The Aspect A-2000 EEG Monitor with BIS is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.

Device Description

The Aspect A-2000 Monitor dimensions are 7 inches wide x 6.8 inches high x 4 inches deep. The active display area is 3.4 inches high x 4.5 inches wide, and displays Raw EEG waveforms, Density Modulated Spectral Array (DSA) (includes spectral edge frequency), Trend plots of processed EEG parameters in real time, Current BIS number, Signal quality and EMG indicators, and Suppression Ratio. The Aspect A-2000 Monitor performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly. A quick test of the DSC-2 is conducted upon first detection of the DSC-2. In addition, comprehensive self tests can be initiated manually from the service menu. Results are reported on the display, and printed automatically if a printer is connected.

AI/ML Overview

The provided documentation for the Aspect A-2000 EEG Monitor with BIS does not contain a specific table of acceptance criteria or a detailed study report demonstrating the device's performance against such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Aspect Medical Systems EEG Monitor, Model A-1050 with BIS) through a comparison of technological characteristics. It mentions that "The following tests have been conducted: software, environmental, mechanical and electrical testing," and that "The Reviewer Guidance for Premarket Notification Submissions (1993) was followed... and all test results are submitted in Section (1)(I)(II)". However, these test results or a summary of them, including specific acceptance criteria and performance data, are not provided in the text.

The information primarily discusses:

Device Description and Intended Use: The purpose of the A-2000 EEG Monitor with BIS is to monitor brain state by acquiring EEG signals and to aid in monitoring anesthetic effects using the BIS variable.
Predicate Device: Aspect Medical Systems EEG Monitor, Model A-1050 with BIS.
Technological Similarities and Minor Differences: Between the A-2000 and A-1050, covering areas like basic functions, hardware, software designs, signal flow, self-test capabilities, alarms, DSC-2, trended variables, and data sampling rate.
References to a Clinical Study: A single clinical study is cited (Gan TJ et al., 1997) to support the use of BIS monitoring in anesthesia for faster emergence and improved recovery. However, this study is not presented as the primary study to meet acceptance criteria for the A-2000 device itself, but rather as evidence for the utility of the BIS parameter in general which the A-2000 also measures.

Based on the provided text, I cannot complete the requested information regarding acceptance criteria and performance with specific numerical details. The document states that tests were conducted and results submitted elsewhere, but those details are not included.

However, I can extract the following limited information:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document refers to "The Reviewer Guidance for Premarket Notification Submissions (1993)" being followed, implying adherence to general regulatory guidance for EEG monitors. Specific quantitative criteria for device performance (e.g., accuracy, precision) are not listed.
- Reported Device Performance:
  - The document implies that the device met the unstated criteria, as it concludes: "Aspect Medical Systems believes the A-2000 EEG Monitor with BIS is substantially equivalent to the Aspect A-1050 EEG Monitor with BIS, and is safe for its intended use."
  - Details on the performance results (e.g., specific accuracy metrics, error rates) from the software, environmental, mechanical, and electrical tests are not provided in the text.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any internal device testing.
- Data Provenance: Not specified for any internal device testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- No information provided regarding experts for establishing ground truth for device performance testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- No information provided regarding any adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study is mentioned for the device itself. The cited clinical study (Gan TJ et al., 1997) is a clinical trial on the effects of BIS monitoring on patient outcomes, not a comparative effectiveness study of the device's diagnostic performance involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device (A-2000 EEG Monitor with BIS) is inherently a standalone device for processing EEG signals and displaying a BIS number. Its "performance" would relate to the accuracy of its signal acquisition, processing, and display, which were presumably assessed during the "software, environmental, mechanical and electrical testing." However, detailed results of this standalone performance are not provided. The device is not an AI or diagnostic algorithm in the modern sense; it's a physiological monitor.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the device's internal performance tests (software, electrical, etc.), the ground truth would likely be established through engineering specifications, known signal inputs, and controlled environmental conditions. However, this is not explicitly detailed.
- For the clinical utility of the BIS parameter itself (as referenced by the Gan TJ et al. study), the ground truth relates to patient outcomes (e.g., emergence time, recovery quality), which is "outcomes data."
The sample size for the training set
- No information provided. The A-2000 monitor is a physiological monitor, not a machine learning algorithm that typically requires a 'training set' in the conventional sense of AI. Its algorithms (like BIS calculation) would have been developed and validated through scientific research, not a specific training set in the context of this 510(k) submission.
How the ground truth for the training set was established
- Not applicable as no training set (in the AI/ML sense) is described. The underlying algorithms for BIS would have been developed based on extensive physiological and clinical research correlating EEG patterns with states of consciousness/anesthesia, with ground truth established through clinical observations, expert assessment, and patient responses.

