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.

This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially indicated for use in defining the configuration of the hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Auditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

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

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 diagnostic systems of this type marketed by Bio-logic. Other related diagnostic devices in the Evoked Potential family include:

510(k) #K803226 Bio-logic Evoked Response Stimulators. 1.
510(k) #K842543 Bio-logic Evoked Potential System. 2.
510(k) #K844992 Bio-logic Portable Evoked Response System. 3.
510(k) #K862690 -- Bio-logic Traveler LT System. 4.
1. 510(k) #K930328 - Navigator and Traveler Evoked Potential Product.

The predicate device, the Bio-logic Evoked Potential system with Navigator Pro hardware, performs Evoked Potential recording and analysis functions, including up to 2 channels of data recording and numerous diagnostic protocols and modalities. This new MASTER Evoked Potential with Navigator Pro device performs many of these same functions in essentially the same ways with a one-channel version of the same hardware, but employs a new software application package with significant new capabilities over those of the predicate device. Through the use of the Auditory Steady State Response (ASSR) modality, which is a variant of the MLR / 40 Hz test modality used in the referenced systems already on the market, hearing threshold levels can quickly and reliably be determined based on physiological rather than behavioral means.

The Auditory Steady State Response test is an alternative to tone burst Auditory Brainstem Response (ABR) testing which is used to predict frequency-specific behavioral hearing thresholds particularly for patients who cannot provide a reliable behavioral response. The ASSR technique avoids one of the inherent pitfalls of the tone burst ABR technique which is the problem of "spectral splatter" (distortions in frequency-specific data due to the start/stop actions of the tone burst) of the short duration acoustic stimulus that is required for ABR measurement. The ASSR technique uses a continuous frequency and/or amplitude modulated tone as the stimulus and can combine several stimuli together simultaneously to assess responses to various frequencies all at the same time. The evoked response recorded from scalp electrodes is reflective of the frequency of the modulation envelope of the stimulus. Thus, assessment of the response spectrum can yield information about the presence of the response to stimuli of varying intensities in order to determine the response threshold. ASSR thresholds have a predictable relationship to behavioral thresholds that is dependent on stimulus frequency and the presence and degree of hearing loss.

The MASTER application software is a modification of software originally designed by and exclusively licensed from researchers at the Rotman Research Institute, Baycrest Centre for Geriatric Care, at The University of Toronto. This software was designed originally for research purposes, and Bio-logic made significant modifications to create double fault conditions for any situation that could impact patient safety (e.g. presentation of prolonged, intense acoustic stimuli), to block the user from making parameter changes that are known to result in poor quality data, and to improve overall reliability, performance and ease of use. Additionally, the user interface has been simplified in terms of operation and information display so that only the relevant operations and data are available. More complex functions that do not have clinical relevance were eliminated from the software.

This system will be used to assist in defining the configuration of the hearing loss particularly in populations that are difficult to test using traditional behavioral audiometry. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

AI/ML Overview

The provided text is a 510(k) summary for the Bio-logic MASTER Evoked Response System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria.

The document states that the modification was designed and incorporated "in accordance with the Bio-logic internal Product Development procedures which are intended to meet ISO-9001. EN-46001 and FDA QSR Design Control specifications." It also mentions a "Hazard/Risk analysis ... performed using the Fault Tree analysis (FTA) approach, and a detailed Risk Assessment was written in accordance with EN-1441." An addendum to this hazard/risk file was written for the new MASTER software.

Therefore, based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as the detailed study information requested, cannot be fully generated as such a study is not explicitly described.

However, I can extract information related to the device's design control and risk assessment, which are usually components of meeting acceptance criteria for medical devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., specific accuracy metrics, threshold determination accuracy) and corresponding reported performance metrics from a clinical study. Instead, it focuses on demonstrating that the new MASTER device has "no significant differences which would adversely affect product safety and effectiveness" compared to its predicate.

The closest to "acceptance criteria" are the statements regarding safety and effectiveness, and the comparison table highlighting similarities and differences with the predicate device.

