BE PLUS / AURA-LTM64 AMPLIFIER

K053606 · Eb Neuro S.P.A. · GWL · Jan 24, 2006 · Neurology

Device Facts

• Record ID: K053606
• Device Name: BE PLUS / AURA-LTM64 AMPLIFIER
• Applicant: Eb Neuro S.P.A.
• Product Code: GWL · Neurology
• Decision Date: Jan 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

The BE Plus / AURA-LTM64 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

System captures bioelectric signals via surface leads/transducers; amplifies and converts signals to digital form; transmits data to host PC for neurophysiology examinations (EEG, EP, polysomnography, polygraphy). Consists of amplifier box, PC interface (PCMCIA or BE Net), and AC/DC adapter; optional LED visual stimulator. Used in clinical settings under physician direction. Features auxiliary FLASH memory for data accumulation during temporary link disconnection. Output viewed by healthcare provider on PC software to assist in clinical decision-making for neurophysiological assessment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Polycarbonate plastic housing; 64 monopolar channels (expandable to 128); 16-bit SAR A/D conversion; sampling rates up to 4096 Hz/channel; CMRR >100dB; fiber optic isolation (CF type); powered by external IEC 60601-1 AC/DC adapter; PCMCIA or BE Net connectivity; auxiliary FLASH memory storage; 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)
• NIC36 Amplifier (K041198)

Submission Summary (Full Text)

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510(k) Summary EB Neuro. S.p.A. BE Plus / AURA-LTM64 Amplifier

JAN 2 4 2006

053606

# 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 Correspondent
The Anson Group
11460 N. Meridian St.
Suite 150
Carmel, IN 46032

| Phone: | [phone] x 103 |
|-----------------|----------------------|
| Facsimile: | [phone] |
| Contact Person: | Carri Graham |
| Date: | December 22, 2005 |

807.92(a)(2)

| Trade Name: | BE Plus / AURA-LTM64 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 |
|------------------|-----------------|---------|
| EB Neuro, S.p.A. | NIC36 Amplifier | K041198 |

Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.

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510(k) Summary EB Neuro, S.p.A. BE Plus / AURA-LTM64 Amplifier

807.92 (a)(4)

#### Device Description

The BE Plus / AURA-LTM64 Amplifier is a fully programmable system which provides a total of 64 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 60601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.

The BE Plus / AURA-LTM64 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Polysomnography (Sleep Analysis) and General Polygraphy.

The BE Plus / AURA-LTM64 Amplifier does not contains 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 BE Plus / AURA-LTM64 Amplifier system consists of three interconnected units: the amplifier box, the PC interface (PCMCIA interface or BE Net) and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.

807.92(a)(5)

#### Intended Use(s)

The BE Plus / AURA-LTM64 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.

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## 807.92(a)(6)

