ANS SCS ACCESSORY KIT

K050922 · Advanced Neuromodulation Systems · GZB · May 18, 2005 · Neurology

Device Facts

• Record ID: K050922
• Device Name: ANS SCS ACCESSORY KIT
• Applicant: Advanced Neuromodulation Systems
• Product Code: GZB · Neurology
• Decision Date: May 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2

Intended Use

Advanced Neuromodulation Systems Spinal Cord Stimulation Accessory Kit is for use during the implantation or revision of an ANS spinal cord stimulation (SCS) system, which is indicated for the management 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.

Device Story

The ANS SCS Accessory Kit consists of surgical tools and components used by surgeons during the implantation or revision of spinal cord stimulation systems. The kit facilitates the surgical procedure to place leads and components for chronic pain management. It is used in a clinical/surgical setting. The device does not perform automated analysis or signal processing; it serves as a procedural support tool for the physician.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural accessory kit for spinal cord stimulation systems. Materials and specifications are consistent with standard surgical instrumentation for implantable neurostimulation devices.

Indications for Use

Indicated for patients requiring implantation or revision of an ANS spinal cord stimulation system for the management of chronic pain of the trunk and limbs.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, overlaid with three human profiles facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 8 2005

Ms. Danielle Alarcon Regulatory Affairs Specialist Advanced Neuromodulation Systems Incorporated 6901 Preston Road Plano, Texas 75024

Re: K050922

Trade/Device Name: ANS SCS Accessory Kit Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: II Product Code: GZB Dated: April 12, 2005 Received: April 20, 2005

Dear Ms. Alarcon:

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 10 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. Danielle Alarcon

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 If you a 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 yours,

Sincerely yours,

Stypk Rurdu

Miriam 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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510(k) Number (if known):

Device Name: ANS SCS Accessory Kit

Indications For Use:

Advanced Neuromodulation Systems Spinal Cord Stimulation Accessory Kit is for use during the implantation or revision of an ANS spinal cord stimulation (SCS) system, which is indicated for the management 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.

Prescription Use _X (Per 21 CFR 801.109) Or Over-The-Counter Use ___

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Hye Rurdes

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

11050922 510(k) Number ...