Parameter for Comparison	Similarity or Difference	Reported Device Performance (as implied by the document's claims of safety and effectiveness)
Intended Use	No differences. 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. This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols, especially for individuals for whom behavioral audiometric results are deemed unreliable. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR or ASSR test protocols. It is designed to be used by trained individuals and its results will be used by trained hearing health care professionals for recommendations on intervention strategies.	The device effectively estimates behavioral hearing thresholds at various frequencies, similar to the predicate device, for the stated patient population. The new ASSR modality offers an alternative to tone burst ABR for predicting frequency-specific behavioral hearing thresholds.
Patient Population	No differences. Can be used for patients of all ages, from children to adults, including infants and geriatric patients.	Suitable for all age groups as intended.
Hardware Configuration	No differences. A one-channel version of the Navigator Pro hardware is used.	The hardware functions reliably and as expected for a one-channel system, consistent with the predicate device.
Computer Control Software	The software for the MASTER is a new Windows-based program designed specifically for the collection of Auditory Steady State Response (ASSR) data. The predicate device was DOS-based and performed a variety of ABR tests, including the 40 Hz test of which ASSR is a variant. Bio-logic made significant modifications to create double fault conditions for any situation that could impact patient safety, to block the user from making parameter changes that are known to result in poor quality data, and to improve overall reliability, performance and ease of use. Additionally, the user interface has been simplified.	The new Windows-based software provides enhanced safety features (double fault conditions, blocking poor parameter changes) and improved reliability, performance, and ease of use compared to the DOS-based predicate. It successfully performs ASSR data collection.
Navigator Pro Firmware	The Digital Signal Processor (DSP) code utilizes the same Loader program as in the predicate device. The program downloaded from the host computer has changes in order to perform the AM/FM modulated stimulation signals for ASSR testing.	The modified firmware successfully enables the generation of AM/FM modulated stimulation signals necessary for ASSR testing, while maintaining the reliability inherent in the DSP control distributed functions.
Patient information and tracking	No significant differences.	Patient information and tracking functionality remains consistent with the predicate device.
Safety Characteristics	No differences. The basic patient connection methods and isolation circuits are the same for both products. No newly-introduced hardware-related methods by which the patient can be harmed or injured.	Safety is maintained at the level of the predicate device, with no new hazards introduced.
Product Labeling	Labeling on the Navigator Pro is unchanged.	Labeling remains appropriate and unchanged for the Navigator Pro component.
Presentation of Data / User Interface	Information displayed on the host computer screen has been completely changed in the MASTER. The user interface is specifically designed to allow the user to enter test protocol information and display results in a manner more intuitive and familiar to Windows users, as opposed to the DOS user interface of the predicate device. Also, the overall display of data is less complex than that of the predicate device.	The user interface is more intuitive, easier to use, and presents data in a less complex manner, enhancing user experience without compromising diagnostic capability.
Patient connections	No differences.	Patient connections (transducers and electrodes) perform as expected.
Anatomical sites	No differences.	The device is used on the same anatomical sites as the predicate.
Physical Characteristics	No differences.	Physical characteristics (size, weight, etc.) are equivalent to the predicate.

2. Sample Size for Test Set and Data Provenance:

The document does not specify a sample size for a test set or discuss any clinical data provenance (e.g., country of origin, retrospective/prospective study). The submission is primarily focused on software modification and substantial equivalence to a predicate device, relying on design controls and risk analysis rather than a new clinical performance study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

This information is not provided in the document as there is no mention of a clinical test set requiring expert-established ground truth.

4. Adjudication Method (Test Set):

This information is not provided as there is no mention of a clinical test set requiring adjudication.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone capability for diagnostic testing by trained healthcare professionals.

6. Standalone Performance Study:

No specific standalone performance study with detailed metrics is reported in this summary. The document states that the software was "originally designed for research purposes" and Bio-logic "made significant modifications... to improve overall reliability, performance and ease of use." The claim of performance is inferred from the device's design to estimate behavioral hearing thresholds reliably through ASSR, a variant of an existing modality. The safety and effectiveness are established through adherence to design control procedures, hazard/risk analysis, and comparison with the predicate device.

