EVRF SYSTEM

K130283 · F Care Systems NV · ONQ · Mar 7, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130283
• Device Name: EVRF SYSTEM
• Applicant: F Care Systems NV
• Product Code: ONQ · General, Plastic Surgery
• Decision Date: Mar 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

Device Story

EVRF System is an electrosurgical coagulation device used for epilation and treatment of lower limb spider veins/telangiectasia. System comprises a microprocessor-controlled generator and a disposable, ultra-fine (0.075 mm) nickel or gold needle. Generator delivers high-frequency (4 MHz) energy pulses to the needle; pulse duration (0.1–0.8s) and power (1–25W) are digitally adjustable via touch screen. Physician operates device in a clinical setting. Energy delivery thermocoagulates the vessel, interrupting blood flow to reduce or eliminate spider vein appearance without damaging surrounding epidermis. Benefits include precise energy delivery for targeted treatment.

Clinical Evidence

Bench testing only. Comparison of output power and pulse settings performed to establish substantial equivalence to the predicate device. Electrical safety testing conducted per IEC 60601-1, IEC 60601-1-2 (EMC), and IEC 60601-2-2.

Technological Characteristics

Monopolar electrosurgical generator; 4 MHz frequency; 1-25W power output; 0.1-0.8s pulse duration. Disposable nickel or gold needles (0.075 mm diameter). Microprocessor-controlled energy delivery. Touch screen interface. Electrical safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.

Indications for Use

Indicated for epilation and treatment of lower limb spider veins or telangiectasia via thermocoagulation. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Veinwave TC3000 (K083352)

Submission Summary (Full Text)

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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.

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#### 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<br>EVRF System | Newlands Clinical trials LTD<br>Veinwave TC3000 |
|------------------------------------|----------------------------------|-------------------------------------------------|
| 510(k) Number | | K083352 |
| Classification and Product<br>Code | 878.4400<br>Product Code ONQ | 878.4400<br>Product Code ONQ |

#### 12.2 Predicate Product Comparison Table

21

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| Feature | F Care Systems NV<br>EVRF System | Newlands Clinical trials LTD<br>Veinwave TC3000 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The EVRF System is<br>intended for the epilation<br>and for the treatment of<br>lower limb spider vein or<br>telangiectasia by<br>thermocoagulation. | The Weinwave TC3000<br>System is intended for the<br>epilation and for the<br>treatment of lower limb<br>spider vein or telangiectasia<br>by thermocoagulation. |
| OTC or Rx | Rx | Rx |
| Mode of Action | Thermocoagulation of<br>tissue by administration of<br>high frequency energy | Thermocoagulation of<br>tissue by administration of<br>high frequency energy |
| Mode of Delivery | Disposable Epilation Needle | Disposable Epilation Needle |
| Disposable Epilation Needle | Identical - Ballet<br>Technologies LTD | Identical - Ballet<br>Technologies LTD |
| Modality | Monopolar | Monopolar |
| Frequency<br>(Monopolar) | 4 MHz | 4 MHz |
| Power Output - monopolar<br>balanced at 500 ohms | 25 watt | 25 watt |

## 12.3 Differences

| Feature | F Care Systems NV<br>EVRF System | Newlands Clinical trials LTD<br>Veinwave TC3000 |
|--------------------------|----------------------------------|-------------------------------------------------|
| Frequency<br>(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

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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

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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 [phone] or [phone] 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

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# 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<br>Chen-A |
|--|------------------|
|--|------------------|

| | Digitally signed by Long H. Chen-A<br>DN: c=US, o=U.S. Government,<br>ou=People,<br>cn=Long H. Chen-A<br>0.9.2342.19200300.100.1.1=130036<br>Date: 2013.03.07 14:33:44 -05'00' |
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