The Galiteo 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 Description

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 umplified 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.

AI/ML Overview

The ESAOTE Galileo Halley Biosound Essote (K970703) is an electroencephalograph (EEG) device intended for acquiring and storing bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

This submission is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials for a new device. The provided document does not contain a study explicitly designed to "prove" the device meets acceptance criteria in the way a clinical trial would. Instead, the "study" is a comparison to predicate devices, demonstrating that the Galileo Halley has similar technical specifications and intended use, implying comparable safety and effectiveness.

Here's an breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the technical specifications of the predicate devices, and the reported device performance indicates that the Galileo Halley meets or exceeds these.

Item	Predicate Devices (Galileo Vega 24 EEG K923950 & Galileo Pleiade EEG K923894) Acceptance Criteria	Galileo Halley Performance
Intended use	EEG signal acquisition	EEG signal acquisition
General system approach	Amplification and pre-processing of EFG signal	Amplification and pre-processing of EEG signal
User input devices	Serial protocol	Serial interface RS232
User output devices	Serial protocol	Serial interface RS232
Operating channels	32	16/32 + 4
A/D conversion	12 bit	12 bit
Sampling rate	512 s/sec/channel	512 s/sec/channel
Resolution	0.5 $\mu$V/bit	0.5 $\mu$V/bit
CMRR	>90dB	>90dB (specifically >100dB in technical characteristics)
IMRR	>120 dB	>120 dB
Noise	< 1.5 $\mu$Vpp	< 1.5 $\mu$Vpp
Low pass filters	15-70 Notch	15-30-60-90-120 Hz
Time constant	0.3-0.1-0.03-0.01 sec.	0.3-0.1-0.03-0.01 sec.
Power supply	from Galileo station	internal (alkaline batteries)

Note: The reported performance of the Galileo Halley often matches or surpasses the predicate devices, for example, offering a broader range of low-pass filters and multiple power supply options, and a higher CMRR.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical data. The "testing" for this 510(k) submission primarily consists of comparing the design and technical specifications of the Galileo Halley to legally marketed predicate devices. There is no mention of a specific number of cases or patients used for performance evaluation in a clinical setting.

Data provenance is not applicable in the sense of patient data, as no such data is presented. The comparison is based on the design specifications of existing, cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a technical comparison for substantial equivalence, not a clinical study involving expert-established ground truth on patient data. The "ground truth" for this submission is the established performance and safety profile of the predicate devices.

4. Adjudication method for the test set

Not applicable. There is no test set in the clinical sense requiring an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Galileo Halley is an EEG acquisition and storage device, not an AI-powered diagnostic tool requiring assessment of reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states that the HALLEY can operate in a "stand-alone mode" where it stores acquired data on internal mass memory without being connected to a GALILEO station. This describes a functional mode of the device itself, not a separate standalone performance study of an algorithm. The standalone functionality refers to its ability to acquire and store EEG data independently, producing files indistinguishable and interchangeable with those from a GALILEO station. The performance of this standalone function is assessed by its technical specifications mirroring the connected mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (Esaote Pleiade K923894 and Esaote Vega 24 K923950), based on their technical specifications, intended use, and general recognition as legally marketed devices.

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an algorithm.

Summary

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K970703

ESAOTE

Safety and Effectiveness Summary Galileo I kalley Biosound Essote

MAY 19 1997

Blosound, Inc. 8000 Castleway Drive Indianapolis. In 46250 317 849.1793 800 428.4374 fax 317 841.8616 http://www.blasound.com/

Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFRS807.92(a).

807.92(a)(1)

な

Submitter Information

Gerald A. Richardson, Official Correspondent Biosound Esaote 8000 Castleway Drive Indianapolis, IN 46350

(317) 849-1793 Phone: Facsimile: (317) 841-8616

Gerald A. Richardson Contact Person:

Date: February 24, 1997

Our mission is to entimate the quality of the by providing diagnostic modical equipment and services of superior quality and valle for the early getection and namigrament of discuse.

