(30 days)
Not Found
No
The device description focuses on basic electronic control (microprocessor) and precise energy delivery, with no mention of AI/ML terms or functionalities like image processing, learning, or data analysis for decision making.
Yes
The device is intended for the "treatment of lower limb spider vein or telangiectasia," which is a therapeutic application.
No
The device is described as being used for treatment (epilation and thermocoagulation of spider veins), not for diagnosing a condition.
No
The device description clearly outlines hardware components including a generator, needle, microprocessor, and LCD screen, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The EVRF System is used for epilation and treating spider veins/telangiectasia by thermocoagulation. This is a therapeutic procedure performed on the body, not a diagnostic test performed on samples from the body.
- Intended Use: The intended use clearly describes a treatment procedure, not a diagnostic test.
- Device Description: The description details a generator and needle used to deliver energy for treatment, not equipment for analyzing biological samples.
Therefore, based on the provided information, the EVRF System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
Product codes
ONQ
Device Description
The EVRF has 2 major parts: 1) the generator and 2) the needle. The generator creates the impulse. The impulse can be set at between in 0.1 second increments. The combination of these two settings means that highly accurate doses of energy can be delivered. The system utilizes a current of 4MHz .The power and impulse values are accurately maintained by a microprocessor and displayed on a LCD screen. The values can be digitally adjusted. The ultra-fine needle (Product Code KCW) has a diameter of 0.075 mm allowing for accurate operation and is protected by a specific isolating sheath. The vessel is thermocoagulated without damaging the epidermis and surrounding tissue. Needles are nickel. In case of a nickel allergy, gold needles are also available. The needles are disposable and can be used for a complete session. The combination of the generator and insulated needle allows for a very precise amount of energy to be delivered to exactly the right place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limb
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)
Safety Testing: The EVRF has passed the requirements for IEC 60601-1 and IEC 60601-1-2 EMC and 60601-2-2 electrical safety testing.
Comparison bench testing was performed - Comparison of output power setting and pulse setting was presented to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K13028/3
510(k) Summary
MAR 7 2013
SPONSOR Company Name: Company Address:
F Care Systems NV Kontichsesteenweg 54 2630 Aartselaar Belgium
Telephone: Fax:
011 32 3 4515139
Rudi Devers
011 32 3 45151245
Contact Person:
September 18, 2012
Summary Prepared
Device Name Trade Name: EVRF Common/Usual Name: Electrosurgical Coagulation Device Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories Product Code: ONQ Device Class: Class II Regulation Number: 21 CFR 878.4400
Predicate Device Company Newlands Clinical Trials LTD
Product Veinwave TC3000 510(k) # K083352
Device Description
The EVRF has 2 major parts: 1) the generator and 2) the needle. The generator creates the impulse. The impulse can be set at between in 0.1 second increments. The combination of these two settings means that highly accurate doses of energy can be delivered. The system utilizes a current of 4MHz .The power and impulse values are accurately maintained by a microprocessor and displayed on a LCD screen. The values can be digitally adjusted. The ultra-fine needle (Product Code KCW) has a diameter of 0.075 mm allowing for accurate operation and is protected by a specific isolating sheath. The vessel is thermocoagulated without damaging the epidermis and surrounding tissue. Needles are nickel. In case of a nickel allergy, gold needles are also available. The needles are disposable and can be used for a complete session. The combination of the generator and insulated needle allows for a very precise amount of energy to be delivered to exactly the right place.
1
Indications for Use
The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
Summary of Technological Characteristics
The EVRF method of action is the delivery of a controlled dose of high frequency energy to the vein, which stops the flow of blood to the area of concern. Once the flow of blood is interrupted, the appearance of the spïder veins is greatly reduced or eliminated. The power generator controls through a micro-controller the delivery of stable energy to the needle and creates the impulse. The system utilizes a current of 4MHz. The impulse can be set between 0.1 seconds and 0.8 second in 0.1-second increments. The power can be set between 1 watt and 25 watt in 1-watt increment for more precision in the treatment.
The remote control has been replaced by a touch screen display allowing an easy access to the function of the EVRF.
The number of impulse per second can be set to 1 or 2 impulses per second The casing of the unit has been redesigned for marketing and ergonomic purposes only. None of these improvements in design and technology are raising any new issues of safety or effectiveness
The needles used with this device are not cleared as a part of this device system, as they are a Class I, 510(k) exempt device (FDA Product Code KWC).
Needles are purchased from Ballet Technologies, Ltd,
Establishment Registration # 3005114964, as sterile, single-use, disposable needles and are device listed by Ballet as accessories to Needle-Type, High Frequency Epilators Classification Code KCW.
Conclusion: The information discussed above demonstrates that the EVRF device is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.
| Feature | F Care Systems NV
EVRF System | Newlands Clinical trials LTD
Veinwave TC3000 |
|------------------------------------|----------------------------------|-------------------------------------------------|
| 510(k) Number | | K083352 |
| Classification and Product
Code | 878.4400
Product Code ONQ | 878.4400
Product Code ONQ |
12.2 Predicate Product Comparison Table
21
2
| Feature | F Care Systems NV
EVRF System | Newlands Clinical trials LTD
Veinwave TC3000 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The EVRF System is
intended for the epilation
and for the treatment of
lower limb spider vein or
telangiectasia by
thermocoagulation. | The Weinwave TC3000
System is intended for the
epilation and for the
treatment of lower limb
spider vein or telangiectasia
by thermocoagulation. |
| OTC or Rx | Rx | Rx |
| Mode of Action | Thermocoagulation of
tissue by administration of
high frequency energy | Thermocoagulation of
tissue by administration of
high frequency energy |
| Mode of Delivery | Disposable Epilation Needle | Disposable Epilation Needle |
| Disposable Epilation Needle | Identical - Ballet
Technologies LTD | Identical - Ballet
Technologies LTD |
| Modality | Monopolar | Monopolar |
| Frequency
(Monopolar) | 4 MHz | 4 MHz |
| Power Output - monopolar
balanced at 500 ohms | 25 watt | 25 watt |
12.3 Differences
| Feature | F Care Systems NV
EVRF System | Newlands Clinical trials LTD
Veinwave TC3000 |
|--------------------------|----------------------------------|-------------------------------------------------|
| Frequency
(Monopolar) | 4 MHz | 4 MHz |
Software
The level of concern was determined to be moderate. The software information provided in this 510(k) followed the requirements found in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Issued May 11, 2005.
Safety Testing
The EVRF has passed the requirements for IEC 60601-1 and IEC 60601-1-2 EMC and 60601-2-2 electrical safety testing.
Comparison bench testing was performed -
- Comparison of output power setting and pulse setting was presented to establish . substantial equivalence.
) OF
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three curved lines representing snakes or streams.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Underwriters Laboratories, Incorporated % Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062
March 7, 2013
Re: K130283
Trade/Device Name: EVRF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: ONQ Dated: February 06, 2013 Received: February 27, 2013
Dear Mr. Devine:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Ned Devine
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Peter D
Rümm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
Indications for Use
510(k) Number (if known): _K130283
Device Name: EVRF System
Indications for Use:
The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Surgical Devices | |
|---|---|
| Division Sign-Off | |
| 510(k) Number: | K130283 |
| | Long H
Chen-A |
| -- | ------------------ |
|---|
| | Digitally signed by Long H. Chen-A
DN: c=US, o=U.S. Government,
ou=People,
cn=Long H. Chen-A
0.9.2342.19200300.100.1.1=130036
Date: 2013.03.07 14:33:44 -05'00' |
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Page | __ of __ |
|---|---|
| ------ | ---------- |
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