HBIDB - HUMAN BRIAN INDEX SOFTWARE

K112077 · Corscience GmbH & Co. KG · OLU · Mar 9, 2012 · Neurology

Device Facts

• Record ID: K112077
• Device Name: HBIDB - HUMAN BRIAN INDEX SOFTWARE
• Applicant: Corscience GmbH & Co. KG
• Product Code: OLU · Neurology
• Decision Date: Mar 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended Use

The HBIdb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP). The HBIdb product is intended for use on children and adults from age 7 to 80 years.

Device Story

HBIdb is a software program for post-hoc statistical analysis of human EEG and ERP data. Input consists of EEG recordings in EDF+ format, recorded on separate devices. The software performs spectral analysis, ERP analysis, and comparison of parameters against the Human Brain Index Reference Database (HBIRD). It produces reports for clinical review. Used in clinical settings by qualified medical professionals. Output serves as an aid to diagnosis; must be considered alongside other clinical findings. Benefits include standardized statistical evaluation of brain potentials to assist in diagnosing neurological conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation were performed using specific EEG test files across multiple Windows operating systems (XP, Vista, 7) to confirm software functionality.

Technological Characteristics

Pure software product; no physical materials. Operates on IBM-compatible PCs. Features include spectral analysis, ERP analysis, normative database comparison, and ICA-based artifact correction. Software developed per IEC 62304:2007. Connectivity via EDF+ file import. Security managed via hardware dongle.

Indications for Use

Indicated for post-hoc statistical evaluation of human EEG and ERP in patients aged 7 to 80 years. Intended for use by qualified medical professionals as an aid to diagnosis; not for use as a sole basis for medication or treatment decisions.

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

• BRC Software Product (K050192)
• NeuroGuide Analysis System (K041263)
• NeuroGraph Evoked Potentials System (K010669)
• Neurometric Analysis System (K974748)

Submission Summary (Full Text)

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MAR - 9 2012

# 510(k) summary

### General Information

# 1 APPLICANT

Date: March 5th, 2012

Name: Corscience GmbH & Co. KG

Address: Henkestr. 91 D-91052 Erlangen Germany

Contact person in the U.S.: Address

Telephone: FAX: E-Mail:

Monroeville, PA 15146 412 – 372 – 8571 412 — 372 — 8575 [e-mail]

Patrik R. Karem SOMNO TECH, L.L.C.

700-706 Seco Rd.

Contact person in Germany: Karlheinz Trost Telephone: FAX: E-Mail:

01149 9131 977986 – 518 01149 9131 977986 – 59 [e-mail]

K. Vrost

Signature:

# 2 TRADE NAME

HBIdb

### 3 COMMON NAME OR CLASSIFICATION NAME

Electroencephalograph

### 4 ESTABLISHMENT REGISTRATION NUMBER

3005488716

# 5 FACILITY ADDRESS

Corscience GmbH & Co. KG Henkestr. 91 D-91052 Erlangen Germany

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# 6 DEVICE CLASSIFICATION

#### 6.1 Classification

This is a class II device

#### 6.2 Classification panel

#### PANEL: NEUROLOGY

Product Code: GWQ

#### 6.3 Regulation Number

882.1400

# 7 PREDICATE DEVICES DESCRIPTIONS

### 7.1 Names

BRC Software Product NeuroGuide Analysis System Neurograph Evoked Potentials System Neurometric Analysis System

#### 7.2 Predicate Device Companies

BRC: BRC Operations Pty. Ltd, P.O. Box 737 Broadway, Sydney, NSW 2007 Australia NeuroGuide: Applied Neurosciece Inc., 228 176th Terrace Drive, St. Petersburg, FL 33708 NeuroGraph: Thuris Corp., 110 Glenn Way # 6, San Carlos, CA 94070 Neurometric: NXLINK, Ltd., 1706 Gaillard PI., Richland, WA 99352

#### 7.3 Predicate Device 510(k)#

BRC: K050192 NeuroGuide: K041263 NeuroGraph: K010669 Neurometric: K974748

### 8 DEVICE DESCRIPTION

The Human Brain Index Software (HBldb) product is a software program for the post-hoc statistical analysis and comparison with a reference data (the Human Brain Index Reference Database (HBIRD)) of the human electroencephalogram (EEG) including spontaneous oscillations of the human brain potentials and event-related potentials (ERPs). The EEG is recorded on a separate device under the standardized HBIdb conditions and is transferred to the HBIdb in EDF+ format for

- display .
- . spectral analysis and
- analysis of event-related potentials .
- comparison of the gathered parameters against the Human Brain Index Reference Database . (HBIRD), and
- compilation of a report. .

