EPOCH 2000 NEUROLOGICAL WORKSTATION

K971819 · Axon Systems, Inc. · GWF · Nov 20, 1997 · Neurology

Device Facts

• Record ID: K971819
• Device Name: EPOCH 2000 NEUROLOGICAL WORKSTATION
• Applicant: Axon Systems, Inc.
• Product Code: GWF · Neurology
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Epoch 2000 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide the health care professionals with information to help access a patient's neurological status during surgery or longterm monitoring in the ICU.

Device Story

Epoch 2000 is a neurological workstation for intraoperative and ICU monitoring; inputs include EEG, evoked potential, and EMG signals via patient electrodes; device processes signals to provide real-time neurological status assessment; operated by healthcare professionals in OR/ICU settings; output displayed for clinician review to guide clinical decision-making during surgery or long-term monitoring; benefits include enhanced neurological status tracking; features include touch-proof connectors, optical/transformer isolation, and built-in hardware/software diagnostics for patient safety.

Clinical Evidence

Bench testing only. Safety and effectiveness validated through design and development processes, including electrical safety testing (UL544, IEC 601-1, C22.2 No. 125) and adherence to American Electroencephalograph Society Intraoperative Monitoring guidelines.

Technological Characteristics

Materials: Insulated ABS plastic enclosures. Sensing: EEG, evoked potential, and EMG electrodes. Electrical: Optical and transformer isolation, line isolation transformer, touch-proof connectors. Standards: UL544, IEC 601-1, C22.2 No. 125. Software: Includes built-in start-up diagnostics and shutdown protection.

Indications for Use

Indicated for patients in operating rooms or critical care units requiring neurological monitoring, including assessment of cerebral ischemia, neuroactive drug effects, long-term coma, seizure tracking, electrocorticography, somatosensory/motor/auditory/visual evoked potentials, and EMG/nerve stimulation.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• Axon Systems Sentinel-4 (K900482A)
• Moberg Medical Neurotrac II (K914571)
• Nicolet Viking IV (K842956, K950270)

Submission Summary (Full Text)

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NOV 20 1997

Epoch 2000 Supplementary Information K971819

Appendix H Summary of Safety and Effectiveness

The following is a revised Summary of Safety and Effectiveness with requested items removed:

## Summary of Safety and Effectiveness

Voluntary regulatory standards Industry:

Meets or exceeds American Electroencephalograph Society Intraoperative Monitoring guidelines for EEG and evoked response devices.

Electrical:

UL544, IEC 601-1, C22.2 No. 125

## Additional patient protection & safety features

"Touch proof" female safety electrode connectors Insulated ABS plastic patient enclosures Optical & transformer isolation Line isolation transformer Built-in software & hardware start-up diagnostics Software & hardware shutdown protection Zero average DC electrical stimulation Hi, medium & low average stimulation intensity limited Peak stimulation intensity limited Hi level electrical stimulator disconnected on fault Preamplifier DC fault limited to safe current (30uA)

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| Type of Monitoring | Equivalent<br>Device | Predicate Devices | | |
|----------------------------------------------------|----------------------------|-------------------------------------------|--------------------------------------------------|----------------------------------------------------|
| | Axon Systems<br>Epoch 2000 | Axon Systems<br>Sentinel-4<br>DC# 900482A | Moberg<br>Medical<br>Neurotrac II<br>DC# K914571 | Nicolet<br>Viking IV<br>DC# K842956<br>DC# K950270 |
| Cerebral ischemia | Yes | Yes | Yes | Yes |
| Show changes in EEG<br>due to neuroactive<br>drugs | Yes | Yes | Yes | Yes |
| Long term coma | Yes | Yes | Yes | Yes |
| Seizure tracking | Yes | Yes | Yes | |
| Electrocorticography | Yes | | Yes | Yes |
| Somatosensory Evoked<br>potentials | Yes | Yes | Yes | Yes |
| Motor evoked potentials | Yes | | | Yes |
| Auditory evoked<br>potentials | Yes | Yes | Yes | Yes |
| Visual evoked potentials | Yes | Yes | Yes | Yes |
| EMG | Yes | Yes | Yes | Yes |
| Direct Nerve<br>stimulation/EMG | Yes | Yes | Yes | Yes |

## Comparison of Intended Use to Predicate Devices

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Based upon the documentation stated above and the safety and effectiveness criteria of the design and development process, validated by testing and quality control procedures, we claim the device to be safe, effective and substantially equivalent to the predicate devices noted.

The Epoch 2000 is similar is concept and function to our original product, the Sentinel-4 EEG/EP Intraoperative Monitor (K900482A), a class II device. This instrument is also used to monitor brain function and neurological activity utilizing EEG and multiple modality evoked potential techniques. The additional features incorporated in this product are designed to meet the current and expanding demands of health care professionals for more effective ways to monitor the neurological status of their patients without compromising safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

NOV 20 1997

Mr. Howard Bailin Vice President, General Manager Axon Systems, Inc. 400-2200 Oser Avenue Hauppauge, New York 11788

K971819 Re : Epoch 2000 Neurological Workstation Trade Name: Requlatory Class: II (two) 84 GWF Product Code: September 9, 1997 Dated: September 10, 1997 Received:

Dear Mr. Bailin:

.. .

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/3/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three distinct lines. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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## Page 2 - Mr. Howard Bailin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of_ 1_

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The Epoch 2000 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide the health care professionals with information to help access a patient's neurological status during surgery or longterm monitoring in the ICU.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------|--------------------------|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K971819 |
| Prescription Use (Per 21 CFR 801.109) | X |
| | OR |
| | Over-The-Counter Use__ |
| | (Optional Format 1-2-96) |