7. Type of Ground Truth Used (if standalone study was done):

Since no specific standalone study is described, the type of ground truth is not explicitly stated. However, the product's function is to "estimate behavioral hearing threshold," implying that the ultimate ground truth for auditory devices would typically relate to actual behavioral hearing thresholds or objective physiological measures that correlate strongly with them.

8. Sample Size for the Training Set:

The document does not provide information on a training set sample size. The software was "originally designed by and exclusively licensed from researchers at the Rotman Research Institute... at The University of Toronto" for "research purposes." This suggests it was developed based on existing research data, but the specific size or nature of this "training" data is not detailed as part of the submission.

9. How Ground Truth for Training Set was Established:

This information is not provided. Given the software's origin in research for "estimating behavioral hearing threshold," the ground truth in the original research would likely have been established through a combination of psychoacoustic behavioral audiometry and physiological measurements (e.g., ABR) that the ASSR technique is designed to complement or predict. However, the document does not elaborate on this for the software's development.

Summary

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Image /page/0/Picture/24 description: The image shows the logo for Bio-logic Systems Corp. The logo features the word "Bio-logic" in a bold, sans-serif font, with the word "SYSTEMS CORP" in a smaller font underneath. The logo is primarily black and white, with the text in white against a black background. There is a registered trademark symbol to the right of the word "Bio-logic".

1 2002 JUL

Koz/895

One Bio-logic Piaza Mundelein, IL 60060-3700 1-800-323-8326 Fax: 847-949-8615 www.bio-logic.com

SECTION 2: SUMMARY AND CERTIFICATION

510(K) SUMMARY

Safety and effectiveness information concerning the MASTER device modification to the Biologic Evoked Potential product family 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 CorpOne Bio-logic PlazaMundelein, IL 60060
--------------	----------------------------------------------------------------------

TELEPHONE: (847)-949-5200

CONTACT PERSON: Norman E. Brunner

DATE ON WHICH THE SUMMARY WAS PREPARED: June 4, 2002

NAME OF DEVICE: Bio-logic MASTER Evoked Response System.

COMMON NAME: Evoked Response System.

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

PREDICATE DEVICE: Navigator Pro Evoked Potential device, reference 510(k) #K994149.

DESCRIPTION OF THE DEVICE:

510(k) #K803226 Bio-logic Evoked Response Stimulators. 1.
510(k) #K842543 Bio-logic Evoked Potential System. 2.
510(k) #K844992 Bio-logic Portable Evoked Response System. 3.
510(k) #K862690 -- Bio-logic Traveler LT System. 4.
1. 510(k) #K930328 - Navigator and Traveler Evoked Potential Product.

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The Auditory Steady State Response test is an alternative to tone burst Auditory Brainstem Response (ABR) testing which is used to predict frequency-specific behavioral hearing thresholds particularly for patients who cannot provide a reliable behavioral response. The ASSR technique avoids one of the inherent pitfalls of the tone burst ABR technique which is the problem of "spectral splatter" (distortions in frequency-specific data due to the start/stop actions of the tone burst) of the short duration acoustic stimulus that is required for ABR measurement. The ASSR technique uses a continuous frequency and/or amplitude modulated tone as the stimulus and can combine several stimuli together simultaneously to assess responses to various frequencies all at the same time. The evoked response recorded from scalp electrodes is reflective of the frequency of the modulation envelope of the stimulus. Thus, assessment of the response spectrum can yield information about the presence of the response to stimuli of varving intensities in order to determine the response threshold. ASSR thresholds have a predictable relationship to behavioral thresholds that is dependent on stimulus frequency and the presence and degree of hearing loss.

