BIS/EEG MODULE

K012466 · General Electric Medical Systems Information Techn · OLW · Oct 1, 2001 · Neurology

Device Facts

• Record ID: K012466
• Device Name: BIS/EEG MODULE
• Applicant: General Electric Medical Systems Information Techn
• Product Code: OLW · Neurology
• Decision Date: Oct 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG Module is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS/EEG Module is intended to monitor the Bispectral Index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.

Device Story

BIS/EEG Module functions as a component of GE Medical Systems Information Technologies host monitoring systems; it does not operate independently. Device acquires EEG signals via sensors/electrodes; processes signals to calculate Bispectral Index (BIS) parameter; transmits data to bedside monitor for display. Used in hospitals/medical facilities under supervision of licensed healthcare practitioners. Provides real-time brain state information to clinicians; aids in monitoring anesthetic agent effects; assists in clinical decision-making regarding anesthesia management; potentially benefits patients by facilitating appropriate anesthetic dosing.

Clinical Evidence

No clinical data. Safety and effectiveness established through bench testing, unit-level module verification, system-level integration testing, and final validation testing.

Technological Characteristics

Modular EEG signal acquisition component; integrates with GE host monitoring systems. Employs Bispectral Index (BIS) processing technology. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult and pediatric patients in hospital or medical facilities to monitor brain state via EEG signal acquisition and to monitor Bispectral Index (BIS) as an aid in assessing effects of certain anesthetic agents.

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

• Aspect Medical Systems, Inc. EEG Monitor with BIS Engine (K974496)
• Aspect Medical Systems, Inc. EEG Monitor with BIS Engine (K923043)
• Aspect Medical Systems, Inc. EEG Monitor with BIS Engine (K011843)

Submission Summary (Full Text)

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OCT - 1 2001

K012466
102

## Section 2 Summary and Certification

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 31, 2001 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Karen Webb<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: Trade Name: | BIS/EEG Module |
| Common/Usual Name: | Electroencephalograph (EEG) |
| Classification Names: | 21 CFR 882.1400 Electroencephalograph |
| Predicate Devices: | K974496, K923043 & K011843 Aspect Medical Systems, Inc. EEG<br>Monitor with BIS Engine |
| Device Description: | The BIS/EEG Module is part of a modular system used to monitor the<br>state of the brain by data acquisition of EEG signals. The module is<br>also used as an aid in monitoring the effects of certain anesthetic<br>agents using Aspect's Bispectral Index® parameter. |
| | BIS/EEG Module works as a component of a GE Medical Systems<br>Information Technologies host monitoring system and does not function<br>on its own. The BIS/EEG Module provides information obtained from<br>the sensors/electrodes to the bedside monitor for display. |
| Intended Use: | The BIS/EEG Module is intended for use under the direct supervision of<br>a licensed healthcare practitioner or by personnel trained in its proper<br>use. The BIS/EEG Module is intended for use on adult and pediatric<br>patients within a hospital or medical facility providing patient care to<br>monitor the state of the brain by data acquisition of EEG signals. |
| | The BIS/EEG Module is intended to monitor the Bispectral Index (BIS),<br>a processed EEG variable which may be used as an aid in monitoring<br>the effects of certain anesthetic agents. |
| Technology: | The BIS/EEG Module employs the same functional scientific technology<br>as its predicate device. |

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K012466
21F2

## Test Summary:

The BIS/EEG Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the BIS/EEG Module:

- Risk Analysis .
- . Requirements Reviews
- Design Reviews �
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- . Performance testing
- Safety testing .
- Environmental testing .

## Conclusion:

The results of these measurements demonstrated that the BIS/EEG Module is as safe, as effective, and perform as well as the predicate device.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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

Ms. Karen Webb Senior Regulatory Affairs Specialist GE medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, Wisconsin 53223

Re: K012466

Trade/Device Name: BIS/EEG Module Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OLT, ORT, OMC Dated (Date on orig SE Itr): July 31, 2001 Received (Date on orig SE ltr): August 1, 2001

Dear Ms. Webb:

This letter corrects our substantially equivalent letter of October 1, 2001.

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.

APR - 9 2012

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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/Resourcesfor You/Industry/default.htm.

for

Sincerely vours.

Kesia Alexander

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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Page 1 of 1

K012466; 510(k) filed on July 31, 2001 510(k) Number (if known):

BIS/EEG Module Device Name:

Indications for Use:

The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare The BIS/ECG Module is microod in to proper use. The BIS/EEG Module is intended for use on precidents of by personner delitor in to pioper receivel facility providing patient cafe to monitor the state of the brain by data acquisition of EEG signals.

The BIS/EEG Module is intended to monitor the Bispectrail Index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

for Mark n Melleus

al. Restorative

510(k) Number K 012466