(76 days)
No
The device description details a system that sequentially switches power based on pre-set parameters (impedance rise, time elapsed). There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The control mechanisms are described as remaining the same as the generator, which is a non-AI/ML device.
Yes
The device is described as being used for "coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone," which are therapeutic interventions.
No.
The device is used for tissue ablation, not for diagnosing conditions. It performs therapeutic functions like coagulation and ablation of tumors.
No
The device description explicitly details hardware components such as an on/off power switch, activation switches, displays, buttons, electrode ports, and cables. It also describes the physical routing of power and the connection to a generator, indicating it is a physical device with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description details how the device delivers power to electrodes for tissue ablation. This is an interventional procedure, not a diagnostic test performed on a sample.
- 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. The device's function is to physically alter tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone."
Product codes
GEI
Device Description
The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator.
The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal.
The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel.
The Cool-tip™ Switching Controller is comprised of the following components:
- Switching controller
- Cable, which delivers power from the generator to the controller .
The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue, non-resectable liver tumors, osteoid osteoma tumors within bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / percutaneous, laparoscopic, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical testing on bovine liver (ex vivo and in vivo) verified that the lesions produced using the Cool-tip™ Switching Controller and Cool-tip™ Generator, along with various electrode configurations, are comparable to those lesions produced by the Cool-tip Generator only and with the same electrode configurations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973297, K984552, K042216, K052796, K053290
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
Ko 70446
Page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Cool-tip™ Switching Controller
1. Submitter Information
Valleylab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 Contact: Julie Ross Senior Requlatory Associate Telephone: 303-581-6773
MAY - 2 2007
Date summary prepared: February 14, 2007
2. Name of Device
Trade or Proprietary Name: Cool-tip™ Switching Controller
Common/Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
3. Predicate Devices
The intended use of the Cool-tip™ Switching Controller is identical to that of the Cooltip™ RF System. The Cool-tip™ RF System received initial FDA clearance in 510(k)s K973297 (10/29/97) and K984552 (3/5/99). Additional clearance with the Cool-tip™ RF System was obtained for specific claims under 510(k)s K042216 (Liver lesions. 11/12/04), K052796 (Osteoid Osteoma claim, 2/3/06) and K053290 (Liver tumor claim, 3/15/06).
4. Device Description
The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached.
The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator.
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K07046
Page 2 of 2
The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal.
The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displaysand buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel.
The Cool-tip™ Switching Controller is comprised of the following components:
- . Switching controller
- Cable, which delivers power from the generator to the controller .
The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.
5. Intended Use
The intended use of the Cool-tip™ Switching Controller is identical to that of the Cooltip™ RF System, as follows:
"The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone."
6. Summary of Technological Characteristics
The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple pre-placed electrodes. The Cool-tip™ Switching Controller has the same basic technological characteristics as the predicate device noted above.
7. Performance and Clinical Data
Radiofrequency ablation with the Cool-tip™ Switching Controller has proven to be safe and efficacious for the ablation of tissue. Preclinical testing on bovine liver (ex vivo and in vivo) verified that the lesions produced using the Cool-tip™ Switching Controller and Cool-tip™ Generator, along with various electrode configurations, are comparable to those lesions produced by the Cool-tip Generator only and with the same electrode configurations.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2007
Valleylab % Ms. Julie Ross Senior Regulatory Associate 5920 Longbow Drive Boulder, Colorado 80301-3299
Re: K070446
Trade/Device Name: Cool-tip™ Switching Controller Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 14, 2007 Received: February 15, 2007
Dear Ms. Ross:
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. Ilsting 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 - Ms. Julie Ross
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ers,
DR Peter D. Remm
kerson
Dep. D.M. 07
7/2
Mark N. Melkerson 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): | KO70446 |
|---|---|
| --------------------------- | --------- |
Device Name: Cool-tip™ Switching Controller
Indications for Use:
"The Cool-tip™ RF Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liven tumors, and osteoid osteoma tumors within bone."
Prescription Use ✔ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Page __ of
AM
Division of General, Restorative. and Neurological Devices
510(k) Number 107046