NIC36 AMPLIFIER

K041198 · Eb Neuro S.P.A. · GWL · Jun 1, 2004 · Neurology

Device Facts

• Record ID: K041198
• Device Name: NIC36 AMPLIFIER
• Applicant: Eb Neuro S.P.A.
• Product Code: GWL · Neurology
• Decision Date: Jun 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

The Nic36 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

Device Story

Nic36 Amplifier is a programmable system for acquiring bioelectric signals from the human body surface. It captures analog signals via leads/transducers, performs analog-to-digital conversion (16-bit SAR), and transmits digital data to a host PC running neurophysiology software. Used in clinical settings for EEG, EP, EMG, polysomnography, and general polygraphy. Operated by physicians or under their direction. System consists of an amplifier box, AC/DC adapter, and optional LED stimulator. Fiber optic link provides CF-type patient isolation. Output is displayed on a host PC for clinical review, aiding in the diagnosis and assessment of neurophysiological conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to the predicate device.

Technological Characteristics

36 monopolar fixed inputs; 16-bit SAR A/D conversion; sampling rate up to 8192 Hz/channel; CMRR >100dB; noise <0.5 µVrms(AC), <7 µVrms(DC). Fiber optic link for CF-type patient isolation. Connectivity via PCMCIA or BE Net. Powered by external IEC 601-1 AC/DC adapter. Dimensions: 203 x 135 x 38 mm; Weight: 0.55 kg. Firmware is resident and runtime downloadable.

Indications for Use

Indicated for use by or under the direction of a physician for the acquisition and transmission of EEG, polygraphy, and polysomnography signals to a PC during neurophysiology examinations. No specific patient population age or gender restrictions are stated.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• Mizar Amplifier (K003154)

Submission Summary (Full Text)

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510(k) Summary EB Neuro. S.p.A. Nic36 Amplitier

JUN - 1 2004

K041198

# 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

### Submitter Information

Carri Graham, Official Corresondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250

[phone] Phone: [phone] Facsimile:

Carri Graham Contact Person:

May 5, 2004 Date:

807.92(a)(2)

| Trade Name: | Nic36 Amplifier | |
|-------------------------|--------------------------------|---------|
| Common Name: | Physiological Signal Amplifier | |
| Classification Name(s): | Physiological Signal Amplifier | |
| Classification Number: | 84GWL | |
| 807.92(a)(3) | | |
| | Predicate Device(s) | |
| EB Neuro, S.p.A. | Mizar Amplifier | K003154 |

Additional Substantial Equivalence Information is provided in the following Technological Characteristics Table.

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510(k) Summary EB Neuro. S.p.A. Nic36 Amplifier

807.92 (a)(4)

#### Device Description

The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog The NiCSO Aniphier is a fully programmation of amplified and converted to digital form mput challiers cach of witch can '00 bonnigation's its power from a dedicated ACDC
(analog to digital conversion). The amplifier receives its power from a dedicated AC/DC (affalog to digital conversion). The amirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.

The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals The NICJO Ampillier is Intended to the surface of the human body. It captures the data, capidled via a lead of thansdaor on assess it on to a host computer running appropriate converts it into a urgital fields of application will be: Electroencephalograph ampirication Soltware. Typted Ticlas or upportunians
(EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.

The Nic36 Amplifier does not contain a Pulse Oximeter module.

The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.

The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the The Nicholo Ampiriter System ocubists be AC/DC adapter; optionally the system may be completed by a led visual stimulator.

807.92(a)(5)

#### Intended Use(s)

The Nic36 Amplifier is intended to be used by or under the direction of a physician for The Nicov Timplifier to graphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

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510(k) Summary
EB Neuro, S.p.A.
Nic36 Amplifier

