(8 days)
Not Found
No
The summary mentions a "BIS algorithm" but provides no details suggesting it uses AI/ML. The lack of mention of AI/ML terms, training/test sets, or performance metrics typically associated with AI/ML models further supports this.
No
The device is described as a monitor that acquires EEG signals and computes parameters to assist in monitoring the state of the brain and the effects of anesthetic agents. It does not exert a therapeutic effect on the patient.
Yes
The device monitors the state of the brain by acquiring EEG signals and computing BIS and other EEG parameters. It is intended to aid in monitoring the effects of certain anesthetic agents and potentially reduce the incidence of awareness with recall during anesthesia and sedation. This involves acquiring and analyzing physiological data to inform clinical decisions, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the BISx4 "houses both the EEG digital signal converter, as well as the host interface software and BIS algorithm." This indicates the presence of hardware components (the digital signal converter) in addition to the software.
Based on the provided information, the BISx4 is not an In Vitro Diagnostic (IVD).
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.
- BISx4 Function: The BISx4 directly acquires and processes EEG signals from the patient's brain. This is a direct measurement from the body, not a test performed on 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 physiological monitoring function, not a diagnostic test on a biological sample.
Therefore, the BISx4 falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 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 EFG nigrals.
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 BISx4 is a device that houses both the EEG digital signal converter, as well as the host interface software and BIS algorithm. The device will acquire up to four channels of referential EEG and compute BIS and other EEG parameters.
The BISx4 will have no display or user interface. Aspect Medical Systems is submitting this 510(k) in response to anesthesiologists/users who are interested in obtaining more than 2 channels of EEG.
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)
Testing: Software, electrical, hazard analysis, EMI statement
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aspect Medical Systems BISx
Reference Device(s)
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
KOS2981
12) 510(k) Summary
NOV - 1 2005
Company name and address: Aspect Medical Systems, 141 Needham St., Newton, MA 02464
Device name: BISx4
Classification: Class II, classification code: GWO
Predicate device: Aspect Medical Systems BISx
Device Description
The BISx4 is a device that houses both the EEG digital signal converter, as well as the host interface software and BIS algorithm. The device will acquire up to four channels of referential EEG and compute BIS and other EEG parameters.
The BISx4 will have no display or user interface. Aspect Medical Systems is submitting this 510(k) in response to anesthesiologists/users who are interested in obtaining more than 2 channels of EEG.
Intended use: The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 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/differences)
The BISx4 is similar to the BISx (predicate device).
Similarities: Same design, technology, indication for use, same enclosure, both possess host interface software, BIS algorithm and a digital signal converter (DSC), both have 2 channels, both process BIS, both process parameters such as EEG, SQI, BIS, EMG, Signal Quality Index , (SQI), Suppression Ratio (SR), electrode impedance.
Differences: Addition of 2 channels, with accompanying changes to connectors, software, cables and yoke to enable acquisition of 4 channels.
Testing: Software, electrical, hazard analysis, EMI statement
Conclusion: The BISx4 is substantially equivalent to the BISx predicate device, and is safe and effective for its intended use.
1
30-Dec-2004 (Ver. 2) Page I of 1
Third Party Review Quality Assessment
| 510(k) No.: | K052981 |
|---|---|
| Third Party Organization: | Intertek Testing Services NA |
| Third Party's Primary Reviewer(s): | Jay Kogoma |
| ODE/OIVD Division: | D6RND |
| Branch/Team: | GSDB |
Section 2 – 510(k) Decision
| Third party recommendation: | SE X NSE ______ Other (specify): ______ |
|---|---|
| ODE/OIVD final decision: | SE X NSE ______ Other (specify): ______ |
Section 3 - Assessment of Third Party Review
| Review Element | Rating (check one) | |||
|---|---|---|---|---|
| Adequate | Minor | |||
| Issue(s) | Major | |||
| Issue(s) | ||||
| a. Determination of device eligibility for third party review | ✓ | |||
| b. Extent of pre-submission consultation with ODE/OIVD division | ✓ | |||
| c. Organization and format of review documentation | ✓ | |||
| d. Determination of 510(k) administrative completeness (screening | ||||
| review) | ✓ | |||
| e. Summary of device characteristics, intended use, and performance | ||||
| (including accessories, if applicable) and reason for 510(k) submission | ✓ | |||
| f. Comparison to legally marketed devices—identification and analysis of | ||||
| key similarities and differences | ✓ | |||
| g. Rationale for conclusions and recommendation | ✓ | |||
| h. Use of guidance documents and standards | ✓ | |||
| i. Resolution of 510(k) deficiencies and FDA requests for additional | ||||
| information | ||||
| j. Scope of reviewer expertise and use of consulting reviewers | ✓ | |||
| k. Other (specify): |
Comments (explanation of ratings/issues): _ Well prepared review, No isSues
.....
Section 4 – ODE/OIVD Assessor Information
| Labels | Values |
|---|---|
| Assessed by: | Michel Janda |
| Date: | 10/28 |
| Tel. No.: | (301) 594-1307 *137 |
Routing: Division -- Clip completed assessment (this page only) to inside front cover of 510(k). DMC -- Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aspect Medical Systems, Inc. c/o Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K052981
Trade/Device Name: BISx4 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: October 21, 2005 Received: October 24, 2005
Dear Mr. Lehtonen:
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-Daniel W. Lehtonen
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/industry/support/index.html
Sincerely yours,
Barbara Bucchud
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
510(k) Number (if known): _KOS298 |
Device Name: Aspect Medical Systems, Inc. BISx4
Indications for Use:
The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 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 EFG nigrals.
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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchner
(Miss) Clara O'Brien
Division Sign-Of Division of General, Restorative, and Neurological Devices
Page i of 1
510(k) Number K052981
(Posted November 13, 2003)