COBRA HAND PIECE

K973366 · Vidamed, Inc. · KNS · Nov 26, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973366
• Device Name: COBRA HAND PIECE
• Applicant: Vidamed, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Nov 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hvperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Device Story

Cobra Hand Piece is an electrosurgical accessory for the VidaMed TUNA System RF Generator; used for transurethral needle ablation (TUNA) of prostatic tissue. Device features two needle electrodes deployed at 90° angles at 4 preset lengths (10-22mm); needles are insulated at the base to protect the urethra. Disposable Cobra Cartridge attaches to a reusable stainless steel handle. Operated by a physician in a clinical setting to ablate prostate tissue; energy delivery via RF generator reduces prostatic obstruction. Benefits include symptom relief for BPH patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological similarities to the previously cleared TUNA system.

Technological Characteristics

Electrosurgical device; stainless steel reusable handle; disposable cartridge; two needle electrodes; 90° deployment angle; 10-22mm adjustable needle length; insulated needle bases; RF energy source (VidaMed TUNA System RF Generator).

Indications for Use

Indicated for men >50 years old with symptomatic benign prostatic hyperplasia (BPH) and prostate sizes 20-50 cc, experiencing urinary outflow obstruction.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• VidaMed TUNA Catheter (K973366)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

k 973344 142

# NOV 26 1997

September 4, 1997

| Submitted by: | VidaMed, Inc.<br>46107 Landing Parkway<br>Fremont, CA 94538 |
|----------------------------|-------------------------------------------------------------|
| Contact:<br>Phone:<br>FAX: | Robin Bush<br>[phone]<br>[phone] |
| Product: | Cobra Hand Piece |
| Common Name: | Electrosurgical Device |

## Intended Use

The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hvperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

## Device Description

The Cobra Hand Piece delivers the energy from the VidaMed TUNA System RF Generator. The Cobra Hand Piece contains two needle electrodes which are deployed at an angle of 90°. The needles can be deployed at 4 preset lengths which vary between 10-22mm. The needles are insulated at the base to protect the urethra during ablation of the prostatic tissue. The disposable Cobra Cartridge is attached to a reusable handle, containing the mechanism for the needle deployment and retraction. The Cobra Hand Piece only works with the VidaMed TUNA System RF Generator.

## Technological Characteristics

VidaMed currently markets the TUNA Catheter as a disposable device. The Cobra Hand Piece represents a modification to the existing TUNA Catheter by creating a disposable cartridge that fits on the reusable handle. The cartridge will be manufactured with materials that are used currently in the TUNA device. The handle will be made of stainless steel, and is reusable to facilitate cleaning and sterilization.

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K973366
2+2
VidaMed Cobra Hand Piece

## Sterilization

The Cobra Cartridge is provided sterile and ready to assemble into the handle. The Cobra Handle is provided non-sterile and must be sterilized prior to use. The handle may sterilized by a variety of methods.

#### Substantial Equivalence

VidaMed's TUNA System and RF Generator have been cleared for the treatment of symptomatic BPH in several 510(k)s. The Cobra Hand Piece is a modification to the existing TUNA Cathether Hand Piece and shares similar features and function with corresponding devices distributed by VidaMed.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings outstretched.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Robin Bush, RAC Vice President, Regulatory and Clinical Affairs VIDAMED 46107 Landing Parkway Fremont, CA 94538

Re: K973366 VidaMed Cobra Hand Piece Dated: September 4, 1997 Received: September 8, 1997 Regulatory Class: II 21 CFR 876.4300/Procode: 78 KNS

Dear Ms. Bush:

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 (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liliau Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ N/A

## Device Name:

Cobra Hand Piece

## Indication for Use:

The Cobra Hand Piece presented in this submission is intended 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973366
Prescription Use ✗ OR Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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