MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

K032805 · Vascular Solutions, Inc. · GEX · Oct 1, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032805
• Device Name: MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Device Story

Vari-Lase Endovenous Laser Procedure Kit provides tools for endovascular access and laser treatment of varicose veins. Kit includes 600µm laser fiber; optional accessories include 0.035" stainless steel guide wire, 5Fr introducer sheath (25, 45, or 55cm), 19 Gauge percutaneous entry needle, or micropuncture kit. Used by clinicians to gain endovascular access for laser ablation of Greater Saphenous Vein. Device facilitates minimally invasive treatment of superficial venous reflux.

Clinical Evidence

No clinical data; no testing required to document safety and effectiveness of this modified procedure kit.

Technological Characteristics

Kit includes 600µm laser fiber, stainless steel guide wire, introducer sheath, and percutaneous entry needle. Laser surgical instrument per 21 CFR 878.4810.

Indications for Use

Indicated for treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• VARI-LASE Procedure Kit (K030654)

Submission Summary (Full Text)

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OCT - 1 2003

K032805

| 510(K) SUMMARY | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Laser Instrument Fiber and Procedure Kit |
| Product Trade Name: | Vari-Lase Endovenous Laser Procedure Kit |
| Classification Name: | Laser Surgical Instrument for use in General and Plastic<br>Surgery and in Dermatology<br>21 CFR 878-4810 (Product Code GEX) |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah Jensen<br>V. P., Regulatory Affairs, Clinical Affairs, and Quality<br>Systems<br>[phone] phone<br>[phone] fax |
| Performance Standards: | No performance standards have been developed under<br>section 514 for this device. |
| Device Description: | The VARI-LASE procedure kit contains a 600µm fiber and<br>may contain one ore more of the following accessories used<br>to gain endovascular access:<br>0.035"/ stainless steel guide wire (lengths from 75 to<br>150cm)<br>5Fr/25, 45 or 55cm introducer sheath<br>19 Gauge/7cm Percutaneous Entry Needle or<br>Micropuncture Kit |
| Intended Use: | The VARI-LASE procedure kit is indicated for the<br>treatment of varicose veins and varicosities associated with<br>superficial reflux of the Greater Saphenous Vein. |
| Summary of Non-Clinical Testing: | No testing was required to document the safety and<br>effectiveness of this modified procedure kit. |
| Predicate Devices: | VARI-LASE Procedure Kit (K030654) |
| Conclusions: | The VARI-LASE Procedure Kit is substantially equivalent<br>to the currently marketed VARI-LASE kit based on a<br>comparison of the indications for use and the components<br>supplied and the technological characteristics of the<br>supplied components. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2003

Ms. Deborah Jensen Vice President, Regulatory Affairs. Clinical Affairs, and Quality Systems Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K032805

Trade/Device Name: Vascular Solutions Vari-Lase™ Endovenous Laser Procedure Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 8, 2003 Received: September 9, 2003

Dear Ms. Jensen:

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 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 - Ms. Deborah Jensen

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/dsma/dsmamain.html

Sincerely yours.

Muriam 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 '

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## Indications for Use Statement

510(k) Number:

K032805

Device Name:

Vascular Solutions Vari-Lase™ Endovenous Laser Procedure Kit

Indications for Use:

The VARI-I.ASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032805