GALILEO EVOKED POTENTIALRE

K963662 · Biosound, Inc. · GWF · Feb 26, 1997 · Neurology

Device Facts

• Record ID: K963662
• Device Name: GALILEO EVOKED POTENTIALRE
• Applicant: Biosound, Inc.
• Product Code: GWF · Neurology
• Decision Date: Feb 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.

Device Story

Computer-based evoked potential electroencephalograph; utilizes specialized hardware/peripherals for signal acquisition. Inputs: electrical brain/peripheral nervous system signals via electrodes; acoustic stimuli (clicks, tones, noise); visual stimuli (checkerboard, bars, strips). Processing: 12-bit A/D conversion; 32-bit accumulation; Motorola MC68000 processor. Outputs: digital color monitor display; thermal/standard printer output. Used in clinical settings by trained personnel. Provides diagnostic data on evoked responses to assist clinicians in assessing neurological function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based system; Motorola MC68000 CPU; 12-bit A/D conversion; 32-bit accumulator. 32-channel analog input/output. Stimulators: constant current electric (0-50 mA), acoustic (TDH39 transducer), and visual (composite video). Safety: IEC 601-1-1 (CEI 62-5) compliant. Isolation: 1500 V AC. Connectivity: standard Centronics printer, digital monitor. Form factor: 220x450x80 mm, ~2 kg.

Indications for Use

Indicated for patients requiring detection and display of evoked responses of electrical activity of the brain and peripheral nervous system.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• Phasis Electromyograph (K922488)
• Nicolet Viking II System (K890495)

Submission Summary (Full Text)

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K963662/A¹

BIOSOUND ESAOTE

Biosound. Inc.

8000 Castleway Drive

Indianapolis, IN 46250

317 849.1793

800 428.4374

fax [phone]

http://www.biosound.com/

Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR¶807.92(a).

807.92(a)(1)

## Submitter Information

Gerald A. Richardson, Official Correspondent

Biosound Esaote

8000 Castleway Drive

Indianapolis, Indiana 46250

Phone: [phone]

Facsimile: [phone]

Contact Person: Gerald A. Richardson

Date: February 10, 1997

Our mission is to enhance the quality of life

providing diagnostic medical equipment and

services of superior quality and value for the

early detection and management of disease.

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Safety and Effectiveness Summary
Galileo Evoked Potential EEG
Biosound Esaote

807.92(a)(2)

Trade Name: Galileo Evoked Potential

Common Name: Evoked Potential Electroencephalograph

Classification Name(s): Electroencephalograph

Classification Number: 84 GWQ

807.92(a)(3)

## Predicate Device(s)

- Phasis Electromyograph K922488
- Nicolet Viking II System K890495

Additional Substantial Equivalence information is provided in the following substantial Equivalence Comparison Table.

807.92(a)(5)

## Intended Use(s)

The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.

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Safety and Effectiveness Summary
Galileo Evoked Potential EEG
Biosound Esaote

# Substantial Equivalence Comparison Table

| Item | Galileo EP Option | Esaote Phasis K922488 |
| --- | --- | --- |
| General Structure | | |
| Intended use | Evoked Potentials | EMG-EP |
| General system approach | Computer based equipment with specialized hardware/peripherals | Same |
| User input devices | ASCII standard keyboard
Function keyboard | Same |
| User output devices | Digital color monitor
Standard Centronics printer
Dedicated thermal printer | Same |
| CPU | MC68000 | MC68010 |
| Operating channels | 24/32 | 2-4 |
| Signal acquisition | 12 bit A/D conversion | 16 bit A/D conversion |
| Trigger In | TTL | Same |
| Trigger Out | TTL | Same |
| Accumulator | 32 bit | Same |
| Preset | 1-9999 | 1-32000 |
| Standard EP Programs | | |
| Somatosensory | Yes | Yes |
| Auditory | Yes | Yes |
| Visual | Yes | Yes |
| P300 | Yes | Yes |
| Electric Stimulator | | |
| Output | Controlled current 0-50 mA | Controlled current 0-100mA |
| Stimulus indicator | Yes | Yes |
| Overload indicator | Yes | Yes |
| Delivered energy limitation | Yes | Yes |
| Acoustic Stimulator | | |
| Output | Earphone TDH39 | Same |
| Mode | Clicks, Tone, Noise | Same |
| Polarity | Rarefaction, condensation, alternate | Same |
| Level | 0-130 dB (SPL) | 0-124 dB (SPL) |
| Zero level adjustment | Yes | Yes |
| Visual Stimulators | | |
| Output for flash stimulator | Yes | Yes |
| Output | Video composite | Same |
| Type | Checkerboard, bars, strips | Same |
| Mode | Reversal, double pattern | Same |

