BIS PEDIATRIC SENSOR

K041670 · Aspect Medical Systems, Inc. · GXY · Jul 6, 2004 · Neurology

Device Facts

• Record ID: K041670
• Device Name: BIS PEDIATRIC SENSOR
• Applicant: Aspect Medical Systems, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jul 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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

Device Story

Single-use, disposable, 4-electrode array; applied to pediatric patient forehead; records electrophysiological signals (EEG). Features integrated smart card memory for configuration/identification. Operates via flexible tines and hydrogel to part skin and create conductive bridge. Used in clinical settings by healthcare providers to monitor patient brain activity. Output facilitates clinical decision-making regarding anesthesia or sedation levels. Benefits include improved fit for smaller pediatric heads compared to previous versions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarities to predicate devices.

Technological Characteristics

Disposable 4-electrode array; pre-gelled; includes electronic smart card memory. Uses flexible tines and hydrogel for skin contact. Dimensions modified for pediatric fit. Class II device (21 CFR 882.1320).

Indications for Use

Indicated for pediatric patients to enable recording of electrophysiological signals (e.g., EEG) via direct skin application.

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 Pediatric EEG BIS Sensor (K001980)
• Aspect Enhanced XP BIS Sensor (K002734)

Submission Summary (Full Text)

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K 041670

# 'JUL - 6 2004

## Appendix D

## 510(k) Summary

Date: May 28, 2004

| Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464<br>Contact Person: Renee Gould [phone] | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | BIS Pediatric Sensor |
| Common Name: | Electrode, Cutaneous Electrode |
| Classification: | Class II device. Refer to 21 CFR 882.1320 |
| Predicate Devices: | K001980, Aspect Pediatric EEG BIS Sensor cleared September 27, 2000<br>and K002734, Aspect Enhanced XP BIS Sensor cleared September 14, 2000. |
| Device Description: | The Sensor is a single patient use, disposable, pre-gelled 4 electrode array that is applied directly to the pediatric patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information. |
| Indications for Use: | The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients. |
| Similarities:<br>same indications for use as the Pediatric Sensor, same intended use as both predicate devices same operating principle as both predicate devices: The flexible tines disk, surrounded by the hydrogel, is used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines, forming a conductive bridge with the skin. incorporate the same basic design as Enhanced Sensor and same montage, incorporate the same materials as both predicate devices, have the same shelf life as both predicate devices, and is packaged using the same materials and processes as both predicate devices. | |
| Differences: | smaller size (overall length shorter) and different basepad shape from the Enhanced Sensor to accommodate smaller heads. The "1-2-4-3 basepad "circles" as stated in the Instructions are a different shape. Refer to the Photographs in Section 3. The electrodes have not changed. The shape was changed for better fit. |

- addition of the 4th electrode and shape change for better fit to the Pediatric Sensor. .

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In summary, the BIS Pediatric Sensor described in this submission is substantially equivalent to the predicate devices. Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as both predicate devices. The indications for use remain the same as the Pediatric Sensor. The fundamental scientific technology remains the same as the Pediatric Sensor and Enhanced Sensor predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2004

Aspect Medical Systems, Inc. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K041670

Trade/Device Name: BIS Pediatric Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 18, 2004 Received: June 21, 2004

Dear Mr. Devine:

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.

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 - Mr. Ned E. Devine, Jr.

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" (21CFR 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 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

C. Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Appendix B

## Indications for Use Statement

210(k) Number (if known)

K041670

Device Name

BIS Pediatric Sensor

Indications For Use

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

Muriam C. Provost

Division of General, Restorative, and Neurological Devices

**510(k) Number** K041670

X Prescription Use (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 CDRH, Office of Device Evaluation (ODE)

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