RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE

{0}------------------------------------------------ # DEC 1 1 2001 K012587 Page 1 of 3 # 510 (K) SUMMARY Precision™ TUNA® Office System Electrosurgical Generator and Accessories Coagulation Devices and Accessories The same products listed above Manufacturer: VidaMed, Inc. 46107 Landing Parkway Fremont, CA 94538 510-492-4900 510-492-4999 (fax) Dr. Yi Chen, RAC GEI KKS 878.4400 876.4300 November 30, 2001 PROVU™ TUNA® System Electrosurgical Cutting and Contact Date of Preparation Trade Name Common Name Classification Name Substantial Equivalence Product Code 21 CFR Section Device Description Indication for Use Technology Characteristics Test Summary Each System of the TUNA System Product Family consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories. Each System of the TUNA System Product Family is indicated for 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. Each System of the TUNA System Product Family delivers low levels of 460 KHz RF energy up to 15 W from each of the 2 needles directly into prostatic tissue to produce a localized necrotic lesion to treat the symptoms associate with BPH. In two multi-centers clinical studies a total of 50 patients with both lateral and median lobe enlargement were treated with the VidaMed Tuna System to relieve their symptoms of BPH and improve their uroflow. The studies demonstrated safety and efficacy in using the VidaMed TUNA system. It was further demonstrated that a shortened needle length across the median lobe starting 1 cm down from the bladder neck and penetrating directly into the adenoma and applying RF energy has not increased the risks associated with the use of the TUNA system from that of treating the lateral lobes. Therefore, it was concluded that the contraindication of patient's with an enlarged middle lobe can be deleted. {1}------------------------------------------------ K012587 Page 2 of 3 # Clinical Study Design Clinical studies using the TUNA® procedure were performed at multiple medical institutions throughout Clinical studies using the TONA procedure were performs secondary to benign prostate hyperplasia the United States. Pauents with lower unnaly and symptoms safety and efficacy of TUNA® An arm of this clinical study included a multicenter, single blind, randomiced study comparing transis in the An arm of this clinical study included a multidenter, oling ransonsely with many of were treated with TURP. Of the 107 pallens treated in the stably, F.F. Rele beetse events. Efficacy was evaluated by measuring peak flow rate and AUA symptom score. Patients 45 years or older with lower urinary tract symptoms secondary to the diagnosis of BPM with have both lateral and median lobe involvement were enrolled in additional 2 studies (PMT and PO1) to SS actions determine safety and efficacy. The prostate glands were between 30 to 100 grams. Of the 50 patients delemine salely and encacy. The problement genere months and 24 had up to 1 year follow-up data. ## Safety Data Safety Data The clinical trials demonstrated that the TUNA® procedure can be performed without the need tor general in The cimical thats demonstrated that the TONA proceed. Treatment with TUNA® procedure is of regional (spinal) and adverse events. The following table summaries the safety data of associated with lew Side eneolas and advonoted only) and that from the 2 additional studies patients librit the onginer TONA VS. FOR tiles (Lasing a degree of median lobe hyperplasia. | Table 1-1 Adverse Events | | | | |--------------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------| | Adverse Event | Original TUNA®<br>Lateral Lobe Studies | P01 Lateral and<br>Median Lobe Studies | PM1 Lateral and<br>Median Lobe Studies | | Obstruction | 44% | 0% | 0% | | Catheterization (for<br>urinary retention) | 41% | 15% | 6% | | Bleeding | 29% | 9% | 6% | | Pain/Discomfort | 23% | * (included in Dysuria) | * (included in Dysuria) | | Urgency | 8% | * (included in Dysuria) | * (included in Dysuria) | | Frequency | 8% | * (included in Dysuria) | * (included in Dysuria) | | Urinary Tract Infection | 6% | 12% | 0% | | Dysuria | 2% | 15%*(irritative<br>symptoms) | 6%*(irritative<br>symptoms) | | Scarring/Stricture | <2% | 0% | 0% | | Impotence | <2% | 0% | 0% | | Retrograde Ejaculation | <1% | 3% (partial) | 0% | | Incontinence | 0% | 0% | 0% | * In the lateral & median lobe studies, Dysuria was described as irritative voiding symptoms, which include pain, discomfort urgency, or frequency. ## Efficacv Data Entery Data The original prospective clinical trial (lateral lobe only) was performed at eight (8) medical centers across the United States. One hundred and sixty seven (167) men over 50 years of age or older with symonmatic BPH were enrolled in this original trial. One hundred and twenty one (121) of these patients were randomized to either TUNA® or TURP: sixty five (65) were treated with TUNA® and fifty six (56) underwent TURP. Forty six (46) additional