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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Total Vein Solutions Inc 06-Oct-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Devices and Radiological Health
Rockville, MD


 

VIA FEDERAL EXPRESS

OCT 6, 2004

Mr. Tyrell Lynn Schiek
General Manager
Total Vein Solutions, Inc.
2425 West Loop South
Suite. 200
Houston, Texas 77027

Dear Mr. Schiek:

We are writing to you because the Food and Drug Administration (FDA) has reviewed information relating to the manufacture and marketing of certain surgical packs and access products by your company without FDA clearance or approval.

Under the Federal Food, Drug and Cosmetic Act (the Act) your surgical packs and access products are considered to be medical devices (Section 201(h)) because they are intended for use in the diagnosis of disease or other conditions, in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or a function of the body. The law requires that certain medical devices be cleared or approved by FDA before they may be offered for sale. This protects the public health by helping ensure that these medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.

A review of your promotional material entitled "Your Complete Supply Source for Office-Based & Ambulatory Vein Surgery" indicates that you are marketing certain surgical packs and access products for use in endovenous procedures with laser and radiofrequency energy. Because you do not have marketing clearance or approval from the FDA for these surgical packs and access products, marketing them for this intended use is a violation of the law.

Therefore, your device is adulterated under section 501(f)(1)(B) of the Act, for failure to obtain FDA premarket approval, and misbranded under section 502(o) of the Act, for failure to notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application is pending before the agency. 21 CFR 807.81(b).

The kind of information you need to submit in order to obtain FDA clearance or approval to market your devices for endovenous procedures with laser or radiofrequency energy is described on FDA's device web site at www.fda.gov/cdrh/devadvice. If you provide a premarket submission, FDA will evaluate this information and decide whether your product may be legally marketed.

Please respond within thirty (30) days of receipt of this letter. Your response may be sent to Carol Shirk, Consumer Safety Officer, General Surgery Devices Branch, Division of Enforcement A, HFZ-323, 2094 Gaither R4d, Rockville, Maryland 20850.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health