(266 days)
Not Found
No
The description focuses on statistical evaluation against a database and does not mention AI or ML techniques.
No
The device is described as software for "posthoc statistical evaluation" of EEG data and generation of reports, not for direct treatment or therapy.
Yes
The intended use explicitly states "posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP)", and the device performs this evaluation by processing gathered data and compiling it into an individualized report (NeuroMarker Report or IntegNeuro Report), which is consistent with the function of a diagnostic device.
No
The device description explicitly mentions "BRC The Nedromancer Data requisition protocols and equipment are utilized at each nechsed laboratory to ensure uniformity of collected data," indicating the use of hardware equipment for data acquisition, making it not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BRC software product analyzes electroencephalogram (EEG) data, specifically evoked response potentials (ERP). EEG measures electrical activity in the brain, which is a physiological signal, not a sample taken from the body for in vitro analysis.
- Intended Use: The intended use is for "posthoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP)." This describes the analysis of a physiological measurement, not an in vitro test.
Therefore, while it's a medical device used for diagnostic purposes, it falls under the category of devices that analyze physiological signals rather than in vitro samples.
N/A
Intended Use / Indications for 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).
Product codes
GWQ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electroencephalogram (EEG)
Anatomical Site
human
Indicated Patient Age Range
6 to 90 years
Intended User / Care Setting
qualified medical professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
To be cleared via this submission Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
K050/92
510(k) Summary BRC Operations Pty. Ltd.
f
Pag 1 of 3
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
7992 Castleway Dr., Indianapolis, IN 46250
Phone:
(317) 849-1916
Facsimile:
| (317) 577-9070 | |
|---|---|
| Contact Person: | Carri Graham |
| Date: | October 14, 2005 |
| Manufacturer: | BRC Operations Pty.Ltd, P.O. Box 737 Broadway |
| 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
System | Nxlink, Ltd |
|---------|--------------------------------|----------------------|
| K010669 | NeuroGraph | Thuris Corp. |
| K041263 | NeuroGuide | Applied Neuroscience |
1
510(k) Summary BRC Operations Pty. Ltd.
Page 2 of 3
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).
2
510(k) Summary BRC Operations Pty. Ltd.
K050/92
Page 3.83
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
Product
To be cleared via
this
submission | Applied
Neuroscience
NeuroGuide
K041263
Exhibit A | Thuris Corp.
NeuroGraph
K010669
Exhibit B | NxLink
Neurometric
Analysis
System
(NAS)
K974748
Exhibit C |
|------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------|
| EEG data comparison
against normative
database | Yes | Yes | Yes | Yes |
| ERP/EP
data comparison
against normative
database | Yes | No | Yes | Yes |
| Population | 6 to 90 years | Birth to 82
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 |
4
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
5
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
Page 1 of 1
510(k) Number K050192