(166 days)
Not Found
No
The device description details hardware components and basic signal processing capabilities typical of an older generation electroencephalograph and evoked potential system. There is no mention of AI, ML, or advanced algorithms for data analysis or interpretation.
No
The device is indicated for detection and display of electrical activity, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system," which directly describes a diagnostic function.
No
The device description explicitly details numerous hardware components including an ACQ board, stimulators (acoustic, visual, and electric), and their specifications (size, weight, power supply, etc.). This indicates it is a hardware device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system." This describes a device that measures physiological signals directly from the patient's body.
- Device Description: The description details components for stimulating and recording electrical activity (EEG, evoked potentials) and sensory responses (acoustic, visual, electric). These are all methods for interacting with and measuring the body's responses, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the living body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates by directly interacting with and measuring the electrical activity of the nervous system in vivo.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
84 GWQ
Device Description
| ACQ board | |
|---|---|
| Analog input | 32 channels |
| Analog output | 32 channels |
| A/D conversion | 12 bit, 10 μ sec/point, 4 converter |
| 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 |
| 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
| |
i
| 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 + con-trolateral 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 us, 10 us steps |
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 us, 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. |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain and the peripheral nervous system.
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
§ 882.1870 Evoked response electrical stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Safety and Effectiveness Summary Galileo Evoked Potential EEG Biosound Esaote
UNDES AOTTE Biosound, Inc. DUPLICATE 8000 Castleway Drive Indianapolis. IN 46250 317 849.1793 800 428.4374 fax 317 841.8616 http://www.biosound.com/
FEB 26 1997
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: (317) 849-1793
Facsimile: (317) 841-8616
Contact Person: Gerald A. Richardson
Date: February 10, 1997
1
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)
Additional Substantial Equivalence information is provided in the following substantial Equivalence Comparision 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.
2
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 |
3
807.92(a)(4)
Device Description
| ACQ board | |
|---|---|
| Analog input | 32 channels |
| Analog output | 32 channels |
| A/D conversion | 12 bit, 10 $\mu$ sec/point, 4 converter |
| 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 |
| 4 |
·
4
| 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
| |
i
| 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 + con-
trolateral 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 us, 10 us steps |
5
5
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 us, 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. |