OLYMPIC CFM 6000

K031149 · Olympic Medical Corp. · OMA · May 14, 2003 · Neurology

Device Facts

• Record ID: K031149
• Device Name: OLYMPIC CFM 6000
• Applicant: Olympic Medical Corp.
• Product Code: OMA · Neurology
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Olympic CFM 6000 is a digital EEG monitor consisting of a Data Acquisition Module and a Main System module. The acquisition module connects to patient electrode leads, amplifies signals, and performs analog-to-digital conversion. The Main System processes, stores, and displays CFM, impedance, and EEG traces. Used in ICU, OR, ER, and research labs by clinicians to monitor brain state and neurological status. Output allows clinicians to observe treatment effects, manage anti-convulsive therapy, and predict neurological outcomes in patients, including infants with hypoxic-ischemic events. Device serves as a digital implementation of the predicate, utilizing digital filters to replicate analog signal processing.

Clinical Evidence

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.

Technological Characteristics

Digital EEG monitor; Data Acquisition Module and Main System module; digital filter and display technology; Class I, Type BF medical electrical equipment; meets IEC 60601-1-1, IEC 60601-1-2:2000, and UL 2601-1 safety standards.

Indications for Use

Indicated for clinicians to acquire and utilize EEG signals in ICU, OR, ER, and research settings to monitor brain state, determine and monitor neurological status in patients post-hypoxic-ischemic event, assist in clinical management/treatment monitoring, predict neurological outcome, monitor seizure frequency/intensity for anti-convulsive therapy management, and predict severity of Hypoxic-Ischemic Encephalopathy and long-term outcomes in infants.

Regulatory Classification

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 (K020335)

Submission Summary (Full Text)

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# 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 [phone] Fax [phone]

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.

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#### 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

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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.

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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 [phone] or [phone] 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

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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