← Product Code [OMC](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC) · K020335 # OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 (K020335) _Olympic Medical Corp. · OMC · Jun 18, 2002 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K020335 ## Device Facts - **Applicant:** Olympic Medical Corp. - **Product Code:** [OMC](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC.md) - **Decision Date:** Jun 18, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1400 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Pediatric ## 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. ## Device Story System acquires EEG signals via patient electrode leads connected to header amplifier module; processes signals to produce three outputs: cerebral function (activity), impedance, and raw EEG. Outputs displayed or recorded on 2-channel strip-chart recorder. Used in ICU, OR, ER, and research labs by clinicians. Provides continuous neurological status monitoring; assists in managing hypoxic-ischemic events, anti-convulsive therapy, and predicting neurological outcomes. Complements other clinical data for patient management. ## Clinical Evidence No clinical data provided; device relies on substantial equivalence to legally marketed predicate devices. ## Technological Characteristics Consists of header amplifier module and plug-in module for signal processing. Outputs: cerebral function, impedance, raw EEG. Connectivity: 2-channel strip-chart recorder. Standards: BS EN 60601-1-1, BS EN 60601-1-2 (EMC). ## Regulatory 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. ## Predicate Devices - Olympic Medical Lectromed Cerebral Function Monitor ([K983229](/device/K983229.md)) - Devices Limited Cerebral Function Monitor 4640 - Applied Medical Research Corporation Cerebral Function Monitor Model 870 ([K791580](/device/K791580.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K020335 ## 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 {4}------------------------------------------------ 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) | ![Signature](signature.png) (Division Sign-Off) Division of General, Restorative and Neurological Devices | 510(k) Number | K020335 | |---------------|---------| |---------------|---------| Olympic Medical 1/29/02 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K020335](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OMC/K020335) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com