EEG MONITOR WITH BIS, MODEL A-2000

K030267 · Aspect Medical Systems, Inc. · OLW · Jan 15, 2004 · Neurology

Device Facts

• Record ID: K030267
• Device Name: EEG MONITOR WITH BIS, MODEL A-2000
• Applicant: Aspect Medical Systems, Inc.
• Product Code: OLW · Neurology
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Aspect A-2000 EEG Monitor with BIS 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 EEG signals from anesthetized or sedated patients via electrodes; transforms analog signals to digital via Digital Signal Converter (DSC); processes signals to calculate BIS parameter and Burst Count; displays data on monitor; used in hospitals/medical facilities by trained personnel/practitioners; aids in guiding anesthetic administration; helps reduce incidence of awareness with recall in adults.

Clinical Evidence

Bench testing only. Software validation, verification of new feature (Burst Count), and hazard/risk assessment performed. No clinical data presented.

Technological Characteristics

Microprocessor-based 2-channel EEG monitor; includes monitor, digital signal converter (DSC), cables, and electrodes. Software-driven signal processing; revision 1.3. Features automatic/manual self-tests and impedance checks.

Indications for Use

Indicated for adult and pediatric patients in hospital or medical facility settings to monitor brain state via EEG signal acquisition and to aid in monitoring effects of certain anesthetic agents, potentially 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 (K011534)
• Aspect Medical Systems A-2000 EEG Monitor with BIS (K031694)

Submission Summary (Full Text)

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K030267 1/3

#### 510(k) SUMMARY VII

Date Prepared: 1/24/03 Updated: 10/28/03

#### Company Name and Address

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

Contact People:

Christinc Vozella Regulatory Affairs Telephone (direct dial): [phone] Fax#: [phone]

Paul J. Manbeg, PhD Vice President, Clinical, Regulatory Affairs, QA Telephone (direct dial): [phone] Fax#: [phone]

#### Devicc Name

Proprietary Name: A-2000™ EEG Monitor with BIS.

Common Namc: EEG Monitor

#### Classification

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

# Prodicate Devices

Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K011534, received FDA clearance 6/15/01

Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K031694, received FDA clearance October 10, 2003

#### Device Description

The Aspect Medical Systems, Inc. EEG BIS Monitor, model A-2000 is an easy to use, nicroprocessor-based, 2 channel maximum, EEG monitoring system. It aso, interoprobes.bor of the brain by data acquisition of EEG of the anesthetized or sedated patient, as well as monitoring the effects of certain anesthetic agents by use of the processed parameter BIS.

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K030267 2/3

The system configuration consists of the monitor, digital signal converter (DSC), cables, electrodes, and an optional printer.

### Intended Use

The Aspect A-2000 EEG Monitor with BIS 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.

#### Summary of Technological Characteristics Compared to Predicate Device

#### Similarities

BIS Monitors (predicate and the subject of this 510(k)) are software devices that monitor the state of the brain by data acquisition of EEG of the anesthetized or sedated patient. They also aid in monitoring the effects of certain anesthetic agents by use of the processed parameter BIS.

They have the same hardware and software designs, signal flow, self-test capabilities (automatic and manual), alarms, and identical Digital Signal Converters (DSC).

The system technology remains the same. That is, EEG signals are transformed from analog to digital, processed within the hardware components using similarly designed hardware and software. System self checks and other tests such as impedance checks are still completed, and alarms are similar. None of the differences affect the system technology, or the safety and effectiveness of the BIS Monitor.

#### Differences

Due to customer request, software is heing modified to add Burst Count, which provides a measurement of the number of EEG bursts per minute. Burst count will be added to the BIS log screen.

Software will be updated to revision 1.3.

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# Summary of Testing

The following tests/analyses have been completed:

- Software validation 1)
- Verification of new feature 2)
- Hazard Analysis and risk assessment 3)

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 Aspect Medical Based on the above, Aspect Modical by equivalent to the predicate devices, and is safe and effective for its intended use.

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

Aspect Medical Systems, Inc. c/o Ms. Christine Vozella Regulatory Affairs 141 Needham Street Newton, Massachusetts 02464

Re: K030267

Trade/Device Name: Aspect A-2000 EEG Monitor with BIS Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE Itr): October 28, 2003 Received (Date on orig SE ltr): October 29, 2003

- - 2 C ស្ថិតនៅក្នុង ស្រុកក្រ

Dear Ms. Vozella:

This letter corrects our substantially equivalent letter of January 15, 2004.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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.

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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

Kevia Alexander

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

K030267 510(k) Number (if known):

Aspect Medical Systems A-2000 EEG Monitor with BIS Device Name:

Indications For Use:

The Aspect A-2000 EEG Monitor with BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. supervision of a licensed heatheader prositional or excitats within a hospital of The BIS Monitor is intended for use on addit and pockation would be and the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain ansociated with the The BIS may be used as an all in moments and stression may be associated with the of BIS monitoring to nelp guide ancinneded and in adults during general unesthesia and sedation.

ਮ Frescription Use (Parl 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)

Miriam C. Provost

ivision Sign-Off) Division of General, Restorative and Neurological Devices

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