(89 days)
K0033547
Not Found
No
The description mentions a microprocessor and software control but does not include any terms or descriptions indicative of AI or ML capabilities.
Yes
The device is described as a radiofrequency generator intended for vessel and tissue coagulation, which is a therapeutic medical procedure.
No
The device description states it is a "Radiofrequency Generator ... intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation." This describes a therapeutic device used for treatment (coagulation), not a diagnostic device used for identifying a condition or disease.
No
The device description explicitly states it is a "bipolar, high frequency electronic, microprocessor and software controlled instrument" and mentions hardware components like the generator itself, instrument cable, and compatibility with disposable RF delivery devices (catheters). This indicates it is a hardware device with integrated software control, not a software-only medical device.
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 description details a generator that delivers radiofrequency energy through disposable devices (catheters) to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are used to provide information about a patient's health status based on the analysis of these samples.
This device is a therapeutic medical device used for a surgical or interventional procedure.
N/A
Intended Use / Indications for Use
The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.
Product codes
GEI
Device Description
The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, microprocessor software-controlled instrument. It allows the user to set Power, Temperature and Time (Set-points and measured values) as well as measured impedance and user messages. The device is for use in a clinical environment during use, and is provided non-sterile.
The model RFG2 is compatible only with the disposable RF delivery devices (e.g., VNUS Closure Catheters) marketed by VNUS Medical Technologies under separate clearance(s).
The instrument cable connects the disposable device to the RF generator. The instrument cable is provided non-sterile and is user sterilizable by autoclave. It has been validated to withstand multiple steam sterilization cycles. With disposable devices that include an integrated cable, a separate instrument cable is not necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 will demonstrate that the VNUS Radiofrequency Generator is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0033547
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
Page 1 of
510(k) Notification
JUN - 7 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k)-safety and effectiveness information is being submitted in This summary of JTO(K)-Salety and SRSCR 3390 and 21 CFR 807.92.
accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: March 1, 2004
KO40638 510(k) number: _______________________________________________________________________________________________________________________________________________________________
Applicant Information: VNUS Medical Technologies, Inc. 2200 Zanker Avenue, Suite F San Jose, CA 95131
FDA Registration Number: 2953189
Contact Person
| Sam Nanavati | |
|---|---|
| Phone Number: | (408) 473-1140 |
| Fax Number: | (408) 944-0292 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | VNUS Radiofrequency Generator, Model RFG2 |
| Classification Name: | Electrosurgical Device |
Predicate Device(s)
Predicate Device(s)
VNUS RF Generator models RF-110 and RF-220 cleared as a part of the VNUS "Closure" VNUS RF Generator models NF-110 and Kr -1 -226 cloulou and Tissue Coagulation System (K0033547)
Device Description:
Device Description.
The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, The VNDS RT Generator, model instrument. It allows the user to set Power, microprocessor 7 Soltware - outrolies user displays of Power, Temperature and Time Temperature and measured values) as well as measured impedance and user messages. (Sel-politis and measured values) as won to the during use, and is provided non-sterile.
The model RFG2 is compatible only with the disposable RF delivery devices (e.g., The model Tr Oz 13 oompatible only marketed by VNUS Medical Technologies under separate clearance(s).
The instrument cable connects the disposable device to the RF generator. The Instrument The instrument cable connoots the user sterilizable by autoclave. It has been validated to Cable Is provided norms of the cable events of the cable are identical to eliminate multiple steam stemization cyoles. " Beth one on integrated cable, a separate instrument cable is not necessary.
Intended Use:
The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.
1
Page 2 of 2
510(k) Notification
Intended Use of Predicate Devices
Intended Use of Predicate Devices
The specified predicate devices are indicated for "coagliation" The specified predicale devices are indicated for "obagana" and tissue coagulation" (VNUS Vessel and Tissue Coagulation System).
Technological Comparison
Technological Comparison
The RF energy is widely used in electrosurgical equipment for many is a lise use of The RF energy is widely used in electrosuryisal oquipments of intended uses. The use of
efficacy of such devices has been well established for a variety of intended uses. The efficacy of such devices has been well outliked over monopolar systems. North bipolar RF energy delivery has potential advantages over it tassue is minimized, is minimized, i
grounding pads are required, and the potential for damage to adjacent of hind grounding pacs are required, and the preenter cash current. The efficiency of bipolar RF
as the patient is no longer the return path for electrical case at lower as the patient is no longer the return path for Novation to be used at lower energy delivery allows byetents on compared with monopolar systems.
The technological characteristics and principals of operation of the VNUS RF Generator, The technological characteristially equivalent to the noted predicate devices.
Test Results:
Performance
Penormance
Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective for its intended use.
Summary of Safety and Effectiveness
Summally of Salety and Enooth ontended use, comparison with currently Based upon the design, materials, tunenting performed by VNUS, it is concluded that the the marketed devices and the non official tooling Porcerary name: TBD) is substantially v NOS Radionequoney Ocherate devices in safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle, with its wings spread and its head turned to the left. The eagle is made up of three curved lines, and it appears to be in flight.
JUN - 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam Nanavati Director, Quality and Regulatory Affairs VNUS Medical Technologies, Inc. 2200 Zanker Road, Suite F San Jose, California 95131
Re: K040638
Ro40050
Trade/Device Name: VNUS Radiofrequency Generator, Model RFG2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 8, 2004 Received: March 10, 2004
Dear Mr. Nanavati:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bectoril 3 re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to connineres prior to May 20, 1978, are econdance with the provisions of the Federal Food, Drug, devices marc Act (Act) that do not require approval of a premarket approval application (PMA). and Costine real (11ct) market the device, subject to the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is clubbined (too as 2017). Existing major regulations affecting your device can may be subject to sach addresses regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I DTF Blocantes own device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must bil ally it cut all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Ace 31equirements) 01); good manufacturing practice requirements as set CFK Fart 607), adocing (21 CFR Part 820), and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Sam Nanavati
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogin maneting of substantial equivalence of your device to a legally premarket notification: "The PDF miding of casion 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 If you desire specific advice ion your ac (301) 594-4659. Also, please note the regulation entitled, Comact the Office of Complanes at (Set , 21 (Set Part 807.97). You may obtain Milsorating by reference to premaironibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Goless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K040638 |
|---|---|
| --------------------------- | --------- |
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The VNUS Radiofrequency Generator is intended for use with VNUS
Children and the characted of for usessel and tissue coagulation The VNUS Radiofrequency Generator is intended for version in the virus of experience
| Prescription Use
(Part 21 CFR 801 Subpart D) | | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) | |
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------- | ------------------------------------------------ | -- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| Page | of ______ |
| VNUS Medical Technologies | 510(k) Number | K040638 |
|---|---|---|
| --------------------------- | --------------- | ---------------- |