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807.92(a)(4)

# Device Description

| ACQ board | |
| --- | --- |
| Analog input | 32 channels |
| Analog output | 32 channels |
| A/D conversion | 12 bit, 10 μsec/point, 4 converters |
| Accumulator | 32 bit |
| Processor | Motorola MC68000 |
| Resident memory | 1 MB |
| Trigger input | TTL |
| Stimulators | |
| a- General features | |
| Working class | I type of equipment B (acoustic and visual)
I type of equipment CF (electrical) |
| Safety requirements | meets standard IEC 601-1-1 (CEI 62-5) |
| Size | 220 mm, 450 mm, 80 mm |
| Weight | approx. 2 Kg |
| Power supply | +15V (0.7 A)
-15V (0.7A)
+5V (1A) |
| Power absorption | approx. 25 VA |
| Working conditions | +5C/ +35C; 30-75%RH |

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Atm pressure 700/1060 mBar

Storage and conveyance conditions -10/50C; 10-95% RH

Atm pressure 500/1060 mBar

Degree of protection against infiltration of liquids and solids

IP20

## b- Acoustic stimulator

Transducer Telephonics TDH39

Stimulation modes Tone, Click, Noise

Stimulation rate from 50 ms to 9980 ms (step 10 ms)

Tone frequency 250,500,1000,1500,2000,2500,3000,4000,5000,7000 8000 Hz

Stimulus output Right monoaural, Left monoaural, Right monoaural + controlateral noise, Left monoaural + controlateral noise, binaural

Acoustic level 0,10,20,30,40,50,60,70,75,80,90 dB SL

Threshold adjustment -4,-2,0, +2, +4, +6 dB

Noise level relative to the stimulus's level -40,-30,-20,-10,0, +10 dB

Polarity of the stimulus (in Click mode) Condensation, Rarefaction, Alternate

Duration tone mode: from 10 to 150 ms, with 10 ms steps click mode: from 50 to 960 µs, 10 µs steps

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# c- Visual stimulator

The stimulator generates two video images (pattern A and B), that are alternatively displayed on screen in response to a trigger command.

Generally, each picture is composed of an arbitrary bit map of 512x256 pixels; in detail the current resident software, divides the image in 5 fields: 4 quadrants and a fixation area. Each field can contain one of the following textures:

- black
- white
- spatial frequency horizontal bars 1
- spatial frequency horizontal bars 2
- spatial frequency vertical bars 1
- spatial frequency vertical bars 2
- spatial frequency chequer board 1
- spatial frequency chequer board 2

and the reverse of all of them.

A composite video signal 1 Vpp is transmitted to the monitor with separate positive synchronisms and 8 contrast levels (2,5,10,20,30,50,75,100%) related to the maximum contrast level set on the .

The line period is 64 µs, the frame frequency 60 Hz.

# d- Electric stimulator

The electric stimulator is constant current type.

Other features are:

- Amplitude: from 0 to 50 mA, with two scales (0-5 and 0-50)
- Precision: +/- 10% full range
- Duration: limited to 0.5 millisec (see Device Hazard Analysis)
- Isolation between the applied elements and the ground: 1500 V AC (see Device Hazard Analysis)
- Patient’s safety: limited energy and stimulation frequency; protection against failure of the current sensor
- Light indicators: stimulus ON, overload, abnormal functioning.