CINCH ANCHOR, MODEL 1194

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized emblem featuring three curved shapes, resembling a caduceus or a symbol of health and medicine. The emblem is black, and the text around the perimeter is also in black. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 8 2008 Advanced Neuromodulation Systems % Ms. Penny Houston Regulatory Affairs Specialist 6901 Preston Road Plano, Texas 75024 Re: K081208 > Trade/Device Name: Cinch Anchor Model 1194 Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class. Class II Product Code: GZB, GZF Dated: April 29, 2008 Received: April 29, 2008 Dear Ms. Houston: 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. Iisting 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. {1}------------------------------------------------ Page 2 - Ms. Penny Houston 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Milliman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement 510(k) Number: K081208 Device Name: ANS Cinch™ Anchor Indications for Use: ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in 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. The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament. Prescription Use _X (Per 21 CFR 801.109) Or Over-The-Counter Use __ Concurrence of CDRH, Office of Device Evaluation (ODE) **Division Sign Off** Division of General, Restorative, and Neurological Devi **510(k) Number**