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

K053290 · Valleylab · GEI · Mar 15, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053290
• Device Name: COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
• Applicant: Valleylab
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cool-tip™ RF Ablation System (Generator and accessories) is intended for use in perculaneous, laparoscopic and intraoperative coagulation and ablation of tisser , such as partial or complete ablation of non-resectable liver tumors.

Device Story

Cool-tip RF System uses RF energy to induce local tissue heating for coagulation and ablation. System components include a microprocessor-based RF generator, peristaltic pump, monopolar electrodes (single or cluster), inflow/outflow tubing, and return pads. Generator delivers up to 200W into 50 Ohm load; monitors tissue impedance, current, power, and electrode tip temperature via embedded thermocouples. Peristaltic pump circulates chilled sterile water through electrode tips to prevent charring; closed-loop cooling prevents water-patient contact. Used in percutaneous, laparoscopic, or intraoperative settings by physicians. Physician monitors real-time impedance and temperature data on generator display to guide energy delivery. Controlled thermal ablation enables destruction of non-resectable liver tumors, providing a minimally invasive alternative to surgical resection.

Clinical Evidence

Clinical evidence includes independent studies demonstrating the system is safe and effective for the ablation of primary and metastatic, unresectable liver tumors. Comparative in vivo and ex vivo product testing confirmed equivalence to currently marketed devices regarding coagulation and ablation of lesions.

Technological Characteristics

System comprises a microprocessor-based RF generator, peristaltic pump, and monopolar stainless steel electrodes. Features include closed-loop chilled water cooling, embedded thermocouples for temperature monitoring, and impedance-based energy control. Delivers up to 200W RF energy. Electrodes are sterile, single-use, and available in single or cluster configurations.

Indications for Use

Indicated for percutaneous, laparoscopic, or intraoperative coagulation and ablation of tissue, specifically for partial or complete ablation of non-resectable liver tumors in patients requiring such procedures.

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 System (K042216)

Submission Summary (Full Text)

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K053290

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### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Cool-tip™ RF System

#### 1. Submitter Information

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

Date summary prepared: November 23, 2005

#### 2. Name of Device

Trade or Proprietary Name Cool-tip™ RF System

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

#### 3. Predicate Devices

The Cool-tip™ RF System of this submission is substantially equivalent to the Cool-tip™ RF System covered by 510(k) notification K042216 dated 11/12/04.

#### 4. Device Description

The Cool-tip ™ RF 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 electrodes causing the coagulation (ablation) of the tissue.

The Cool-tip ™ RF 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.

The Cool-tip™ RF System 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

510(K) Notification Cool-tip ™ RF System November 23, 2005

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# KOS3290

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monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.

#### 5. Intended Use

The Cool-tip™ RF Ablation System (Generator and accessories) is intended for use in perculaneous, laparoscopic and intraoperative coagulation and ablation of tisser , such as partial or complete ablation of non-resectable liver tumors.

#### દ. Summary of Technological Characteristics

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

#### 7. Performance and Clinical Data

Comparative in vivo and ex vivo product testing has shown the Cool-tip™ RF System to be equivalent to currently marketed devices with regard to coagulation/ablation of lesions. Independent clinical studies have shown the use of the system to be clinically safe and effective for ablation of primary and metastatic, unresectable liver tumors.

510(K) Notification Cool-tip™ RF System November 23 2005

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Valleylab Division of Tyco Healthcare Group, LP c/o Mr. Charles M. Copperberg 5920 Longbow Drive Boulder, Colorado 80301-3299

Re: K053290

Trade/Device Name: Cool-tip™ RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 12, 2006 Received: January 13, 2006

Dear Mr. Copperberg:

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

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## Page 2 - Mr. Charles M. Copperberg

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. 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" (21CFR 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/dsma/dsmamain.html

Sincerely vours.

elmee

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

Enclosure

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## Indications for Use

510(k) Number (if known): K053290

Device Name: Cool-tip™ RF System

Indications for Use:

"The Cool-tip™ RF Ablation System (Generator and accessories) is intended for use in percutaneous, laparoscopic and intraoperative coagulation and abletined of tissue, such as partial or complete ablation of non-resectable liver tumors."

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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elmoe

(Division Sign-Of Division of General, Restorative. and Neurological Devices

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(Posted November 13, 2000(k) Number_ K053290