VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

K030654 · Vascular Solutions, Inc. · GEX · Jun 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030654
• Device Name: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 18, 2003
• 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

Vari-Lase Endovenous Laser Procedure Kit is a surgical accessory set used to facilitate endovascular access for laser treatment of varicose veins. Kit includes 600um laser fiber, 0.035"/150cm stainless steel guide wire, 5Fr/45cm introducer sheath, and 19 Gauge/7cm percutaneous entry needle. Used by clinicians in a surgical or clinical setting to gain access to the Greater Saphenous Vein. The fiber delivers laser energy to treat venous reflux. The kit components assist the physician in navigating the vasculature to the target site. Benefits include minimally invasive treatment of superficial venous reflux.

Clinical Evidence

No clinical data. Bench testing conducted to verify integrity and biocompatibility of marker bands on the fiber and introducer sheath.

Technological Characteristics

Kit includes 600um laser fiber, stainless steel guide wire, introducer sheath, and percutaneous entry needle. Components feature marker bands for visualization. Device is a mechanical surgical accessory kit for use with laser systems.

Indications for Use

Indicated for patients with 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

• EVLT Kit (K023543)
• SLT Venous Fiber Delivery Systems (K023624)
• Angiodynamics ELVS Kit

Submission Summary (Full Text)

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030654

JUN 1 8 2003

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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>2495 Xenium Lane North<br>Minneapolis, Minnesota 55441 |
| 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 600um fiber and<br>the following accessories used to gain endovascular access:<br>0.035" / 150cm stainless steel guide wire<br>5Fr/45cm introducer sheath<br>19 Gauge/7cm Percutaneous Entry Needle |
| 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: | Testing has been conducted to verify the integrity and<br>biocompatility of the marker bands that are placed on the<br>fiber and introducer sheath. |
| Predicate Devices: | EVLT Kit (Diomed, Inc. K023543)<br>SLT Venous Fiber Delivery Systems (Surgical Laser<br>Technologies, Inc. K023624)<br>Angiodynamics ELVS Kit (Angiodynamics, Inc.) |
| 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

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## Public Health Service

JUN 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah L. Jensen Vice President, Regulatory Affairs, Clinical Research, and Quality Systems Vascular Solutions, Inc. 2495 Xenium Lane North Minneapolis, Minnesota 55441

Re: K030654

Trade/Device Name: 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 30, 2003 Received: June 2, 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 L. 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Miriam 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:

k030654

Device Name:

Vascular Solutions Vari-Lase™ Endovenous Laser Procedure Kit

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 Veion

Miriam C. Provost

ion Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K036654