Summary

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974496

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION II

510(k) SUMMARY

Date Prepared: November 26, 1997

Company Name and Address

Aspect Medical Systems, Inc. 2 Vision Drive Natick, MA 01760-2059

Contact People:

Christine Morgida Manager, Regulatory Affairs Paul J. Manberg, PhD Vice President, Clinical and Regulatory Affairs

Device Name

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

Classification

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

Predicate Device

Aspect Medical Systems EEG Monitor, Model A-1050 with BIS ™ This 510(k), #K963644, received FDA clearance October 8, 1996.

Device Description

The Aspect A-2000 Monitor performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly. A quick test of the DSC-2 is conducted upon first detection of the DSC-2.

In addition, comprehensive self tests can be initiated manually from the service menu. Results are reported on the display, and printed automatically if a printer is connected.

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Digital Signal Converter (DSC-2)

The DSC-2 is used in the A-2000 system, and is identical to the digital signal converter used with the A-1050 system (510(k) #K952347, FDA clearance date -1/16/96). It is an electrically isolated, low noise, high gain amplifier.

2.50 x 3.75 x 1.00", and its weight is 4.5 ounces. Its dimensions are:

Printer

A two inch thermal strip printer is optional. When printing is initiated, an 8-10 second real time EBG strip is printed. When the monitor is displaying a trend, the printer outputs a horizontal trend plot of the entire case at the same scale as the main display.

Intended Use

The Aspect A-2000 EEG monitor with BIS is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research.

The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.

Gan TJ, Glass PS, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index (BIS) Monitoring Allows Faster Emergence and Improved Recovery From Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology October 1997; (4) 87: 808-15.

Summary of Technological Characteristics Compared to Predicate Device

Similarities

Both devices are EEG machines that monitor the state of the brain by data acquisition of EEG of the anesthetized or sedated patient in the intensive care unit, operating room and for clinical research. Also, both are indicated for use as an aid in monitoring the effects of certain anesthetic agents by use of the processed parameter BIS.

The A-2000 and A-1050 Monitors with BIS have the same basic functions. The hardware systems are similar. the A-2000 Monitor having more highly integrated components. They have similar hardware and software designs, signal flow, self-test capabilities (automatic and manual), alarms, and identical Digital Signal Converters (DSC-2).

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The A-2000 and A-1050 alarm capabilities include: System Error Message Alarms for patient condition (i.e. EEG Isoelectric), lead connection (i.e. DSC Disconnected) and equipment messages (i.e. Software Errors). Both the A-1050 and A-2000 Monitors have written messages. Both have audible alarms associated with error messages.
Numeric Display Limit Alarms for the primary trend. Both the A-1050 and A-2000 Monitors have 3 ascending tones when the high limit is reached, and three descending tones when the low limit is reached.

A description of the System Error Message Alarms can be found in Section VII of the Operator's Manual. A description of the Numeric Display Limit Alarms can be found in Section II of the Operator's Manual.

