ANS AXXESS PERCUTANEOUS LEAD

K032034 · Advanced Neuromodulation Systems · GZB · Oct 3, 2003 · Neurology

Device Facts

• Record ID: K032034
• Device Name: ANS AXXESS PERCUTANEOUS LEAD
• Applicant: Advanced Neuromodulation Systems
• Product Code: GZB · Neurology
• Decision Date: Oct 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANS Axxess™ Percutaneous Leads (41XX Series) are designed to be utilized as the lead component of spinal cord stimulation systems and is used to aid in the management of chronic pain of the trunk and/or extremities. The ANS Axxess™ Percutaneous Lead system is designed to be used with the following devices: ANS Renew Receiver (34XX series) and Transmitter (35XX series) ANS Lead Extension Models 3341, 3342, 3343, and 3346

Device Story

ANS Axxess Percutaneous Lead (Models 4143, 4146, 4153, 4156) functions as lead component for spinal cord stimulation (SCS) systems. Device delivers electrical stimulation to spinal cord to manage chronic pain of trunk/extremities. Used in conjunction with ANS Renew Receiver/Transmitter and ANS Lead Extensions. Implanted by physician; provides therapeutic electrical pulses to target nerves. Benefits include pain management for patients with chronic pain conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Percutaneous lead for spinal cord stimulation; part of a system including receiver, transmitter, and extensions. Class II device (21 CFR 882.5880).

Indications for Use

Indicated for management of chronic pain of the trunk and/or extremities in patients requiring spinal cord stimulation.

Regulatory Classification

Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Reference Devices

• ANS Renew Receiver (34XX series)
• ANS Transmitter (35XX series)
• ANS Lead Extension Models 3341, 3342, 3343, and 3346

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2003

Katryna Warren Senior Regulatory Affairs Specialist Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024

Re: K032034

Trade/Device Name: ANS Axxess Percutaneous Lead, Models 4143, 4146, 4153 and 4156 Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: June 30, 2003 Received: July 8, 2003

Dear Ms. Warren:

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

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Page 2 - Ms. Katryna Warren

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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ANS Axxess™ Percutaneous Lead

Indications For Use:

The ANS Axxess™ Percutaneous Leads (41XX Series) are designed to be utilized as the lead component of spinal cord stimulation systems and is used to aid in the management of chronic pain of the trunk and/or extremities.

The ANS Axxess™ Percutaneous Lead system is designed to be used with the following devices:

ANS Renew Receiver (34XX series) and Transmitter (35XX series) ANS Lead Extension Models 3341, 3342, 3343, and 3346

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milkerson

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

ೆ 10(k) Number_