PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles connected by flowing lines, creating a sense of unity and movement. Public Health Service AUG 2 9 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Yi Chen, RAC Dircctor of Regulatory Affairs and Quality Assurance VidaMed®, Inc. 46107 Landing Parkway Fremont, California 94538 Re: K011787 Precision™ TUNA® Office System with Model 6800 Cartridge, Model 6198 Handle, Model 7800 RF Generator (with no rectal temperature monitoring tape) 21 CFR 876.4300/Procode: 78 KNS 21 CFR 878.4400/Procode: 78 GEI Regulatory Class: II Dated: June 7, 2001 Received: June 8, 2001 Dear Dr. Chen: This letter corrects our substantially equivalent letter of July 6, 2001, regarding the Precision™ TUNA® This letter converth Model 6800 Cartridge, Model 6198 Handle, Model 7800 RF Generator (with no rectle temperature monitoring tape) which also listed in error the Cobra Handpiece as an component. We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to legally marketed predicate devices marketed we nave dolemined the do rece is becomment of 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). You may, therefore, market the device, subject to the general controls provisions of Costherio (rec (rec)/ - 1 ou mb) provisions of the Act include requirements for annual registration, listing of the rice. The general connect protice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your device is elassilied (boo such additional controls. Existing major regulations affecting your device Apploval) in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in decommitation atsem. Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) the Quanty Dystem Regaration (20) 2017, FDA will verify such assumptions. Failure to comply with the and that, affough perfour Qin regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this may parent full premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ ## Page 2 - Dr. Yi Chen This letter will allow you to continue marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Nancy C Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ## INDICATIONS FOR USE Page ***_ of _*** 510 (k) Number (if known): *K*011787 Device Name: TUNA Office System Indications For Use: The TUNA Office System is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C Brogdon Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K011787 Prescription Use V (Per 21 CFR 801.109) OR Over-The-Counter Use ....... (Optional Format 1-2-96) 00004