#### 807.92(a)(6)

## Technological Characteristics

| Item | EB Neuro<br>MIZAR Amplifier<br>K003154 | EB Neuro<br>Nic36 Amplifier<br>This Submission |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Acquisition of EEG, polygraphy<br>and polysomnography signals and<br>transmission of these signals to a<br>PC during recording of<br>neurophysiology examinations | Acquisition of EEG, polygraphy<br>and polysomnography signals and<br>transmission of these signals to a<br>PC during recording of<br>neurophysiology examinations |
| EEG/Polygraphic channel | 32/40<br>(64/96/128 with expansion<br>boards) | 36 monopolar fixed - (no<br>expansion boards) |
| DC channel | 32/40 | 4 |
| A/D conversion | 16 bit Sigma-Delta A/D<br>effectively transferred to host | 16 bit SAR effectively transferred<br>to host |
| Sampling rate | User selectable (128, 256, 512..<br>.up to 32 KHz/Channel | User selectable (128, 256, 512...<br>up to 8192 Hz/Channel) |
| CMRR | >100dB | >100dB |
| Noise | < 1.5 µVpp | <0.5 µVrms(AC) <7 µVrms(DC) |
| Power Supply | External IEC 601-1 mains adapter<br>Internal batteries (optional) | External IEC 601-1 mains adapter |
| Internal Storage | N/A | N/A |
| Amplifier - PC Interface | PCMCIA or BE Net | PCMCIA (NicPCMCIA) or BE Net<br>(NicNet) |
| Other Interfaces | 128x64 graph LCD display 5<br>push buttons | Power on LED / LED matrix Ohm<br>Meter |
| Use standard sensors and<br>electrodes | Yes (electrodes and sensors are<br>not included with the Amplifer) | Yes (electrodes and sensors are not<br>included with the Amplifier) |
| Dimension | 250 (L) x 170 (W) x 65 (h)<br>(mm) | 203 (L) x 135 (W) x 38 (H) (mm) |
| Weight | 1.5 Kg | 0.55 Kg |
| Isolation | Fiber optic link<br>Patient isolation BF type | Fiber optic link<br>Patient isolation CF type |
| Safety Standards | | |
| | IEC 601-1<br>IEC 601-1-2<br>IEC 601-2-26<br>IEC 601-1-4 | IEC 601-1<br>IEC 601-1-2<br>IEC 601-2-26<br>IEC 601-1-4 |
| System Components | Amplifier.<br>Head box<br>AC/DC Adapter<br>PCMCIA or BE Net Interfaces/<br>DC Input box (optional)<br>LED Flash stimulator (optional) | Amplifier<br>AC/DC Adapter<br>PCMCIA (NicPCMCIA) or BE Net<br>(NicNet) Interface<br>/DC Input box (NicDCIN)<br>(optional)<br>LED Flash stimulator (NicLED<br>Photic Stimulator) (optional) |
| Firmware | Resident and Runtime<br>downloadable | Resident and Runtime<br>downloadable |
| Patient connection and<br>inputs | 32 monopolar – 32 plugs<br>8 bipolar – 16 plugs<br>1 Thermistor - 2 plugs<br>2 Reference inputs – 2 plugs<br>14 ISO GROUND inputs – 14<br>plugs | 36 monopolar inputs – 36 plugs<br>2 Referemce inputs – 2 plug<br>2 ISO GROUND inputs – 2 plug |
| | | |

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Image /page/4/Picture/2 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three interconnected figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2004

EB Neuro, S.P.A. c/o Ms. Carrie Graham The Anson Group, LLC 7992 Castleway Group Indianapolis, Indiana 46250

Re: K041198 Trade/Device Name: Nic36 Amplifier Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWL Dated: May 5, 2004 Received: May 7, 2004

Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). alle Cosmetic Ac. (Act) that to not required to the general controls provisions of the Act. The 1 ou may, mercrore, manel act include requirements for annual registration, listing of general controll provided on the 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 If your device is classified (soc above) also Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD a may be subject to back as a sublema, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri of ibeautes or our device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must of any I colcal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Fier 31equirements,01); good manufacturing practice requirements as set CFR Part 807); mooning (21 CFR Part 820); and if applicable, the electronic form in the qualify by solling (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Carrie Graham

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter with anow you to ogen mailions of substantial equivalence of your device to a legally prematication. "The Privation of thing of cation 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, Comacs the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Miriam C. Provost

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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### Indications for Use

Ko41198 510(k) Number (if known):

Nic36 Amplifier Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Nic36 Amplifier is intended to be used by or under the direction of a physician for The Nicco Ampillier is michied to be acourby signals and transmission of these acquisition of EEG, polygraphy and polysiology examinations.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** k041198