VASCULAR SOLUTIONS SCLERO-KIT

K043019 · Vascular Solutions, Inc. · FMI · Dec 1, 2004 · General Hospital

Device Facts

• Record ID: K043019
• Device Name: VASCULAR SOLUTIONS SCLERO-KIT
• Applicant: Vascular Solutions, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vascular Solutions Sclero-Kit is indicated for delivery of sclerosing agents. Sclerosing agents may be used for treatment of small uncomplicated varieosities of the lower extremities that show simple dilation with competent valves.

Device Story

Vascular Solutions Sclero-Kit is a sterile, disposable procedural kit; contains 10ml syringe, 3ml syringe with needle, butterfly needle, extension tubing, and syringe connector. Used by clinicians for delivery of sclerosing agents to treat small, uncomplicated lower extremity varicosities with competent valves. Kit components are standard medical devices bundled for user convenience. No complex electronics or software involved.

Clinical Evidence

No clinical evaluations of this product have been conducted. Bench testing and biocompatibility assessments were performed to confirm design verification and suitability for intended use.

Technological Characteristics

Kit includes 10ml syringe, 3ml syringe with needle, butterfly needle, extension tubing, and syringe connector. Sterile, disposable, manual delivery system. No energy source, software, or complex electronics.

Indications for Use

Indicated for delivery of sclerosing agents for the treatment of small uncomplicated varicosities of the lower extremities exhibiting simple dilation with competent valves.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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K043019

# DEC - 1 2004

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Common/Usual Name: | Injection Kit |
|-----------------------------|---------------------------------------------------------------------------------------------------|
| Product Trade Name: | Vascular Solutions Sclero-Kit |
| Classification Name: | Unclassified<br>Product Code: FMF, FMI, FPA |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon<br>Senior 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:

Each kit is provided sterile and contains disposable 10ml syringe, 3ml syringe with needle, butterfly needle with attached extension tubing and syringe connector.

#### Intended Use:

The Vascular Solutions Sciero-Kit is indicated for delivery of sclerosing agents. Scierosing agents may be used for treatment of small uncomplicated varieosities of the lower extremities that show simple dilation with competent valves.

#### Summary of Non-Clinical Testing:

Testing conducted included assessments of the design verification of the Sclero-Kit along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Sclero-Kit for its intended use.

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#### Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

### Predicate Devices:

The VSI Sclero-Kit is a kit of routincly used medical components that have been The VEI Delero terrilized for the convenience of the end user for use in the treatment of small uncomplicated varicosities. The kit components are equivalent to the predicate needle and syringe devices. This combination of devices is commonly combined for use in the treatment varicosities as described in the current medical textbooks and literature.

#### Conclusions:

The Sclero-Kit is substantially equivalent to the predicate needle and syringe devices. The testing performed confirms that the Sclero-Kit will perform as intended.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized waves or lines, often interpreted as an abstract representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Ms. Sara L. Coon Senior Regulatory Affairs Associate Vascular Solutions, Incorporated 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K043019

Trade/Device Name: Vascular Solutions Sclero-Kit Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 2, 2004 Received: November 3, 2004

Dear Ms. Coon:

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.

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Page 2 - Ms. Coon

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.

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 vou 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 vours.

Susen Runne
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number:

K043019_______________________________________________________________________________________________________________________________________________________________________

l Device Name:

Vascular Solutions Scleto-Kit

Indications for Use:

The Vascular Solutions Sclero-Kit is indicated for delivery of sclerosing agents. Sclerosing a The Vascular Solutions Scietty-Att I. Incomplicated varicosities of the lower extremities that show simple dilation with competent valves.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Dvorak

Page 1 of _

(Division Sion-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: k443914