DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES

K062996 · Axon Systems, Inc. · GXZ · Jan 12, 2007 · Neurology

Device Facts

• Record ID: K062996
• Device Name: DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
• Applicant: Axon Systems, Inc.
• Product Code: GXZ · Neurology
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Device Story

Disposable stimulator probes deliver electrical stimulation to tissue during intraoperative neurological monitoring; used by surgeons to locate/identify motor nerves and spinal nerve roots and assess nerve function. Bipolar probes also record nerve action potentials. Device consists of plastic handle, stainless steel active electrode shaft (insulated to tip), and flexible lead wire with DIN 42802 'touch-proof' safety connector. Monopolar configurations require separate return electrode. Probes are sterile, single-use, and may be bent for microscopic access. Output is electrical stimulation delivered to nerves; healthcare providers use device to guide surgical navigation and monitor nerve integrity, potentially reducing risk of nerve damage during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Insulated stainless steel probe shaft; plastic handle; DIN 42802 'touch-proof' safety connector. Monopolar and bipolar configurations. Sterile, single-use. No active electronic components; passive conductive probe.

Indications for Use

Indicated for use in patients undergoing surgery to locate, identify, and monitor cranial motor nerves, peripheral nerves, and spinal nerve roots.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• Technomed Europe - Disposable Probes (K050325)
• Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869)

Submission Summary (Full Text)

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## 510(k) Summary

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

| Summary Date:<br>Submitter's<br>Information: | September 29, 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]<br>JAN 1 2 2007 |
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| Trade Names:<br>Common Name:<br>Classification<br>Name:<br>Classification: | Axon Systems Disposable Stimulator Probes<br>Stimulator Probes<br>Stimulator, Nerve (21. CFR 874.1820)<br>Needle Electrode (21. CFR 882.1350)<br>Class II (Performance Standards)<br>Panels: Ear, Nose and Throat; 874.1820<br>Neurology; 882.1350<br>Procodes: ETN, GXZ |
| Predicate<br>Devices: | Technomed Europe - Disposable Probes (K050325)<br>Xomed Surgical Products - Ball Tip Monopolar stimulating probe<br>(K992869) |

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#### Summary:

#### Description

Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. The probes are supplied sterile and are for single use only.

The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof" safety connector(s) on the distal end. Monopolar electrodes require a separate stimulator return electrode

Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve.

The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.

#### Intended Use

To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

### Technological Characteristics

Axon Systems' Disposable Stimulator Probes consist of an insulated probe shaft of various lengths mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802 "touch-proof" safety connector on the other end. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices.

#### Conclusions

Axon Systems' Disposable Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 1 2 2007

Re: K062996

Trade/Device Name: Disposable monopolar and bipolar stimulator probes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: November 29, 2006 Received: November 30, 2006

Dear Mr. Bailin:

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.

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,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K062996 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Name: | Disposable monopolar and bipolar stimulator probes |
| Indications For Use: | To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal<br>nerve roots during surgery. |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number_I062996