# Technological Characteristics

| Item | EB Neuro<br>MIZAR Amplifier<br>K003154 | EB Neuro<br>Nic36 Amplifier<br>K041198 | EB Neuro<br>BE Plus / AURA-<br>LTM64 Amplifier<br>This Submission |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations |
| EEG/Polygraphic channel | 32/40 (64/96/128 with expansion boards) | 36 monopolar fixed – (no expansion boards) | 64 monopolar (128 with the double Amplifier configuration expansion) |
| DC channel | 32/40 | 4 | 4 |
| A/D conversion | 16 bit Sigma-Delta A/D effectively transferred to host | 16 bit SAR effectively transferred to host | 16 bit SAR effectively transferred to host |
| Sampling rate | User selectable (128, 256, 512 ... up to 32KHz/Channel) | User selectable (128, 256, 512... up to 8192 Hz/Channel) | User selectable (128, 256, 512... up to 4096 Hz/Channel) |
| CMRR | >100dB | >100dB | >100dB |
| Noise | <1.5μVpp (0.5μVrms) | <0.5μVrms (AC)<br><7μVrms (DC) | <0.5μVrms (AC)<br><7μVrms (DC) |
| Power Supply | External IEC 60601-1 Mains<br>Internal batteries (optional) | External IEC 60601-1 Mains | External IEC 60601-1 Mains |
| Internal storage | N/A | N/A | Auxiliary FLASH memory to accumulate data when optical link is temporary unconnected.<br>Real time clock on board. Precision of hundreds of seconds. Coin battery auxiliary supply. |
| Time marker of data acquisition flow | N/A | N/A | |
| Amplifier - PC Interface | PCMCIA or BE Net | PCMCIA (NicPCMCIA) or BE Net (NicNet) | PCMCIA or BE Net |
| Item | EB Neuro<br>MIZAR Amplifier<br>K003154 | EB Neuro<br>Nic36 Amplifier<br>K041198 | EB Neuro<br>BE Plus / AURA-<br>LTM64 Amplifier<br>This Submission |
| Other Interfaces | 128x64 graph LCD<br>display 5 push buttons | Power On LED / LED<br>matrix Ohm Meter | Power On LED (bicolor) /<br>LED matrix Ohm Meter |
| Use standard<br>sensors and<br>electrodes | Yes (electrodes and<br>sensors are not included<br>with the Amplifier) | Yes (electrodes and<br>sensors are not included<br>with the Amplifier) | Yes (electrodes and<br>sensors are not included<br>with the Amplifier) |
| Dimension | 250 (L) x 170 (W) x 65<br>(H) (mm) | 203 (L) x 135 (W) x 38<br>(H) (mm) | 194 (L) x 125 (W) x 37<br>(H) (mm) |
| Case material | Polycarbonate plastic | Polycarbonate plastic | Polycarbonate plastic |
| Total weight | 1.5 Kg | 0.55 Kg | 0.48 Kg |
| Isolation | Fiber optic link<br>Patient isolation BF type<br>Auxiliary I/O<br>components ports:<br>N°2 BF type<br>N°1 B type | Fiber optic link<br>Patient isolation CF type<br>Auxiliary I/O<br>components ports:<br>N°2 B type | Fiber optic link<br>Patient isolation CF type<br>Auxiliary I/O components<br>ports:<br>N°2 B type |
| Safety Standard | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26<br>IEC 60601-1-4 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26<br>IEC 60601-2-40<br>IEC 60601-1-4 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26<br>IEC 60601-2-40<br>IEC 60601-1-4 |
| System<br>Components | Amplifier<br>Head box<br>AC/DC Adapter<br>PCMCIA or BE Net<br>Interfaces<br>DC Input box (optional)<br>LED Flash stimulator<br>(optional) | Amplifier<br>AC/DC Adapter<br>PCMCIA<br>(NicPCMCIA) or BE<br>Net (NicNet) Interfaces<br>DC Input box<br>(NicDCIN) (optional)<br>LED Flash stimulator<br>(NicLED Photic<br>Stimulator) (optional) | Amplifier<br>AC/DC Adapter<br>PCMCIA or BE Net<br>Interfaces<br>DC Input box (optional)<br>LED Flash stimulator<br>(optional) |
| Firmware | Resident and Runtime<br>downloadable | Resident and Runtime<br>downloadable | Resident and Runtime<br>downloadable |
| Patient connection<br>and inputs | 32 Monopolar inputs -<br>32 plugs<br>8 Bipolar inputs - 16<br>plugs<br>1 Thermistor - 2 plugs<br>2 Reference inputs - 2<br>plugs<br>14 ISO GROUND<br>inputs — 14 plugs | 36 Monopolar inputs -<br>36 plugs<br>2 Reference inputs - 2<br>plugs<br>2 ISO GROUND inputs<br>- 2 plugs | 64 Monopolar inputs - 64<br>plugs<br>2 References inputs - 2<br>plugs<br>2 ISO GROUND inputs -<br>2 plugs |
| Item | EB Neuro<br>MIZAR Amplifier<br>K003154 | EB Neuro<br>Nic36 Amplifier<br>K041198 | EB Neuro<br>BE Plus / AURA-<br>LTM64 Amplifier<br>This Submission |
| I/O connections | 1 Fiber optic port<br>1 AC/DC Adapter port<br>3 Auxiliary components<br>port: generic TX/RX<br>serial I/O, LED Flash<br>stimulator, pression<br>button connector | 1 Fiber optic port<br>2 Auxiliary components<br>port: AC/DC Adapter,<br>generic TX/RX serial<br>I/O, DC Input box<br>(NicDCIN), LED Flash<br>stimulator (NicLED<br>Photic Stimulator) | 1 Fiber optic port<br>1 Auxiliary components<br>port: AC/DC Adapter,<br>generic TX/RX serial I/O,<br>DC Input box, LED Flash<br>stimulator<br>1 Amplifier Link<br>expansion port: AC/DC<br>Adapter, BE Plus/AURA-<br>LTM64 Amplifier |

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510(k) Summary
EB Neuro, S.p.A.
BE Plus / AURA-LTM64 Amplifier

.

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510(k) Summary
EB Neuro, S.p.A. BE Plus / AURA-LTM64 Amplifier

:

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.

Public Health Service

JAN 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EB Neuro. S.P.A. c/o Ms. Carri Graham Anson Group 11460 N. Meridian Street, Suite 150 Carmel, Indiana 46032

Re: K053606

Trade/Device Name: BE Plus / AURA-LTM64 Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: December 21, 2005 Received: December 27, 2005

Dear Ms. Graham:

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

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#### Page 2 - Ms. Graham

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.

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" (21 CFR Part 807.97). 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.ida.gov/cdrh/industry/support/index.html.

Sincerely vours.

Kaibaichnichum

Mark N. Melkerson Acting 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

510(k) Number (if known):

Device Name: BE Plus / AURA-LTM64 Amplifier

Indications For Use:

The BE Plus / AURA-LTM64 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.

Prescription Use X (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)

Charbare Buchupdomxr

Division of General. Restorative, and Neurological Devices

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**510(k) Number** K053606