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

Device Description

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 electrodes 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. 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.

AI/ML Overview

The provided documentation is a 510(k) premarket notification for the Cool-tip™ RF Ablation System, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously marketed devices rather than proving safety and effectiveness through a de novo study with explicit acceptance criteria.

Therefore, the document does not contain details about acceptance criteria, a specific study proving device performance against these criteria, or the detailed information on sample sizes, ground truth establishment, or expert involvement typically found in a clinical study report for proving novel device efficacy or safety.

Instead, the submission relies on comparative in vivo and ex vivo product testing and independent clinical studies that have already shown the use of the system to be safe and effective. This implies that the device is an iteration or re-submission, building upon prior approvals.

Given this, I cannot extract the requested information in the format requested. However, I can summarize what is stated, and highlight what is missing:

Here's what can be inferred/extracted from the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated. The core acceptance for a 510(k) is "substantial equivalence" to predicate devices.

Reported Device Performance:

Performance Aspect	Reported Statement
Coagulation/Ablation of Lesions	"Comparative in vivo and ex vivo product testing has shown the Cool-tip™ RF Ablation System to be equivalent to currently marketed devices with regard to coagulation/ablation of lesions."
Clinical Safety and Effectiveness	"Independent clinical studies have shown the use of the system to be clinically safe and effective for ablation of non-resectable liver lesions."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not specified. The document mentions "comparative in vivo and ex vivo product testing" and "independent clinical studies" but does not provide details on the sample sizes, study designs (retrospective/prospective), or data provenance for these underlying studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not specified. As the specific studies are not detailed, information on ground truth establishment and expert qualifications is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Does not apply. This device is an ablation system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to interpretation improvement is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Does not apply. This is a medical device for tissue ablation, not an algorithm. The "standalone performance" would relate to its physical ablation capabilities, which are attested to by the "comparative in vivo and ex vivo product testing."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Implied: For ablation devices, ground truth would typically come from pathological examination of ablated tissue, imaging follow-up to confirm lesion necrosis, or clinical outcomes data related to disease progression. However, the document does not explicitly state which methods were used in the "independent clinical studies" or "comparative in vivo and ex vivo product testing."

8. The sample size for the training set:

Not specified. This is not a machine learning device, so the concept of a "training set" in that context does not apply. If "training set" refers to data used to refine the device design, that information is not provided.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device, not a detailed clinical study report. It refers to existing data and studies to support its claim without detailing the methodologies, sample sizes, or ground truth establishment of those underlying studies.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Cool-tip™ RF Ablation System

K04216

1. Submitter Information

Vallevlab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 Contact: Charles M. Copperberg Manager, Requlatory Telephone: 303-530-6247

Date summary prepared: August 13, 2004

Name of Device 2.

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

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

3. Predicate Devices

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

Cool-tip™ RF Ablation System (K984552) >
RITA Medical Systems RF Generator and Accessories (K993944, K021329, K031257 and K031926)
RadioTherapeutics RF Generator and LeVeen Electrode (K012315 and K000241)

4. Device Description

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.

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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.

Intended Use 5.

Summary of Technological Characteristics 6.

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

7. Performance and Clinical Data

Comparative in vivo and ex vivo product testing has shown the Cool-tip™ RF Ablation 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 non-resectable liver lesions.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

Mr. Charles M. Copperberg Manager, Regulatory Valleylab A Division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, Colorado 80301

Re: K042216

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: August 13, 2004 Received: August 16, 2004

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 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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Page 2 - Mr. Charles M. Copperberg

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _KOY 22 2 1 6

Device Name: Cool-tip™ RF Ablation System

Indications For Use:

"The Cool-tip™ RF Ablation System (Generator and Accessories) is "The Cool-lip" Nr Ablation Cycloin (Socoln (Socoroscopic and intraoperative)
intended for use in percutaneous, laparoscopic and an complete oble intended for use in percularieous, laparessopic an or complete ablation of non-resectable liver lesions."

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

510(K) Notification Cool-tip RF Ablation System August 13, 2004

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.