BIS QUATRO SENSOR

K093183 · Aspect Medical Systems, Inc. · GXY · Oct 23, 2009 · Neurology

Device Facts

• Record ID: K093183
• Device Name: BIS QUATRO SENSOR
• Applicant: Aspect Medical Systems, Inc.
• Product Code: GXY · Neurology
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

BIS Quatro Sensor is a cutaneous electrode designed for patient skin application to facilitate electrophysiological signal recording (e.g., EEG). It functions as a passive interface component for monitoring systems. The device represents a minor modification to the predicate Enhanced BIS Sensor (K002734), specifically involving a change in the aqueous hydrogel formulation. It is intended for clinical use by healthcare professionals. The device does not perform signal processing itself but enables the acquisition of signals for subsequent analysis by compatible monitoring equipment. Benefit includes reliable signal acquisition for patient monitoring.

Clinical Evidence

No clinical data. Bench testing only, including electrical, mechanical, shelf life, and biocompatibility testing, alongside a hazard analysis to validate the hydrogel formulation change.

Technological Characteristics

Cutaneous electrode; aqueous hydrogel interface; passive sensing component. Class II, 21 CFR 882.1320, Product Code GXY. No active energy source or software.

Indications for Use

Indicated for patients requiring electrophysiological signal recording, such as EEG, via cutaneous 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 Medical Systems Enhanced BIS Sensor (K002734)

Submission Summary (Full Text)

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### k 693183 510 k :

### SECTION 6

# OCT 2 3 2009

# 510(k) SUMMARY Date Prepared: August 31, 2009

#### 1. Company Name and Address

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

Contact Person:

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

#### 2. Device Name

ﻪ

| Proprietary Name: | BIS Quatro 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).

#### Predicate Device 6.

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

#### 7. Device Description

This 510(k) is being submitted for the BIS Quatro which is a minor modification to the 510(k) cleared Enhanced Sensor (K#002734). The formulation of the aqueous hydrogel is being changed.

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.

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

### Indications for use for Quatro Sensor:

The BIS Quatro 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 Quatro has the same intended use and fundamental scientific technology as the predicate device, Enhanced Sensor (K#002734).

### Summary of Testing

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

- . Electrical
- Mechanical .
- Shelf Life .
- . Biocompatibility
- Hazard Analysis .

Results indicate the device meets its performance specifications and is safe for its intended use.

# Conclusion:

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

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

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

Re: K093183

OCT 2 3 2009

Trade/Device Name: BIS Quatro Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: October 8, 2009 Received: October 9, 2009

Dear Mr. 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. Iisting 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 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/MedicalDevices/Safety/ReportalProblem/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 yours,

Eva Kimm
Malvina B. Fudakowski M.D.

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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K093183

Indications for Use

510(k) Number (if known)

大093183

Device Name

BIS Quatro Sensor

Indications for Use

The BIS Quatro 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)

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Raff

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

510(k) Number: k095183

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