Printer support Both the A-1050 and A-2000 Monitors have printer support . capabilities.
Self tests (automatic and manual) Both monitors have automatic testing upon ● start up. Both monitors have manual testing of the DSC-2, as well as the hardware filter performance.
DSC-2 (digital signal converter) The A-2000 Monitor DSC-2 is identical to ● the A-1050 Monitor DSC-2 (other than a color change to the case).
Trend BIS, SR, SQI, EMG Both the A-1050 and A-2000 Monitors can trend . all 4 of the above processed EEG variables. Both prominently display the primary trend in the graphic display.
Data sampling rate (16,384 samples per second) Identical ●

Minor Differences

There are 3 minor differences that occur in the following areas:

Processed Parameters ●

CSA and DSA

The Aspect A-2000 Monitor has processed EEG displayed as DSA (Density Spectral Array) whereas the Aspect A-1050 Monitor with BIS graphically displays processed EEG as CSA and DSA. Both are graphic representations of the same thing, i.e. power spectra.

Median Frequency

The Aspect A-2000 Monitor does not have median frequency because this parameter is not used widely by anesthesiologists. Median frequency is defined as the frequency at which 50% of the total power lies to either side of it.

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Alarms

System Error Message Alarms

System Enor Message Anams
Both the A-2000 and the predicate device have written messages for 3 categories of errors (i.e. patient condition, lead connection and equipment messages). The differences are that the written messages may differ slightly (i.e. "DSC Power Regulation Fault" in the that the with BIS will read "DSC Power Regulation" in the A-2000 Monitor). Also, with regard to the audible alam, the Aspect A-1050 Monitor with BIS has a single tone alarm, whereas the A-2000 Monitor has a two tone alarm.

Numeric Display Limit Alarms

In both the Aspect A-2000 and A-1050 Monitors, this alarm occurs for those variables that are primary trended. For the A-2000 Monitor, these high and low limit alams occur for the BIS. In the predicate device, the auxiliary alarms, i.e. EMG, Suppression Ratio and Signal Quality can be primary trended in addition to the BIS.

The following tests have been conducted: software, environmental, mechanical and electrical The Northwing tosts have boom concerting. The Reviewer Guidance for Premarket Notification valuation tosting, as won as tollowed (other than packaged product storage test - Appendix A, Subinistions (1933) was tone will be completed once the package is finalized) and all test results are Scoton (1) (1) (11), this toor malysis was completed, and this document indicates Aspect has made diligent efforts to identify all the potential hazards that could be anticipated, and have found ways to mitigate them by various hardware and software designs, including labeling.

Aspect Medical Systems believes the A-2000 EEG Monitor with BIS is substantially equivalent to the Aspect A-1050 EEG Monitor with BIS, and is safe for its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Ms. M. Christine Morgida Manager. Regulatory Affairs Aspect Medical Systems, Inc. 2 Vision Drive Natick, MA 01760-2059

APR - 9 2012

Re: K974496 Trade/Device Name: Aspect Medical System A-2000 EEG Monitor with BIS Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT, OLT Dated (Date on orig SE ltr): November 26, 1997 Received (Date on orig SE ltr): November 28, 1997

Dear Ms. Morgida:

This letter corrects our substantially equivalent letter of February 6, 1998.

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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Page 2 - Ms. M. Christine Morgida

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/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,
Kesia Alexander

Image /page/5/Picture/7 description: The image shows the handwritten word "for" in cursive script. The letter 'f' is elongated with a large loop extending below the baseline, and the letters 'o' and 'r' are connected and smaller in size. The writing appears to be done with a pen or fine-tipped marker, and the overall style is elegant and flowing.

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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P. 3

Page of

510 (k) NUMBER (IF KNOWN) :

Aspect Medical Systems EEG Monitor with BIS, Model A-i DEVICE NAME : INDICATIONS FOR USE:

The Aspect A-2000 EEG Monitor with BIS is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The BIS, a processed EEG variable, may be used as an aid in .. . . monitoring the effects of certain anesthetic agents.

Gan TJ, Glass PS, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index (BIS) Monitoring Allows Faster Emergence and

Improved Recovery From Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology October 1997; (4) 87: 808-15

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. (Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number	K974496
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Prescription Use (Per 21 CFR 801.109)	X	OR	Over-The-Counter-Use (Optional Format 1-2-96)
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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).