Not Found
No
The description focuses on processing EEG signals and computing a proprietary index (BIS Index) using an algorithm, without mentioning AI or ML. The performance studies listed are standard for medical devices and do not indicate AI/ML training or validation.
No.
The device is for monitoring brain activity (EEG signals and BIS Index) and aiding in understanding the effects of anesthetic agents to potentially reduce awareness during anesthesia. It collects and processes data but does not treat, prevent, or mitigate a disease or condition.
Yes
The device is intended to monitor the state of the brain by acquiring EEG signals and computing the Bispectral (BIS) Index, which is used to aid in monitoring the effects of anesthetic agents. This direct measurement and interpretation of physiological signals to assess a patient's state falls under the definition of a diagnostic device, even if it's for monitoring rather than diagnosing a specific disease.
No
The device description explicitly states the BISx is a "component" and a "single enclosure" that processes EEG signals and attaches to sensors and patient monitoring systems. This indicates it is a physical hardware device, not solely software.
Based on the provided information, 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 BISx is described as a device that processes EEG signals acquired directly from the patient's brain via sensors. It computes parameters like the Bispectral (BIS) Index.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device directly interacts with the patient's physiological signals.
Therefore, the BISx falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatic 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, OLT
Device Description
The BISx is a component that processes up to two channels of EEG and computes the Bispectral (BIS) Index and other EEG parameters (same as predicate device), uniting the functionality of the Digital Signal Converter (DSC-XP) and the BIS algorithm into a single enclosure. The BISx mates on one side with Aspect's BIS sensors (up to 2 channel, all currently marketed). On the other side, the BISx attaches to OEM (other equipment manufacturers) patient monitoring systems, allowing them to display Aspect's proprietary BIS Index on their integrated patient monitoring display.
Combining the functions of the DSC-XP and the BIS algorithm into a single enclosure provides our OEM Business Partners with a more durable, more compact, and less expensive way to include the BIS Index parameter into their patient monitoring systems.
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 pediatic patients
Intended User / Care Setting
licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a 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 analysis/verifications/validations were performed:
- Risk analysis
- Software validation
- Electronic verification
- Mechanical/environmental validation
Results show all tests/analyses PASS. Therefore, the device is substantially equivalent to the predicate device, and safe for its intended use.
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.
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
FEB 2 5 2004
510(k) SUMMARY
Date Prepared: January 14, 2004
Company Name and Address
Aspect Medical Systems, Inc. 141 Needham St. Newton, MA 02464
Christine M. Vozella Contact Person: Regulatory Affairs/Quality Assurance 1775 Rockies Ct. Lafayette, CO 80026 Home office telephone (direct dial): (303) 926-5624 Fax #: (303) 604-6477
Device Name
Proprietary Name: BISx EEG Monitor Common Name:
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
Aspect Medical Systems A-2000 (XP) EEG Monitor with BIS System This 510(k), #K030267, received FDA clearance January 13, 2004
Device Description
The BISx is a component that processes up to two channels of EEG and computes the Bispectral (BIS) Index and other EEG parameters (same as predicate device), uniting the functionality of the Digital Signal Converter (DSC-XP) and the BIS algorithm into a single enclosure. The BISx mates on one side with Aspect's BIS sensors (up to 2 channel, all currently marketed). On the other side, the BISx attaches to OEM (other equipment manufacturers) patient monitoring systems, allowing them to display Aspect's proprietary BIS Index on their integrated patient monitoring display.
Combining the functions of the DSC-XP and the BIS algorithm into a single enclosure provides our OEM Business Partners with a more durable, more compact, and less expensive way to include the BIS Index parameter into their patient monitoring systems.
U
1
Indications for Use
BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatic 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
- The indications for use are identical. ●
- The fundamental technology has not changed, in that the BIS technology remains ● the same
- . The BISx has the same operating principal in that both acquire raw EEG using the same signal processing, both filter and digitize EEG, and both calculate BIS,
- Functionality is the same in that there is a DSC (digital signal processor) and BIS . algorithm that function using the same technology as the predicate device.
- Both have 2 channel maximum EEG monitoring capability. .
Minor Differences
- DSC-XP and BIS algorithm are housed together in a single enclosure. In the . predicate device, the algorithm resides within the Monitor, and the DSC-XP is a separate enclosure.
- The BISx has 2 printed circuit boards. In the predicate device, there are 4 printed . circuit boards (2 in the DSC-XP, and 2 in the Monitor).
- Source code differs in that there are additional commands and additional . messages that have been incorporated in the BISx, such as: new command for a sensor impedance check, and a command for a hardware id. " new
- There are additional communication protocols ●
- There is more memory in the BISx. Also, the DSP processor is faster. .
Testing
The following analysis/verifications/validations were performed:
- Risk analysis
- Software validation
- Electronic verification
- Mechanical/environmental validation
Results show all tests/analyses PASS. Therefore, the device is substantially equivalent to the predicate device, and safe for its intended use.
2
Conclusion
Based on the above, Aspect Medical Systems believes the BISx is substantially
f the same and instructive to levice, and is sofa and effective for its intended use, Based on the above, Aspect Medical Systems belleves the 212. In a see and effective for its intended use.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aspect Medical Systems Inc. c/o Mr. Ned E. Devine Entela Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K040183
Trade/Device Name: BISX Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT, OLT Dated (Date on orig SE Itr): February 11, 2004 Received (Date on orig SE ltr): February 12, 2004
APR - 9 2012
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of February 25, 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.
4
Page 2 - Mr. Ned E. Devine
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 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/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.
.
Sincerely vours.
Kesia Alexander
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: BISx
Indications For Use:
The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It 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.
X Prescription Use (Part 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)
of Device Evaluation (ODE)
for Made A. Millheim
- Restorative,
Page 1 of
510(k) Number