BIO-LOGIC EVOKED POTENTIAL FOR ABAER I

• K Number: K992807
• Device Name: BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
• Manufacturer: BIO-LOGIC SYSTEMS CORP.
• Date Cleared: 1999-09-14 ( 25 days)
• Product Code: GWJ
• Regulation Number: 882.1900

Intended Use

The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented to the patient's ear through an earphone or headphoners, and the Brainstem Auditory Evoked Response from the patient is recorded using EEG electrodes placed on the scalp. Although this Brainstem Response is very low in amplitude (with respect to surrounding EEG "noise"), the stimulus-response cycle is repeated many times and the resulting responses are averaged from the time of the stimuli. The random noise averages to zero, but if the Brainstem Response signal is present, it's signal will be easily determined in the averaged signal. The Bio-logic EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional. The primary feature modification represented in this Special 510(k) is for the use of a new algorithm and protocol to generally assist in test data interpretation, and specifically assist in the assessment of signal-tonoise ratio and the quality of the Brainstem Auditory Evoked Response in infants. Based on this automatic assessment, the speed of testing may be reduced and/or the quality of the data recording may be improved. This new feature is used in conjunction with the current EP program, without compromising the quality of recorded data or limiting the control and flexibility of the health care professional administering the test.

Device Description

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. The predicate device referenced above is the latest in a series of this type marketed by Bio-logic. Other related devices comprising the Evoked Potential family include: - 1. 510(k) #K803226 Bio-logic Evoked Response Stimulators. - 2. 510(k) #K842543 Bio-logic Evoked Potential System. - 3. 510(k) #K844992 Bio-logic Portable Evoked Response System. - 4. 510(k) #K862690 Bio-logic Traveler LT System. The predicate device performs Evoked Potential recording and analysis functions, providing up to 8 channels of simultaneous data recording. This device has both hardware and software modifications and unprovements over the related devices. Related Device #1 above is the first Evoked Potential device marketed by Bio-logic. It provides for up to 4 channels of data recording. Related Device #2 above is a hardware/software modification to the first device. Related Device #3 above is similar to #2, but utilizes a "portable" computer for ease of use and transportability. Device #4 utilizes hardware variations over devices #1, #2 and #3, primarily to enhance size-reduction and portability. It provides for a maximum of 2 channels of data recording. Trade names of "Traveler", "Express" and "LT" are associated with these transportable devices. Data recording hardware is available in three variations: the "E" Series, for up to 2 channels of data recording; the "SE" Series, for up to 4 channels of data recording; and the "Explorer" Series, for up to 8 channels of data recording. The Evoked Potential software is essentially the same for all of these products, with variations in models to accommodate differences in the hardware. Evoked Potential systems can be used for three different kinds of tests: Auditory Evoked Potentials (AEP), Visual Evoked Potentials (VEP), and Somatosensory Evoked Potentials (SEP). These variations are called "modalities", and are offered as options in all three models of hardware marketed by Bio-logic. Each modality has its own unique hardware requirements. The modifications associated with this new modified device are to the software only, and do not change the hardware in any way. Also, the change only affects the operation of the Auditory Evoked Potential software functionality. There are no changes to any part of the VEP or SEP hardware or software. The AEP test works on the basis of repeating a stimulus-response cycle. An auditory stimulation (click, tone, etc.) is presented to the patient through the use of an earphone or headphones. The EEG response from the brain is read through the use of scalp electrodes placed on the patient. The response time of interest is approximately from 1 - 20 milliseconds following the stimulus. The response voltage for this time period is amplified, digitized and stored in the AEP system computer's memory. The stimulation is then repeated, the EEG response is read again, and this cycle is repeated many times . Each time the response is read, it is averaged together with all previous responses. The final data record is the result of averaging several thousand (usually 2000-3000) responses. This averaging process is necessary because the EEG signal is very small, much lower in voltage than the surrounding EEG "noise" present in the recording. The noise is averaged out over the many readings, because the noise will have an average net value of zero. The result from the averaging process will be the signal. Some of the EEG responses may have large amounts of noise or other artifact caused by random events such as patient movement or externally-generated electrical noise. These artifacts are usually characterized by very high amplitude voltages (relative to normal EEG levels). The EP program automatically monitors the response for abnormally-high voltage levels. When a response contains such artifacts, the response is discarded, not averaged, and not counted in the cycle count. In preparation for running an AEP test, the user (EP Technologist, etc.) defines the test parameters through the use of a test protocol. In standard testing situations, most of these parameters will remain the same from test. One of the