(110 days)
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 tumors.
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 monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.
The Cool-tip™ RF System is intended for percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, specifically for partial or complete ablation of non-resectable liver tumors.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Equivalence to currently marketed devices regarding coagulation/ablation of lesions. | Comparative in vivo and ex vivo product testing has shown the Cool-tip™ RF System to be equivalent to currently marketed devices for coagulation/ablation of lesions. | This indicates that the device's functional performance in ablating tissue is comparable to established devices. |
| Clinical safety and effectiveness for ablation of primary and metastatic, unresectable liver tumors. | 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. | This addresses the clinical utility and patient outcomes for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document states: "Comparative in vivo and ex vivo product testing" and "Independent clinical studies." However, it does not specify the sample size for these tests or the clinical studies.
Regarding data provenance:
- "in vivo and ex vivo product testing" likely refers to studies performed on biological tissue, potentially animal models (in vivo) and excised tissue (ex vivo), without explicit mention of human subjects for the comparative testing directly.
- "Independent clinical studies" implies human subject data, but the country of origin and whether they were retrospective or prospective studies are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in either the comparative testing or the independent clinical studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information provided regarding human readers improving with or without AI assistance, as AI is not a component of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a hardware system for RF ablation, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable to the Cool-tip™ RF System.
7. Type of Ground Truth Used
The document implies the ground truth for "coagulation/ablation of lesions" would be based on direct assessment of the ablated tissue, likely through histological examination (pathology) or macroscopic evaluation. For "clinical safety and effectiveness," the ground truth would be based on patient outcomes, imaging follow-up (e.g., to confirm tumor ablation), and adverse event monitoring. However, the specific methods for establishing ground truth are not explicitly detailed.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or machine learning. The "comparative in vivo and ex vivo product testing" and "independent clinical studies" serve as performance validation, not as training for an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the provided information, this question is not applicable.
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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: 303-530-6247
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 (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 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) |
|---|
| -------------------------------------------------------- |
elmoe
(Division Sign-Of Division of General, Restorative. and Neurological Devices
Page __ of ___
(Posted November 13, 2000(k) Number_ K053290
§ 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.