(11 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a "microprocessor-based" system without mention of advanced algorithms.
No
The device is a monitor that aids in monitoring the effects of anesthetic agents by acquiring EEG signals; it does not directly treat or diagnose a disease or condition.
Yes
The device is used to monitor the state of the brain by data acquisition of EEG signals and aid in monitoring the effects of certain anesthetic agents, which aligns with the purpose of a diagnostic device to acquire data for assessing a physiological state.
No
The device description explicitly states it is a "microprocessor- based, 2 channel maximum, EEG monitoring system," indicating it includes hardware components for data acquisition and processing.
Based on the provided information, the Aspect Medical Systems BIS EEG Monitor, A-3000, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- BIS Monitor Function: The BIS Monitor directly acquires and analyzes electrical signals from the brain (EEG signals) from within the body of the patient. It is a monitoring device that measures physiological activity in real-time.
- Intended Use: The intended use describes monitoring the state of the brain and the effects of anesthetic agents by acquiring EEG signals directly from the patient. This is a form of in vivo monitoring.
Therefore, because the device operates by acquiring signals directly from the patient's body rather than testing specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aspect Medical Systems BIS EEG Monitor, A-3000, 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
GWQ
Device Description
The Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests/analyses have been completed:
- Software Validation
- 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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows a date and a number. The number is K052362. The date is SEP - 9 2005. The text is in black ink on a white background.
Page ① of 2
510(k) SUMMARY
Date Prepared: July 14, 2005
Company Name and Address
Aspect Medical Systems, Inc. 141 Needham St. Newton, MA 02464
Contact People: Christine Vozella Director, Regulatory Affairs/Quality Assurance Telephone (direct dial): (617) 559-7028 Fax #: (617) 559-7948
Device Name
Proprietary Name: A-3000 EEG Monitor with BIS
Common Name: EEG Monitor
Classification
Electroencephalograph (EEG) monitors have been clussified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400)
Predicate Devices
Aspect Medical Systems A-2000 EEG Monitor with BIS This 510(k), #K030267, received FDA clearance 1/15/04
Aspect Medical Systems BISx This 510(k), K040183, received FDA clearance 2/25/04
Device Description
The Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.
Indications for use
The Aspect Medical Systems BIS EEG Monitor, A-3000, 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
(っ-)
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Image /page/1/Picture/0 description: The image shows a rectangular box with the text "K052362" written inside. The text is written in a simple, sans-serif font, and the characters are evenly spaced. The box is outlined in black, and the background is white. The text appears to be a code or identification number.
Page 2 of 2
reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Summary of Technological Characteristics Compared to Predicate Device
Similarities
-
- Indications for use and intended use are identical
-
- System technology characteristics remains the same.
-
- Both have, display and/or calculate the following:
- . 2 channel maximum
- Raw EEG .
- BIS (BIS algorithm is the same as the predicate device)
- Suppression Ratio .
- . Artifact detection
- . Alarms, audible and visual
- Message region
- Self tests (automatic and manual) ●
- Trend BIS, SR, SQI, Burst count ●
Differences
- Screen is slightly larger, now with color and touch .
- EMG display style is vertical, rather than horizontal .
- SQI display is a signal strength indicator style, rather than a thermometer �
- . Expanded BIS trend options
- Housing is slightly larger, and color is two tone ●
- USB ports in addition to RS-232 .
- . Different operating system
- Battery -- (from nickel metal hydride to lithium ion) ●
- Host software (data storage, user interface communication) .
- . BISx
Summary of Testing
The following tests/analyses have been completed:
- 0 Software Validation
- 0 Hazard Analysis and Risk Assessment
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 BIS Monitor is substantially equivalent to the predicate devices, and is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2005
Aspect Medical Systems, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K052362
Trade/Device Name: BIS EEG Monitor, A-3000 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: August 25, 2005 Received: August 29, 2005
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
3
Page 2- Mr. Neil E. Devine, Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Barbara Buelus
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K052362 |
| Device Name: | BIS EEG Monitor, A-3000 |
Indications For Use:
The Aspect Medical Systems BIS EEG Monitor, A-3000, 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 statential
brain by data acquisition of EFC signels 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.
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1-7
Saubare Bucher for MXM
(Division Sign-Off)
and Neurological De
Page 1 of
510(k) Number K052362