(286 days)
Not Found
No
The description focuses on standard EEG signal processing and computation of the Bispectral Index (BIS), without mentioning AI or ML algorithms.
No
The device is described as an EEG monitor that monitors brain states and effects of anesthetic agents, rather than directly treating a condition.
Yes
The device "monitors the state of the brain by data acquisition of EEG signals" and is used "as an aid in monitoring the effects of certain anesthetic agents," which are diagnostic activities. It helps clinicians understand the patient's physiological state (brain activity, effects of anesthesia), which is a key characteristic of a diagnostic device.
No
The device description explicitly states it acquires EEG signals from sensors attached to the patient's head and performs computations. This indicates the device includes hardware components (sensors and the acquisition unit) in addition to the software for computation and display.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device directly monitors physiological signals (EEG) from the patient's head.
- The intended use describes monitoring the state of the brain by acquiring EEG signals. This is a direct physiological measurement, not an analysis of a sample.
- The device description confirms it acquires EEG from sensors attached to the patient's head. This reinforces that it's a direct measurement device.
Therefore, this device falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
"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; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of 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
Device Description
"The BIS EEG Monitor, VIEW, is an EEG Monitor that displays EEG, as well as reports and graphs the BIS valuc by acquiring two channels maximum of EFG from sensors attached to the patient's head, and performing the computations necessary to produce the Bispectral Index (BIS). The BIS is then numerically displayed for the clinician's use.
It also displays other parameters such as SQI (signal quality) and EMG."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's head
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
"licensed healthcare practitioner or by personnel trained in its proper use" / "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 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): 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
Page 1 of 2
SECTION 6
SPECIAL 510(k) SUMMARY Date Prepared: August 31, 2006 Revised June 11, 2007
Company Name and Address
JUN 1 8 2007
Aspect Medical Systems, Inc. One Upland Rd. Norwood, MA 02062
Contact Person:
Vikram Verma Manager, Regulatory Affairs/Quality Assurance Telephone (direct dial): (617) 559-7134 Fax #: (617) 559-7948
Device Name
Proprietary Name: Aspect Medical Systems BIS EEG Monitor, VIEW
Common Name: EEG Monitor
Classification
Electroencephalograph (EEG) monitors have been classified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400)
Predicate Device
Aspect Medical Systems A-3000 EEG Monitor with BIS (K052362)
Device Description
The BIS EEG Monitor, VIEW, is an EEG Monitor that displays EEG, as well as reports and graphs the BIS valuc by acquiring two channels maximum of EFG from sensors attached to the patient's head, and performing the computations necessary to produce the Bispectral Index (BIS). The BIS is then numerically displayed for the clinician's use.
It also displays other parameters such as SQI (signal quality) and EMG.
1
K06.2613
Page 2 of 2
Indications for use
The BIS EEG Monitor, VIEW, 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; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.
Summary of Technological Characteristics Compared to Predicate Device
The BIS VIEW Monitor has the same intended use and fundamental scientific technology as the predicate device. It has a lesser number of features as compared to the predicate device, such as no secondary data trending, soft keys in place of touch screen, a smaller screen, no trend review screen and a different housing color as compared to the predicate device.
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 VIEW Monitor is substantially equivalent to the predicate device, and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
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. Vikram Verma Manager, RA/QA One Upland Road Norwood, Massachusetts 02062
Re: K062613
Trade/Device Name: BIS EEG Monitor View Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): May 10, 2007 Received (Date on orig SE ltr): May 14, 2007 APR - 9 2012
Dear Mr. Verma:
This letter corrects our substantially equivalent letter of June 18, 2007.
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 (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 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.
3
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/CDRH/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/ReportalProblem/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
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
510(k) Number (if known): K062613
Device Name: BIS EEG Monitor, VIEW
Indications for Use: 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; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation."
Prescription Use (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 Evaluat
Page __ of of
Mark McMullen
and Neurological Devices
510(k) Number
(Posted November 13, 2003)