(82 days)
Not Found
No
The description focuses on standard signal acquisition, processing, and storage functions typical of an EEG device, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is described as an electroencephalograph (EEG) intended for acquiring and storing bioelectric signals for diagnosis and prognosis of neurological disease, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "diagnosis and prognosis of neurological disease."
No
The device description explicitly states it is an "intelligent patient box" and includes hardware functions like amplification, filtering, sampling, and A/D conversion.
Based on the provided information, the Galiteo Halley Electroencephalograph is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to acquire and store bioelectric signals from the brain for the diagnosis and prognosis of neurological disease. This involves measuring electrical activity directly from the patient's body.
- Device Description: The device description details the hardware components for acquiring, processing, and storing these bioelectric signals. It focuses on the electrical measurement and recording aspects.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Galiteo Halley Electroencephalograph does not perform any analysis on such specimens.
Therefore, the Galiteo Halley Electroencephalograph is a medical device used for in vivo (within the body) measurement of brain activity, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
84 GWQ
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
14
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.
1
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.
2
Safety and Effectiveness Summary Galiko Halley
Biosound Essone
Substantial Equivalence Comparison Tal ble
| Item | Galileo Halley Option | Galileo Vega 24 EEG
K923950 & Gallico
Pleiade EEG K923894 |
|-------------------------|---------------------------------------------------|-----------------------------------------------------------------|
| 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
EFG 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/bit
0.6 |
| CMMR | >90dB | >90dB |
| IMRR | >120 dB | >120 dB |
| Noise | 100 dB |
| IMRR | > 120 dB |
| Noise |