SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE

K973596 · Spacelabs Medical, Inc. · OLW · Feb 3, 1998 · Neurology

Device Facts

• Record ID: K973596
• Device Name: SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
• Applicant: Spacelabs Medical, Inc.
• Product Code: OLW · Neurology
• Decision Date: Feb 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Spacelabs Medical 90482 BIS Module is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The Bispectral Index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.

Device Story

Module acquires/processes 1-2 channels of EEG signals; derives Bispectral Index (BIS) to correlate EEG activity to brain state. Calculates spectral edge frequency, electromyogram activity, median power frequency, signal quality index, and EEG suppression. Uses licensed Aspect Medical Systems bispectral analysis algorithm and proprietary sensor. Integrates with Spacelabs Medical Patient Care Information System (PCIS) via SDLC communications for waveform/digital data display, review, and editing. Used in ICU, OR, and research settings by clinicians. Provides real-time monitoring of anesthetic effects; aids clinical decision-making regarding anesthesia depth.

Clinical Evidence

Bench testing only. Performance testing conducted to ensure device meets functional specifications and safety standards, including IEC 601-1 and IEC 601-2-26 for electroencephalographs.

Technological Characteristics

Modular unit; interfaces with Spacelabs Medical PCIS. Uses proprietary Aspect Medical sensor for EEG acquisition. Bispectral analysis algorithm licensed from Aspect Medical. Connectivity via SDLC communications. Complies with IEC 601-1 and IEC 601-2-26 safety standards.

Indications for Use

Indicated for monitoring brain state via EEG signal acquisition in ICU, OR, and clinical research settings. Used as an aid in monitoring anesthetic agent effects. Prescription use only. Applied externally to the scalp.

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

• EEG Monitor, Models A-1000/A-1050 with the Processed Monitor (K963644)

Submission Summary (Full Text)

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FEB - 3 1998 ×973596

15220 N.E. 40th Street
P.O. Box 97013
Redmond, Washington 98073-9713
206-882-3700

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

## Spacelabs Medical 90482 Bispectral Index Analysis (BIS) Module

- Russ Garrison Submitter's Name: 1. Director of Regulatory Affairs
- Spacelabs Medical Inc. Company: 15220 N.E. 40th Street Redmond, WA 98073
- [phone] Telephone:
- [phone] Facsimile:
- Spacelabs Medical 90482 BIS Module Name of Device: 2.

Flectroencephalograph (EEG) Monitor Classification: OLW, ORF, OLT, ONC

- We consider the Spacelabs Medical 90482 BIS Predicate Device: 3. Module to be substantially equivalent to the EEG Monitor, Models A-1000/A-1050 with the Processed Monitor, Models, currently marketed by Aspect Medical Systems, Inc. (510[k] reference K963644). Both monitoring systems provide the means to monitor the state of the brain by data acquisition and processing of EEG signals in a clinical hospital environment or research setting. Both also use the identical bispectral analysis algorithm, a processed EEG variable displayed as a numerical value, as an aid in monitoring the effects of certain anesthetic agents. The bispectral analysis algorithm used in the Spacelabs Medical 90482 BIS Module has been licensed from Aspect Medical Systems and the 90482 BIS Module uses a Digital Signal Converter (DSC-2) and a proprietary sensor developed by Aspect Medical to operate in the BIS mode.

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- The Spacelabs Medical 90482 BIS Module is a slim, Device Description: 4. lightweight singular modular unit that, when used in conjunction with a Spacelabs Medical Patient Care Information System (PCIS), provides the capability to acquire, process and display one (1) or two (2) channels of brain electrical activity (EEG). The EEG data is processed to derive a Bispectral Index (BIS) to correlate the EEG activity to the state of the brain. Other trended parameters may also be processed, including spectral edge frequency, electromyogram activity, median power frequency, a signal quality index, and suppression of the EEG signal.
The Module is the primary interface to the patient The Module is capable of being monitored. acquiring and processing EEG signals for a single patient. The Module accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical Patient Care Information System (PCIS) monitor via SDLC communications. The PCIS system provides the display, review and editing capabilities for the care provider.

- The Spacelabs Medical 90482 BIS Module is Intended Use: 5. intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The Bispectral Index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
- The design, components, storage technology and Comparison of 6. energy source of the 90482 BIS Module are similar Technological to its predicate device. Both the 90482 BIS Module Characteristics: and the Aspect EEG/BIS Monitor provide the means for interfacing with a patient, collecting EEG data, and processing the data for alarm generation and display of EEG waveforms and numeric BIS values on a bedside or central monitoring system. The bispectral analysis algorithm has been licensed from Aspect Medical and, to operate in the BIS mode, a specific proprietary sensor provided by Aspect Medical Systems must be used.

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The only significant difference between the The only significant BIS Module and the comparable Spacelabs Medical by Aspect Medical are in the system Tharketed By Rop 90482 BIS Module, which hardware packaging of the spatibility with the Patient is designed for modular companisms offered by Spacelabs Medical.

- The Spacelabs Medical 90482 BIS Module will be Testing: The Spacellabs Medical be loss performance testing 7. prior to release. Final testing for the system includes various performance tests designed to includes various peno manos all of its functional ensure that the device morning as specifications. Safety testing will be performed by third party Safety lesting will be pononewice complies to agencies - to - enours safety standards for medical applicable industry and only and on 1, C222.2 No. 601-1, and s, including OELOS for for the safety of IEC IEC 601-1.
electroencephalographs specifically, IEC 601-2-26.
In conclusion, the Spacelabs Medical 90482 BIS Module is as safe and offective In conclusion, the Spacelabs Medical School by Aspect Medical Systems and as the prodicate state or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Mr. Russ Garrison Director of Regulatory Affairs Spacelabs Medical, Incorporated 15220 North East 40th Street Redmond, Washington 98073

APR - 9 2012

Re: K973596

Trade/Device Name: Spacelabs Medical 90482 Bispectral Index Analysis (BIS) Module Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, ORT, OLT, OLT, OMC Dated (Date on orig SE ltr): December 18, 1997 Received (Date on orig SE Itr): December 22, 1997

Dear Mr. Garrison:

This letter corrects our substantially equivalent letter of February 3, 1998.

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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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/Reportalroblem/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.

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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## INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known): Not Known (New Submission)

Device Name: Spacelabs Medical 90482 Bispectral Index Analysis (BIS) Module

Indications for Use:

1

Condition to be screened, monitored, treated or diagnosed. Coridition to be sereoned, monito, abnormalities in electroencephalograph (EEG) signals in the brain.

Prescription use only.

Prescription asc offity.
Yes. Caution statement is provided in the introductory page of the Patient Tes. Gaution System which includes the operating instructions for this Module.

Parts of body applied to . . ... ... ... .. .. . Faris or body upplies to the Module are applied externally to the scalp.

Frequency of use. Frequency as directed by physician.

Physiological purpose.

- To monitor the state of the brain by data acquisition of EEG signals ● in the intensive care unit, operating room and for clinical research, and
- To display a Bispectral 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) |
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(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | KA73596 |
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