PRECISION PLUS TUNA OFFICE SYSTEM

K014224 · Vidamed, Inc. · GEI · Jan 23, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014224
• Device Name: PRECISION PLUS TUNA OFFICE SYSTEM
• Applicant: Vidamed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precision™ Plus TUNA® Office 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.

Device Story

Precision™ Plus TUNA® Office System treats BPH symptoms via transurethral needle ablation. System components: RF generator, sterile single-use cartridge, reusable handle, reusable telescope, single-use return electrode, sterile tubing set. Operation: 460 kHz RF energy (up to 15 W) delivered via two needles into prostatic tissue; creates localized necrotic lesion. Each lesion requires 3 minutes. Used in clinical setting by physician. Output: controlled thermal ablation of prostate tissue. Benefit: reduction of urinary outflow obstruction symptoms.

Clinical Evidence

Bench testing only. Lesion equivalence between the Precision™ Plus TUNA® Office System and the predicate PROVu™ TUNA® System was established through laboratory bench testing.

Technological Characteristics

RF electrosurgical generator; 460 kHz frequency; 15 W power output; two-needle delivery system; sterile single-use and reusable components; thermal ablation principle.

Indications for Use

Indicated for treatment of urinary outflow obstruction symptoms secondary to BPH in men >50 years old with prostate sizes 20-50 cc.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• PROVu™ TUNA® System

Submission Summary (Full Text)

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KCi4224
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## JAN 2 3 2002 510 (K) SUMMARY Manufacturer: VidaMed, Inc. 46107 Landing Parkway Fremont, CA 94538 510-492-4900 510-492-4999 (fax) Dr. Yi Chen, RAC Contact December 21, 2001 Date of Preparation Precision™ Plus TUNA® Office System Trade Name Electrosurgical Generator and Accessories Common Name Classification Name Electrosurgical Cutting and Coagulation Devices and Accessories Precision™ TUNA® Office System Substantial Equivalence PROVu™ TUNA® System Product Code GEI KNS 21 CFR Section 878.4400 876.4300 Device Description The Precision™ Plus TUNA® Office System 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. The Precision™ Plus TUNA® Office System is indicated for Indication for Use 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. Technology Characteristics The Precision™ Plus TUNA® Office System 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. Each lesion takes 3.0 minutes. Test Summary Lesion equivalence between the Precision™ Plus TUNA® Office System and the PROVu™ TUNA® System has been established through lab bench testing.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular arrangement of text around a central symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The central symbol is a stylized representation of a human figure embracing a globe.

## JAN 2 3 2002

Dr. Yi Chen, R.A.C. Director of Regulatory Affairs and Quality Assurance · VIDAMED® 46107 Landing Pkwy FREMONT CA 94538

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K014224

Trade/Device Name: Precision™ Plus TUNA® Office System with Model 7900 RF Generator, Model 6900 Cartridge, and Model 6198 Handle 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: December 21, 2001 Received: December 26, 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 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, 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 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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This letter will allow you to begin 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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

Enclosure

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## INDICATIONS FOR USE

Page of

510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Precision™ Plus TUNA® Office System

Indications For Use:

Device Name:

The Precision™ Plus TUNA® Office System is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatio of Symptoms ude to unnary outher. So on 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 /
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Lygum

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