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Safety and Effectiveness Summary Galileo Halley Biosound Fisaone

807.92(a)(2)

all the said

Galileo Halley Trade Name: Intelligent Patient Box Common Name: Electroencephalograph Classification Name(s):

84 GWQ Classification Number:

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 Galiteo 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 Galiko Halley
Biosound Essone

Substantial Equivalence Comparison Tal ble

Item	Galileo Halley Option	Galileo Vega 24 EEGK923950 & GallicoPleiade EEG K923894
General Structure
Intended use	EEG signal acquisition	EEG signal acquisition
General system approach	Amplification and pre-processingof EEG signal	Amplification and pre-processing ofEFG 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 $\mu$ V/bit	0.5 $\mu$ V/bit0.6
CMMR	>90dB	>90dB
IMRR	>120 dB	>120 dB
Noise	< 1.5 $\mu$ Vpp	< 1.5 $\mu$ 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 Elfectiveness Summary Galiko 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 umplified 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 uA current
· aquisition of the EEG potentials by means of the scalp electrodes
· their amplification in differential mode
· their sampling by means of a istantaneous sample and hold
· analog to digital conversion of the samples
. low and high pass filtering, by means off 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 Essote

· 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 trasmitting the data to a GALILEO station, it stores them on a 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 algorythm 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 Halky Biosound I saote

Image /page/5/Figure/1 description: This image is a block diagram of a system. The system takes a patient input and passes it through analog amplifiers and an A/D converter. The signal is then processed by a DSP TMS 320 CSX and stored in FLASH RAM. The system also includes an isolator, serial port, ACIA RS232, LCD, PCMCIA controller driver, and PCMCIA.

fig. 1 - HALLEY general block diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Safety and Effectiveness Summary Galiko Halley Biosound Essoke

Image /page/6/Figure/1 description: The image shows a block diagram of a system. The system consists of a patient box connected to a Galileo ACQ board, which is connected to a PC. The PC has a mass memory and a Galileo file. The patient box is connected to electrodes, and the Galileo ACQ board is connected to the PC via a SCSI interface.

2a-Standard GALILEO station

Image /page/6/Figure/3 description: The image shows a diagram of a system with two main components: HALLEY and PC. HALLEY is connected to electrodes on one side and communicates with the PC via an RS232 serial interface. The PC has a Mass Memory unit and stores a Galileo File.

2b-HALLEY in GALILEO station mode

Image /page/6/Figure/5 description: The image shows two diagrams, one labeled "HALLEY" and the other labeled "PC". The HALLEY diagram has three lines labeled "electrodes" coming out of the left side and a box labeled "Removable Mass Memory" at the bottom. A line extends from the "Removable Mass Memory" box to the right, labeled "Galileo file". The PC diagram has three horizontal lines inside the PC box and a "Removable Mass Memory" box at the bottom with a line extending to the right, labeled "Galileo File".

2c-HALLEY in stand-alone mode

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Safety and Effectiveness Summary (jaliko Halley Biosound I saok

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Technical Characteristics

Number of channels	16 or 32 EEG or poligraphic channels, plus 4 DCauxiliary channels
Sampling format	12 bits for the EEG or poligraphic channels, 18 bitfor the auxiliary channels
Sampling rate	512 s/sec/channel
Resolution	0.5 / V/bit
Dynamic range	+ /- 1mV (EEg/poligraphic channels)128 mV (DC channels)
CMRR	> 100 dB
IMRR	> 120 dB
Noise	< 1.5 u Vpp
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 DiskOr
	two slots for PCMCIA Flash Memory Cards
Impedance measurement	by means of 30Hz - 0.3 #A current
Power supply	4 internal alkaline batteries 60x15 mm, 1.5 VOr
	4 auxiliary external batteries 60x24 mm, 1.5V
Interfaces	RS232PCMCIA
	2x8 characters Liquid Crystal Display2 push-buttons
Dimensions	90x45x150 mm
Weight	450 gr

000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 61:07 7661791191199 ---

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1997

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

Re : K970703 Halley Input Box Trade Name: 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) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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

K970703 510(K) Number if (if known): __

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)

(Division Sign-Off)
Division of Cardiovascular Devices

Division of Cardiovascular
and Neurological Devices
510(k) Number

Prescription Use

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).