AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

K050194 · Axon Systems, Inc. · GXZ · Apr 26, 2005 · Neurology

Device Facts

• Record ID: K050194
• Device Name: AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
• Applicant: Axon Systems, Inc.
• Product Code: GXZ · Neurology
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

Device Story

Disposable, sterile subdermal needle electrodes; interface between patient and diagnostic/monitoring equipment. Comprised of small gauge stainless steel needle, lead wire, and DIN 42802 touch-proof safety connector. Used in clinical electro-diagnostic studies or intraoperative monitoring; detects electro-physiological signals or provides electrical stimulation. Inserted subcutaneously by physician or technologist under physician supervision. Safety connector prevents connection to AC outlets. Output signals processed by external recording/monitoring equipment to assist clinicians in diagnosing acute dysfunction in corticospinal axonal conduction; facilitates intraoperative monitoring and electro-diagnostic assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel needle; insulated lead wire; DIN 42802 touch-proof safety connector. Sterile, single-use. Passive device; no internal energy source or software.

Indications for Use

Indicated for patients undergoing clinical electro-diagnostic studies or intraoperative monitoring requiring recording of biopotential signals (EEG, EMG, nerve potentials) or electrical stimulation for diagnosis of acute corticospinal axonal conduction dysfunction. For use by licensed physicians or technologists under physician supervision.

Regulatory Classification

Identification

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

Predicate Devices

• Sterile Subdermal Needle Electrodes (K010019)
• Various Needle Electrodes (K990015)
• Spiral Electrode (K934779)

Submission Summary (Full Text)

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APR 2 6 2005

Appendix J Summary of Safety and Effectiveness

K050194

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# 11. Summary of Safety and Effectiveness

| Company Name: | Axon Systems, Inc.<br>400-2200 Oser Ave<br>Hauppauge, NY 11788 | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------|
| Contact:<br>Phone:<br>Fax:<br>Email: | Howard Bailin<br>Vice President, C.O.O.<br>631 436 5112<br>631 436 5141<br>[e-mail] | | |
| Summary Date | January 17, 2005 | | |
| Proprietary Name: | Subdermal Needle Electrodes<br>Twisted Pair Needle Electrodes<br>Corkscrew (spiral) Needle Electrode | | |
| Common Name: | Subdermal Needle Electrodes | | |
| Classification: | Class II<br>Number:<br>Procodes: | (Performance Standards)<br>882.1350<br>GXZ | Needle Electrode |
| Predicate Devices | Manufacturer: Nicolet Biomedical | Trade Name: Sterile Subdermal Needle Electrodes | FDA number: K010019 |
| | Manufacturer: TechnoMed Europe | Trade Name: Various Needle Electrodes | FDA number: K990015 |
| | Manufacturer: Agram Export-Import Company | Trade Name: Spiral Electrode | FDA number: K934779 |

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### Device Description

Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously.

The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.

The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet.

Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.

Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

#### Intended Use

Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

#### Technological Characteristics

Axon Systems' Subdermal Needle Electrode consists of an insulated wire, of various lengths, electrically connected to a small gauge, stainless steel needle on one end, and a DIN 42802 "touch-proof" safety connector on the other end. The connector is specifically designed so that it cannot be plugged into AC power outlet. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices.

#### Conclusions

Axon Systems' Subdermal Needle Electrodes 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

APR 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howard Bailin Vice President, Chief Operating Officer Axon Systems, Inc. 400-2200 Oser Avenue Hauppauge, New York 11788

Re: K050194

Trade/Device Name: Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: April 1, 2005 Received: April 5, 2005

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 vours,

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting 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 | K050194 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Subdermal Needle Electrodes |
| Indications for Use | Axon Systems' Subdermal Needle Electrodes are intended for use<br>with recording, monitoring and stimulation/recording equipment for<br>the recording of biopotential signals including<br>electroencephalograph (EEG), electromyograph (EMG) and nerve<br>potential signals and for stimulation during the intraoperative<br>diagnosis of acute dysfunction in corticospinal axonal conduction. |

Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1,Enive

cd Deve o

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