← Product Code [GWQ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ) · K970703 # GALILEO HALLEY (K970703) _Biosound Esaote, Inc. · GWQ · May 19, 1997 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K970703 ## Device Facts - **Applicant:** Biosound Esaote, Inc. - **Product Code:** [GWQ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ.md) - **Decision Date:** May 19, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1400 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for 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. ## Regulatory 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](/device/K923894.md)) - Esaote Vega 24 ([K923950](/device/K923950.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970703 BIO SOUND ESAOTE Biosound, Inc. 8000 Castleway Drive Indianapolis, IN 46250 317 849.1793 800 428.4374 fax 317 841.8616 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: (317) 849-1793 Facsimile: (317) 841-8616 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. 354d 000000 0000000000 00000000020622521E 10:14 2661/91/90 {1} 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. 354d 0000000 00000000000 000000000000000000000000000000000000000000000 {2} 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 | 354d 0000000 00000000000 000000000∠06∠∠5∠TE 10:14 2661/91/90 {3} 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) PAGE 05 0000000 000000000000 0000000000000000000000000000000000000000000000000000 {4} 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. PAGE 90 0000000 000000000000 0000000002062252TE 10:14 2661/91/90 {5} Safety and Effectiveness Summary Galileo Halley Biosound Isolate ![img-0.jpeg](img-0.jpeg) fig.1 - HALLEY general block diagram PAGE 07 0000000 000000000000 0000000000000000000000000000000000000000000 {6} Safety and Effectiveness Summary Galileo Halley Biosound Esaote ![img-1.jpeg](img-1.jpeg) 2a-Standard GALILEO station ![img-2.jpeg](img-2.jpeg) 2b-HALLEY in GALILEO station mode ![img-3.jpeg](img-3.jpeg) 2c-HALLEY in stand-alone mode PAGE 894d 0000000 000000000000 00000000000000000000000000000000000000000000 {7} 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 | 354d 0000000 00000000000 000000000∠06∠S∠TE DT:0T ∠66T/9T/S0 {8} DEPARTMENT OF HEALTH & 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. {9} 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, ![img-4.jpeg](img-4.jpeg) Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10} # 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) ![img-5.jpeg](img-5.jpeg) Prescription Use ☑ --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K970703](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K970703) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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