BIS CLICK SENSOR/CABLE

K091854 · Aspect Medical Systems, Inc. · GXY · Jul 2, 2009 · Neurology

Device Facts

• Record ID: K091854
• Device Name: BIS CLICK SENSOR/CABLE
• Applicant: Aspect Medical Systems, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

BIS Click Sensor system consists of disposable sensor and reusable cable; applied to patient skin to record electrophysiological signals (EEG). Modification to predicate BIS SRS includes addition of smart card memory to disposable sensor; stores lot number, expiration date, and connection count for monitor messaging. Reusable cable enables indefinite use. Used in clinical settings; operated by healthcare professionals. Output provides signal data to monitor; facilitates clinical monitoring of patient electrophysiological state.

Clinical Evidence

No clinical data. Bench testing only, including mechanical, electrical, multiple-use, and shelf-life testing, plus hazard analysis. Results confirmed device meets performance specifications.

Technological Characteristics

Cutaneous electrode system; disposable sensor with integrated smart card memory; reusable cable. Connectivity via smart card interface for monitor messaging. Class II device (21 CFR 882.1320).

Indications for Use

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

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 BIS SRS (K050313)
• Aspect Medical Systems Enhanced BIS Sensor (K002734)

Submission Summary (Full Text)

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K091854

## SECTION 6

# 510(k) SUMMARY Date Prepared: May 22, 2009

### 1. Company Name and Address

JUL - 2 2009

Aspect Medical Systems, Inc. One Upland Road Norwood, MA 01532

Contact Person:

Vikram Verma Manager, RA/QA Telephone (direct dial): [phone] Fax #: [phone]

### 2. Device Name

Proprietary Name: BIS Click Sensor Common Name: Electrode, Cutaneous Electrode

#### 3. Classification

Cutaneous Electrodes have been classified by the Neurological Devices Panel as Class II, 84 GXY. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for cutaneous electrodes. (21 CFR 882.1320).

#### 6. Predicate Device

Aspect Medical Systems BIS SRS This 510(k), #K050313, received FDA clearance on February 24, 2005

Aspect Medical Systems Enhanced BIS Sensor This 510(k), # K002734, received FDA clearance on September 14, 2000

### 7. Device Description

The BIS Click Sensor is a system comprised of the BIS Click disposable sensor and the reusable cable.

This 510(k) is being submitted for the BIS Click which is a minor modification to the BIS SRS (K#050313) to enable the reusable cable to be used for indefinite uses with the disposable sensors and to recognize the smart card on the disposable sensor. The disposable sensor has been modified to add a smart card memory

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device containing information for lot number, expiration date, and number of connections. This information is used by the monitor for end user messaging, like in the Enhanced Sensor (K#002734).

A hazard analysis was conducted for the device. All identified hazards have been sufficiently mitigated. A summary of validation test results is included in this 510(k). All the results are acceptable.

Aspect Medical Systems has concluded that the device is substantially equivalent to the predicate devices (BIS SRS, K#050313, and BIS Enhanced Sensor, K#002734), and is safe and effective for its intended use.

## Indications for use for BIS Click Sensor:

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

## Summary of Technological Characteristics Compared to Predicate Device

The BIS Click has the same intended use and fundamental scientific technology as the predicate devices, BIS SRS (K#050313) and Enhanced Sensor (K#002734).

### Summary of Testing

r

The following tests/analyses have been completed for the BIS Click Sensor:

- 0 Mechanical
- Electrical .
- Multiple use ●
- Shelf Life .
- Hazard Analysis ●

Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use.

### Conclusion:

Based on the above, Aspect Medical Systems believes the BIS Click Sensor is substantially equivalent to the predicate devices, and is safe and effective for its intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aspect Medical Systems, Inc. c/o Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville. NY 11747

Re: K091854

Trade/Device Name: BIS Click Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: June 19, 2009 Received: June 19, 2009

Dear Ms. Conry:

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.

JUL - 2 2009

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.

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.

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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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Rohm, m br

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

510(k) Number (if known).

K091854

Device Name

BIS Click Sensor/Cable

## Indications for Use

The BIS Click 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-TheCounter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE) Kristen Bousshe

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number C