COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES

K052796 · Valleylab · GEI · Feb 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052796
• Device Name: COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
• Applicant: Valleylab
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.

Device Story

Cool-tip RF Ablation System uses RF energy to induce tissue coagulation/ablation. System components: microprocessor-based RF generator, peristaltic pump, electrodes, inflow/outflow tubing, return pads. Electrodes (single or cluster) are monopolar stainless steel with internal thermocouples for temperature monitoring. Peristaltic pump circulates chilled sterile water through electrode to prevent overheating; water remains enclosed. Generator delivers up to 200W; monitors impedance, current, power, temperature. Used in percutaneous, laparoscopic, or intraoperative settings by physicians. Real-time monitoring of impedance and temperature allows manual control of energy delivery. Clinical benefit: targeted destruction of liver lesions and osteoid osteoma tumors.

Clinical Evidence

Independent clinical data provided to support safety and effectiveness for the ablation of osteoid osteoma lesions.

Technological Characteristics

Microprocessor-controlled RF generator; monopolar stainless steel electrodes with internal thermocouples; peristaltic pump for closed-loop chilled water cooling; 200W max output; 50 Ohm resistive load; impedance/temperature monitoring; sterile, single-use electrodes.

Indications for Use

Indicated for patients requiring percutaneous, laparoscopic, or intraoperative coagulation and ablation of tissue, specifically non-resectable liver lesions and osteoid osteoma tumors within bone.

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

• Cool-tip™ RF Ablation System (K984552, K042216)

Submission Summary (Full Text)

{0}------------------------------------------------

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

< 052796

Page 1 of 2

## Cool-tip™ RF Ablation System

#### Submitter Information 1.

Valleylab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 Contact: Robert C. Moore Manager, Regulatory Telephone: [phone]

Date summary prepared: February 3. 2006

#### Name of Device 2.

Trade or Proprietary Name: Cool-tip™ RF Ablation System

Common/Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories

#### Predicate Devices 3.

The Cool-tip™ RF Ablation System is substantially equivalent to the following legally marketed medical devices:

- Cool-tip™ RF Ablation System (K984552, K042216 )
#### Device Description 4.

The Cool-tip™ RF Ablation System consists of a microprocessor based RF generator, a peristaltic pump, electrodes, inflow and outflow tubing for electrode cooling, and return pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the clectrodes causing the coagulation (ablation) of the tissue.

The Cool-tip™ RF Ablation System generator is capable of delivering up to 200 watts (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the delivery of the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature.

2006 FEB 3

{1}------------------------------------------------

K 052796

Page. 2 of (2)

The Cool-tip™ electrodes are available in either a single electrode or a cluster electrode configuration. The electrodes are monopolar devices. The cluster electrode is three electrode shafts combined into one handle in a triangular patter with approximately 0.5 cm. separation. The electrodes are provided sterile, for single use only. The shaft of the electrode is stainless steel that is insulated to various lengths from the tip of the electrode. Embedded within the tip of each electrode is a thermocouple for temperature measurement. Cooling of the electrode is provided by chilled sterile water which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the sterile water does not contact the patient. Because of the monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.

#### ട്. Intended Use

The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.

#### 6. Summary of Technological Characteristics

The Cool-tip™ RF Ablation System has the same basic technological characteristics as the predicate devices noted above.

#### 7. Performance and Clinical Data

Independent Clinical data have shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.

FEB 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert C. Moore, Jr., RAC Manager, Regulatory Compliance Vallevlab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, Colorado 80301-3299

Re: K052796

Trade/Device Name: Cool-tip™ RF Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 31, 2006 Received: February 1, 2006

Dear Mr. Moore:

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 such 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.

{3}------------------------------------------------

Page 2 - Mr. Moore

This letter will allow you to begin marketing your device as described in your Section 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours

Sincerely yours,

farbay Buchner

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known) K052796

Device Name: Cool-tip™ RF Ablation System

Indications For Use:

"The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone."

### PLEASE DO NOT WRITE BELOW THIS I INE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR 801.109) OR

Over-The Counter Use ________

(Optional Format 1-2-96)

Darbaro Buehus
(Division Sign-Off)

Division of General. Restorative. and Neurological Devices

510(k) Number K052796