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.
1. 510(k) #K842543 Bio-logic Evoked Potential System.
1. 510(k) #K844992 Bio-logic Portable Evoked Response System.
1. 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
1. 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.

AI/ML Overview

Below is a description of the acceptance criteria and the study to prove the device meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided K99 summary does not explicitly define quantitative acceptance criteria for the new POVR algorithm. Instead, it describes qualitative benefits and functional improvements.

Acceptance Criteria (Inferred from Document)	Reported Device Performance (Summary)
Reduced Test Completion Time	"The use of the POVR algorithm will usually reduce time for test completion"
Objective Quality Determination	"The use of the POVR algorithm... offers an objective basis for determination of data recording quality."
Improved Data Recording Quality	"the quality of the data recording may be improved." (When POVR threshold is ultimately reached)
Equivalent Safety Characteristics	"No differences. There is no change to any of the patient-connected hardware or the hardware control software."
Equivalent Intended Use	"No differences."
Equivalent Patient Population	"No differences. However, the optimal POVR points may differ between infant and adult populations. The present POVR algorithm is optimized for infants."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of a clinical trial or formal validation study with a defined sample size. The performance claims regarding reduced test time and improved quality are descriptive based on the algorithm's design and expected behavior, rather than formal statistical testing on a distinct dataset.

Sample Size: Not specified.
Data Provenance: Not specified. The document implies internal development and testing rather than external clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Given the lack of a formal test set described for a clinical study, there is no mention of experts establishing a "ground truth" for such a set in the traditional sense. The document refers to the role of trained professionals in evaluating data:

Number of Experts: Not specified.
Qualifications of Experts: "registered EP Technologist or Audiologist receives in the interpretation of such data records." and "All program 'recommendations' are subject to review by the EP Technologist or Physician."

4. Adjudication Method for the Test Set:

Not applicable, as a formal test set and a related adjudication process are not described in the document. The document highlights that human professionals retain ultimate oversight and decision-making authority: "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."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The document focuses on the automated nature of the POVR algorithm and its potential benefits (speed and objectivity) compared to purely manual termination of tests. It does not evaluate human reader performance with and without AI assistance.

6. Standalone Performance Study:

The document describes the POVR algorithm as running "in the background" and making calculations to determine when to automatically end the test. This suggests a standalone functional evaluation of the algorithm's performance in achieving its stated goals (e.g., reaching a statistical threshold correctly and terminating a recording). However, a formal "standalone study" with quantifiable metrics presented is not detailed. The description of its operation serves as the primary evidence of its standalone function.

7. Type of Ground Truth Used:

The ground truth for the device's function is the inherent signal-to-noise ratio within the recorded Auditory Evoked Potential (AEP) data. The POVR algorithm's calculation is intended to statistically represent this signal-to-noise ratio. The ultimate "ground truth" for a meaningful AEP recording is the presence of a discernible Brainstem Auditory Evoked Response, which is assessed by trained professionals. The algorithm aims to objectively quantify this.

Type of Ground Truth: The intrinsic statistical properties of the AEP signal and noise, as interpreted and validated by expert judgment of AEP recordings.

8. Sample Size for the Training Set:

Not specified. The document does not discuss a "training set" in the context of machine learning, but rather describes the design and optimization of a statistical algorithm ("Point-Optimized Variance Ratio"). The optimization for infants is mentioned, suggesting specific parameter tuning, but not based on a quantified training dataset with ground truth labels.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a classical machine learning "training set" with ground truth establishment is not discussed. The algorithm appears to be designed based on neurophysiological principles and statistical methods to quantify signal-to-noise ratio in AEPs, rather than being trained on a labeled dataset. The statement "The present POVR algorithm is optimized for infants" suggests internal parameter tuning based on understanding infant AEP characteristics, but the method for establishing "ground truth" during this optimization is not detailed.

Summary

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K99 2807

SEP | 4 1955

One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: 847-949-8615

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: (847)-949-5200

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:

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

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K992f0.1

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
1. The number of sweeps must be greater than some pre-defined minimal number.

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.

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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<992807

The following comparison is provided as a summary of technological characteristics relative to the predicate Evoked Potential devices. This is to demonstrate that this new modification to the Evoked Potential program has no significant differences which would adversely affect product safety and effectiveness.

Parameter for comparison	Similarity or Difference
Intended Use	No differences.
Population	No differences. However, the optimal POVR points maydiffer between infant and adult populations. The presentPOVR algorithm is optimized for infants.
Hardware Configuration	This modified program is primarily intended to be usedwith the Bio-logic 2-channel "E" Series hardware, but canalso be used with the 4-channel "SE" Series hardware.
Computer Control Software	The fundamental EP software is unchanged, except forthe addition of the POVR algorithm running in thebackground.
Patient information and tracking.	No differences.
Performance	The use of the POVR algorithm will usually reduce timefor test completion, and offers an objective basis fordetermination of data recording quality.
Safety Characteristics	No differences. There is no change to any of the patient-connected hardware or the hardware control software.There is no change to the basic computer hardwarerequired or to the computer operating system.
Product Labeling	No differences.
Anatomical sites.	No differences.
Physical Characteristics	No differences.

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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Norman E. Brunner Vice-President of Research and Development Bio-logic Systems Corp. One Bio-logic Plaza Mundelein, Illinois 60060-3700

APR - 9 2012

Re: K992807

Trade/Device Name: Biol-logic Evoked Potential for ABAER I Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ Dated (Date on orig SE ltr): August 19, 1999 Received (Date on orig SE ltr): August 20, 1999

Dear Mr. Brunner:

This letter corrects our substantially equivalent letter of September 14, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Norman E. Brunner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Page 1 of 1

992 for

510(k) Number (if known):

Not Assigned

Device Name: Modification to Bio-logic Evoked Potential for ABAER I

Indications For Use:

The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological The Bio-logic Evoked Potential (EP) product lanny is use an avditory stimulus (click, tone, etc.) is presented data necessary for the diagnols of additions and the Brainsten Auditions Dycked Response from the patient is to the patient's ear through an eaphones, and the brainstern Response is very low in ampitude (with repect to surrounding EEG "noise"), the stimulus-response cycle is repeared many times and servers it's signal uill be to surrounding EEG "holse" ), the sumulise of the is repeated many land 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 infants and geriatic patients. It I he Blo-logic by System can be used to patiens of an ago, Inchanismal audiometic results are decided, such a is especially indicated for use in testing mained or whome of the Bio-bio-bio-bio-bio-bio-bio-bio-books is to infants, young cindicit, and cogintively infection 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 processed to quality of the Rringer I he primary teature modification representially assist in the assessment of signal-to-noise ration may be mainsted and/or the assist in test data interpreation, and specifically assessment, the speed of testing may be reduced and/or the Auditory Evoked Response in Inis adolfied is used in this and in with the urrent EP program, with othe corrent without quality of the other lecorded data or limiting the control and flexibility of the health care professional administering the test.

(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 General Restorative Devices 6992807

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

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).