BRC SOFTWARE PRODUCT

K050192 · Brc Operations Pty Limited · OLU · Oct 20, 2005 · Neurology

Device Facts

• Record ID: K050192
• Device Name: BRC SOFTWARE PRODUCT
• Applicant: Brc Operations Pty Limited
• Product Code: OLU · Neurology
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

Device Story

BRC software product consists of two main components: Neuromarker Data Acquisition Software and BRC Cognition Acquisition Software. Neuromarker software collects EEG/ERP data at licensed laboratories using standardized protocols; data is transmitted to a central facility for processing against the Brain Resource International Database (BRID), which contains normative data from approximately 2,400 participants. Cognition Acquisition Software, loaded on a computerized touchscreen system, gathers cognitive performance information; this data is also transmitted to the central facility. The system produces two reports: the NeuroMarker Report (EEG/ERP analysis) and the IntegNeuro Report (cognitive performance). Used by qualified medical professionals to assist in clinical decision-making through statistical comparison of patient data against normative databases. Benefits include standardized, objective posthoc evaluation of neurophysiological and cognitive data.

Clinical Evidence

No clinical data provided. The device relies on comparison against a normative database (BRID) containing data from approximately 2,400 healthy participants.

Technological Characteristics

Software-based system for EEG/ERP and cognitive data analysis. Features include data acquisition software, central analysis facility processing, and normative database comparison (BRID). Operates on computerized touchscreen systems for cognitive data collection. Connectivity involves data transmission from clinical sites to a central facility. No specific hardware materials or sterilization methods are applicable as this is a software-only submission.

Indications for Use

Indicated for qualified medical professionals to perform posthoc statistical evaluation of human EEG and ERP data in patients aged 6 to 90 years.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Neurometric Analysis System (K974748)
• NeuroGraph (K010669)
• NeuroGuide (K041263)

Submission Summary (Full Text)

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K050/92

510(k) Summary BRC Operations Pty. Ltd.

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# OCT 2 0 2005 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

### 807.92(a)(1)

# Submitter Information

| The Anson Group<br>7992 Castleway Dr., Indianapolis, IN 46250<br>Phone:<br>[phone]<br>Facsimile:<br>[phone] | |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Contact Person: | Carri Graham |
| Date: | October 14, 2005 |
| Manufacturer: | BRC Operations Pty.Ltd, P.O. Box 737 Broadway<br>Sydney, NSW 2007 Australia |
| 807.92(a)(2) | |
| Trade Name: | BRC Software Product |
| Common Name: | Electroencephalograph |
| Classification Name(s): | Electroencephalograph |
| Classification Number: | 882.1400 |
| 807.92(a)(3) | Predicate Device(s) |

| K974748 | Neurometric Analysis<br>System | Nxlink, Ltd |
|---------|--------------------------------|----------------------|
| K010669 | NeuroGraph | Thuris Corp. |
| K041263 | NeuroGuide | Applied Neuroscience |

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510(k) Summary BRC Operations Pty. Ltd.

K050192

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807.92 (a)(4)

## Device Description

The BRC software product is composed of the following major components: BRC The DRC software produisition Software and the BRC Neuromarker Analysis Software. Neuromarker Data Acquisition Software is used to collect the data gathered at BRC I he Nedromancer Data requisition protocols and equipment are utilized at each nechsed laboratory to ensure uniformity of collected data. The data is then transmitted to the DRC Central Analysis Facility where the Neuromarker Analysis Software is used to DIC Central Interfall Pagainst the Brain Resource International Database (BRID). The process the gatibled and againta from approximately 2,400 normative (i.e., without a database Currently contains ada cohol abuse, or serious medical condition) participants. The results of the processed data is compiled into an individualized report called the NeuroMarker Report.

The BRC Cognition Acquisition Software is one component of the BRC NeuroMarker The DRC Cognition Frequence is loaded on a computerized touchscreen system and used to gather cognitive patient performance information. This data is transmitted from used to gamer cogment person personal Analysis Facility for processing and formatting into report form (IntegNeuro Report).

The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

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510(k) Summary BRC Operations Pty. Ltd.

K050/92

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807.92(a)(5)

## Intended Use(s)

The BRC software product is to be used by qualified medical professionals for the posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

### 807.92(a)(6)

### Technological Characteristics

| | BRC Software<br>Product<br>To be cleared via<br>this<br>submission | Applied<br>Neuroscience<br>NeuroGuide<br>K041263<br>Exhibit A | Thuris Corp.<br>NeuroGraph<br>K010669<br>Exhibit B | NxLink<br>Neurometric<br>Analysis<br>System<br>(NAS)<br>K974748<br>Exhibit C |
|------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------|
| EEG data comparison<br>against normative<br>database | Yes | Yes | Yes | Yes |
| ERP/EP<br>data comparison<br>against normative<br>database | Yes | No | Yes | Yes |
| Population | 6 to 90 years | Birth to 82<br>years | Unknown | 6 to 90 years |
| Product code | GWQ-EEG | GWQ-EEG | GWQ-EEG | GWQ-EEG |
| Classification | 882.1400 | 882.1400 | 882.1400 | 882.1400 |
| Indications for Use | See attached | See Exhibit B | See Exhibit A | See Exhibit C |
| Web Questionnaire | Yes | No | No | No |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

OC1 2 0 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BRC Party Limited c/o Carri Graham The Anson Group, LLC 7992 Castleway Drive Indianapolis, Indiana 46250

Re: K050192

Trade/Device Name: BRC Software Product Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Codc: GWQ Dated: October 14, 2005 Reccived: October 18, 2005

Dear Ms. Graham:

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 r ou may) atests 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organizating of substantial equivalence of your device to a legally premarket notincation: "The PDF Intamigation 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 If you desire specific acries ion your as [phone]. Also, please note the regulation entitled, Colliable of Compulation nation notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionmational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara Bonchuk
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050192

# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K050192

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The BRC software product is to be used by qualified medical professionals for the post-The BRC sollwate product is to be accu by qualified more of the more of the statistical evalued response potentials (ERP).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Pomelund for KM

ral. Restorative, Division of G and Neurological Devices

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510(k) Number K050192