(26 days)
Not Found
No
The summary describes a radiofrequency generator that controls energy delivery, measures parameters, and displays information. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing focuses on electrical, mechanical, thermal, and software verification/validation, which are standard for medical devices and do not indicate AI/ML.
Yes
The device is used for vessel and tissue coagulation, which is a therapeutic intervention.
No
The device is described as a radiofrequency generator used for vessel and tissue coagulation, not for diagnosing medical conditions. It supplies, measures, and displays RF output power, load impedance, and elapsed time of RF delivery, and interfaces with a sensor for temperature display during RF delivery, all of which are related to therapy delivery, not diagnosis.
No
The device description explicitly states it is a "Radiofrequency Generator" and details its hardware functions like supplying, measuring, and displaying RF output power, impedance, and temperature. It also mentions mechanical, electrical, and thermal testing, indicating it is a physical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "vessel and tissue coagulation" using radiofrequency energy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a generator that delivers RF energy to catheters for coagulation. It measures and displays parameters related to the energy delivery and temperature within the tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze biological specimens.
The device is a therapeutic device used for a surgical procedure.
N/A
Intended Use / Indications for Use
The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel and tissue
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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
1
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
2
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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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
3033 Campus Drive
Plymouth, MN 55441
Tel: 763-398-7000
Fax: 763-591-3248 |
|----------------|-----------------------------------------------------------------------------------------------|
| Contact Person | Laura Moen-Ftacek
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).