BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM

K073626 · Bio-Logic Systems Corp. · GWJ · Feb 5, 2008 · Neurology

Device Facts

• Record ID: K073626
• Device Name: BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
• Applicant: Bio-Logic Systems Corp.
• Product Code: GWJ · Neurology
• Decision Date: Feb 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1900
• Device Class: Class 2

Intended Use

The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.

Device Story

Master II Evoked Response System is a Windows-based software application operating on the Navigator Pro hardware platform. It utilizes Auditory Steady State Response (ASSR) modality to record and analyze human physiological data. The system delivers continuous frequency and/or amplitude-modulated tones as stimuli; it can combine multiple stimuli simultaneously to assess responses across various frequencies. Scalp electrodes capture evoked responses, which are analyzed to predict frequency-specific behavioral hearing thresholds. The device is intended for use by clinicians to assist in the diagnosis and treatment of audiovestibular and hearing-related disorders, specifically benefiting patients unable to provide reliable behavioral responses.

Clinical Evidence

No clinical data provided; device relies on established ASSR technological principles for physiological data recording and analysis.

Technological Characteristics

Windows-based software application; utilizes Auditory Steady State Response (ASSR) modality; hardware platform: Navigator Pro; stimulus: continuous frequency and/or amplitude modulated tones; input: scalp electrode physiological signals.

Indications for Use

Indicated for patients requiring diagnosis of audiovestibular and hearing-related disorders, particularly those unable to provide reliable behavioral responses.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• K021895 Master, a Modification to Bio-logic Evoked Potential

Submission Summary (Full Text)

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Bio-logic Systems Special 510(k) Master II Evoked Response System

K073626

December 21, 2007

## PREMARKET NOTIFICATION [510(K)] SUMMARY

FEB - 5 Wic

Trade Name:

Master II Evoked Response System

Common or Usual Name: Evoked Response Auditory Stimulator

Classification Name and Number: stimulator, auditory, evoked response 882.1900

Classification Name: stimulator, auditory, evoked response (per 21 CFR section 882.1900)

| Manufacturer's Name: | Bio-logic Systems<br>One Bio-logic Plaza<br>Mundelein, IL 60060 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Nicohl Wilding<br>Director Quality Assurance and Regulatory Affairs<br>One Bio-logic Plaza<br>Mundelein, IL 60060 |
| Telephone Number:<br>Fax Number: | 800-323-8326 ext. 267<br>847-949-8615 |
| Predicate Device(s): | K021895 Master, a Modification to Bio-logic Evoked<br>Potential |
| Device Description: | Master II Evoked Response System is a Windows® based<br>software application for use with the Navigator Pro hardware<br>platform using Auditory Steady State Response Modality for<br>the recording and analysis of human physiological data for<br>the purpose of neurological diagnosis and treatment of<br>audiovestibular and hearing related disorders. |
| Intended Use: | The Master II Evoked Response System is intended for the<br>recording and analysis of human physiological data<br>necessary for the diagnosis of audiovestibular and hearing-<br>related disorders. |
| Technological<br>Characteristics: | Master II is a Windows® based application using Auditory<br>Steady State Response (ASSR) modality. ASSR is used to<br>predict frequency-specific behavioral hearing thresholds<br>particularly for patients who cannot provide a reliable<br>behavioral response. The ASSR technique uses a<br>continuous frequency and/or amplitude modulated tone as<br>the stimulus and can combine several stimuli together |

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December 21, 2007

Bio-logic Systems Special 510(k) Master II Evoked Response System

> 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.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

FEB - 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio-logic Systems Corp. % Ms. Nicohl Wilding One Bio-logic Plaza Mundelein, IL 60060

Re: K073626 Trade/Device Name: Bio-Logic Master II Evoked Response System Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: January 21, 2008 Received: January 23, 2008

Dear Ms. Wilding:

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.

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 - Ms. Nicohl Wilding

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.

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark W. Millerson

Mark N. Melkerson 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

510(k) Number:

Device Name: Master II Evoked Response System

## indications for Use:

The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.

> Prescription Use (per 21 CFR 801.109) and/or

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of C /Office of Device Evaluation (ODE)

(Division Sign-(Division of General, Restorative, Divisionological Devices

510(k)

: