(28 days)
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.
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.
The provided text is a 510(k) summary for the BIS Engine, a component of an EEG Monitor. The submission focuses on a software change allowing the device to process up to 4 channels of EEG, compared to the predicate device's 2 channels. The core BIS technology and algorithm remain unchanged.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative thresholds). Instead, it states that the device's substantial equivalence is based on:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| 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." |
| Software Validation | "The applicable testing was completed... Results show all tests are acceptable." |
| Substantial Equivalence | "The BIS Engine - 4 channel support is substantially equivalent to the Predicate Device." This is based on the fundamental technology, indications for use, BIS technology/algorithm, parameters, operating principle, signal processing design, hardware design, and electrical/mechanical designs remaining the same. The only difference is the capability to process up to 4 channels (vs. 2) of EEG, with the BIS parameter still calculated in 2-channel mode. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a clinical performance study using patient data. The validation described is focused on software and risk analysis for the change from 2-channel to 4-channel EEG processing. It doesn't mention a dataset of patient EEGs used to evaluate the performance of the 4-channel processing itself in terms of diagnostic or clinical accuracy.
- Sample Size: Not specified for a clinical performance test set.
- Data Provenance: Not specified for a clinical performance test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The submission focuses on software validation and risk analysis, not on establishing ground truth for a clinical dataset.
4. Adjudication Method for the Test Set
This information is not provided, as there is no mention of a clinical "test set" requiring ground truth adjudication.
5. 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 study was performed or discussed. The device is an EEG monitor component, not an AI-assisted diagnostic tool for human readers in the context of a "multi-reader, multi-case" study. The 510(k) summary clearly states: "The BIS, a processed EBG variable, may be used as an aid in monitoring the effects of certain anesthetic agents." This implies it provides data, not an interpretation that human readers would "improve with."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself, the BIS Engine, is an algorithm-only component that processes EEG signals. The submission describes its validation as part of a larger device. While the BIS algorithm itself processes data without human intervention, the "standalone performance" in the context of typical AI algorithm evaluations (e.g., sensitivity, specificity for a specific diagnostic task) is not presented. The document is about the change in channel capacity, not a de novo evaluation of the BIS algorithm's core performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Ground truth, in the context of a clinical performance study, is not described as part of this 510(k) submission. The validation focused on the software's ability to process the increased number of channels and on risk analysis for the hardware/software change.
8. The Sample Size for the Training Set
Not applicable. This submission is for a modification to an existing device's software (increasing channel capacity) where the core algorithm remains the same. There's no mention of retraining an AI model or a new training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI model in this submission.
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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 Monitorwith 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.
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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.
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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
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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 | _________________ |
ﺳ
§ 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).