ORTHOMON

K061113 · Axon Systems, Inc. · GWF · May 23, 2006 · Neurology

Device Facts

• Record ID: K061113
• Device Name: ORTHOMON
• Applicant: Axon Systems, Inc.
• Product Code: GWF · Neurology
• Decision Date: May 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

Device Story

OrthoMon is an intraoperative neurophysiological monitoring system used by surgeons and OR staff. It records and stimulates biopotential signals, including EMG, evoked responses, and nerve/muscle potentials. The system comprises a console (computer, controller, stimulator), a patient module at the OR table, an electrode preamplifier harness with 8 recording sites, and a surgeon-controlled, microprocessor-based probe. The probe directs stimulation, controls test functions, and provides visual feedback. The system supports free-run EMG, stimulus-evoked EMG, transcranial electrical motor evoked potentials, and train-of-four monitoring. It features a touch-screen interface, audible signal triggers, and network/Internet connectivity for data review. By providing real-time feedback on nerve and spinal cord function, the device assists in avoiding nerve root injury during orthopedic instrumentation placement.

Clinical Evidence

Bench testing only. The device underwent functional testing using accepted laboratory procedures to verify design and development processes.

Technological Characteristics

8-channel monitoring system; includes console, patient module, and electrode preamplifier harness. Uses disposable surface electrodes. Features a surgeon-controlled, microprocessor-based probe for stimulation and test control. Connectivity includes network and Internet access. Interface is touch-screen with optional keyboard/mouse. Provides audible and visual feedback.

Indications for Use

Indicated for intraoperative monitoring of neural motor pathways, localization and assessment of spinal nerves, and verification of spinal instrumentation placement to prevent nerve root injury in patients undergoing surgery.

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: Eclipse Neurological Workstation (K050798)
• NuVasive: Neurovision JJB (K051384)
• Datex-Ohmeda: M-NMT Neuromuscular Transmission Module (K955026)

Submission Summary (Full Text)

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MAY 2 3 2006

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# 510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.

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| Summary Date:<br>Submitter's<br>Information: | April 14, 2006<br>Howard Bailin<br>Vice President, C.O.O.<br>Axon Systems, Inc.<br>400-2200 Oser Ave<br>Hauppauge, NY 11788<br>P: 631 436 5112<br>F: 631 436 5141<br>[e-mail] |
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| Trade Name: | OrthoMon |
| Common Name: | EMG monitor, Evoked Potential System |
| Classification<br>Name: | Evoked Response, Electromyograph |
| Classification: | Number:<br>882.1870 Electromyograph Monitor, Surgical Nerve<br>Stimulator/Locator, Diagnostic Electromyograph,<br>Evoked Response Stimulator |
| Product Codes: | GWF, IKN |
| Predicate Devices | Axon Systems: Eclipse Neurological Workstation (K050798)<br>NuVasive: Neurovision JJB (K051384)<br>Datex-Ohmeda: M-NMT Neuromuscular Transmission<br>Module (K955026) |

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## Description: The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function.

The system performs these functions automatically or manually and uses several neurophysiological techniques including: free run and stimulus evoked electromyography (EMG), transcranial electrical motor evoked potentials and train of four.

The main OrthoMon system components include: the console, housing the computer, controller and sensory and motor evoked potential electrical stimulator and patient module located at the OR table to route stimuli to the appropriate sites and electrode preamplifier harness. The electrode harnesses contains 8 recording sites. Each site connects to a quick-apply disposable surface electrode.

A pre-sterilized, disposable, hand-held, microprocessor controlled probe operated by the surgeon, connects to the patient module. The probe directs stimulation to the appropriate site, controls certain test functions and settings and provide visual indication of test results.

The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones.

The system is network compatible for data review within the hospital and permits secure information access over the Internet.

Technologically, OrthoMon is similar to the predicate devices. The exceptions are the use of a surgeon controlled probe to select certain test functions and to direct the stimulation: and use of quick-apply disposable surface electrodes.

OrthoMon was tested functionally using accepted laboratory test procedures.

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Image /page/2/Picture/0 description: The image shows the logo for Axon Systems. The logo is in black and white and features the word "AXON" in large, bold letters. Below the word "AXON" is the word "SYSTEMS" in smaller letters. To the right of the logo is the text "pg 3:3" in a handwritten font.

The OrthMon system is intended for use to record, monitor Intended Use: and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

> The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

- Conclusions: Based on the technical information provided in this 510(k) and the safety and effectiveness criteria of the design and development process, validated and verified, we claim the OrthoMon to be safe, effective and substantially equivalent to the predicate device(s) noted.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2006

Axon Systems C/o Mr. Howard Bailin Vice President, C.O.O, 400- 2200 Oser Avenue, Hauppauge, NY 11788.

Re: K061113

Trade Name: Orthomon System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Stimulator Regulatory Class: II Product Code: GWF, IKN Dated: April 14, 2006 Received: April 21, 2006

Dear Mr. Bailin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is togens actment date of the Medical Device Amendments, or to conninered province way 20, 1976, are excordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dictere, mains 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 (PMA), it may be subject to such 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.

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); 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.

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Page 2 - Mr. Howard Bailin

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Hubert Lenoir
Carol N. Miller, MS

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Cover Letter Executive Summary

# Indications for Use Statement

510(k) Number

K0611/3

Device Name

## OrthoMon

Indications for Use

The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

Hubert Romero

(Division Sign-Off) (Division of General, Restorative,
Division of General, Restorative, Division of Gener Devices
and Neurological Devices

**510(k) Number** K061113

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)