(353 days)
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No
The document describes a microprocessor-based EEG monitoring system that processes EEG signals to derive a parameter (BIS). There is no mention of AI, ML, or any related concepts in the description, intended use, or performance studies. The processing appears to be based on established signal processing techniques rather than AI/ML algorithms.
No
Explanation: This device is for monitoring brain activity and the effects of anesthetic agents. It collects data but does not treat any condition or disease.
Yes
The device is intended to monitor the state of the brain by acquiring EEG signals and aid in monitoring the effects of certain anesthetic agents, which are diagnostic activities.
No
The device description explicitly lists hardware components such as the monitor, digital signal converter (DSC), cables, electrodes, and an optional printer, indicating it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Aspect A-2000 EEG Monitor with BIS directly monitors the electrical activity of the brain (EEG signals) and processes this data to provide a parameter (BIS) related to the state of the brain and the effects of anesthetic agents. This is a direct measurement of physiological activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes monitoring the state of the brain and the effects of anesthetic agents by acquiring EEG signals. This is a real-time, in-vivo measurement.
Therefore, the device falls under the category of a medical device that performs physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
OLW, OMC, ORT
Device Description
The Aspect Medical Systems, Inc. EEG BIS Monitor, model A-2000 is an easy to use, microprocessor-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.
The system configuration consists of the monitor, digital signal converter (DSC), cables, electrodes, and an optional printer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
brain
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
licensed healthcare practitioner or by personnel trained in its proper use / hospital or medical facility providing patient care
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests/analyses have been completed:
Software validation
Verification of new feature
Hazard Analysis and risk assessment
Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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): (303) 926-5624 Fax#: (303) 604-6477
Paul J. Manbeg, PhD Vice President, Clinical, Regulatory Affairs, QA Telephone (direct dial): (617) 559-7076 Fax#: 617-559-7948
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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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of a bird in flight, with three curved lines forming the body and wings. The bird is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
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
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- 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 (800) 638-2041 or (301) 796-7100 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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