute values, only
trends. No therapeutic
effect of sensor. | Multi-purpose
inputs for peripheral
biosignal
acquisition such as
heart rate, skin
conductance
(GSR),
temperature,
breathing, SpO2.
ECG adapter clips
supplied, breathing
sensor available | SpO2 Pulse Rate,
Plethysmogram, PPG | Subject device and
software work only with
accessories supplied.
Therefore mis-reading or
false values less likely to
occur
->
Better
effectiveness and
safety |
| Video recording | Possible | Possible | Possible | Same or better
effectiveness |
| Specification | Subject Device
EEG NeuroAmp II.5s | Predicate Device
Corscience EEG
NeuroAmp
K073557 | Comparison of
subject device
with predicate
device based on
safety and
effectiveness | |
| Indications for Use | Biofeedback and relaxation
purposes | Biofeedback and
relaxation purposes | same | |
| Common name,
Product code,
Regulation number | EEG/ERP measurement &
biofeedback device,
GWQ, GWE, GWJ, OLV & HCC
21 CFR 882.1400, 21 CFR
882.5050, 21 CFR 882.1890 &
21 CFR 882.1900 | Biofeedback device
HCC
21 CFR 882.5050 | same or better
effectiveness | |
| Power supply | Power supply via USB port
(galvanic isolation according to
IEC 60601-1) | Power supply via USB
port (galvanic isolation
according to IEC
60601-1) | Same
→ Same safety | |
| Software | Cygnet, BEE Lab | Cygnet, BEE Lab | Same
→ same
effectiveness | |
| Windows 10 and 7
compatible | Yes | Yes | Same
→ Same
effectiveness | |
| x23/x39 EEG amplifier
interface | Yes | No | Subject device
allows to connect
additional
peripherals
→ Same or better
effectiveness | |
| No. peripheral
channels inputs | 8 | 3 | More peripheral
channels allow | |
| No. peripheral
channels outputs | 8 | 1 | for more
peripherals
attached
simultaneously.
→ Better
effectiveness | |
| EEG resolution | 32 bit | 13 bit | Much better | |
| Input noise | μ$ V/ $Hz$ ; μ$ Vp-p | μ$ Vp-p | technical | |
| Overvoltage warning | yes | yes | performance. The
subject device | |
| EEG bandwidth | DC ... 100/160Hz | 0.056 ... 70Hz | has full DC | |
| Peripheral channel
resolution | 24 bit | 13 bit | coupling, which
allows the work | |
| Peripheral channel | DC ... 100/160Hz | DC ... 70Hz | with slow cortical | |
11
| Title |
|---|
| Premarket Notification for EEG NeuroAmp II.5s |
| Document Name | NeuroAmp II.5s_510(k).doc |
|---|---|
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
12
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
13
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
11.2. EEG-Biofeedback (Neurofeedback) Functionality
The EEG NeuroAmp II.5s and its predicate device EEG NeuroAmp (K073557) have the same functionality and similar technical data. The technical data of the EEG NeuroAmp II.5s are superior to those of the EEG NeuroAmp and it has more peripheral channels. In addition, the EEG NeuroAmp II.5s can be equipped to be a 23- or 39-channel EEG recording device by connecting the NeuroAmp x23/x39 accessories. The differences in technical data between the subject and predicate device are listed in the table below. The neurofeedback functionality of both devices is the same.
14
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| ------- | ----------------------------------------------- |
| Document Name | NeuroAmp II.5s_510(k).doc |
|---|---|
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG | |
|---|---|
| -------------------------- | -- |
| bandwidth | potentials, higher
bandwidth and
lower noise. This
results in better
signal-to-noise
ratio and signal
quality. Higher
resolution and
better signal
quality allow for
better signal
processing.
-> Better
effectiveness |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Neurofeedback
functionality | Yes |
| Biofeedback sensor
interface | Yes |
15
| Title | Premarket Notification for EEG NeuroAmp II.5s |
|---|---|
| Document Name | NeuroAmp II.5s_510(k).doc |
| Issue | 1.3 |
| Project | COR035 |
| Date | Nov 13th, 2020 |
| Corscience GmbH & Co. KG |
12 Brief Summary of Performance Testing
Electrical Safety The EEG NeuroAmp II.5s was tested according to the following standard: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 ● +A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. (or IEC 60601-1: 2012 reprint) – CB Scheme Results indicate that the EEG NeuroAmp 11.5 complies with the applicable standard. The EEG NeuroAmp II.5s was tested according to the following standards: Electromagnetic Compatibility IEC 60601-1-2: Edition 4.0; 2014-02, Medical electrical equipment – ● Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. ● IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. Results indicate that the EEG NeuroAmp II.5s complies with the applicable standards. Performance Testing The EEG NeuroAmp II.5s was verified for EEG hardware performance in - Bench accordance with internal requirements and the applicable clauses of the following standards: ● IEC 62366-1: 2015, Medical devices - Application of usability engineering to medical devices. . IEC 80601-2-26: 2019, Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. . IEC 60601-2-40:2016 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment. Results indicate that the EEG NeuroAmp II.5s complies with its predetermined specifications and the applicable standards.
The optional accessories "NeuroAmp x23", "NeuroAmp x39", "ERP Sync", "Combination Sensor" and tactile feedback device "Brumm" have been tested according to ISO 10993-1, IEC 60601-1 and IEC 60601-1-2 and have shown full compliance to these standards. ISO 10993-1 applies only to "Combination Sensor" and "Brummi".
13 Conclusions
Based on the above, Corscience GmbH & Co. KG concludes, that EEG NeuroAmp II.5s is substantially equivalent to legally marketed predicate devices and effective for its intended use and performs as well as or better than the predicate devices.