CLOSURERFG RADIOFREQUENCY GENERATOR

K141858 · Covidien · GEI · Aug 5, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141858
• Device Name: CLOSURERFG RADIOFREQUENCY GENERATOR
• Applicant: Covidien
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 5, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.

Device Story

ClosureRFG Radiofrequency Generator (RFG3) delivers controlled radiofrequency (RF) energy to compatible endovenous RF catheters and stylets; used for vessel and tissue coagulation. Device measures and displays RF output power, load impedance, and elapsed delivery time; interfaces with catheter-based sensors for continuous temperature monitoring during operation. Used in clinical settings by healthcare professionals. Output data assists clinicians in monitoring energy delivery parameters to ensure effective coagulation. Benefits include controlled thermal treatment of vessels.

Clinical Evidence

Bench testing only. Verification and validation included mechanical strength, electrical safety, electromagnetic compatibility, thermal performance, environmental testing, packaging integrity, software verification/validation, simulated use, and tissue model testing. Results demonstrate performance comparable to the predicate.

Technological Characteristics

Electrosurgical generator for RF energy delivery. Features include RF output power control, impedance monitoring, and temperature sensing. Connectivity includes interface with compatible RF catheters. Software-controlled user interface. Design verification included mechanical, electrical, and thermal testing.

Indications for Use

Indicated for use with radiofrequency catheters for vessel and tissue coagulation.

Regulatory Classification

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.

Predicate Devices

• VNUS™ Radio Frequency Generator – RFGPlus Model RFG2 (K040638)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2014

Covidien Ms. Laura Moen-Ftacek Regulatory Affairs Product Manager 3033 Campus Drive Plymouth, Minnesota 55441

Re: K141858

Trade/Device Name: ClosureRFG Radiofrequency Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 9, 2014 Received: July 10, 2014

Dear Ms. Ftacek:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name

ClosureRFG Radiofrequency Generator

### Indications for Use (Describe)

The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/1 description: The image contains the word "COVIDIEN" in blue font. To the left of the word is a blue square with a white square in the middle. The blue square is divided into four smaller squares, with the top left and bottom right squares being a darker shade of blue than the other two.

## 510(k) Summary

## ClosureRFG™ Radiofrequency Generator

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R § 807.92.

#### 1 Submitter Information

| Applicant | Covidien<br>3033 Campus Drive<br>Plymouth, MN 55441<br>Tel: [phone]<br>Fax: [phone] |
|----------------|-----------------------------------------------------------------------------------------------|
| Contact Person | Laura Moen-Ftacek<br>Regulatory Affairs Product Manager |
| Date Prepared | July 9, 2014 |

#### 2 Subject Device

| Device Trade Name | ClosureRFG™ Radiofrequency Generator |
|---------------------------|----------------------------------------------------------------|
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation | 21 CFR 878.4400 |
| Product Code | GEI |
| Classification Panel | General and Plastic Surgery |

#### 3 Predicate Devices

| Device Trade Name | VNUS™ Radio Frequency Generator – RFGPlus Model RFG2 |
|-----------------------|------------------------------------------------------|
| 510(k) Number | K040638 |
| 510(k) Clearance Date | June 7, 2004 |

#### 4 Device Description

The ClosureRFG Radiofrequency Generator (RFG3) is designed to provide controlled delivery of radiofrequency (RF) energy to RF catheters marketed by Covidien. The RFG3 is for use with the ClosureFast™ endovenous radiofrequency catheters and ClosureRFSTM endovenous radiofrequency stylet, intended for vessel and tissue coagulation.

The RFG3 supplies, measures, and displays RF output power, load impedance (displayed for ClosureRFS only), and elapsed time of RF delivery. The RFG3 also interfaces with a sensor in the catheter to provide a continuous display of measured temperature during RF delivery.

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Image /page/4/Picture/1 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle inside, and the word "COVIDIEN" in blue, sans-serif font. The square is divided into three vertical sections, with the center section being a lighter shade of blue. The word "COVIDIEN" is located to the right of the square.

#### 5 Indications for Use

The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.

#### Comparison of Technological Characteristics 6

The proposed RFG3 is substantially equivalent to the currently marketed VNUS Radio Frequency Generator - RFGPlus Model RFG2 (K040638). The proposed and predicate devices share the following technological characteristics:

- Indications for Use/Intended Use
- Fundamental Scientific Technology
- Principles of Operation ●
- Compatibility with commercially available RF Catheters

Modifications have been made the generator enclosure and to the overall user interface to increase the ease of use of the device and provide a state of the art user experience. They do not impact the safety and effectiveness of the device.

#### 7 Performance Testing Summary

To demonstrate substantial equivalence of the proposed RFG3 to the predicate device, the following design verification and validation testing was performed:

- Mechanical ●
- Mechanical Strength ●
- Electrical ●
- Thermal ●
- Environmental
- Electromagnetic Compatibility and Electrical Safety
- Thermal
- Environmental ●
- Packaging Integrity
- Software Verification and Validation ●
- Simulated Use ●
- . Tissue Model

The results of the testing demonstrate that the RFG3 meets all requirements and has comparable performance to the predicate device.

#### 8 Conclusions

Based on the intended use, technological characteristics, safety and performance testing included in this submission. Covidien considers the proposed RFG3 to be substantially equivalent to the currently marketed VNUS Radio Frequency Generator - RFGPlus Model RFG2 (K040638).