The MASTER application software is a modification of software originally designed by and exclusively licensed from researchers at the Rotman Research Institute. Baverest Centre for Geriatric Care, at The University of Toronto. This software was designed originally for research purposes, and Bio-logic made significant modifications to create double fault conditions for any situation that could impact patient safety (e.g. presentation of prolonged, intense acoustic stimuli), to block the user from making parameter changes that are known to result in poor quality data, and to improve overall reliability, performance and ease of use. Additionally, the user interface has been simplified in terms of operation and information display so that only the relevant operations and data are available. More complex functions that do not have clinical relevance were eliminated from the software.

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INTENDED USE:

This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially indicated for use in defining the configuration of the hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstern Response) or ASSR (Auditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

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. EN-46001 and FDA QSR Design Control specifications. A detailed Hazard/Risk analysis for the EP family of products 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. An addendum to this Hazard/Risk file was written based on a review of this new MASTER software design.

The Navigator Pro patient-connection hardware is unchanged with this modification. A onechannel version of this hardware is used with the MASTER program. There are no newlyintroduced hardware-related methods by which the patient can be harmed or injured through the use of this device. The same patient isolation methods are used in both products, and the Navigator Pro utilizes a medical-grade power supply. Direct hardware control of all Navigator Pro functions is provided from the Digital Signal Processor (DSP) and its program code located inside the Navigator Pro package, just as it is in the predicate device. By distributing the hardware-specific functions to the DSP, the Windows-based host computer program has fewer real-time demands, resulting is high reliability and performance.

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The MASTER software does not make any final decisions that result in any direct forms of diagnosis or treatment. The system is designed to be used for auditory diagnostic testing by trained health care professionals. Audiologists and physicians perform evoked potential testing and interpret the results. The results of the test are then used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

The following table provides a summary comparison of the technological characteristics of the new MASTER device relative to the Bio-logic Evoked Potential with Navigator Pro predicate device. This is to demonstrate that this new MASTER device has no significant differences which would adversely affect product safety and effectiveness.

Parameter forComparison	Similarity or Difference
Intended Use	No differences.
Patient Population	No differences.
HardwareConfiguration	No differences.
Computer ControlSoftware	The software for the MASTER is a new Windows-based programdesigned specifically for the collection of Auditory Steady StateResponse (ASSR) data. The predicate device was DOS-based andperformed a variety of ABR tests, including the 40 Hz test of whichASSR is a variant.
Navigator ProFirmware	The Digital Signal Processor (DSP) code in the Navigator Pro hardwarebox utilizes the same Loader program as in the predicate device. Theprogram downloaded from the host computer has changes in order toperform the AM/FM modulated stimulation signals for ASSR testing.
Patient informationand tracking	No significant differences.
Safety Characteristics	No differences. The basic patient connection methods and isolationcircuits are the same for both products.
Product Labeling	Labeling on the Navigator Pro is unchanged.
Presentation of Data /User Interface	Information displayed on the host computer screen has been completelychanged in the MASTER. The user interface is specifically designed toallow the user to enter test protocol information and display results in amanner more intuitive and familiar to Windows users, as opposed to theDOS user interface of the predicate device. Also, the overall display ofdata is less complex than that of the predicate device.
Patient connections(transducers andelectrodes)	No differences
Anatomical sites	No differences.
PhysicalCharacteristics	No differences.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion on the left and a stylized symbol on the right. The symbol features three abstract human profiles facing right, stacked on top of each other, creating a sense of depth and unity. The overall design is simple, clean, and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. IUIL 1 2007

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

Re: K021895

Trade Name: Bio-logic Master Evoked Response System Regulation Number: 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: II Product Code: GWJ Dated: June 7. 2002 Received: June 10, 2002

Dear Mr. Brunner:

We have reviewed your Section 510(k) premarket 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) 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,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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.

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Page 2 – Mr. Norman E. Brunner

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Stipt Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): #K021895

Device Name: MASTER, Modification to Bio-logic Evoked Potential Product.

Indications For Use:

This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Anditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as andiologists an physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

Bio-logic EP Systems can be used for patients of all ages, from children to adults, including infants and geriaric patients. The use of the Bio-logic EP family of products is to be performed under the prescription of a physician or other trained health care professional.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hut Rhodes

Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).