VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

K050021 · Vascular Solutions, Inc. · GEX · Mar 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050021
• Device Name: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 18, 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.

Device Story

The Vari-Lase Endovenous Laser Procedure Kit is a surgical kit used to gain endovascular access for the treatment of varicose veins. The kit includes a 600µm laser fiber, a stainless steel guide wire (0.035", 75-150 cm), an introducer sheath (5Fr, 25-55 cm), and a percutaneous entry needle or micropuncture kit. The device is used by clinicians in a clinical setting to facilitate endovenous laser procedures. The fiber delivers laser energy to the vein to treat superficial reflux. The kit provides the necessary components for percutaneous access and fiber placement, enabling the physician to perform the procedure to alleviate symptoms associated with varicose veins.

Clinical Evidence

Bench testing only; biocompatibility and performance of the fiber were verified.

Technological Characteristics

Kit includes 600µm fiber, stainless steel guide wire, introducer sheath, and percutaneous entry needle. Components are standard surgical accessories for endovascular access. No specific material standards or software/algorithm components are described.

Indications for Use

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

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.

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 1 8 2005

KO 50021 510(K) SUMMARY Laser Instrument Fiber and Procedure Kit Common/Usual Name: Vari-Lase Endovenous Laser Procedure Kit Product Trade Name: Laser Surgical Instrument for use in General and Plastic Classification Name: Surgery and in Dermatology 21 CFR 878-4810 (Product Code GEX) Vascular Solutions, Inc. Manufacturer: 6464 Sycamore Court Minneapolis, Minnesota 55369 2134812 Establishment Registration: Linda Busklein Contact: St. Regulatory Affairs Associate [phone] phone [phone] fax No performance standards have been developed under Performance Standards: section 514 for this device. The VARJ-LASE procedure kit contains a 600µm fiber and Device Description: the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150 cm) 5Fr/25. 45, or 55 cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture kit The VARI-LASE procedure kit is indicated for the Intended Use: treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein. T'esting has been conducted to verify the biocompatility and Summary of Non-Clinical Testing: performance of the fiber. Vari-Lase Endovenous Laser Procedure Kit Predicate Devices: The VARI-LASE Procedure Kit is substantially equivalent Conclusions: to the identified predicate device based on a comparison of the indications for use and the components supplied and the technological characteristics of the supplied components.

{1}------------------------------------------------

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

Public Health Service

MAR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050021

K050021
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: January 4, 2005 Received: January 5, 2005

Dear Ms. Busklein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regard nament date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the exactions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) that to not requently subject to the general controls provisions of the Act. The You may, merciole, manel the device, books of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device ts classified (socre) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of the may be subject to suell doditions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a seculations administered by other Federal agencies. You must of any rederal statures and regarations salading, but not limited to: registration and listing (21 Comply with an the Act 870girls Part 801); good manufacturing practice requirements as set CFR in the quality systems (2) CFR egulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 -- Ms. Linda Busklein

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin harketing your device of your device of your device to a legally premarket notification. The FDA inding of substantial equively 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 if you desire specific advice for your ac not the consisted on the regulation entitled, the regulation of the regulation contact the Office of Compliance at (210) 275 on (21CFR Pat1807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Musbranding by reference to prematics noutheansmall of the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) other general information on your responsionnies and its toll-free number (800) 6.8-204 or 1 Manufacturers, International and Consumer Assistance at no restaurantes and consistences himl.

Sincerely yours,

Elther

Miriam C. Provost, PhD

Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use Statement

510(k) Number: Ko Sopal

STO(R) Patents ..

Device Name:

Vascular Solutions Vati-Lase® Endovenous Laser Procedure Kit

Indications for Use:

The VARI-LASE procedure kit is indicated for the treatment of varicose veins and The VARF-LASE procedure int as as as the Greater Saphenous Vein.

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)

96

Page 1 of

Grative