VALLEYLAB MICROWAVE ABLATION GENERATOR by COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON

The Valleylab Microwave Ablation Generator is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

Device Description

The Valleylab Microwave Ablation Generator is designed to provide microwave power for the ablation of soft tissue in medical procedures. It was cleared for commercial distribution (K011676) by demonstrating substantial equivalence to existing Radiofrequency and Microwave Ablation systems.

The Microwave Ablation Generator is designed to be used with proprietary microwave antennas (cleared in K011676 and K032702) which are placed directly into the tissue to be ablated. The Valleylab Microwave Ablation Generator is a nonsterile electrical device that is not intended to contact the patient.

The Microwave Ablation Generator is used with a pump to circulate cooling fluid (sterile saline) to the antennas, and an optional integrated cart. The device's power output and duration (time) are controlled by the user via manual controls on the front panel of the generator. The display on the front of the device shows power (watts), duration of power delivery (minutes and seconds), and elapsed time.

The antenna is connected to the generator and radiates power to the tissue under treatment. The antennas are provided sterile, for single use only. The shaft of each antenna is made of insulated stainless steel. Three antennas of different lengths are available for use in percutaneous procedures, and a single length antenna fing surgical procedures. The active portion of the antenna is 3.7cm in length for all models. The percutaneous antennas are cooled by circulating sterile saline through the antenna. The surgical antennas are not internally cooled. The system pump circulates fluid from a reservoir to the antenna through sterile tubing. Sterile fluid is confined within the antenna and tubing, and does not contact the patient.

AI/ML Overview

This appears to be a 510(k) summary for the Valleylab Microwave Ablation Generator, seeking to expand its intended use to include the ablation of non-resectable liver tumors.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the expanded indication in a quantitative, tabular format. Instead, it describes comparative non-clinical testing and refers to existing clinical studies.

Acceptance Criteria (Implied)	Reported Device Performance
Non-clinical Equivalence (Lesion Characteristics): Ablation size and geometry of lesions should be comparable to predicate devices, and lesions should have similar pathologic and imaging characteristics.	Bench Testing (Bovine Livers) & In-vivo Testing (Porcine Livers): Compared ablation size and geometry with predicate Cool-tip™ RF System. "In some instances there was a difference in lesion size. However, the lesions that are generated by both systems have similar pathologic and imaging characteristics."
Safety and Effectiveness for Liver Tumor Ablation	Clinical Testing (Review of Existing Studies): "A review of the existing studies have shown that the use of the system to be clinically safe and effective for ablation of liver tumors."
Compliance with Safety Standards	"evaluation of the device to the current versions of the relevant safety standards" (No specific results provided, but implies compliance was met).
Thermal Profile Performance	"thermal profile testing" (No specific results provided).
Performance in proximity to vasculature	"evaluation of ablation characteristics next to vasculature" (No specific results provided).
Software Functionality	"software testing" (No specific results provided).

2. Sample Size Used for the Test Set and Data Provenance

Non-clinical Testing (Bench and In-vivo):
- Sample Size: Not explicitly stated (e.g., number of livers, number of ablations). It mentions "single and multiple antenna comparisons."
- Data Provenance:
  - Bench Testing: Bovine livers (ex-vivo, not human or patient data).
  - In-vivo Testing: Porcine livers (animal model, not human or patient data).
  - Retrospective/Prospective: These were likely prospective studies designed for this submission.
Clinical Testing:
- Sample Size: Not explicitly stated. The document refers to "A review of the existing studies," implying a synthesis of previously conducted research rather than a new clinical trial undertaken for this submission.
- Data Provenance: Not specified, but generally, human clinical studies would be prospective or retrospective patient data from various clinical sites. The text indicates "existing studies," so it would be entirely retrospective in relation to this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document for either the non-clinical or clinical testing.

