PLACER

K032349 · Advanced Neuromodulation Systems · GZB · Oct 3, 2003 · Neurology

Device Facts

• Record ID: K032349
• Device Name: PLACER
• 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

Advanced Neuromodulation Systems Spinal Cord Stimulation Leads are indicated for 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. The PLACER is intended to be used with ANS Trial Leads (percutaneous), ANS Permanent Quattrode® Leads, ANS Permanent Octrode® Leads, ANS Lamitrode S-Series Leads and peripheral nerve leads.

Device Story

PLACER is an implanted spinal cord stimulation lead system; used for chronic pain management of trunk and limbs. Device functions as an electrode array to deliver electrical stimulation to spinal cord or peripheral nerves. Operated by physicians in clinical settings; used in conjunction with ANS Trial, Quattrode, Octrode, and Lamitrode S-Series leads. Output is electrical stimulation; intended to mitigate pain symptoms. Benefits include potential reduction in chronic pain levels for patients unresponsive to other therapies.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to existing legally marketed devices.

Technological Characteristics

Implanted spinal cord stimulation lead system. Components include percutaneous trial leads, Quattrode, Octrode, and Lamitrode S-Series leads. Functions as an electrical interface for neuromodulation. No software or complex algorithms described.

Indications for Use

Indicated for treatment of chronic pain of the trunk and limbs in patients requiring spinal cord stimulation, either as sole therapy or as an adjunct to 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)

{0}------------------------------------------------

Image /page/0/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 design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2003

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

Re: K032349

Trade/Device Name: PLACER™ Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: June 29, 2003 Received: August 5, 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. Ilsting 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

{1}------------------------------------------------

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 vours.

Mark N. Milliman

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

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name: PLACER™

Indications for Use:

Advanced Neuromodulation Systems Spinal Cord Stimulation Leads are indicated for 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.

The PLACER is intended to be used with ANS Trial Leads (percutaneous), ANS Permanent Quattrode® Leads, ANS Permanent Octrode® Leads, ANS Lamitrode S-Series Leads and peripheral nerve leads.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milham

eral. Restorative and Neurological D

510(k) Number K032344

Prescription Use _ (Per 21 CFR 801.109) Or

Over-The-Counter Use __