(137 days)
Not Found
No
The description focuses on basic signal acquisition and output (cerebral function, impedance, raw EEG) and does not mention any advanced processing or analytical capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as a monitor that acquires and utilizes EEG signals to assess neurological status, not to provide treatment.
Yes.
The device is used to monitor the neurological status, assist in the prediction of neurological outcome, and monitor seizures, all of which are diagnostic functions.
No
The device description explicitly states it consists of three hardware modules: a header amplifier module, a plug-in module, and a 2-channel strip-chart recorder. This indicates it is a hardware-based system, not software-only.
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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the Olympic Medical Lectromed Cerebral Function Monitor System acquires and utilizes EEG signals from the patient. This involves placing electrodes on the patient's head to measure electrical activity of the brain within the body.
- Intended Use: The intended uses all relate to monitoring the neurological status of patients by analyzing these in vivo (within the living organism) signals.
Therefore, since the device operates by acquiring signals directly from the patient's body rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
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.
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:
- to monitor the state of the brain .
- for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.
- for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
- to assist in the prediction of neurological outcome -
- to monitor and record frequency and intensity of seizures to assist in ﮯ management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy u and long-term outcome in infants who have suffered an hypoxic-ischemic event.
Product codes
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 that produces three outputs that 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
a variety of clinicians; intensive care unit, operating room, clinical research; intensive care areas, Operating Room, Emergency Room, and clinical research lab
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 4 Summary & Certification
4.1 510(k) Summary of Safety and Effectiveness
4.1.1 Classification
Electroencephalograph, 21 CFR 882.1400, Class II, . OMC Neurology
4.1.2 Device Name
Proprietary: Olympic Medical Lectromed Cerebral Function Monitor System
Common Name: EEG Monitor
4.1.3 Company
Olympic Medical 5900 First Ave. S. Seattle, WA 98108
4.1.4 Contact
Edward B. (Ted) Weiler, Ph.D. Vice President, Research and Development Phone (206) 268-5151; Fax (206) 762-4200
4.1.5 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.
4.1.6 Predicate Device
- Olympic Medical Lectromed Cerebral Function Monitor . (K983229).
- Devices Limited Cerebral Function Monitor 4640 in commercial distribution in the U. S. prior to May 28, 1976.
- Applied Medical Research Corporation Cerebral Function Monitor ・ Model 870 (K791580)
4.1.7 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 that produces three outputs that may be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
1
4.1.8 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
4.2 Class III certification
Not applicable
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mr. Edward B. Weiler, Ph.D. Director of Special Projects Olympic Medical 5900 First Avenue South Seattle, WA 98108
9 2012 APR
Re: K020335
Trade/Device Name: Olympic Medical Lectromed Cerebral Function Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC Dated (Date on orig SE ltr): May 10, 2002 Received (Date on orig SE Itr): May 13, 2002
Dear Mr. Weiler:
This letter corrects our substantially equivalent letter of June 18, 2002.
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.
3
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.
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
Image /page/3/Picture/10 description: The image shows a stylized, cursive letter 'f'. The letter is drawn with a flowing, continuous line, creating a sense of elegance and movement. The stroke begins with a sharp upward curve, forming the upper loop of the 'f', and then descends in a graceful arc to create the lower loop. The overall impression is one of simplicity and sophistication.
Enclosure
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Section 3 Indications for use
510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME: Olympic Medical Lectromed Cerebral Function Monitor System
INDICATIONS FOR USE:
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:
- to monitor the state of the brain .
- for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.
- for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
- to assist in the prediction of neurological outcome -
- to monitor and record frequency and intensity of seizures to assist in ﮯ management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy u and long-term outcome in infants who have suffered an hypoxic-ischemic event.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-the-Counter Use |
|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K020335 |
|---|---|
| --------------- | --------- |
Olympic Medical
1/29/02