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.

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.

AI/ML Overview

The Olympic CFM 6000 aims to demonstrate clinical equivalence to its predicate device, the Olympic Medical Lectromed Cerebral Function Monitor (K020335), by reproducing the analog signal processing and display digitally.

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the device's performance. However, the overarching acceptance criterion is that the output of the CFM 6000 is "clinically identical" to that of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Clinical identity of output to predicate device	Comparison tests using both bench and clinical input data demonstrated that the output of the CFM 6000 is "clinically identical" to that of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "clinical input data" but does not specify the sample size or the provenance of this data (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Their Qualifications for Ground Truth Establishment

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No information is provided about a multi-reader, multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is an EEG monitor, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

The study described is focused on the comparison of the Olympic CFM 6000 against its predicate device to demonstrate clinical identity, implying it is assessing the standalone performance of the new device relative to a known standard. However, the term "standalone (i.e. algorithm only without human-in-the loop performance)" as it relates to AI is not applicable here, as this is a medical device, not an AI algorithm in the contemporary sense. The device is designed to acquire and process EEG signals for clinicians to interpret.

7. Type of Ground Truth Used

The ground truth for the comparison tests was the output of the predicate device, the Olympic Medical Lectromed Cerebral Function Monitor. The study aimed to show that the new device's output was "clinically identical" to this established predicate.

8. Sample Size for the Training Set

The document does not mention the use of a "training set" in the context of machine learning or AI. The development process described involves reproducing analog signal processing digitally, implying engineering and validation against the known behavior of the predicate device rather than training an algorithm on a distinct dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set (in the AI context) is mentioned, there is no information on how its ground truth would have been established. The development likely involved direct engineering to mimic the existing analog CFM technology.

Summary

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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 (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

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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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.

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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 (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

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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:

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

Regulation Number and Section

§ 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).