BIS EEG MONITOR, MODEL A-3000

K052362 · Aspect Medical Systems, Inc. · OLW · Sep 9, 2005 · Neurology

Device Facts

• Record ID: K052362
• Device Name: BIS EEG MONITOR, MODEL A-3000
• Applicant: Aspect Medical Systems, Inc.
• Product Code: OLW · Neurology
• Decision Date: Sep 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Aspect Medical Systems BIS EEG Monitor, A-3000, is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Device Story

Microprocessor-based 2-channel EEG monitoring system; acquires raw EEG signals from patient; processes signals to calculate BIS (Bispectral Index), suppression ratio, and burst count; provides artifact detection and trend analysis. Used in hospitals/medical facilities under supervision of licensed healthcare practitioners. Output displayed on color touch screen; includes audible/visual alarms. Assists clinicians in guiding anesthetic administration; helps reduce incidence of awareness with recall during general anesthesia and sedation. Features USB and RS-232 connectivity; lithium-ion battery powered.

Clinical Evidence

Bench testing only. Software validation and hazard analysis/risk assessment performed. Results indicate device meets performance specifications and is safe for intended use.

Technological Characteristics

Microprocessor-based 2-channel EEG monitor. Features: color touch screen, USB and RS-232 ports, lithium-ion battery. Software-based signal processing for EEG, BIS, suppression ratio, and artifact detection. Same BIS algorithm as predicate. Class II device (21 CFR 882.1400).

Indications for Use

Indicated for adult and pediatric patients in hospital or medical facilities to monitor brain state via EEG signal acquisition; used as an aid in monitoring anesthetic agent effects and reducing incidence of awareness with recall in adults during general anesthesia and sedation.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Aspect Medical Systems A-2000 EEG Monitor with BIS (K030267)
• Aspect Medical Systems BISx (K040183)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Date Prepared: July 14, 2005

### Company Name and Address

Aspect Medical Systems, Inc. 141 Needham St. Newton, MA 02464

Contact People: Christine Vozella Director, Regulatory Affairs/Quality Assurance Telephone (direct dial): [phone] Fax #: [phone]

### Device Name

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Proprietary Name: A-3000 EEG Monitor with BIS

Common Name: EEG Monitor

### Classification

Electroencephalograph (EEG) monitors have been clussified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400)

### Predicate Devices

Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K030267, received FDA clearance 1/15/04

Aspect Medical Systems BISx This 510(k), K040183, received FDA clearance 2/25/04

### Device Description

The Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.

### Indications for use

The Aspect Medical Systems BIS EEG Monitor, A-3000, is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the

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reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

### Summary of Technological Characteristics Compared to Predicate Device

### Similarities

- 1. Indications for use and intended use are identical
- 2. System technology characteristics remains the same.
- 3. Both have, display and/or calculate the following:
- . 2 channel maximum
- Raw EEG .
- BIS (BIS algorithm is the same as the predicate device)
- Suppression Ratio .
- . Artifact detection
- . Alarms, audible and visual
- Message region
- Self tests (automatic and manual) ●
- Trend BIS, SR, SQI, Burst count ●

### Differences

- Screen is slightly larger, now with color and touch .
- EMG display style is vertical, rather than horizontal .
- SQI display is a signal strength indicator style, rather than a thermometer �
- . Expanded BIS trend options
- Housing is slightly larger, and color is two tone ●
- USB ports in addition to RS-232 .
- . Different operating system
- Battery -- (from nickel metal hydride to lithium ion) ●
- Host software (data storage, user interface communication) .
- . BISx

### Summary of Testing

The following tests/analyses have been completed:

- 0 Software Validation
- 0 Hazard Analysis and Risk Assessment

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 Monitor is substantially equivalent to the predicate devices, and is safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2005

Aspect Medical Systems, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052362

Trade/Device Name: BIS EEG Monitor, A-3000 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: August 25, 2005 Received: August 29, 2005

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. Neil 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 vours.

Barbara Buelus
for

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

Enclosure

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## Indications for Use

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K052362 |
| Device Name: | BIS EEG Monitor, A-3000 |

Indications For Use:

The Aspect Medical Systems BIS EEG Monitor, A-3000, is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the statential
brain by data acquisition of EFC signels brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Prescription Use
(Part 21 CFR 801 Subpart D) X

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1-7

Saubare Bucher for MXM
(Division Sign-Off)

and Neurological De

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**510(k) Number** K052362