SUNSPOTS PRE-GELLED SURFACE ELECTRODES

K062198 · Axon Systems, Inc. · GXY · Dec 19, 2006 · Neurology

Device Facts

• Record ID: K062198
• Device Name: SUNSPOTS PRE-GELLED SURFACE ELECTRODES
• Applicant: Axon Systems, Inc.
• Product Code: GXY · Neurology
• Decision Date: Dec 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.

Device Story

Pre-gelled surface electrodes serve as interface between patient and neurodiagnostic/neuromonitoring equipment. Input: electrophysiological signals from skin/muscle surface; Output: electrical stimulation or recorded signals. Device consists of conductive elements (Ag/AgCl or carbon) with hydrogel coupling medium on polyester/polyethylene foam substrate. Leaded versions use copper/carbon fiber wires with DIN 42802 connectors; snap versions connect directly to amplifiers. Used in clinical or intraoperative settings by physicians/technicians. Output allows clinicians to monitor neurological activity or perform nerve stimulation, aiding in diagnostic or intraoperative decision-making. Benefits include non-invasive signal acquisition and stimulation delivery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: polyester fabric or polyethylene foam substrate, conductive carbon, Ag/AgCl, conductive hydrogel. Connectivity: DIN 42802 'touch proof' safety connector or male snap connector. Non-sterile, single-use. No active electronic components or software.

Indications for Use

Indicated for patients requiring electrophysiological signal recording (EEG, EMG, evoked potentials) or peripheral nerve electrical stimulation during neurodiagnostic studies or intraoperative monitoring. For use under licensed physician supervision.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Pre-gelled Surface Electrodes (K971914)
• Surface Electrodes (K931030)
• Medi-Trace 133 ECG Pellet Electrodes (K821137)

Submission Summary (Full Text)

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062198

## DEC 1 9 2006

### 14. 510(k) Summary

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

| Summary Date: | July 10, 2006 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's<br>Information: | 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] |
| Trade Name: | Pre-gelled Disposable Surface Electrodes; Sunspots Pre-gelled<br>Surface Electrodes |
| Common Name: | Pre-gelled Surface Electrodes |
| Classification<br>Name: | Surface Electrode |
| Classification: | Number: 882.1320 Surface Electrode |
| Product Codes: | GXZ |
| Predicate<br>Devices: | Manufacturer: Nicolet Biomedical<br>Trade Name: Pre-gelled Surface Electrodes<br>FDA number: K971914<br><br>Manufacturer: Medicotest, Inc.<br>Trade Name: Surface Electrodes<br>FDA number: K931030<br><br>Manufacturer: Tyco Health Kendall (Graphic Controls)<br>Trade Name: Medi-Trace 133 ECG Pellet Electrodes<br>FDA number: K821137 |
| Description: | Electrodes are the interface medium between neurodiagnostic or<br>neuromonitoring equipment and the patient. Electrodes are used in<br>electro-diagnostic clinical studies or during intraoperative monitoring<br>for electroencephalography (EEG), electromyography (EMG) or<br>evoked potentials recording and electrical stimulation.<br><br>The electrodes used to detect electro-physiological signals or<br>provide electrical stimulation cutaneously. The electrodes are non- |

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sterile and are designed to be disposable, for single use only. Pre-gelled Surface Electrodes are noninvasive as they are placed cutaneously or in contact with the skin or muscle surface and are used under the supervision of a licensed physician. Axon Systems' Pre-gelled Surface Electrodes (PGSE) are supplied with leads or with snap connector. The leaded electrodes are comprised of a laminated, flexible structure composed of polyester fabric or polyethylene foam and use conductive carbon coated with Aq/AqCl and activated carbon mesh material and conductive hydrogel on one side as the coupling medium to the skin. No other adhesive is used. The active conductor is electrically connected to flexible, copper or carbon fiber lead wire and an industry standard DIN 42802 "touch proof" safety connector on the other end. The safety connector is connected to the recording input or electrical stimulator output of the neurodiagnostic or neuromonitoring equipment. The snap connector electrode is comprised of a polyethylene foam substrate with medical grade adhesive and uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is coated with conductive hydrogel to form the coupling medium to the skin. The pellet is attached to a male snap which is used to connect the electrode directly to the recording amplifier. Intended Use: Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only. Technologically, the Pre-gelled Surface Electrodes are similar to the Technological predicate devices. The exceptions are in physical dimensions only. Comparison: No new technology or basic materials are used in these designs. The Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures. Conclusions: Based on the technical information provided and the safety and effectiveness criteria of the design and development process, we claim the Pre-gelled Surface Electrodes to be safe, effective and substantially equivalent to the predicate device(s) noted.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howard Bailin VP, Chief Operating Officer Axon Systems, Inc. 400-2200 Oser Ave. Hauppauge, NY 11788

DEC 1 9 2006

Re: K062198

Trade/Device Name: Pre-gelled Surface Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 7, 2006 Received: November 9, 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 Cometic 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. To ameral controls provisions of the Act include requirements for annual registration, listing of devines, 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 a vice your 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 Ramp); 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 and giam 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 Statement

510(k) Number

K062198

Device Name

Pre-gelled surface electrodes

Indications for Use

Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.

Prescription Use
(Part 21 CFR 801 part D) AND/OR
vision Sign-Off)
motive

3-2

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

**510(k) Number**

Division of Occal Devices

(Division )

(Division Sign-Old)
Division of General, Restorative,
Division of General, Devices