WIDE SPACED QUATTRODE LEADS

K072462 · Advanced Neuromodulation Systems · GZB · Oct 11, 2007 · Neurology

Device Facts

• Record ID: K072462
• Device Name: WIDE SPACED QUATTRODE LEADS
• Applicant: Advanced Neuromodulation Systems
• Product Code: GZB · Neurology
• Decision Date: Oct 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. ANS Percutaneous Leads model number 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508, and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.

Device Story

Wide Spaced Quattrode Leads are implantable components of spinal cord stimulation (SCS) systems; designed to deliver electrical stimulation to spinal cord or peripheral nerves. Leads function as electrodes to transmit electrical pulses from an implanted receiver/transmitter system to target neural tissue. Used by physicians in clinical settings to manage chronic, intractable pain. Output consists of electrical stimulation; intended to modulate pain signaling. Benefits include pain relief for patients unresponsive to other therapies.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design similarity to predicate devices.

Technological Characteristics

Implantable percutaneous leads; multi-electrode configuration (Quattrode); designed for spinal cord and peripheral nerve stimulation. Operates as part of an electrical stimulation system. Materials and sterilization methods consistent with existing Class II spinal cord stimulator leads.

Indications for Use

Indicated for patients with chronic pain of the trunk and limbs, or severe intractable peripheral nerve pain. Used as sole therapy or adjunct in multidisciplinary pain management.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2007

Advanced Neuromodulation Systems % Ms. Mia Ware 6901 Preston, Road Plano, Texas 75024

Re: K072462

Trade/Device Name: Wide Spaced Quattrode Leads Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB, GZF Dated: August 29, 2007 Received: September 14, 2007

Dear Ms. Ware:

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 - Ms. Mia Ware

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours

F+
Mark Melkerson

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

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name: Wide Spaced Quattrode Leads

## Indications For Use:

The ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. ANS Percutaneous Leads model number 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508, and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, office of Device Evaluation (ODE)

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

510(k) Number

16072462

Prescription Use X (Per 21 CFR 801.109)

Or

Over-The-Counter Use