CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. Inside the circle is a stylized symbol of three human figures in profile, with their arms raised. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 5 2006 Mr. Jeff Kasoff Director of Regulatory Affairs Life-Tech, Incorporated 4235 Greenbriar Dr. Stafford, Texas 77477-3995 Re: K052954 R052751 Trade/Device Name: ContiStim Continuous Stimulating Catheter Nerve Block Regulation Number: 21 CFR 868.5140 Regulation Name: Anethesia conduction kit Regulatory Class: II Product Code: CAZ Dated: February 9, 2006 Received: February 9, 2006 Dear Mr. Kasoff: We have reviewed your Section 510(k) premarket notification of intent to market the device we mayo lowed your and have determined the device is substantially equivalent (for the itelered above and have actornitiosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Antendinents, or to act research Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Ocournay, therefore, market the device, subject to the general approvin uppression (the Act. The general controls provisions of the Act include condivis provisions of the sixtration, 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 (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the be announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Jeff Kasoff Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 Issualled of a basis and sevice complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal states and registered to: registration of limited to: registration You must comply with an the 7te o requirement) (21 CFR Part 801); good manufacturing practice and listing (21 CFR I at 607), laocing (21 CFR results), and 100%), and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, at the requirements as set form in the quality systems (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) This letter will anow you to begin madional equivalence of your device to a premiarket nothleadon. The PDA muling or sassistion 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), If you desire specific advise for Jour at (240) 276-0120. 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 may outain other general misternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. 2 Sincerely yours, Susan Runne Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the text "U.S. Food and Drug Administration". The text is in white font and is set against a black background. The text appears to be the title or heading of a document or website. Image /page/2/Picture/3 description: The image shows the logo of the Department of Health and Human Services. The logo consists of a symbol on the left and the text "Department of Health and Human Services" on the right. The symbol appears to be a stylized representation of a human figure. The text is stacked in three lines, with "Department of" on the top line, "Health and" on the second line, and "Human Services" on the bottom line. FOR DEVICES AND RADIOLOGICAL HE FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH ## Indications for Use 510(k) Number (if known): Device Name: ContiStim Continuous Stimulating Catheter Nerve Block Set Indications for Use: The Continuous Stimulating Catheter News Block Set permits The Continuous Stimulating Stimulating Carmers and rerve plexus for continuous placement of catherers next to herves and analgesia techniques. It is indicated for use up to 72 hours. Prescription Use ﺳﮯ ﺍ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Any lion Concurrence of CDRH, Office of Device Evaluation (ODE) General Hospital, Decal Devices K052954 http://www.fda.gov/cdrh/ode/INDICATE.HTML 8/31/2005