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 Description

The Aspect Medical Systems, Inc. A-2000 EEG BIS Monitor (hereafter referred to as the BIS Monitor) is an easy to use, microprocessor- based, 2 channel maximum EEG monitoring system. It is used to monitor the state of the brain by data acquisition of EEG. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the A-2000™ EEG Monitor with BIS, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Description (Implied)	Acceptance Criteria (Implied)	Reported Device Performance
Reduction of awareness with recall	Significant reduction in incidence of awareness with recall	A-2000™ EEG Monitor with BIS guided anesthesia reduced awareness by: - 82% (B-Aware study) - 78% (Safe-II study) - 78% (Kaplan study - during sedation in ICU)

Note on Acceptance Criteria: The document does not explicitly state specific numerical acceptance criteria for the device. Instead, it relies on the results of clinical studies demonstrating a significant reduction in the incidence of awareness with recall when the BIS technology is used. The performance is presented as the achieved reduction rates in awareness.

2. Sample Sizes and Data Provenance

The provided text describes several clinical studies, not all of which were solely for the approval of this specific device, but rather for the BIS technology generally. It's important to distinguish between studies proving the device meets criteria (which are implied by the efficacy of the core BIS technology the device implements) and studies that inform the general clinical utility of BIS monitoring.

B-Aware study (a prospective, randomized, double-blinded, multi-center study):
- Test Set Sample Size: 2503 total patients. 1227 assigned to BIS monitoring, and 1228 to routine care.
- Data Provenance: Multi-center (specific countries not mentioned, but generally implied to be within settings where such large clinical trials are conducted, likely Western countries). Prospective.
Safe-II study (a prospective cohort study):
- Test Set Sample Size: 5057 patients with BIS monitoring compared to a historical group of 7801 patients without BIS monitoring.
- Data Provenance: Not explicitly stated, but "prospective cohort study" suggests data was collected forward in time. Historical group implies retrospective data collection for that comparison group.
Kaplan study:
- Test Set Sample Size: Not explicitly stated, but it determined a 78% reduction in risk.
- Data Provenance: Not explicitly stated.
AIM (Awareness Incidence and Monitoring) study (a prospective, observational, cohort, multi-center study):
- Test Set Sample Size: 19,576 patients.
- Data Provenance: 7 hospitals in the US. Prospective, observational. This study was to determine the current incidence of awareness, not directly the device's efficacy.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not provide details on:

The number of experts used to establish the ground truth for individual cases in the test sets.
The specific qualifications of those experts (e.g., "radiologist with 10 years of experience").

The "ground truth" for the studies appears to be the occurrence or non-occurrence of awareness with recall, which is a clinical outcome typically determined by patient interview protocols and clinical assessment, not by a panel of experts reviewing individual cases in a traditional sense.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing awareness with recall in the studies. The awareness with recall is treated as a clinical outcome. For the B-Aware study, being double-blinded implies that neither the patient nor the direct caregivers/investigators assessing the outcome knew whether the patient was in the BIS or control group, which is a form of bias reduction, but not necessarily an adjudication method for individual case ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The studies presented are large-scale clinical trials comparing patient outcomes (incidence of awareness) in groups with and without BIS monitoring. These are clinical effectiveness studies, not specifically multi-reader studies assessing reader performance improvement.

6. Standalone (Algorithm Only) Performance

The device is an EEG monitor that calculates a BIS (Bispectral Index) value. The effectiveness is measured by the clinical outcome (reduction in awareness) when this value is used to guide anesthetic administration by a human practitioner. Therefore, it is inherently a human-in-the-loop performance measurement. The concept of "standalone" performance (algorithm only) doesn't directly apply in the same way it would for a diagnostic image analysis algorithm. The BIS value is an algorithm output, but its utility is realized through physician interpretation and action.

7. Type of Ground Truth Used

Clinical Outcomes/Patient Reported Outcomes: The primary ground truth for the effectiveness studies is the incidence of awareness with recall experienced by patients. This is a direct patient outcome, likely assessed through structured interviews or clinical criteria, rather than pathology, imaging, or expert consensus on a diagnostic finding.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. The BIS algorithm itself was developed prior to these studies. These studies evaluate the clinical utility of the device implementing that algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set (if any was used for the development of the underlying BIS algorithm) was established. The focus of this 510(k) summary is on the clinical effectiveness of the complete medical device system in reducing awareness based on the output of the BIS algorithm.

Summary

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K031694

October 10, 2003

VII 510(k) SUMMARY

Date prepared: 10//09/03

Company Name and Address

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

Contact People:

Christine Vozella Regulatory Affairs 1775 Rockies Ct. Lafayette, CO 80026 Telephone (303) 926-5624 Fax #: (303) 604-6477

Paul J. Manberg, PhD Vice President, Clinical and Regulatory Affairs Aspect Medical Systems 141 Needham St. Newton, MA 02464 Telephone (direct dial): (617) 559-7076 Fax #: 617-559-7400

Device Name

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

Predicate Devices

Aspect Medical Systems EEG Monitor with BIS, Model A-2000 510(k) #K011534 and GE Medical Systems BIS Module 510(k) #K012466.

Description

There are no changes to the Monitor.

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Indications for Use

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.

Brief Description of Clinical Tests

The B-Aware study was a prospective, randomized double blinded multi-center study to determine if the BIS technology reduces the incidence of awareness. 1227 were assigned to BIS monitoring, and 1228 to routine care (no BIS was used). Results of this study (n=2503) are that BIS guided anesthesia significantly reduced the incidence of awareness by 82%.

The Safe-II was a prospective cohort study undertaken to determine if BIS monitoring would result in a reduction of awareness. This study compared the patients having had BIS monitoring (n=5057) with a historical group (n=7801) that had no BIS monitoring. Results are that use of BIS significantly reduced the incidence of awareness by78%.

The Kaplan study showed the risk of awareness and recall was reduced by 78% during sedation in the ICU setting.

The AIM (Awareness Incidence and Monitoring) study was a prospective, observational, cohort, multi-center study conducted in 7 hospitals in the US. This study was undertaken to determine the current incidence of intra-operative awareness in the US. Results of this study (n=19576) are that 1-2 cases of awareness per 1000 occur in the US, and this is similar to other non-US findings (i.e. Australia and Sweden).

The fact is that there are 20 million cases of anesthesia every year in the US, and there are 20,000 - 40,000 cases of awareness per year. Study results show that this number can be reduced by approximately 80% with the use of BIS monitoring, and can thus offer clinically meaningful benefit. A reduction in awareness provides a public health benefit, in that BIS technology can now provide anesthesiologists with a way to reduce this often debilitating, yet preventable medical error.

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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 1775 Rockies Court Lafayette, Colorado 80026

Re: K031694 Trade/Device Name: EEG Monitor with BIS Model A2000 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, ORT, OMC, OLT Dated (Date on orig SE ltr): May 30, 2003 Received (Date on orig SE Itr): June 3, 2003

APR - 9 2012

Dear Ms. Vozella:

This letter corrects our substantially equivalent letter of October 10, 2003.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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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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Page I of I

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K031694 510(k) Number (if known): Device Name: A-2000 EEG Monitor with BIS

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Cilla all
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number 031694

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).