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Results of comparison of individual EEG/ERP parameters with the database are intended for use as an aid to diagnosis. No medication or treatment is applied based on this comparison alone. The results have to be considered only in conjunction with other clinical findings.

# 9 INDICATIONS FOR USE

The HBIdb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP). The HBIdb product is intended for use on children and adults from age 7 to 80 years.

# 10 REQUIRED COMPONENTS

- HBIdb Software .
- User manual .
- SW dongle .

#### Optional accessory

- None .

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# 11 SUMMARY TABLE OF COMPARISONS

| | HBI software<br>product<br>To be cleared<br>via<br>this<br>submission | BRC software<br>product<br>(K050192) | NeuroGuide<br>Analysis<br>System<br>(K041263) | NeuroGraph<br>Evoked<br>Potential<br>System<br>(K010669) | Neurometric<br>Analysis<br>System<br>(K974748) |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The HBIdb<br>product is to<br>be used by<br>qualified<br>medical<br>professionals<br>for the post-<br>hoc statistical<br>evaluation of<br>the human<br>electroenceph<br>alogram<br>(EEG),<br>utilizing<br>evoked<br>response<br>potentials<br>(ERP). The<br>HBIdb product<br>is intended for<br>use on<br>children and<br>adults from<br>age 7 to 80<br>years. | The BRC<br>software product<br>is to be used by<br>qualified<br>medical<br>professionals for<br>the post-hoc<br>statistical<br>evaluation of the<br>human electro-<br>encephalogram<br>(EEG), utilizing<br>evoked<br>response<br>potentials<br>(ERP). | The<br>NeuroGuide<br>Analysis<br>System<br>product is to<br>be used by<br>qualified<br>medical<br>professionals<br>for the post-<br>hoc statistical<br>evaluation of<br>the human<br>electro-<br>encephalogra<br>m (EEG). | The<br>NeuroGraph<br>Evoked<br>Potential<br>System<br>(NeuroGraph<br>EPS) is for use<br>by qualified<br>medical<br>professionals<br>and is intended<br>to record and<br>display electro-<br>encephalogram<br>(EEG) and<br>evoked potential<br>(EP) data in<br>private<br>practices, clinics<br>or hospital<br>environments to<br>assist in the<br>diagnosis and<br>monitoring of<br>central and<br>peripheral<br>nervous system<br>disorders | The<br>Neurometric<br>Analysis<br>System<br>product is to<br>be used by<br>qualified<br>medical<br>professionals<br>for the post-<br>hoc statistical<br>evaluation of<br>the human<br>electroencep<br>halogram<br>(EEG). |
| EEG<br>data<br>comparison<br>against<br>normative<br>database | Yes | Yes | Yes | Yes | Yes |
| ERP/EP data<br>comparison<br>against norm.<br>database | Yes | Yes | No | Yes | No |
| Population | 7 to 80 years | 6 to 90 years | Birth to 82 y. | Unknown | 6 to 90 years |
| Product code | GWQ | GWQ | GWQ | GWQ | GWQ |
| Classification<br>ICA based<br>artifact<br>Correction | 882.1400<br>Yes | 882.1400<br>No | 882.1400<br>No | 882.1400<br>No | 882.1400<br>No |
| Decomposition<br>of ERPs into<br>independent<br>components | Yes | No | No | No | No |

All software products are to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electro-encephalogram (EEG) and compare the obtained EEG data against a normative database.

The age groups of all products are similar so that the software can be used on EEGs of subjects from childhood until old age.

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# 12 SUMMARY OF DEVICE TESTING

The HBIdb product has been developed and validated according to the standard IEC 62304:2007. Software documentation and testing was provided in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

For verification and validation of the product, all software functions were tested by means of specific EEG test files. Verification and validation were performed on an IBM compatible computer on the following operating systems: Windows XP 32 bit, Vista 32 bit, Windows 7 32 and 64 bit. The security dongle was validated by means of a special utility supplied by the producer of the dongle.

The standard ISO 10993-1 does not apply to this product because it is a pure software product.

## 13 CONCLUSIONS

Based on the above, Corscience GmbH & Co. KG concludes, that the HBldb product is substantially equivalent to legally marketed predicate software products.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

#### Public Health Service

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

Corscience GmbH & Co. KG c/o Mr. Karlheinz Trost Quality Management and Regulatory Affairs 700-706 Seco Road Monroeville, PA 15146

MAR - 9 2012

Re: K112077

Trade/Device Name: Human Brain Index Software (HBIdb) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: January 30, 2012 Received: January 31, 2012

Dear Mr. Trost:

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. Karlheinz Trost

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Emili. Hemmi, MD

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

510(k) Number (if known): イバノ2077

Device Name: _ Human Brain Index Software (HBIdb)

Indications For Use:

The HBldb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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 Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112077

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