(78 days)
Not Found
No
The description focuses on electrosurgical principles and hardware, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the "Treatment of incompetent (i.e., refluxing) perforator and tributary veins," which is a therapeutic application.
No
The device is described as an electrosurgical system for coagulation, indicating it performs a therapeutic action rather than diagnosing a condition. It delivers energy and relays feedback, but this feedback is for treatment monitoring, not diagnostic assessment.
No
The device description explicitly states it is a bipolar, high frequency electrosurgical system and a sterile disposable device, indicating it is a hardware device that delivers energy.
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" and "Treatment of incompetent (i.e., refluxing) perforator and tributary veins." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a "bipolar, high frequency electrosurgical system" that delivers "bipolar RF energy to the desired treatment site." This is a description of a surgical tool used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions by examining samples taken from the body.
Therefore, the VNUS RFS and RFSFlex devices are therapeutic devices used in surgical procedures, not IVDs.
N/A
Intended Use / Indications for Use
The VNUS RFS and RFSFlex Devices are intended for use in vessel and tissue coagulation including: Treatment of incompetent (i.e., refluxing) perforator and tributary veins.
Product codes
GEI
Device Description
The VNUS RFS family of devices is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where blood vessel and tissue coagulation is desired. These devices are compatible with separately cleared Radiofrequency (RF) Generator, and the Instrument Cable manufactured by VNUS Medical Technologies. The VNUS RFS family of devices are sterile disposable devices intended for a singleuse only. The device's function is to deliver bipolar RF energy to the desired treatment site and relay temperature and other feedback to the RF Generator. The disposable device is available in 2 bipolar configurations and multiple lengths for selection by the physician based on preference for method of vessel access, location and length of the vessel to be treated. This submission reflects a name change, minor modification of the indication statement (more specific inclusion of perforator and tributary veins), and minor design changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel and tissue, perforator and tributary veins
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)
Results of in-vitro testing demonstrate that the VNUS RFS and RFSFlex devices are safe and effective for their intended function. The materials used in the VNUS RFS and RFSFlex Devices have been shown to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982816, K003092, K030557, K033547
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
VNUS® RFS and RFSFlex Devices
Summary of Safety and Effectiveness
- Determination of Substantial Equivalence A. VNUS RFS and RFSFlex devices
B. Common Name
Bipolar Electrosurgical Instrument
C. Predicate Device(s)
VNUS® Closure® System (K982816, K003092, and K030557); and VNUS® Vessel and Tissue Coagulation System (proprietary name: TBD) (K033547)
D. Device Description
The VNUS RFS family of devices is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where blood vessel and tissue coagulation is desired. These devices are compatible with separately cleared Radiofrequency (RF) Generator, and the Instrument Cable manufactured by VNUS Medical Technologies.
The VNUS RFS family of devices are sterile disposable devices intended for a singleuse only. The device's function is to deliver bipolar RF energy to the desired treatment site and relay temperature and other feedback to the RF Generator. The disposable device is available in 2 bipolar configurations and multiple lengths for selection by the physician based on preference for method of vessel access, location and length of the vessel to be treated. This submission reflects a name change, minor modification of the indication statement (more specific inclusion of perforator and tributary veins), and minor design changes.
ய் Intended Use
The VNUS RFS and RFSFlex Devices are intended for use in vessel and tissue coagulation including:
- Treatment of incompetent (i.e., refluxing) perforator and tributary veins .
Intended Use of Predicate Devices F.
The specified predicate devices are indicated for "coagulation of blood vessels in patients with superficial vein reflux" (VNUS Closure System) and "vessel and tissue coagulation" (VNUS Vessel and Tissue Coagulation System).
G. Technological Comparison
RF energy has been widely used in electrosurgical equipment for many years. The safety and efficacy of such devices has been well established for a variety of intended uses. The use of bipolar RF energy delivery has potential advantages over monopolar systems. No grounding pads are required, and the potential for damage to adjacent tissue is minimized, as the patient is no longer the return path for electrical current. The efficiency of bioolar RF energy delivery allows systems such as the VNUS RF Generator to be used at lower voltage and power settings as compared with monopolar systems.
1
Page 2 of (2)
The technological characteristics and principals of operation of the VNUS RFS family of devices are substantially equivalent to the noted predicate devices relv on the delivery of RF energy to achieve their intended use.
Discussion of Clinical/Non-Clinical Tests and Conclusions H.
Performance
Results of in-vitro testing demonstrate that the VNUS RFS and RFSFlex devices are safe and effective for their intended function.
Biocompatibility
The materials used in the VNUS RFS and RFSFlex Devices have been shown to be biocompatible.
l. Summary of Safety and Effectiveness
Based upon the intended use, design, materials, function, comparison with currently marketed devices and the non-clinical testing it is concluded that the VNUS RFS and RFSFlex Devices are substantially equivalent to the noted predicate devices. The RF ablation/coagulation of blood vessels (i.e., VNUS Closure) has a well-established history of safe an efficacious use in over 100,000 procedures.
Signature
Brady Esch . Directory, R&D VNUS Medical Technologies, Inc.
2
Public Health Service
0C1 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VNUS Medical Technologies, Inc. c/o Sam Nanavati 750 Chesapeake Drive Redwood City, California 94063
Re: K052003
Trade/Device Name: VNUS® RFS and RFS Flex Devices Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 22, 2005 Received: July 25, 2005
Dear Mr. Nanavati:
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 adultcration.
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 docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Sam Nanavati
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Harlow Annett
to!
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name: Derices VNUS® RFS and RFSFlex
510(k) Number (if known):
): K052003
Indications for Use:
The VNUS RFS and RFSFlex devices are intended for use in vessel and tissue coagulation including:
Treatment of incompetent (i.e., refluxing) perforator and tributary veins .
Over the Counter Use: (Per 21 CFR 801.109)
or
Prescription Use:
(Please do not write below this line - continue on another Page if needed)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Caitano Pereira
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052005
. - -
Premarket Notification [510(K)] Submission
Page 42