K Number
K112077
Device Name
HBIDB - HUMAN BRIAN INDEX SOFTWARE
Date Cleared
2012-03-09

(232 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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).
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. . 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.
More Information

Not Found

No
The description focuses on standard statistical analysis and comparison with a reference database, with no mention of AI or ML techniques.

No
The device is described as a software program for statistical analysis and comparison of EEG data, intended as an aid to diagnosis. It does not apply any medication or treatment but rather provides information for diagnostic purposes.

Yes

The device aids in diagnosis by comparing EEG/ERP parameters with a reference database, even though it states that "No medication or treatment is applied based on this comparison alone" and "The results have to be considered only in conjunction with other clinical findings." Its function as an "aid to diagnosis" aligns with the definition of a diagnostic device.

Yes

The device description explicitly states it is a "software program" and its function is the "post-hoc statistical analysis and comparison" of EEG data. It receives data from a separate device and performs analysis and reporting. There is no mention of hardware components being part of the device itself, only the computer it runs on and a security dongle, which are not considered part of the medical device hardware in this context.

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. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The HBIdb product analyzes electroencephalogram (EEG) data. EEG is a measurement of electrical activity in the brain, recorded from electrodes placed on the scalp. This is a non-invasive measurement of physiological activity, not an analysis of a sample taken from the body.
  • Intended Use: The intended use is for the "post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP)." This involves analyzing existing EEG data, not performing a test on a biological sample.
  • Input Modality: The input modality is "Electroencephalogram (EEG)," which further confirms it's not an IVD.

While the device is used as an "aid to diagnosis," this is a common function for many medical devices that are not IVDs. The key distinction is the nature of the input data – biological samples for IVDs versus physiological measurements for devices like this EEG analysis software.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GWQ, OLU

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. .
    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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human Brain

Indicated Patient Age Range

The HBIdb product is intended for use on children and adults from age 7 to 80 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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050192, K041263, K010669, K974748

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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 rpkarem@somnotech.com

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 trost@corscience.de

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

1

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. .

2

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 .

3

11 SUMMARY TABLE OF COMPARISONS

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

4

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.

5

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.

6

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 (800) 638-2041 or (301) 796-7100 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

7

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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