(28 days)
K002837, K923043A
Not Found
No
The document explicitly states that the fundamental scientific technology and BIS technology remain the same as the predicate device, and the only change is the ability to process more EEG channels. There is no mention of AI or ML.
No
The device is intended to monitor the state of the brain and as an aid in monitoring the effects of anesthetic agents, which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
The device is intended to monitor the state of the brain by acquiring EEG signals and using the BIS (a processed EEG variable) as an aid in monitoring the effects of anesthetic agents. This falls under the definition of a diagnostic device as it provides information for medical decision-making by observing and measuring physiological states.
No
The device description explicitly states it is a "small printed circuit board (PCB)" and can be packaged in a housing, indicating it is a hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the state of the brain by acquiring EEG signals and using a processed EEG variable (BIS) to aid in monitoring the effects of anesthetic agents. This involves directly interacting with the patient's body to collect physiological signals.
- Device Description: The device is described as a printed circuit board that processes EEG signals. This is consistent with a medical device that interacts with the body, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a disease or condition based on the analysis of such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is focused on monitoring physiological signals directly from the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLW, OMC, ORT
Device Description
The Aspect Medical Systems, Inc. BIS Engine - 4 channel support provides the means for incorporating Aspect's proprietary BIS technology into OEM (original equipment manufacturer's, i.e. our business partner's) finished devices. It is a small printed circuit board (PCB) that can either reside inside the OEM finished device or is re-designed for smaller size and packaged in a housing that will connect to the OEM finished device.
The fundamental scientific technology has not changed. The BIS technology remains the same. The BIS Engine - 4 channel support (subject of this 510(k)) has the same basic function, and same operating principal as the Predicate Device.
Only the software is changing. More specifically, the only difference is that the BIS Engine (subject of this 510(k)) can process up to 4 channels of EEG, compared to the Predicate Device, which can process up to 2 channels of EEG. The BIS processed parameter will only be calculated when in 2 channel maximum mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intensive care unit, operating room, clinical research
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 analysis and validation was performed:
- Risk analysis
- Software validation
Results of risk analysis: There are no additional hazards introduced by the BIS Engine - 4 channel that are severe enough to warrant tracking on the risk management record.
Results of validation: The applicable testing was completed (the modified BIS Engine will be a component to a finished device owned by our business partners, and as such, there are no patient or user safety concerns due to the BIS Engine in and of itself).
Results show all tests are acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K002837, K923043A
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.
Not Found
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).
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).
0
510(k) SUMMARY
Date Prepared: June 11, 2001
4011834
Company Name and Address
Aspect Medical Systems, Inc. 141 Needham St. Newton, MA 02464
| Contact Person: | Christine M. Vozella |
|---|---|
| Director, Regulatory Affairs/Quality Assurance | |
| Device Name |
| Proprietary Name: | BIS Engine (PCB component in an EEG Monitor) |
|---|---|
| Common Name: | EEG Monitor |
Classification
Electroencephalograph (EEG) monitors and their software have been classified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400)
Predicate Device
| BIS Engine | K002837, FDA cleared September 19, 2000 |
|---|---|
| A-1000 EEG Monitor | |
| with 4 channel amplifier | |
| (DSC-4) | K923043A, FDA cleared December 3, 1992 |
Device Description
The Aspect Medical Systems, Inc. BIS Engine - 4 channel support provides the means for incorporating Aspect's proprietary BIS technology into OEM (original equipment manufacturer's, i.e. our business partner's) finished devices. It is a small printed circuit board (PCB) that can either reside inside the OEM finished device or is re-designed for smaller size and packaged in a housing that will connect to the OEM finished device.
The fundamental scientific technology has not changed. The BIS technology remains the same. The BIS Engine - 4 channel support (subject of this 510(k)) has the same basic function, and same operating principal as the Predicate Device.
Only the software is changing. More specifically, the only difference is that the BIS Engine (subject of this 510(k)) can process up to 4 channels of EEG, compared to the Predicate Device, which can process up to 2 channels of EEG. The BIS processed parameter will only be calculated when in 2 channel maximum mode.
1
Intended Use
Intended to monitor the state of the brain by data acquisition of BEG signals in the intensive care unit, operating room and for clinical research.
The BIS, a processed EBG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
Summary of Technological Characteristics Compared to Predicate Device
The BIS Engine - up to 4 channel support is substantially equivalent to the Predicate device (BIS Engine - up to 2 channel support).
Similarities
The fundamental technology has not changed. The indications for use are the same. The BIS technology remains the same. The BIS algorithm is the same. The BIS Engine has the same parameters, same operating principle, and same signal processing design. The hardware design is the same. The electrical and mechanical designs are the same.
Minor Differences
Only the software is changing. More specifically, the only difference is that the BIS Engine (subject of this 510(k)) can process a maximum of 4 channels of EEG, compared to the Predicate Device, which can process a maximum of 2 channels of EEG. The BIS processed parameter will only be calculated when in 2 channel maximum mode.
The following analysis and validation was performed:
-
- Risk analysis
- Software validation 2)
Results of risk analysis: There are no additional hazards introduced by the BIS Engine - 4 channel that are severe enough to warrant tracking on the risk management record.
Results of validation: The applicable testing was completed (the modified BIS Engine will be a component to a finished device owned by our business partners, and as such, there are no patient or user safety concerns due to the BIS Engine in and of itself).
Results show all tests are acceptable.
The BIS Engine - 4 channel support is substantially equivalent to the Predicate Device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Ms. Christine M. Vozella Director, Regulatory Affairs/Quality Assurance Aspect Medical Systems, Inc. 141 Needham Street Newton, Massachusetts 02464
Re: K011834 Trade/Device Name: BIS Engine Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): June 11, 2001 Received (Date on orig SE ltr): June 12, 2001 APR - 9 2012
Dear Ms. Vozella:
This letter corrects our substantially equivalent letter of July 10, 2001.
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. Christine M. Vozella
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/CDRH0ffices/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 yours,
Kesia Alexander
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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
4
Indications for Use Statement
| 510(k) Number (if known) | K011834 |
|---|---|
| Device Name | Aspect Medical Systems, Inc. BIS Engine (4 channel support) |
| Indications for Use | 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. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K011834 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use | _________________ |
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