non-randomized patients were treated with TUNA, making the total TUNA® treated population one hundred and eleven (111). Mean change and percentage change from baseline and between the two groups for AUA (American Urological Association) symptom score, quality of life (QOL) score and post void residual urine volume were measured at 12 months following treatment. {2}------------------------------------------------ | | Timepoint | | | |---------------------------|-----------|---------|----------| | Parameter | Baseline | 6 month | 12 month | | AUA Symptom Score | | | | | TUNA | 23.8 | 10.6 | 11.9 | | TURP | 24.1 | 7.9 | 7.8 | | Peak Flow Rate | | | | | TUNA | 8.9 | 13.4 | 14.8 | | TURP | 8.9 | 21.0 | 21.1 | | Post Void Residual Volume | | | | | TUNA | 91.4 | 63.6 | 65.9 | | TURP | 81.9 | 45.6 | 47.1 | | Quality of Life | | | | | TUNA | 4.7 | 1.9 | 1.9 | | TURP | 4.8 | 1.6 | 1.4 | ### Efficacy Data of the TUNA* vs. TURP Study Table 1-2 * TUNA treated 111 patients Similar results were seen from the additional studies (lateral and median lobes). Tables 1-3 and 1-4 demonstrated the efficacy results of the all studies. | Table 1-3 Total Symptom Score Overview | | | | |----------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Visit | Original TUNA<br>Lateral Lobe Studies<br>(American Urological<br>Association Symptom Score) | P01 Lateral and<br>Median Lobe Studies<br>(International Prostate<br>Symptom Score) | PM1 Lateral and<br>Median Lobe Studies<br>(International Prostate<br>Symptom Score) | | Pretreatment | 24.6 | 21.0 | 24.0 | | 1 Month | 12.5 | 16.0 | 13.0 | | 3 Month | 9.6 | 10.0 | 10.0 | | 6 Month | 10.1 | 10.0 | 5.0 | | 12 Month | 10.6 | 11.0 | N/A | | Visit | Original TUNA<br>Lateral Lobe<br>Studies | P01 Lateral and<br>Median Lobe Studies | PM1 Lateral and<br>Median Lobe Studies | |--------------|------------------------------------------|----------------------------------------|----------------------------------------| | Pretreatment | 8.306 | 8.6 | 6.4 | | 1 Month | 16.565 | 10.2 | 11.4 | | 3 Month | 15.024 | 12.0 | 15.1 | | 6 Month | 14.748 | 13.7 | 11.0 | | 12 Month | 13.432 | 12.7 | N/A | #### Table 1-4 Peak Uroflow Rate (Qmax) Overview As of 2000, over 25,000 patients worldwide have been treated with TUNA®, with over 6,000 in the United States. TUNA® has proved to be a successful minimally invasive therapy. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle, completing the official emblem of the department. ### Public Health Service # DEC 1 1 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850 Dr. Yi Chen, R.A.C. Director of Regulatory Affairs and Quality Assurance VIDAMED® 46107 Landing Pkwy FREMONT CA 94538 Re: K012587 Trade/Device Name: As identified in Enclosure 1 Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: 79 GEI Dated: September 27, 2001 Received: September 28, 2001 Dear Dr. Chen: 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 for use surver in the encreations 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) 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 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 I lease of a a 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. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device to a legally marketed Ilouitcation. The I Drice 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 IT you desire spoolilo active act your an of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|-----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616) | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616) | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654) | | Other | (301) 594-4692) | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on any promote the regulation entitled, "Misbranding Offically of Compilance at (2017 e att 807.97). Other general information on by recence to promation nearly be obtained from the Division of Small Manufacturers, your responsional 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/dsma/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 Enclosures (1) Trade/Device Name (2) Indications for Use {5}------------------------------------------------ # INDICATIONS FOR USE Page 510 (k) Number (if known): _ Device Name: TUNA® System Product Family, including Precision™ TUNA® Office System PROVu™ TUNA® System Indications For Use: The TUNA® System Product Family, including Precision™ TUNA® Office System and PROVu™ TUNA® System, is indicated 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) | Prescription Use | <div style="display:inline-block; vertical-align:middle;"> <img alt="Tick" src="tick.png" style="height:1em; vertical-align:middle;"/></div> | OR | Over-The-Counter Use ______ | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----|-----------------------------| | (Per 21 CFR 801.109) | | | | Nancy Broadon | (Division Sign-Off) | | |---------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K012587 | (Optional Format 1-2-9) Enclosure 2 (Optional Format 1-2-96) Enclosure 2 00003