(88 days)
Not Found
No
The description focuses on hardware components, basic control mechanisms (manual and impedance control), and monitoring of physical parameters (impedance, current, power, temperature). There is no mention of AI, ML, or any learning or adaptive algorithms.
Yes.
The device is intended for the "coagulation and ablation of tissue" and is used to ablate "non-resectable liver lesions," indicating a direct therapeutic action on the body.
No
The device is intended for the coagulation and ablation of tissue, which is a therapeutic function, not a diagnostic one. While it monitors parameters like impedance and temperature during the procedure, this monitoring is for controlling the therapeutic delivery rather than for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a generator, pump, electrodes, tubing, and return pads. It is a system that utilizes software to control these hardware components for RF ablation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that delivers RF energy to heat and destroy tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action directly on the patient.
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 lesions."
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
percutaneous, laparoscopic and intraoperative
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
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.
Key Metrics
Not Found
Predicate Device(s)
K984552, K993944, K021329, K031257, K031926, K012315, K000241
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Pago
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 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.
1
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.
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.
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.
2
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.
3
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
4
Page 1 of 1
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)
OR
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