(76 days)
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.
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.
The Cool-tip™ Switching Controller is an adjunct device for the Cool-tip™ RF Ablation Generator, designed to facilitate the simultaneous activation of multiple electrodes. It routes power from the generator, allowing the physician to ablate lesions with one single electrode, one cluster electrode, or simultaneously with two or three pre-placed electrodes. The controller sequentially switches power between electrodes until the selected procedure time is reached. It also automates the manual function of cauterization during electrode removal.
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
The provided text does not explicitly state numerical acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity). Instead, the acceptance is based on the device demonstrating safety and efficacy comparable to a predicate device. The key performance aspect is the ability of the switching controller to produce similar therapeutic effects (lesions) as the predicate device when using various electrode configurations.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Efficacy: The Cool-tip™ Switching Controller, when used with the Cool-tip™ RF Ablation Generator and various electrode configurations, should be safe and efficacious for tissue ablation, producing lesions comparable to those produced by the Cool-tip™ Generator alone with the same electrode configurations. | "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." |
| Functional Equivalence: The controller should not alter the basic functions (timing, temperature measurement, impedance measurement, power available at electrodes) or control mechanisms of the generator, and maintain the same indications for use. | The document explicitly states: "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." |
| Intended Use: The device's intended use should remain identical to that of the predicate device (Cool-tip™ RF System). | The document states: "The intended use of the Cool-tip™ Switching Controller is identical to that of the Cool-tip™ 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.'" |
2. Sample Size Used for the Test Set and Data Provenance
The study involved preclinical testing on bovine liver, both ex vivo (outside the body) and in vivo (in a living organism). The document does not specify a precise numerical sample size (e.g., number of livers, number of ablation procedures, or number of electrodes tested).
However, the data provenance is clearly stated as bovine liver, indicating an animal model. The study is described as "preclinical testing," implying it's a prospective study designed to compare the new device to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. The comparison of lesion characteristics likely involved direct measurement and observation rather than expert consensus on a diagnostic outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This device is an accessory to an existing RF ablation system and its performance demonstration focuses on the equivalence of the generated lesions, not on diagnostic accuracy involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The Cool-tip™ Switching Controller is a hardware accessory that automates power delivery for RF ablation electrodes. It does not involve algorithms for interpretation or generate diagnostic outputs that would have a "standalone performance" in the typical sense of AI/software. Its performance is intrinsically tied to its interaction with the RF generator and electrodes.
7. The Type of Ground Truth Used
The ground truth for this study was based on the characteristics of the lesions produced by the RF ablation. The statement "lesions produced... are comparable" implies a physical assessment of ablation zones (e.g., size, shape, completeness) as the reference for comparison. This would likely involve macroscopic and/or microscopic examination of the ablated tissue.
8. The Sample Size for the Training Set
The document does not mention a training set. This is not a machine learning device, so the concept of a training set as used in AI development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this hardware device, this question is not applicable.
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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.
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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 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.
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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
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| 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)
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Division of General, Restorative. and Neurological Devices
510(k) Number 107046
§ 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.