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 Description

Electrodes are the interface medium between neurodiagnostic or neuromonitoring equipment and the patient. Electrodes are used in electro-diagnostic clinical studies or during intraoperative monitoring for electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. The electrodes used to detect electro-physiological signals or provide electrical stimulation cutaneously. The electrodes are non-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.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The submission primarily focuses on establishing substantial equivalence to predicate devices through functional testing rather than defining specific numerical acceptance criteria. The acceptance criteria can be inferred as meeting the functional performance of the identified predicate devices, as no novel technology or basic materials were used, and "Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures."

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance	Equivalent to predicate devices (Nicolet Biomedical Pre-gelled Surface Electrodes, Medicotest, Inc. Surface Electrodes, Tyco Health Kendall ECG Pellet Electrodes) based on "accepted laboratory test procedures."	"The Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures. 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." (This indicates the device met the functional performance, though no specific numerical results are provided in the summary.)
Materials	Identical or substantially equivalent to predicate devices.	"No new technology or basic materials are used in these designs."
Intended Use	Same as predicate devices.	"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." (This matches the general intended use of surface electrodes.)
Physical Dimensions	May vary from predicate devices.	"The exceptions are in physical dimensions only."

Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. Instead, it refers to "functional testing using accepted laboratory test procedures." It's likely that a sample of the manufactured electrodes was subjected to these functional tests.

The data provenance is not specified beyond "accepted laboratory test procedures." There is no mention of country of origin or whether the testing was retrospective or prospective in a clinical sense.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not applicable. The submission is for a medical device (surface electrodes) and does not involve AI or ground truth established by experts in the context of diagnostic interpretation. The "ground truth" for this device would be its physical and electrical properties meeting specifications through engineering and quality control testing.
Adjudication Method:

This is not applicable as there is no diagnostic test or AI algorithm requiring adjudication of results.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. The submission is for a physical medical device (surface electrodes), not an AI algorithm. Therefore, there's no comparison of human readers with vs. without AI assistance.
Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This is not applicable. The device is a physical surface electrode, not an algorithm.
The Type of Ground Truth Used:

For a physical medical device like a surface electrode, the "ground truth" is established through engineering specifications, material properties, and functional performance tests (e.g., impedance, adhesion, signal integrity). The document states "Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures." This implies that the 'ground truth' was based on meeting the established performance characteristics for surface electrodes.
Sample Size for the Training Set:

This is not applicable. The submission is for a physical medical device, not an AI algorithm requiring a training set.
How the Ground Truth for the Training Set Was Established:

This is not applicable for the reasons stated above.

Summary

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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'sInformation:	Howard BailinVice President, C.O.O.Axon Systems, Inc.400-2200 Oser AveHauppauge, NY 11788P: 631 436 5112F: 631 436 5141hbailin@axonsystems.com
Trade Name:	Pre-gelled Disposable Surface Electrodes; Sunspots Pre-gelledSurface Electrodes
Common Name:	Pre-gelled Surface Electrodes
ClassificationName:	Surface Electrode
Classification:	Number: 882.1320 Surface Electrode
Product Codes:	GXZ
PredicateDevices:	Manufacturer: Nicolet BiomedicalTrade Name: Pre-gelled Surface ElectrodesFDA number: K971914Manufacturer: Medicotest, Inc.Trade Name: Surface ElectrodesFDA number: K931030Manufacturer: Tyco Health Kendall (Graphic Controls)Trade Name: Medi-Trace 133 ECG Pellet ElectrodesFDA number: K821137
Description:	Electrodes are the interface medium between neurodiagnostic orneuromonitoring equipment and the patient. Electrodes are used inelectro-diagnostic clinical studies or during intraoperative monitoringfor electroencephalography (EEG), electromyography (EMG) orevoked potentials recording and electrical stimulation.The electrodes used to detect electro-physiological signals orprovide 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).