(110 days)
Not Found
No
The device description focuses on hardware components, basic signal processing (monitoring impedance, current, power, temperature), and manual or impedance-controlled operation. There is no mention of AI, ML, or any learning algorithms.
Yes
The device is intended for the "coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors," which directly treats a medical condition.
No
The device is an RF ablation system used for tissue coagulation and ablation, primarily for treating non-resectable liver tumors. Its function is therapeutic (destroying tissue), not diagnostic (identifying or characterizing a condition).
No
The device description clearly outlines multiple hardware components including a generator, peristaltic pump, electrodes, tubing, and return pads. It is a system that includes both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors." This describes a therapeutic procedure performed directly on the patient's tissue in vivo.
- Device Description: The device description details a system that delivers radiofrequency energy to heat and destroy tissue. This is a therapeutic intervention, not a diagnostic test performed on samples in vitro.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
The device is a therapeutic device used for tissue ablation, not a diagnostic device.
N/A
Intended Use / Indications for Use
"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."
Product codes (comma separated list FDA assigned to the subject device)
GEI
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 monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
1
KOS3290
Page 2 of 2
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
2
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
3
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
4
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