4. Adjudication Method for the Test Set

This information is not provided in the document. For the non-clinical testing, it mentions lesions were "evaluated histologically and physically," which implies some form of assessment, but not an adjudication method. For the clinical testing, as it's a "review of existing studies," the adjudication method would depend on the individual studies reviewed, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This document describes a device for microwave ablation, not an AI/CAD (Computer-Aided Detection/Diagnosis) device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted as described in this summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm. It's a medical device (generator and antennas) for tissue ablation. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

Non-clinical Testing (Bovine/Porcine Livers):
- Histology: Lesions were "evaluated histologically." This implies detailed microscopic examination of tissue.
- Physical Evaluation: Lesions were also evaluated "physically," likely referring to gross measurements and visual inspection.
- This combines expert assessment (histology interpretation) with direct measurement.
Clinical Testing (Review of Existing Studies):
- The document states the review "shown that the use of the system to be clinically safe and effective." This often implies ground truth established through a combination of:
  - Pathology: Confirmation of tumor type and complete ablation in excised specimens or biopsies.
  - Imaging Follow-up: Assessment of tumor recurrence or residual disease using modalities like CT, MRI, or ultrasound.
  - Clinical Outcomes Data: Patient survival, complications, quality of life, etc.
- The specific methods for establishing ground truth within the "existing studies" are not detailed in this summary.

8. The Sample Size for the Training Set

This document does not describe the development of an algorithm that would require a "training set." It's a hardware device (microwave ablation generator). Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

As explained above, this concept is not applicable to the device described.

Summary

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510(k) Summary or 510(k) Statement

510(k) Summary

Submitter Information: NOV 2 5 2008

Covidion

Energy-based Devices Formerly known as Valleylab, a Division of Tyco Healthcare LP 5920 Longbow Drive Boulder, CO Contact: Philip E. Ake Senior Regulatory Associate Phone: 303-581-6934 Fax: 303-230-6313 Email: Philip.Ake@Covidien.com

Name of Device

Trade name: Valleylab Microwave Ablation Generator Common/Classification name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)

Predicate Devices

The Valleylab Microwave Ablation Generator is substantially equivalent to the following legally marketed medical devices:

VivaWave Microwave System (K011676) ●
Cool-tip™ RF System (K053290) .

Device Description 4.

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panel of the generator. The display on the front of the device shows power (watts), duration of power delivery (minutes and seconds), and elapsed time.

Intended Use

The MW Ablation Generator is not intended for use in cardiac procedures

Summary of Technology Characteristics

The Valleylab Microwave Ablation Generator operates at 915 MIIZ. The generator is capable of operating up to 60 W. The amount of power delivered depends on the antenna used and is controlled by the generator firmware. The user has the ability to select the desired power and time limits within the system specifications. The generator firmware is responsible for the system error codes.

The technological characteristics of the Valleylab Microwave Ablation generator are not being modified; this 510(k) is for a change to the intended use of the device.

The original Intended Use of the MW Ablation generator was for use on soft tissue. This submission expands the intended use to include partial or complete ablation of non-resectable liver tumors. The Cool-tip generator intended use includes ablation of liver tumors.

Summary Non-clinical testing

Bench Testing was conducted on bovine livers and in-vivo testing on porcine livers to compare the ablation size and geometry of lesions created by the Microwave Ablation Generator and the Cool-tip™ RF System. The testing included single and multiple antenna comparisons. The lesions were evaluated histologically and physically. The testing revealed that in some instances there was a difference in lesion size. However, the lesions that are generated by both systems have similar pathologic and imaging characteristics.

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Other testing included: thermal profile testing, performance testing, evaluation of ablation characteristics next to vasculature, an evaluation of the device to the current versions of the relevant safety standards, and software testing.

Summary of Clinical testing

A review of the existing studies have shown that the use of the system to be clinically safe and effective for ablation of liver tumors.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2008

Covidien, % Mr. Philip E. Ake Senior Regulatory Associate 5920 Longbow Drive Boulder, Colorado 80301-3299

Re: K072687

Trade/Device Name: Valleylab Microwave Ablation Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: November 14, 2008 Received: November 17, 2008

Dear Mr. Ake:

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.

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Page 2 - Mr. Philip E. Ake

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances 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.

Mark M. Mulhern

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 Statement

510(k) Number (if known):

Device Name: Valleylab Microwave Ablation Generator

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Williams

(Division Sign-Off) (Division Sign of General, Restorative, Divisionomical Devices

510(k) Number

Regulation Number and Section

§ 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.