BIS BILATERAL SENSOR

K062692 · Aspect Medical Systems, Inc. · GXY · Dec 13, 2006 · Neurology

Device Facts

• Record ID: K062692
• Device Name: BIS BILATERAL SENSOR
• Applicant: Aspect Medical Systems, Inc.
• Product Code: GXY · Neurology
• Decision Date: Dec 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Device Story

The BIS Bilateral Sensor is a single-patient-use, disposable, pre-gelled 6-electrode array applied to the patient's forehead. It records electrophysiological signals (EEG) for clinical monitoring. The sensor includes an integrated electronic smart card memory device in the tab area for configuration and identification data. It functions as an interface between the patient and a compatible monitoring system, enabling the collection of 4 channels of EEG data (compared to 2 channels in the predicate). The device is intended for use by healthcare professionals in clinical settings to facilitate neurological monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to the predicate device.

Technological Characteristics

Disposable, pre-gelled 6-electrode array; cutaneous application; includes integrated smart card memory for configuration/ID; 4-channel EEG collection; biocompatible materials consistent with predicate.

Indications for Use

Indicated for patients requiring electrophysiological (EEG) signal recording via cutaneous electrodes applied to the forehead.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Aspect Enhanced XP BIS Sensor (K002734)

Submission Summary (Full Text)

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K062692
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# DEC 1 3 2006

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## Appendix E

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## 510(k) Summary

| Date: | September 7, 2006 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464 |
| Contact Person: | Renee Gould [phone] |
| Proprietary Name: | BIS Bilateral Sensor |
| Common Name: | Electrode, Cutaneous Electrode |
| Classification: | Class II device. Refer to 21 CFR 882.1320 |
| Product Code: | GXY |
| Predicate<br>Device: | K002734, Aspect Enhanced XP BIS Sensor cleared September 14,<br>2000 |
| Device Description: | The Sensor is a single patient use, disposable, pre-gelled 6 electrode<br>array that is applied directly to the patient's forehead to record electro-<br>physiological signals. It has an electronic smart card memory device<br>in the tab area that contains configuration and identification<br>information. |
| Indications for Use: | The BIS Bilateral Sensor is applied directly to the patient's skin to<br>enable recordings of electrophysiological (such as EEG) signals. |
| Similarities: | |
| • same indications for use, | |
| • same intended use, | |
| • same fundamental scientific technology, | |
| • incorporates the same basic design, | |
| • 2 channels of BIS, | |
| • incorporates the same materials and biocompatibility, | |
| • has the same shelf life, | |
| • is packaged using the same materials and processes, and | |
| • incorporates smart card memory device. | |
| Differences: | |
| • | addition of montage on the other side of the head, |

- addition of the 2 electrodes, and .
- 4 channels of EEG collected. .

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K062692
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In summary, the BIS Bilateral Sensor is substantially equivalent to the predicate device. Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as the predicate device. The indications for use remain the same as the Enhanced Sensor. The fundamental scientific technology remains the same as the Enhanced Sensor predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aspect Medical Systems, Inc. % Ms. Renee Gould Director, Regulatory, Quality Assurance 141 Needham Street Newton, Massachusetts 02464

Rc: K062692

Trade/Device Name: BIS Bilateral Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 9, 2006 Received: November 13, 2006

Dear Ms. Gould:

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.

DEC 1 3 2006

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.

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Page 2 – Ms. Renee Gould

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix C

Indications for Use Statement

510(k) Number (if known)

K062692

Device Name

BIS Bilateral Sensor

Indications For Use

The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Prescription Use X (Per 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 nice Evaluation (ODE) DRH O

Mark H. Mcllwra

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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