VEINWAVE, TC3000

K083352 · Newlands Clinical Trials, Ltd. · ONQ · Jun 12, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083352
• Device Name: VEINWAVE, TC3000
• Applicant: Newlands Clinical Trials, Ltd.
• Product Code: ONQ · General, Plastic Surgery
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

Device Story

Veinwave/TC3000 is an electrosurgical coagulation device used by clinicians to treat lower limb spider veins/telangiectasia and for epilation. The system comprises a power generator and a sterile, single-use disposable needle. The operator delivers a controlled dose of 4MHz high-frequency energy to the target vein via the needle. This thermocoagulation process interrupts blood flow, causing the spider vein to reduce in appearance or be eliminated. The generator allows adjustment of impulse duration (0.2 to 1.0 seconds) and power output (30% to 60%). The device provides a non-invasive or minimally invasive method for vascular cosmetic improvement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Electrosurgical coagulation device; monopolar modality; 4 MHz frequency; power output ~30 watts at 500 ohms. System includes power generator and sterile, single-use disposable needles. Energy delivery is controlled via adjustable impulse duration (0.2-1.0s) and power settings (30-60%).

Indications for Use

Indicated for epilation and treatment of lower limb spider veins or telangiectasia in patients requiring 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

• Surgi-Max Electrosurgery Generator (K061174)
• Primaeva Medical System (K080145)

Submission Summary (Full Text)

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K083352

Submitter: Newlands Clinical Trials, Ltd.

Veinwave/TC3000 Premarket Notification: Traditional 510(k)

### 510(k) Summary

# JUN 1 2 2009

;

| Submitter Name:<br>Submitter | Newlands Clinical Trials, Ltd.<br>Newlands Medical Centre |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 315 Chorley New Road<br>Bolton, UNITED KINGDOM BL1 5BP |
| Establishment<br>Registration # | 3006786864 |
| Owner/Operator # | 10022858 |
| Phone Number: | 603 369 3550 |
| Fax Number: | 603 369 3562 |
| Contact Person: | William Greenrose |
| Date Prepared: | 31 October 2008 |
| Device Trade<br>Name: | Veinwave/TC3000 |
| Common Name | Electrosurgical Coagulation Device |
| Classification<br>Name, Number &<br>Product Code: | Electrosurgical cutting and coagulation device and<br>accessories<br>878.4400<br>GEI |
| Predicate Devices: | Surgi-Max Electrosurgery Generator - K061174 - Ellman<br>International Inc.<br>Primaeva Medical System - K080145 - Primaeva Medical,<br>Inc. |
| Device Description<br>and Statement of<br>Intended Use | Device Description: The Veinwave/TC3000 system consists<br>of a power generator and a needle through which a<br>controlled dose of radio frequency energy is delivered and is<br>intended for epilation, and for the treatment of lower limb<br>spider vein or telangiectasia by thermocoagulation. |

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Submitter: Veinwave/TC3000 Newlands Clinical Trials, Ltd. Premarket Notification: Traditional 510(k) Intended Use: The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation. Summary of The Veinwave/TC3000 method of action is the delivery of a Technological controlled dose of high frequency energy to the vein, which Characteristics stops the flow of blood to the area of concern. Once the flow of blood is interrupted, the appearance of the spider veins is greatly reduced or eliminated. The power generator controls the delivery of energy to the needle and creates the impulse. The system utilizes a current of 4MHz. The impulse can be set between 0.2 seconds and 1 second in 0.1 second increments. The power can be set between 30% and 60% in 5% increments. Needles are purchased from Ballet Technologies, Ltd, Establishment Reqistration # 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 Veinwave/TC3000 device is substantially equivalent to the predicate devices. o This summary includes only information that is also Declarations covered in the body of the 510(k). o This summary does not contain any puffery or unsubstantiated labeling claims. o This summary does not contain any raw data, i.e., contains only summary data. o This summary does not contain any trade secret or confidential commercial information. o This summary does not contain any patient identification information.

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| | | Summary of Technical Characteristics |
|--|--|--------------------------------------|
|--|--|--------------------------------------|

| Feature | Veinwave/TC3000 | Surgi-Max Electrosurgery Generator | Primaeva Medical System |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K083352 | K061174 | K080145 |
| Manufacturer | Newlands Clinical<br>Trials, Ltd. | Ellman International<br>Inc. | Primaeva Medical, Inc. |
| Classification # &<br>Product Code | 878.4400<br>GEI | 878.4400<br>GEI | 878.4400<br>GEI |
| Intended Use | The Veinwave/TC3000<br>system is intended for<br>epilation, and for the<br>treatment of lower limb<br>spider vein or<br>telangiectasia by<br>thermocoagulation. | Various, including:<br>Hemostasis and<br>Nonablative<br>Coagulation for control<br>of bleeding, epilation,<br>and telangiectasia | The Primaeva Medical<br>System is intended for<br>use in Dermatologic<br>and General Surgical<br>procedures for<br>electrocoagulation and<br>hemostasis. |
| OTC or Rx | Rx | Rx | Rx |
| Mode of Action | Thermocoagulation of<br>tissue by<br>administration of high<br>frequency energy | Thermocoagulation of<br>tissue by<br>administration of high<br>frequency energy | Thermocoagulation of<br>tissue by<br>administration of high<br>frequency energy |
| Mode of Delivery | Disposable epilation<br>needle | Various, including<br>disposable needles | Reusable Electrode<br>Insertion Device and<br>disposable Electrode<br>Cartridge |
| Modality | Monopolar | Monopolar & bipolar | |
| Frequency<br>(monopolar) | 4 MHz | 4 MHz | |
| Power Output -<br>monopolar<br>balanced at 500<br>ohms | ~ 30 watt* | ~ 60 watt* | |

* Surgi-Max has a higher wattage output because it is intended for surgical applications on larger vessels in addition to small veins, while the Veinwave is only intended for the listed uses on small veins.

Section 5.0: 510(k) Summary

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newlands Clinical Trials Limited % Oserve America, Incorporated Mr. William Greenrose President 220 River Road Claremont, New Hampshire 03743

JUN 1 2 2009

Re: K083352

Trade/Device Name: Veinwave/TC3000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: ONQ Dated: April 29, 2009 Received: May 1, 2009

Dear Mr. Greenrose:

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.

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. William Greenrose

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/ucm115809.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K083352

Veinwave/TC3000 Device Name:

Indications For Use:

The Veinwave/TC3000 system is intended for 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ix Reporter for nix

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083352

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