ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076

K994330 · Aspect Medical Systems, Inc. · GXY · Jan 18, 2000 · Neurology

Device Facts

• Record ID: K994330
• Device Name: ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
• Applicant: Aspect Medical Systems, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

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

Device Story

The Aspect Medical Systems EEG Sensor (BIS Sensor +) is a disposable, single-patient-use, low-impedance electrode array. It consists of three Zipprep electrodes mounted on a flexible basepad with hydrogel and skin-parting tines. The device is applied to the patient's forehead and temple to collect EEG signals. It connects to an Aspect monitor via a low-profile tab containing an electronic smart card memory device, which stores configuration, identification, lot number, and expiration data. The monitor uses the differential signal between the temple and forehead electrodes to calculate the BIS (Bispectral Index). The device is intended for use by clinicians to facilitate EEG signal acquisition, aiding in monitoring patient electrophysiological status.

Clinical Evidence

Bench testing only. Electrical and mechanical testing, along with software and hardware testing (including EMI), were performed to validate the sensor and the integrated smart card memory device. All tests passed in accordance with specifications.

Technological Characteristics

Cutaneous electrode array; Zipprep design with flexible tines and hydrogel; polyethylene basepad; single-patient-use; disposable. Includes an integrated electronic smart card memory device for configuration and identification. Biocompatible materials tested per ISO 10993. Connectivity via tab interface to Aspect monitors.

Indications for Use

Indicated for patients requiring the recording of electrophysiological (EEG) signals via cutaneous application to the frontal/temporal area.

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 Medical Systems Zipprep EEG Sensor (K961821)

Submission Summary (Full Text)

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K994330

# JAN | 8 2000

V 510(k) SUMMARY

### Prepared December 21, 1999

#### Company Name and Address

Aspect Medical Systems, Inc 2 Vision Drive Natick, MA 01760-2059

Contact Person:

Christine Morgida Manager, Regulatory Affairs and Quality Assurance Telephone: [phone] x2026

### Device Name

| Proprietary Name: | Aspect Medical Systems EEG Sensor |
|-------------------|-----------------------------------|
| Common Name: | Electrode, Cutaneous Electrode |

#### Classification

Cutaneous Electrodes have been classified by the Neurological Devices Panel as Class II devices. Refer to 21 CFR 882.1320.

## Predicate Device

Aspect Medical Systems Zipprep EEG Sensor 510(k) #K961821, clearance date 10/4/96

### Description

The Aspect Medical Systems, Inc. EEG Sensor (hereafter referred to as the Aspect Sensor, Aspect EEG Sensor, or BIS Sensor +), is a rectangular shaped, pre-gelled array of three (3) Zipprep ® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals.

It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal/temporal area. The Aspect Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with Aspect monitors.

The main body of the Aspect Sensor, which houses two (2) electrodes, is placed on the forehead. The satellite area, which houses one (1) electrode, is placed over the temple area. The Aspect Sensor collects EEG signals from these areas, and the differential signal from the temple to the center of the forehead is used to calculate the BIS. The area and distance between electrodes was chosen for ease of application, and to obtain maximum amplitude of the EEG signal, with a minimum of artifact.

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The "Zipprep" patented electrode design is constructed using flexible tines mounted on a polyethylene basepad with an adhesive. The flexible tines, surrounded by hydrogel, are used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines and forms a conductive bridge with the skin.

The Aspect Sensor connects to a monitor at a single point (tab) that is low profile and easy to insert and remove. The tab has an electronic smart card memory device that contains configuration and identification information. This allows better tracking/traceability of the product for Aspect, as well as communicating product information to the user.

All materials are biocompatible, and have been tested in accordance with ISO 10993. Skin contacting materials are the same as the Predicate Device.

### Indications for Use

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

### Summary of Technological Characteristics

The Aspect Sensor has the same technological characteristics with regard to Zipprep design, some configuration capability, and materials. However, the smart card memory device, with its expanded configuration capabilities, could be considered a minor technological difference, in that with the addition of the smart card memory device, configuration capabilities are expanded further. The smart card memory device contains information concerning the lot number, date of manufacture and expiration date.

### Summary of Testing

Aspect Medical Systems has conducted electrical and mechanical testing on the Sensor. In addition, software and hardware testing (including EMI testing) were conducted on the components of the system affected by the inclusion of the smart card memory device.

All tests passed in accordance with their specification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Ms. Christine Morgida Manager. Regulatory Affairs and Ouality Assurance Aspect Medical Systems, Inc. 2 Vision Drive Natick, Massachusetts 01760-2059

K994330 Re:

Trade Name: Aspect Medical Systems EEG Sensor, Model 186-0076 Regulatory Class: II Product Code: GXY Dated: December 22, 1999 Received: December 23, 1999

Dear Ms. Morgida:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Ms. Christine Morgida

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Styp L. Rhodes

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

| 510(k)<br>Number<br>(if known) | K 99 4330 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Aspect Medical Systems, Inc.<br>EEG Sensor<br>(BIS Sensor +) |
| Indications for<br>Use | The EEG Sensor (BIS Sensor +) is applied directly<br>to the patient's skin to enable recording of<br>electrophysiological (such as EEG) signals. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Styph Rlvels

(Division Sign-Off) Division of General Restorative Devices K994J30 510(k) Number_

× Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter Use

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