(34 days)
Not Found
No
The summary describes standard EEG signal processing and display, with no mention of AI or ML algorithms for analysis, interpretation, or prediction.
No
The device is described as monitoring and assisting in the prediction and management of neurological conditions, but it does not directly treat or provide therapy to the patient. It acquires and processes EEG signals to provide information for clinical decision-making.
Yes
The device is intended to acquire and utilize EEG signals to monitor the state of the brain, determine and monitor neurological status, assist in predicting neurological outcomes, and monitor seizures, all of which are diagnostic functions.
No
The device description explicitly states it consists of two main components: a Data Acquisition Module (which handles signal acquisition, amplification, and A/D conversion) and a Main System module (which processes, stores, and displays the data). This indicates the device includes hardware components beyond just software.
Based on the provided information, the Olympic CFM 6000 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.
- Olympic CFM 6000 Function: The Olympic CFM 6000 acquires and utilizes EEG signals. EEG (Electroencephalography) is a method of recording electrical activity of the brain using electrodes placed on the scalp. This is a measurement of physiological activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly describes monitoring the state of the brain, neurological status, and seizure activity by acquiring EEG signals. This is a direct measurement of brain function, not a diagnostic test performed on a bodily fluid or tissue sample.
Therefore, the Olympic CFM 6000 falls under the category of a medical device that measures physiological signals, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Olympic CFM 6000 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 a 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 management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy ー and long-term outcome in infants who have suffered an hypoxic-ischemic event.
Product codes
OMA, OMC
Device Description
The Olympic CFM 6000 consists of two main components: A Data Acquisition Module and a Main System module. The Data Acquisition Module is used to connect the patient electrode leads, amplify the signal, and perform the analog-to-digital conversion. The Main system accepts data from the amplifier. processes and stores the signal. and displays the CFM, impedance, and EEG traces and provides the user interface for control of the device.
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
variety of clinicians, 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
Comparison tests were performed using both bench and clinical input data to demonstrate that the output of the CFM 6000 is clinically identical to that of the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Olympic Medical Lectromed Cerebral Function Monitor (K020335)
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 6 - 510(k) Summary
6.1 Classification
6.2 Submitter/Contact
Edward B. (Ted) Weiler, Ph.D. Vice President, Research and Development Olympic Medical 5900 First Ave. S. Seattle, WA 98108 Phone (206) 268-5151 Fax (206) 762-4200
Prepared: 4/8/2003
6.3 Device Name
Proprietary Name: Olympic CFM 6000 Common Name: EEG Monitor Classification Name: Electroencephalograph per 21 CFR 882.1400, Neurology- OMA, DMA, DMC Class II,
6.4 Predicate Device
Olympic Medical Lectromed Cerebral Function Monitor (K020335).
6.5 Device Description
The Olympic CFM 6000 consists of two main components: A Data Acquisition Module and a Main System module. The Data Acquisition Module is used to connect the patient electrode leads, amplify the signal, and perform the analog-to-digital conversion. The Main system accepts data from the amplifier. processes and stores the signal. and displays the CFM, impedance, and EEG traces and provides the user interface for control of the device.
6.6 Intended Use
The Olympic CFM 6000 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.
6.7 Comparison to Predicate Device
The Olympic CFM 6000 is a digital implementation of the predicate device. All analog signal processing and display provided in the predicate device have been reproduced using digital filter and display technology in the Olympic CFM 6000. Additional convenience features have been added.
1
6.8 Summary of Comparison Tests
Comparison tests were performed using both bench and clinical input data to demonstrate that the output of the CFM 6000 is clinically identical to that of the predicate device.
6.9 Safety and Standards
The device is designed to meet at least the following safety standards:
- IEC CANICSA 60601-1-1, class I, Type BF, Medical Electrical -Equipment, Part 1: General Requirements for safety
- IEC 60601-1-2:2000, Medical electrical equipment General requirements for safety. Electromagnetic compatibility >
- UC 2601 -1 Standard for Safety for Medical Electrical Equipment, -
- Part 1, General Requirements for Safety V
2
Image /page/2/Picture/1 description: The image is the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the outside. Inside the circle is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Olympic Medical Corporation c/o Edward B. Weiler, Ph.D. Vice President, Research and Development 5900 First Avenue South Seattle, Washington 98108
Re: K031149
Trade/Device Name: Olympic CFM 6000 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OMC Dated (Date on orig SE ltr): April 8, 2003 Received (Date on orig SE ltr): April 15, 2003
APR - 9 2012
Dear Mr. Weiler:
This letter corrects our substantially equivalent letter of Mav 14, 2003.
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, Ph.D.
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 (OS) 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.
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
Rev H
Section 4 - Indications for Use
510(k) NUMBER (IF KNOWN): _ K 03 1149
DEVICE NAME: Olympic CFM
INDICATIONS FOR USE:
The Olympic CFM 6000 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 a 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 management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy ー 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 V
OR Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
Division of 88
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031149
Olympic Medical
11 of 82
4/8/2003