VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100

K061373 · Vnus Medical Technologies, Inc. · GEI · Aug 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061373
• Device Name: VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
• Applicant: Vnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Story

VNUS ClosureFAST Catheter is an electrosurgical device used for endovascular coagulation of blood vessels. It functions by delivering radiofrequency (RF) energy to an intravascular catheter, which heats the target blood vessel to a specific temperature to achieve coagulation. The device is used in patients diagnosed with superficial vein reflux. It is operated by healthcare professionals in a clinical setting. The device provides a therapeutic benefit by treating venous reflux through controlled thermal energy delivery.

Clinical Evidence

Bench testing and biocompatibility testing were performed. No clinical study data was provided; substantial equivalence is based on performance testing and comparison to the predicate device.

Technological Characteristics

Electrosurgical device (21 CFR 878.4400). Operates via delivery of RF energy to an intravascular catheter to induce thermal coagulation. Materials are biocompatible.

Indications for Use

Indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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

• VNUS® ClosurePlus™ Catheter (K030557)

Submission Summary (Full Text)

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# KOLI373

### 510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

15 May 2006 Date Prepared:

510(k) number:

# AUG 0 1 2006

#### Applicant Information:

VNUS Medical Technologies, Inc. 5799 Fontanoso Way San Jose, CA 95138

| Contact Person: | Carelle Karimimanesh |
|-----------------|----------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information:

| Classification: | Class II |
|----------------------|-------------------------------------------|
| Trade Name: | VNUS® ClosureFAST™ Catheter |
| Classification Name: | Electrosurgical Device (21 CFR §878.4400) |

#### Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the VNUS® ClosurePlus™ Catheter (K030557).

The technological characteristics and principals of operation of the VNUS ClosureFAST catheter are substantially equivalent to the noted predicate devices rely on the delivery of RF energy to an intravascular catheter that heats a blood vessel to a specific temperature to achieve the intended use.

#### Intended Use:

The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

#### Test Results:

Performance

r orrormants Nostantially equivalent to the predicate device effective for its intended function.

#### Biocompatibility

The materials used in the VNUS ClosureFAST Catheters have been shown to be biocompatible.

#### Summary:

Based on the intended use, product performance, and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VNUS Medical Technologies, Inc. % Carelle Karimimanesh Director, Regulatory Affairs 2200 Zanker Road, Suite F San Jose, California 95131

Re: K061373

Trade/Device Name: VNUS® ClosureFAST™ Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 15, 2006 Received: May 17, 2006

AUG 0 1 2006

Dear Carelle Karimimanesh:

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 gencral 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 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 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); good manufacturing practice requirements as set 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.

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Page 2 – Carelle Karimimanesh

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Bnechuk

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: VNUS® ClosureFAST™ Catheter

510(k) Number: K061373

## Indications for Use:

The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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Prescription Use: (21 CFR §801 Subpart D) or

Over the Counter Use: (21 CFR §801 Subpart C)

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Hubera Buclian

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K061573

CONFIDENTIAL