K Number
K072687
Device Name
VALLEYLAB MICROWAVE ABLATION GENERATOR
Date Cleared
2008-11-25

(428 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

No
The description focuses on the hardware and manual controls for power and duration, with no mention of AI or ML capabilities.

Yes

The device is intended for the "coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors," which directly describes a therapeutic application to treat a medical condition.

No

This device is designed for therapeutic ablation of soft tissue, including tumors, not for diagnosing medical conditions.

No

The device is a Microwave Ablation Generator, which is a physical electrical device that generates microwave power and is used with physical antennas and a pump. It is not solely software.

Based on the provided information, the Valleylab Microwave Ablation Generator is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for "coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors." This is a therapeutic procedure performed directly on the patient's tissue.
  • Device Description: The device is a "nonsterile electrical device that is not intended to contact the patient." It provides microwave power to antennas that are placed into the tissue. This is a direct intervention on the patient's body.
  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The Valleylab Microwave Ablation Generator does not perform any such analysis of specimens.

The device is a therapeutic medical device used for tissue ablation within the patient's body.

N/A

Intended Use / Indications for Use

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.

Product codes

NEY

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 for 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue, liver tumors

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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.
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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K011676, K053290

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

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

$\omega$ 72687

Page 1 of 3

510(k) Summary or 510(k) Statement

510(k) Summary

  1. 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

  1. Name of Device

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

  1. 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.

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

1

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Page 2 of 3

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.

  1. Intended Use

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.

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

  1. 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.

  1. 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.

2

Ko7 2687

Page 3 of 3

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.

  1. 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.

3

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.

4

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

5

Ko 72687

Indications for Use Statement

510(k) Number (if known):

Device Name: Valleylab Microwave Ablation Generator

Indications for Use:

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.

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