VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

K051287 · Vascular Solutions, Inc. · GEX · Jul 29, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051287
• Device Name: VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 29, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Story

Vari-Lase Endovenous Laser Procedure Kit is a surgical kit used for endovenous laser ablation of varicose veins. Kit components include a 600 um laser fiber, guide wires (0.035" or 0.018"), introducer sheath or catheter, percutaneous entry needles (19G/21G), and a fiber lock. The device is used by physicians in a clinical setting to treat superficial venous reflux. The laser fiber is inserted into the target vein; laser energy is delivered to induce thermal ablation, closing the vein. This minimally invasive procedure aims to alleviate symptoms of venous insufficiency and improve patient outcomes by redirecting blood flow to healthy veins.

Clinical Evidence

Bench testing only; biocompatibility and performance testing conducted on kit components.

Technological Characteristics

Kit includes 600 um laser fiber, guide wires, introducer sheath/catheter, and percutaneous entry needles. Operates as a laser surgical instrument for endovenous ablation. No specific materials or software algorithms described.

Indications for Use

Indicated for patients with varicose veins, varicosities, or incompetence/reflux of superficial veins in the lower extremity, specifically involving 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 Endovenous Laser Procedure Kit (K051287)
• Diomed EVLT kit
• Angiodynamics EVLS kit

Submission Summary (Full Text)

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| | 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: | Linda Busklein<br>St. Regulatory Affairs Associate<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 one or more of the<br>following:<br>600 um laser fiber<br>0.035" or 0.018" guide wire<br>Introducer sheath or catheter<br>19 Gauge/7cm Percutancous Entry Needle<br>21 Gauge/7 cm Percutaneous Entry Needle<br>Fiber lock | |
| 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 and for<br>treatment of incompetence and reflux of superficial veins in<br>the lower extremity. | |
| Summary of Non-Clinical Testing: | Testing has been conducted to verify the biocompatility and<br>performance of the components. | |
| Predicate Devices: | Vari-Lase Endovenous Laser Procedure Kit<br>Diomed EVLT kit<br>Angiodynamics EVLS kit | |
| Conclusions: | The VARI-LASE Procedure Kit is substantially equivalent<br>to the identified predicate devices based on a comparison of<br>the indications for use and the components supplied and<br>the technological characteristics of the supplied<br>components. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2005

Ms. Linda Busklein Sr. Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K051287

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: May 17, 2005 Received: May 18, 2005

Dear Ms. Busklein:

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. Linda Busklein

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.

Stypt Rhodes

Mark N. Melkerson Acting 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

102128 510(k) Number:

Vascular Solutions Vari-Lase® Endovenous Laser Procedure Kit Device Name:

Indications for 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 and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Prescription Use _ X (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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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