(123 days)
The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.
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 clectrodes 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.
Here's an analysis of the provided text regarding the Cool-tip™ RF Ablation System, extracting the requested information about acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be > X%"). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance aspect focuses on safety and effectiveness.
| Acceptance Criterion Type | Description from Document | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | "Independent Clinical data have shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions." | "safe and effective with regard to ablation of osteoid osteoma lesions." |
| Technological Characteristics | "The Cool-tip™ RF Ablation System has the same basic technological characteristics as the predicate devices noted above." | Implied to be equivalent to predicate devices (K984552, K042216 ) in terms of generator, pump, electrodes, cooling, and monopolar operation. |
| Intended Use | "The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone." | The FDA found the device substantially equivalent for the stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Independent Clinical data has shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions."
- Sample Size: The exact sample size for the clinical data is not specified in this 510(k) summary.
- Data Provenance: The country of origin of the data is not specified. The document only mentions "Independent Clinical data." It also does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. The document does not detail how the ground truth for the clinical data, specifically regarding the "ablation of osteoid osteoma lesions," was established or by whom.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The submission focuses on the performance of the device itself, not on human readers' interpretive abilities with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is an RF ablation system, a surgical instrument, not an AI or diagnostic algorithm. Therefore, a "standalone algorithm only" study, as typically understood in the context of AI performance, is not applicable and was not performed or described. The clinical data evaluates the device's physical effect on tissue.
7. Type of Ground Truth Used
Based on the nature of the device (RF ablation system for osteoid osteoma lesions), the ground truth for effectiveness ("ablation of osteoid osteoma lesions") would most likely be established through:
- Histopathology/Pathology: Examination of tissue samples post-ablation to confirm coagulation/necrosis.
- Imaging Follow-up: Post-procedural imaging (e.g., MRI, CT) to assess the extent of ablation and lesion necrosis.
- Clinical Outcomes Data: Resolution of symptoms associated with the osteoid osteoma.
However, the specific method used to establish ground truth is not explicitly stated in the document.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning algorithms. Since the Cool-tip™ RF Ablation System is a physical medical device and not an AI algorithm, a "training set" in this context is not applicable and therefore, no sample size for such a set is provided.
9. How the Ground Truth for the Training Set Was Established
As answered in point 8, the concept of a "training set" is not applicable to this physical medical device. Therefore, the method for establishing ground truth for a training set is not relevant or described.
{0}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
< 052796
Page 1 of 2
Cool-tip™ RF Ablation System
Submitter Information 1.
Valleylab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 Contact: Robert C. Moore Manager, Regulatory Telephone: 303-530-6241
Date summary prepared: February 3. 2006
Name of Device 2.
Trade or Proprietary Name: Cool-tip™ RF Ablation System
Common/Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
Predicate Devices 3.
The Cool-tip™ RF Ablation System is substantially equivalent to the following legally marketed medical devices:
Device Description 4.
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 clectrodes 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.
2006 FEB 3
{1}------------------------------------------------
K 052796
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.
ട്. Intended Use
The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.
6. Summary of Technological Characteristics
The Cool-tip™ RF Ablation System has the same basic technological characteristics as the predicate devices noted above.
7. Performance and Clinical Data
Independent Clinical data have shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
FEB 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert C. Moore, Jr., RAC Manager, Regulatory Compliance Vallevlab A division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, Colorado 80301-3299
Re: K052796
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: January 31, 2006 Received: February 1, 2006
Dear Mr. Moore:
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. Moore
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" (21 CFR 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/industry/support/index.html.
Sincerely yours
Sincerely yours,
farbay Buchner
Mark N. Melkerson Acting 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) K052796
Device Name: Cool-tip™ RF Ablation System
Indications For Use:
"The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone."
PLEASE DO NOT WRITE BELOW THIS I INE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21CFR 801.109) OR
Over-The Counter Use ________
(Optional Format 1-2-96)
Darbaro Buehus
(Division Sign-Off)
Division of General. Restorative. and Neurological Devices
510(k) Number K052796
§ 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.