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.

AI/ML Overview

This document is a 510(k) premarket notification for the ClosureRFG Radiofrequency Generator, a medical device. It does not contain information about acceptance criteria or a study proving device meets acceptance criteria in the format requested. The document describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria values, reported device performance metrics, sample sizes, ground truth establishment, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the specific studies.

However, I can extract the following information that is present in the document:

Device Name: ClosureRFG Radiofrequency Generator
Intended Use: The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.
Type of Testing Performed (as listed in Section 7):
- Mechanical
- Mechanical Strength
- Electrical
- Thermal
- Environmental
- Electromagnetic Compatibility and Electrical Safety
- Packaging Integrity
- Software Verification and Validation
- Simulated Use
- Tissue Model
Conclusion of Testing (Section 7 and 8): "The results of the testing demonstrate that the RFG3 meets all requirements and has comparable performance to the predicate device." and "Covidien considers the proposed RFG3 to be substantially equivalent to the currently marketed VNUS Radio Frequency Generator - RFGPlus Model RFG2 (K040638)."

Missing Information (not found in the provided document):

Table of acceptance criteria and reported device performance: Specific values are not provided.
Sample sizes used for the test set and data provenance: No details on the number of units tested, the source of data, or whether it was retrospective/prospective.
Number of experts used to establish ground truth for the test set and their qualifications: Not applicable for this type of device (an electrosurgical generator). Ground truth in this context would likely be based on technical specifications and engineering standards, not expert clinical consensus.
Adjudication method for the test set: Not applicable for this type of device.
MRMC comparative effectiveness study: Not conducted as this is an energy generator and not an AI-assisted diagnostic or prognostic device.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not explicitly stated but would be based on engineering specifications, regulatory standards, and established physical principles for electrosurgical devices.
Sample size for the training set: Not applicable, as this is hardware with software, not a machine learning algorithm that is "trained" in the typical sense.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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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	Covidien3033 Campus DrivePlymouth, MN 55441Tel: 763-398-7000Fax: 763-591-3248
Contact Person	Laura Moen-FtacekRegulatory 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

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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).

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.