(26 days)
The Aspect EEG Monitors with BIS are 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 Bispectral Index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
The Aspect Medical Systems, Inc. EEG Monitors, Models A-1000 and A-1050 with the processed parameter BIS, (hereafter referred to as the Aspect EBG Monitors with BIS) are microprocessor-based, up to 4 channel EEG monitors designed for use in the OR, ICU and for clinical research.
They acquire and display real-time EEG waveforms, as well as process the real time EEG data using digital signal processing techniques including the Fast Fourier Transform technique, and display the processed EEG data in several different formats. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.
The system configuration includes a monitor, digital signal converter (DSC), optional printer, cables and electrodes.
The EEG Monitors with BIS conform to UL 544, CSA 22.2 no. 125 Risk Class 3, IEC 601-1. They also meet electromagnetic interference specifications outlined in IEC 801-2,3,4,5.
The Aspect EEG Monitors with BIS consist of two main components:
-
- Monitor
- Digital Signal Converter (DSC) - 4 channel maximum
A-1000 - 2,4 channel DSC A-1050 - up to 2 channel DSC
Monitors
The monitors are microprocessor-based, and provide signal processing and display capabilities, displaying up to 4 channels of real time (i.e. "raw") EEG data as well as computing and displaying processed EEG parameters (examples of some processed parameters are listed below). They also display trend plots of processed EEG parameters in real time.
The front panel is configured with a large display screen, an index display board composed of a numeric index display and an alphanumeric index label display. There are a number of soft and hard keys, such as Set-up, Print, Alarm Limits, Trend, EEG. CSA+. DSA+. Review and Event.
The monitors contain the processors for processing the EEG data, calculating the variables and displaying the waveforms and variables.
The monitors consists of a PC-based CPU, an IPU and an FPU. The latter two are Digital Signal Processing subsystems for EEG processing.
The provided document does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria. The document is a 510(k) summary for the Aspect Medical Systems, Inc. EEG Monitors, Models A-1000 and A-1050, which primarily describes the device, its components, and its intended use. It also includes the FDA's substantial equivalence letter.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance.
- If standalone performance was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document mentions "Bispectral Index (BIS) Monitoring Allows Faster Emergence and Improved Recovery From Propofol/Alfentanil/N2O Anesthesia. In preparation for Anesthesiology," but this is a reference to a publication in preparation and does not detail a specific study proving acceptance criteria for the device itself within this submission.
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OCT - 8 1996
VI 510(k) Summary
Description
The Aspect Medical Systems, Inc. EEG Monitors, Models A-1000 and A-1050 with the processed parameter BIS, (hereafter referred to as the Aspect EBG Monitors with BIS) are microprocessor-based, up to 4 channel EEG monitors designed for use in the OR, ICU and for clinical research.
They acquire and display real-time EEG waveforms, as well as process the real time EEG data using digital signal processing techniques including the Fast Fourier Transform technique, and display the processed EEG data in several different formats. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.
The system configuration includes a monitor, digital signal converter (DSC), optional printer, cables and electrodes.
The EEG Monitors with BIS conform to UL 544, CSA 22.2 no. 125 Risk Class 3, IEC 601-1. They also meet electromagnetic interference specifications outlined in IEC 801-2,3,4,5.
The Aspect EEG Monitors with BIS consist of two main components:
-
- Monitor
- Digital Signal Converter (DSC) - 4 channel maximum
A-1000 - 2,4 channel DSC A-1050 - up to 2 channel DSC
Monitors
The monitors are microprocessor-based, and provide signal processing and display capabilities, displaying up to 4 channels of real time (i.e. "raw") EEG data as well as computing and displaying processed EEG parameters (examples of some processed parameters are listed below). They also display trend plots of processed EEG parameters in real time.
The front panel is configured with a large display screen, an index display board composed of a numeric index display and an alphanumeric index label display. There are a number of soft and hard keys, such as Set-up, Print, Alarm Limits, Trend, EEG. CSA+. DSA+. Review and Event.
The monitors contain the processors for processing the EEG data, calculating the variables and displaying the waveforms and variables.
The monitors consists of a PC-based CPU, an IPU and an FPU. The latter two are Digital Signal Processing subsystems for EEG processing.
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tize up to four (4) channels of EEG waveform data in either a bipolares
as received and arcuit monitors courant of the DSCs. If the current oxceeds the exported.
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SCs are connected to the monitor by a flexible monitor interface cable.
The became
There are a number of processed parameters which include the following:
Compressed Spectral Array (CSA), Density Spectral Arny (DSA), Suppression Ratio(SR), S
Spectral Edge Frequency (SEF), Signal Quality Index (SQD) and the Bispectral Indox (BIS sations for Use
acquisition of EBG signals in the in
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Summary
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
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, Massachusetts 01760-2059
APR - 9 2012
Re: K963644
Trade/Device Name: EEG Monitor, Models A-1000™ and A-1050™ Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT, OLT Dated (Date on orig SE ltr): September 11, 1996 Received (Date on orig SE ltr): September 12, 1996
Dear Ms. M. Morgida:
This letter corrects our substantially equivalent letter of October 8, 1996.
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.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows a signature on the left side and some text on the right side. The signature appears to be a cursive "for". The text on the right side includes words such as "Malv", "Director", "Division", "and", "Office", and "Center". The text seems to be part of a formal document or letter.
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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III INDICATIONS FOR USE
The Aspect EEG Monitors with BIS are 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 Bispectral Index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
Reference:
Glass P, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index (BIS) Monitoring Allows Faster Emergence and Inproved Recovery From Propofol/Alfentanii/N2O Anesthesia. In preparation for Anesthesiology.
Richard N. Phillips
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
§ 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).