parameters is the number of stimulation cycles to be used. In order for the test to be completed as quickly as possible, it is desirable to use the smallest number of cycles. However, if the number of cycles is too small, the average will still contain large amounts of "hoise" and the quality of the data may be lowered. In general, the higher the number of cycles, the better will be the quality and reliability of the data. So, there is a trade-off between the time to perform the test and the quality of the test results. Using the standard AEP program, the normal procedure would be to setup the number of stimulations for some nominal number at the lower end of the range, say 2000. The test would then be run to completion and the data manually reviewed by the user. If the quality of the data is considered to be too low, the test would be re-run with a higher number of stimulations. Another approach is for the user to set the number of stimulations to be a number on the high end of the range and continually monitor the accumulating average that is continuously displayed on the computer's monitor screen. Because the averaged data is updated to the screen every few seconds, it is possible to manually stop the test after the data looks "good enough" to the user. While this is admittedly a somewhat subjective measure not necessarily consistent from one user to the next, it is acceptable because of the training that a registered EP Technologist or Audiologist receives in the interpretation of such data records. This Special 510(k) is for a modification to the standard Bio-logic AEP device, adding a software algorithm that automatically runs in the "background" while the AEP data recording is progressing. The purpose of this algorithm is to calculate a statistical value called "POVR", standing for "Point-Optimized Variance Ratio". For several (up to 10) strategically-selected data points at specific time latencies from the time of the stimulus, the algorithm makes a calculation intended to represent signal-to-noise ratio (S/N) at these points. This calculation is run on the accumulated data average every 256 stimulation-response cycles ("sweeps"). The result of the calculation is the POVR number, which is a statistical measure of the "power" level of the signal with respect to the noise. In normal testing, the POVR number will gradually increase as the number of sweeps increases and the resulting S/N ratio gets larger. When the POVR number reaches a specific threshold, the quality of the recording is considered to be high, and the test is automatically ended. There are two additional conditions to the termination of the test recording: - 1. The number of artifact sweeps must be lower than a pre-defined percentage of the sweeps, and - 2. The number of sweeps must be greater than some pre-defined minimal number. In addition, the maximum number of sweeps is set by the user in the AEP protocol, so that the test recording will also be ended when this maximum is reached. In this case, the POVR calculation will be below the stopping threshold, indicating that the quality of the data may still be too low. A second POVR number, less than the stopping POVR number, is used by the algorithm to make a pass/refer recommendation to the user. In any case, because the standard AEP capabilities still exist in the software, the user may evaluate the data recording and make the determination as to whether or not the recording is of acceptable quality, or if more testing is necessary. This modification to the standard Bio-logic AEP program allows for a more objective and quantifiable measure of the data recording quality, while also achieving test completion more quickly in many cases. In those cases where the testing time is not reduced, but the POVR threshold is ultimately reached, the resulting data recording quality will likely be higher than if the same test had been performed manually. This is because the manual test is terminated when the number of sweeps reaches the pre-set number in the protocol, regardless of the quality of the result. The modified program with the POVR algorithm will continue the stimulus-response cycle until the POVR threshold is reached.

Predicate Devices

K930328

Reference Devices

K803226, K842543, K844992, K862690

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a new algorithm for calculating a statistical value (POVR) to assess signal-to-noise ratio and data quality. While this is an automated process, it is based on a defined statistical calculation and thresholding, not on learning from data or adapting its behavior in a way characteristic of AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No
The device is used for diagnosis and analysis of physiological data, not for treatment or therapy.

Diagnostic

Yes

The device is indicated for "the diagnosis of auditory and hearing-related disorders" and "neurological diagnosis and treatment of sensory disorders" which clearly defines it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Bio-logic Evoked Potential family of products includes both hardware and software components, and while the modification in this 510(k) is software-only, the overall device is not.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• Device Function: The Bio-logic Evoked Potential (EP) product family records and analyzes human physiological data (Brainstem Auditory Evoked Response from the scalp) in response to an auditory stimulus. It does not analyze specimens taken from the body.
• Intended Use: The intended use is for the recording and analysis of physiological data necessary for the diagnosis of auditory and hearing-related disorders. This is a direct measurement of a physiological response, not an analysis of a biological sample.

