SYNAMPS2

K023771 · Neuroscan · GWQ · Feb 6, 2003 · Neurology

Device Facts

• Record ID: K023771
• Device Name: SYNAMPS2
• Applicant: Neuroscan
• Product Code: GWQ · Neurology
• Decision Date: Feb 6, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.

Device Story

SynAmps2 is an EEG/ERP/EP amplifier and data acquisition system. It captures electrical brain activity via multiple electrodes connected to a patient-side Headbox. The Headbox transmits signals to a System Unit, which interfaces with a host computer via USB 2.0. The system supports up to 512 channels by connecting multiple System Units. Operated by trained EEG technologists or physicians in clinical or research settings. The host computer software controls data acquisition. Physicians interpret the acquired EEG/EP data to aid in clinical monitoring and diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

EEG/ERP/EP amplifier and data acquisition system. Comprises a patient-side Headbox and a System Unit. Connectivity via USB 2.0 to a host computer. Supports up to 512 channels. Class II device under 21 CFR 882.1400.

Indications for Use

Indicated for patients requiring EEG monitoring and diagnosis in clinical settings, and for EEG and long/middle/short-latency EP registration in research environments. Intended for use by trained technologists or physicians.

Regulatory Classification

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.

Predicate Devices

• SynAmps (K001324)

Submission Summary (Full Text)

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## V. 510(k) Summary

Safety and effectiveness information concerning this device is summarized below. Because this is not a Class III device, the special certification defined in this section is not required.

| Submitted by: | Neuroscan<br>7850 Paseo Del Norte, Suite 101<br>El Paso, TX 79912<br>Phone: [phone] ext 217<br>Fax: [phone] | FEB 06 2003 |
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| Contact Person: | Elvira Garcia | |
| Date Prepared: | October 30, 2002 | |
| Proprietary Name: | SynAmps2 | |
| Common Name: | Electroencephalograph (EEG) | |
| Classification Name: | GWQ, GWP, GWF, GWE, GWJ | |
| Device Classification<br>Class II: | 21 CFR § 882.1400 Electroencephalograph | |
| Predicate Device: | SynAmps<br>510(k) # K001324 | |

## Description of the Device:

The SynAmps2® Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition electronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual electrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.

The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.

The system operates under the software control of a host computer over a USB 2.0 interface. Data flows from the SynAmps2 amplifier over this interface. Multiple System Units may be connected to the host, to obtain systems of up to 512 channels.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2003

Neuroscan Elvira Garcia Quality Assurance Manager 7850 Paseo Del Norte, Suite 101 El Paso, Texas 79912

Re: K023771

Trade/Device Name: SynAmps2 Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: November 6, 2002 Received: November 12, 2002

Dear Ms. Garcia:

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. Iisting 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.

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Page 2 - Ms. Elvira Garcia

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Muriam C Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## IV. Statement of Indications for Use

| Applicant: | Neuroscan<br>7850 Paseo Del Norte, Suite 101<br>El Paso, TX 79912<br>Phone: [phone] ext. 217<br>Fax: [phone] |
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KOLS 771 51(k) Number:

Device Name:

Neuroscan SynAmps2

Indications For Use: The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.

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Concurrence of CDRH, Office of device Evaluation (ODE)

Musiam C. Provost

eral, Restorative Division Neurological Devices

510(k) Number K023771

(Per 21 CFR 801.109)

SynAmps2 510(k) Application