VARI-LASE BRIGHT TIP FIBER

K070216 · Vascular Solutions, Inc. · GEX · Mar 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070216
• Device Name: VARI-LASE BRIGHT TIP FIBER
• Applicant: Vascular Solutions, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Vari-Lase® Bright Tip fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Story

Vari-Lase Bright Tip is a 600um core laser fiber (3.5m length) designed for endovenous laser ablation. Distal tip features ceramic encasement to provide ultrasound visibility during clinical procedures. Device functions as a delivery system for laser energy to treat venous reflux. Used by physicians in clinical settings to ablate incompetent veins. Ceramic tip enhances clinician ability to monitor fiber position via ultrasound, ensuring accurate placement and energy delivery. Benefits include improved procedural visualization and effective treatment of superficial venous disease.

Clinical Evidence

Bench testing only. Testing included assessment of physical properties, ultrasound visibility, energy transmission, and tip integrity (tensile strength and burn-back) following simulated clinical use.

Technological Characteristics

600um core laser fiber, 3.5m length. Distal tip encased in ceramic for ultrasound visibility. Energy transmission via laser. Sterilization method not specified.

Indications for Use

Indicated for treatment of varicose veins, varicosities, and venous incompetence/reflux of the Great Saphenous Vein and superficial lower extremity veins.

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 Kits (K050021)

Submission Summary (Full Text)

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## 510(k) Summary (As required by 21 CFR 807.92(c))

# 510(k) Number:_ n 0 702 1 p

#### Date Prepared

January 17, 2007

#### Submitter Information

| Submitter's Name: | Vascular Solutions, Inc. |
|-------------------|----------------------------------------------|
| Address: | 6464 Sycamore Court<br>Minneapolis, MN 55369 |

| Contact Person: | Deborah L. Neymark |
|-----------------|------------------------------------|
| | Vice President, Regulatory Affairs |
| | Phone [phone] |
| | Fax [phone] |

#### Device Information

| Trade Name: | Vari-Lase® Bright Tip™ |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Optical Fiber |
| Class: | II |
| Classification Name: | Laser Surgical Instrument for use in General and Plastic<br>Surgery and in Dermatology<br>(21 CFR 870.4810, Product Code GEX) |

#### Predicate Devices

Vari-Lase Endovenous Laser Procedure Kits (K050021) manufactured by Vascular Solutions, Inc.

#### Device Description

The Vari-Lase Bright Tip Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in ceramic which provides ultrasound visibility during clinical use.

#### Intended Use/Indications for Use

The Vari-Lase® Bright Tip fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

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#### Summary of Testing

Bench testing was conducted on the modified laser fiber and included an assessment of physical properties and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Bench tests included visibility under ultrasound, energy transmission, and integrity of the tip following simulated clinical use (tensile strength of the ceramic tip and burn-back)

#### Statement of Equivalence

The Vari-Lase Brite Tip fiber is substantially equivalent to the currently marketed Vari-Lase Fiber, based on comparisons of the device classification, indications for use, technological characteristics, and sterilization methods.

#### Conclusion

The Vari-Lase Bright Tip Fiber is substantially equivalent to the currently marketed Vari-Lase Fibers, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black line drawing, and the text is also in black.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. % Ms. Deborah L. Neymark Vice President, Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369

MAR 1 6 2007

Re: K070216

Trade/Device Name: Vari-Lase® Bright Tip" Regulation Number: 21 CFR 870.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 17, 2007 Received: January 23, 2007

Dear Ms. Neymark:

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. Neymark

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 vouts.

for
Mark N. Molkerson

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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### Indications for Use Statement

510(k) Number: K070216

#### Device Name:

Vari-Lase® Bright Tip™ Fiber

#### Indications for Use:

The Vari-Lase® Bright Tip fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great 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 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
14070216

510(k) Number