Therefore, the device falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bio-logic Evoked Potential (EP) product family is intended for use in the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders.
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented to the patient's ear through an earphone or headphoners, and the Brainstem Auditory Evoked Response from the patient is recorded using EEG electrodes placed on the scalp. Although this Brainstem Response is very low in amplitude (with respect to surrounding EEG "noise"), the stimulus-response cycle is repeated many times and the resulting responses are averaged from the time of the stimuli. The random noise averages to zero, but if the Brainstem Response signal is present, it's signal will be easily determined in the averaged signal.
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented to the patient's ear through an earphone or headphones, and the Brainstem Auditory Evoked Response from the patient is recorded using EEG electrodes placed on the scalp. Although this Brainstem Response is very low in amplitude (with respect to surrounding EEG "noise"), the stimulus-response cycle is repeated many times and the resulting responses are averaged from the time of the stimuli. The random noise averages to zero, but if the Brainstem Response signal is present, it's signal will be easily determined in the averaged signal. The Bio-logic EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional. The primary feature modification represented in this Special 510(k) is for the use of a new algorithm and protocol to generally assist in test data interpretation, and specifically assist in the assessment of signal-to-noise ratio and the quality of the Brainstem Auditory Evoked Response in infants. Based on this automatic assessment, the speed of testing may be reduced and/or the quality of the data recording may be improved. This new feature is used in conjunction with the current EP program, without compromising the quality of recorded data or limiting the control and flexibility of the health care professional administering the test.

Product codes (comma separated list FDA assigned to the subject device)

GWJ

Device Description

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. This is a modification to the standard Bio-logic AEP device, adding a software algorithm that calculates a statistical value called "POVR" (Point-Optimized Variance Ratio). This algorithm calculates the signal-to-noise ratio at strategically-selected data points and automatically ends the test when a specific threshold is reached, or when other conditions related to artifact sweeps and minimum sweep numbers are met. The software also provides a pass/refer recommendation. The fundamental EP software is unchanged, except for the addition of the POVR algorithm running in the background.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

scalp (for EEG electrodes)

Indicated Patient Age Range

The Bio-logic AEP System can be used for patients of all ages, from children to adults, including infants and geriatric patients.

Intended User / Care Setting

Prescription Use (Per 21 CFR 801.109); physician or other trained health care professional; EP Technologist or Audiologist

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)

To establish the safety and effectiveness of this modification to the Bio-logic Evoked Potential software, the modification was designed and incorporated into the product in accordance with the Bio-logic internal Product Development procedures which are intended to meet ISO-9001 and FDA QSR Design Control specifications. A detailed Hazard/Risk analysis was performed using the Fault Tree analysis (FTA) approach, and a detailed Risk Assessment was written in accordance with EN-1441, the International Standard for Hazard/Risk analysis. The use of the POVR algorithm will usually reduce time for test completion, and offers an objective basis for determination of data recording quality.

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.

K930328

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.

K803226, K842543, K844992, K862690

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).

Summary

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K99 2807

SEP | 4 1955

One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: [phone]

SECTION 2: SUMMARY AND CERTIFICATION

510(K) SUMMARY

Safety and effectiveness information concerning the Bio-logic Evoked Potential product and this Software modification is summarized below.

Because this is not a CLASS III device, the special certification defined for this section is not required.

PREPARED BY: Bio-logic Systems Corp One Bio-logic Plaza Mundelein, IL 60060

TELEPHONE: [phone]

CONTACT PERSON: Norman E. Brunner

DATE ON WHICH THE SUMMARY WAS PREPARED: August 18, 1999

NAME OF DEVICE: Bio-logic Evoked Potential.

COMMON NAME: Evoked Response System.

CLASSIFICATION NAME: Evoked Response Auditory Stimulator (per CFR 882-1900).

PREDICATE DEVICE: Bio-logic Navigator and Traveler Evoked Potential Product, reference 510(k) #K930328.

