(189 days)
Not Found
No
The description focuses on signal acquisition and output of raw and processed EEG data (cerebral function, impedance). There is no mention of AI/ML algorithms for interpretation, prediction, or advanced analysis beyond basic signal processing. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is used for monitoring the state of the brain by acquiring EEG signals, not for treating a disease or condition.
Yes
The device is intended to "monitor the state of the brain by acquisition of EEG signals," which points to gathering information about a patient's health status. It acquires raw EEG, cerebral function (activity), and impedance, all of which are physiological measures used for diagnosis or monitoring the progression of a condition. Thus, it is a diagnostic device.
No
The device description explicitly states it consists of a header amplifier module and a plug-in module, which are hardware components used for signal acquisition and output.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Olympic Medical Lectromed Cerebral Function Monitor System directly acquires and monitors EEG signals from the patient's brain. This is a direct physiological measurement, not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states monitoring the state of the brain by acquiring EEG signals. This aligns with a physiological monitoring device, not an IVD.
Therefore, the device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
Product codes (comma separated list FDA assigned to the subject device)
OMA, OMA, OMC
Device Description
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which may be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw 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
Not Found
Intended User / Care Setting
intensive care unit, operating room, and for 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)
Not Found
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.
Aspect Medical Systems A-2000 EEG Monitor with BIS. (K974496), SpaceLabs 90482 EEG BIS Module (K973596)
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
3/23/99
K 983229
Section 2 - Summary & Certification
A. 510(k) Summary of Safety and Effectiveness
Classification
Electroencephalograph, 21 CFR 882.1400, Class II, OMA, OMA, Neurology
Device Name
Proprietary: Olympic Medical Lectromed Cerebral Function Monitor System Common Name: EEG Monitor
Company
Olympic Medical 5900 First Ave. S. Seattle, WA 98108
Contact
Edward B. (Ted) Weiler, Ph.D. Director of Special Projects Phone (206) 767-3500; Fax (206) 762-4200
Intended Use
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
Predicate Device
Aspect Medical Systems A-2000 EEG Monitor with BIS. (K974496) SpaceLabs 90482 EEG BIS Module (K973596)
Device Description
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which mav be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
Safety and Standards
The device meets the following safety standards:
- . BS EN 60601-1-1
- BS EN 60601-1-2: 1993 Medical Electrical Equipment . Part 1. General requirements for safety Section 1.2 Collateral Standard for EMC
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 9 2012
Edward B. Weiler, Ph.D. Engineering Manager Olympic Medical Corporation 5900 First Avenue South Seattle, Washington 98108
Re: K983229
Trade/Device Name: Olympic Medical Lectromed Cerebral Function Monitor System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OMA, OMC Dated (Date on orig SE ltr): December 29, 1998 Received (Date on orig SE ltr): December 30, 1998
Dear Mr. Weiler:
This letter corrects our substantially equivalent letter of March 23, 1999.
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.
2
Page 2 - Mr. Edward B. Weiler
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/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. Malvina B. Eydelman, M.D. N Director
Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
INDICATION FOR USE
510(k) NUMBER (IF KNOWN): K 983229 DEVICE NAME: Olympic Medical Lectromed Cerebral Function Monitor System
INDICATIONS FOR USE:
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use OR (Optional Format 1-2-96)
BocceDs
(Divis on Sign-Off) Division of General Restorative Devices 1983229 510(k) Number
Olympic LCFM 510(k)