GALILEO HALLEY

K970703 · Biosound Esaote, Inc. · GWQ · May 19, 1997 · Neurology

Device Facts

• Record ID: K970703
• Device Name: GALILEO HALLEY
• Applicant: Biosound Esaote, Inc.
• Product Code: GWQ · Neurology
• Decision Date: May 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Galileo Halley Electroencephalograph is intended for use in acquiring and storing bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

Device Story

Galileo Halley is an intelligent patient box for digital electroencephalography; functions as either a peripheral component for a Galileo station or a stand-alone pocket EEG recorder. Input: bioelectric signals via scalp electrodes. Processing: differential amplification; filtering (high/low pass via DSP); 12-bit A/D conversion; impedance measurement (30Hz/0.3µA current). Output: digital EEG data transmitted via RS232 to Galileo station or stored on internal PCMCIA mass memory (hard-disk or Flash cards). Used in clinical settings; operated by trained personnel. Stand-alone mode provides 24-hour autonomy. Data stored in Galileo standard file format for subsequent review and analysis by clinicians to support neurological diagnosis and prognosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

16/32 EEG channels + 4 DC auxiliary channels; 12-bit A/D conversion; 512 s/sec/channel sampling rate; CMRR >100 dB; IMRR >120 dB; noise <1.5 μVpp. DSP-based filtering (Butterworth 1st order high-pass, 2nd order low-pass). Connectivity: RS232, PCMCIA. Power: internal alkaline batteries. Form factor: 90x45x150 mm, 450g. Medical isolation per IEC60.601.

Indications for Use

Indicated for acquisition and storage of bioelectric signals from brain activity for diagnosis and prognosis of neurological disease in patients requiring EEG monitoring.

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

• Esaote Pleaide (K923894)
• Esaote Vega 24 (K923950)

Submission Summary (Full Text)

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K970703

BIO SOUND 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 requirement for 510(k) summaries specified in 21CFR 807.92(a).

807.92(a)(1)

# Submitter Information

Gerald A. Richardson, Official Correspondent

Biosound Esaote

8000 Castleway Drive

Indianapolis, IN 46350

Phone: [phone]

Facsimile: [phone]

Contact Person: Gerald A. Richardson

Date: February 24, 1997

Our mission is to enhance the quality of life by 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 Halley

Biosound Esaote

807.92(a)(2)

Trade Name: Galileo Halley

Common Name: Intelligent Patient Box

Classification Name(s): Electroencephalograph

Classification Number: 84 GWQ

807.92(a)(3)

## Predicate Device(s)

| Esaote | Pleaide | K923894 |
| --- | --- | --- |
| Esaote | Vega 24 | K923950 |

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

807.92(a)(5)

## Intended Use(s)

The Galileo Halley Electroencephalograph is intended for use in acquiring and storing bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

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Safety and Effectiveness Summary

Galileo Halley

Biosound Essence

Substantial Equivalence Comparison Table

| Item | Galileo Halley Option | Galileo Vega 24 EEG K923950 & Galileo Pleiade EEG K923994 |
| --- | --- | --- |
| General Structure | | |
| Intended use | EEG signal acquisition | EEG signal acquisition |
| General system approach | Amplification and pre-processing of EEG signal | Amplification and pre-processing of EEG signal |
| User input devices | Serial interface RS232 | Serial protocol |
| User output devices | Serial interface RS232 | Serial protocol |
| Operating channels | 16/32 + 4 | 32 |
| A/D conversion | 12 bit | 12 bit |
| Sampling rate | 512 s/sec/channel | 512 s/sec/channel |
| Resolution | 0.5 μ V/bit | 0.5 μ V/bit
0.6 |
| CMMR | >90dB | >90dB |
| IMRR | >120 dB | >120 dB |
| Noise | < 1.5 μ Vpp | < 1.5 μ Vpp |
| Low pass filters | 15-30-60-90-120 Hz | 15-70 Notch |
| Time constant | 0.3-0.1-0.03-0.01 sec. | 0.3-0.1-0.03-0.01 sec. |
| Power supply | internal (alkaline batteries) | from Galileo station |

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Safety and Effectiveness Summary
Galileo Halley
Biosound Esaote

# Description of the device and operating principles

The GALILEO HALLEY option is an intelligent patient box (fig. 1), able to work both in connection with a GALILEO station or as stand-alone.