DESCRIPTION OF THE DEVICE:

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. The predicate device referenced above is the latest in a series of this type marketed by Bio-logic. Other related devices comprising the Evoked Potential family include:

• 1. 510(k) #K803226 Bio-logic Evoked Response Stimulators.
• 2. 510(k) #K842543 Bio-logic Evoked Potential System.
• 3. 510(k) #K844992 Bio-logic Portable Evoked Response System.
• 4. 510(k) #K862690 Bio-logic Traveler LT System.

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人 492fc.1

The predicate device performs Evoked Potential recording and analysis functions, providing up to 8 channels of simultaneous data recording. This device has both hardware and software modifications and unprovements over the related devices. Related Device #1 above is the first Evoked Potential device marketed by Bio-logic. It provides for up to 4 channels of data recording. Related Device #2 above is a hardware/software modification to the first device. Related Device #3 above is similar to #2, but utilizes a "portable" computer for ease of use and transportability. Device #4 utilizes hardware variations over devices #1, #2 and #3, primarily to enhance size-reduction and portability. It provides for a maximum of 2 channels of data recording. Trade names of "Traveler", "Express" and "LT" are associated with these transportable devices. Data recording hardware is available in three variations: the "E" Series, for up to 2 channels of data recording; the "SE" Series, for up to 4 channels of data recording; and the "Explorer" Series, for up to 8 channels of data recording. The Evoked Potential software is essentially the same for all of these products, with variations in models to accommodate differences in the hardware.

Evoked Potential systems can be used for three different kinds of tests: Auditory Evoked Potentials (AEP), Visual Evoked Potentials (VEP), and Somatosensory Evoked Potentials (SEP). These variations are called "modalities", and are offered as options in all three models of hardware marketed by Bio-logic. Each modality has its own unique hardware requirements. The modifications associated with this new modified device are to the software only, and do not change the hardware in any way. Also, the change only affects the operation of the Auditory Evoked Potential software functionality. There are no changes to any part of the VEP or SEP hardware or software.

The AEP test works on the basis of repeating a stimulus-response cycle. An auditory stimulation (click, tone, etc.) is presented to the patient through the use of an earphone or headphones. The EEG response from the brain is read through the use of scalp electrodes placed on the patient. The response time of interest is approximately from 1 - 20 milliseconds following the stimulus. The response voltage for this time period is amplified, digitized and stored in the AEP system computer's memory. The stimulation is then repeated, the EEG response is read again, and this cycle is repeated many times . Each time the response is read, it is averaged together with all previous responses. The final data record is the result of averaging several thousand (usually 2000-3000) responses. This averaging process is necessary because the EEG signal is very small, much lower in voltage than the surrounding EEG "noise" present in the recording. The noise is averaged out over the many readings, because the noise will have an average net value of zero. The result from the averaging process will be the signal.

Some of the EEG responses may have large amounts of noise or other artifact caused by random events such as patient movement or externally-generated electrical noise. These artifacts are usually characterized by very high amplitude voltages (relative to normal EEG levels). The EP program automatically monitors the response for abnormally-high voltage levels. When a response contains such artifacts, the response is discarded, not averaged, and not counted in the cycle count.

In preparation for running an AEP test, the user (EP Technologist, etc.) defines the test parameters through the use of a test protocol. In standard testing situations, most of these parameters will remain the same from test. One of the parameters is the number of stimulation cycles to be used. In order for the test to be completed as quickly as possible, it is desirable to use the smallest number of cycles. However, if the number of cycles is too small, the average will still contain large amounts of "hoise" and the quality of the data may be lowered. In general, the higher the number of cycles, the better will be the quality and reliability of the data. So, there is a trade-off between the time to perform the test and the quality of the test results.

2

K992f0.1

Using the standard AEP program, the normal procedure would be to setup the number of stimulations for some nominal number at the lower end of the range, say 2000. The test would then be run to completion and the data manually reviewed by the user. If the quality of the data is considered to be too low, the test would be re-run with a higher number of stimulations. Another approach is for the user to set the number of stimulations to be a number on the high end of the range and continually monitor the accumulating average that is continuously displayed on the computer's monitor screen. Because the averaged data is updated to the screen every few seconds, it is possible to manually stop the test after the data looks "good enough" to the user. While this is admittedly a somewhat subjective measure not necessarily consistent from one user to the next, it is acceptable because of the training that a registered EP Technologist or Audiologist receives in the interpretation of such data records.

This Special 510(k) is for a modification to the standard Bio-logic AEP device, adding a software algorithm that automatically runs in the "background" while the AEP data recording is progressing. The purpose of this algorithm is to calculate a statistical value called "POVR", standing for "Point-Optimized Variance Ratio". For several (up to 10) strategically-selected data points at specific time latencies from the time of the stimulus, the algorithm makes a calculation intended to represent signal-to-noise ratio (S/N) at these points. This calculation is run on the accumulated data average every 256 stimulation-response cycles ("sweeps"). The result of the calculation is the POVR number, which is a statistical measure of the "power" level of the signal with respect to the noise. In normal testing, the POVR number will gradually increase as the number of sweeps increases and the resulting S/N ratio gets larger. When the POVR number reaches a specific threshold, the quality of the recording is considered to be high, and the test is automatically ended.

There are two additional conditions to the termination of the test recording:

• 1. The number of artifact sweeps must be lower than a pre-defined percentage of the sweeps, and
• 2. The number of sweeps must be greater than some pre-defined minimal number.

In addition, the maximum number of sweeps is set by the user in the AEP protocol, so that the test recording will also be ended when this maximum is reached. In this case, the POVR calculation will be below the stopping threshold, indicating that the quality of the data may still be too low. A second POVR number, less than the stopping POVR number, is used by the algorithm to make a pass/refer recommendation to the user. In any case, because the standard AEP capabilities still exist in the software, the user may evaluate the data recording and make the determination as to whether or not the recording is of acceptable quality, or if more testing is necessary.

This modification to the standard Bio-logic AEP program allows for a more objective and quantifiable measure of the data recording quality, while also achieving test completion more quickly in many cases. In those cases where the testing time is not reduced, but the POVR threshold is ultimately reached, the resulting data recording quality will likely be higher than if the same test had been performed manually. This is because the manual test is terminated when the number of sweeps reaches the pre-set number in the protocol, regardless of the quality of the result. The modified program with the POVR algorithm will continue the stimulus-response cycle until the POVR threshold is reached.

INTENDED USE:

The Bio-logic Evoked Potential (EP) product family is intended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented to the patient's ear through an earphone or headphoners, and the

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K 992507

Brainstem Auditory Evoked Response from the patient is recorded using EEG electrodes placed on the scalp. Although this Brainstem Response is very low in amplitude (with respect to surrounding EEG "noise"), the stimulus-response cycle is repeated many times and the resulting responses are averaged from the time of the stimuli. The random noise averages to zero, but if the Brainstem Response signal is present, it's signal will be easily determined in the averaged signal.

The Bio-logic AEP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

The primary feature modification represented in this Special 510(k) is for the use of a new algorithm and protocol to generally assist in test data interpretation, and specifically assist in the assessment of signal-tonoise ratio and the quality of the Brainstem Auditory Evoked Response in infants. Based on this automatic assessment, the speed of testing may be reduced and/or the quality of the data recording may be improved. This new feature is used in conjunction with the current EP program, without compromising the quality of recorded data or limiting the control and flexibility of the health care professional administering the test.

SAFETY AND EFFECTIVENESS SUMMARY

To establish the safety and effectiveness of this modification to the Bio-logic Evoked Potential software, the modification was designed and incorporated into the product in accordance with the Bio-logic internal Product Development procedures which are intended to meet ISO-9001 and FDA QSR Design Control specifications. A detailed Hazard/Risk analysis was performed using the Fault Tree analysis (FTA) approach, and a detailed Risk Assessment was written in accordance with EN-1441, the International Standard for Hazard/Risk analysis.

Because this modification to Evoked Potential consists of only software, there are no newly-introduced hardware-related methods by which the patient can be harmed or injured through the use of this device. In addition, the program does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program "recommendations" are subject to review by the EP Technologist or Physician, and may be modified, overridden or deleted as determined by a qualified user. The program provides extensive functionality to allow the qualified user to review all raw data collected and otherwise customize the data analysis to suit his or her requirements.

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