Therefore it includes the amplification, filtering, sampling, A/D conversion and data transmission functions, which in the other GALILEO stations are performed by the amplified patient box and by the GALILEO ACQ board.

In the stand-alone mode HALLEY also memorizes the acquired data in GALILEO standard file format; in the other GALILEO stations the operative system of the PC itself accomplishes this operation.

Figure n.2 shows the functional diagram of a GALILEO station which does not use HALLEY, of HALLEY in the GALILEO station mode and of HALLEY in stand-alone mode.

# Halley in "GALILEO station" mode

In this working mode, HALLEY is an EEG patient box for digital electroencephalography. Thus, it performs the following functions:

- measurement of the electrode impedance, by injecting a 30 Hz - 0.3 µA current
- acquisition of the EEG potentials by means of the scalp electrodes
- their amplification in differential mode
- their sampling by means of a instantaneous sample and hold
- analog to digital conversion of the samples
- low and high pass filtering, by means of a DSP (high pass filtering Butterworth 1 order; low pass Butterworth 2 order)
- transmission of the digital data to the GALILEO station, by means of a serial RS232 port
- execution of the commands received from the GALILEO station

From the hardware point of view, all these functions are performed by the following components.

- differential amplifiers with 0.5 to 120 Hz analog filters (16 or 32)
- 8x1 multiplexers (2 or 4)

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Safety and Effectiveness Summary

Galileo Halley

Biosound Isolate

- 12 bit AD Converters (2 or 4)
- 4x1 multiplexer (auxiliary channels)
- 12 bit AD Converter
- DSP TMS320C5x
- 512 KB flash RAM + 1256 KB static RAM
- ACIA RS232, with isolation stage (medical isolation IEC60.601)
- Slots PCMCIA II (2)
- 2x8 LCD

## Halley in stand-alone mode

In this working mode, HALLEY performs all the previous functions but, instead of transmitting the data to a GALILEO station, it stores them on an internal mass memory support (PCMCIA removable hard-disk or 2 Flash Memory Cards).

In order to comply with a precise project specification, these memory supports must be directly read and managed from a GALILEO station; therefore, the data are organized and memorized by following the format of the GALILEO standard files. In other words, the files produced by a GALILEO station or by HALLEY are indistinguishable and interchangeable.

No compression algorithm is used.

When it works in stand-alone mode, Halley is like as a pocket EEG recorder with a 24 hours autonomy.

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Safety and Effectiveness Summary

Galileo Halley

Biosound Isolate


fig.1 - HALLEY general block diagram

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Safety and Effectiveness Summary

Galileo Halley

Biosound Esaote


2a-Standard GALILEO station


2b-HALLEY in GALILEO station mode


2c-HALLEY in stand-alone mode

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Safety and Effectiveness Summary

Galileo Halley

Biosound Ixacte

# Technical Characteristics

| Number of channels | 16 or 32 EEG or poligraphic channels, plus 4 DC auxiliary channels |
| --- | --- |
| Sampling format | 12 bits for the EEG or poligraphic channels, 18 bit for the auxiliary channels |
| Sampling rate | 512 s/sec/channel |
| Resolution | 0.5 μV/bit |
| Dynamic range | +/-1mV (EEg/poligraphic channels)
128 mV (DC channels) |
| CMRR | >100 dB |
| IMRR | >120 dB |
| Noise | <1.5 μVpp |
| Low pass filters | 15-30-60-90-120 Hz |
| Time constant | 0.3-0.1-0.03-0.01 sec |
| Mass memory | one slot for PCMCIA Hard Disk
or
two slots for PCMCIA Flash Memory Cards |
| Impedance measurement | by means of 30Hz - 0.3 μA current |
| Power supply | 4 internal alkaline batteries 60x15 mm,1.5 V
or
4 auxiliary external batteries 60x24 mm,1.5V |
| Interfaces | RS232
PCMCIA
2x8 characters Liquid Crystal Display
2 push-buttons |
| Dimensions | 90x45x150 mm |
| Weight | 450 gr |

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
MAY 19 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Gerald A. Richardson
Official Correspondent
Biosound, Inc.
8000 Castleway Drive
Indianapolis, Indiana 46250

Re: K970703
Trade Name: Halley Input Box
Regulatory Class: II
Product Code: 84GWQ
Dated: February 24, 1997
Received: February 26, 1997

Dear Mr. Richardson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gerald A. Richardson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, 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 (if known): K970703

Device Name: Halley Input Box

Indications For Use:

The intended use is for acquisition and storage of bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