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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tyco Healthcare/Kendall 21-Jul-06

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
2098 Gaither Road
Rockville, MD 20850


 

July 21, 2006

Warning Letter

Via Federal Express

Mr. Richard Meelia
President & CEO
Tyco Healthcare/Kendall
15 Hampshire Street
Mansfield, MA 02048


Re: K024010
Kendall Dover® Silver Hydrogel Coated Silicone Foley Catheter

Dear Mr. Meelia:

The Center for Devices and Radiological Health (CDRH), Office of Compliance (OC) has reviewed information on your internet web site, www.kendallhq.com, about your line of Foley catheters, the Kendall Dover® Silver Hydrogel Coated Silicone Foley Catheters (Dover® Catheters), which your site promotes as reducing urinary tract infections, encrustation, urethritis, and stricture. The web site also states that the Dover© Catheters have a reduced risk of hypersensitivity. These devices are adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act because use of these devices for the clinical benefits listed above are new intended uses for which clearance or approval from the U.S. Food and Drug Administration (FDA) has not been obtained.

Under section 201(h) of the Act, these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

Background

The Dover® Catheters are sterile, single patient use devices, coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer. They are class 11 devices subject to special controls. 21 CFR 876.5130. The classification regulation for this type of device states that they are inserted through the urethra and are used to pass fluids to or from the urinary tract. Consistent with this regulation, a review of our records has determined that you obtained marketing clearance (K024010) for the Dover© Catheter for use in the drainage and/or collection and/or measurement of urine. The Dover® Catheters were found to be substantially equivalent to the Kendall Dover® Foley Catheter predicate device. However, your submission did not support the claims of clinical benefits of reduced risk of hypersensitivity and/or the reduction in urinary tract infections, encrustation, urethritis, and stricture.

In a letter from Mr. David Olson, Vice President of Regulatory Affairs, dated March 1, 2004, your firm agreed to use only approved materials and to not promote the antimicrobial properties of the "Dover® Silver coated catheters". Despite this, our recent review of your Dover Urologicals brochure identified antimicrobial effectiveness claims for the Dover® Catheters. For example, your promotional materials state that:

  • "DOVER catheters feature a proprietary combination of silicone and silver that can lead to reduced encrustation and a lower incidence of urethral irritation and stricture while eliminating latex allergy and toxicity concerns."

  • "New surface technologies that release far greater quantities of ionic silver or other antiinfective agents into the aqueous environment contiguous to the catheter surface might even prevent CAUTIs caused by intraluminal contaminants."

Although claims such as the reduction in urethritis or decreased encrustation may be based upon published literature, the claims have not been reviewed or cleared by the Office of Device Evaluation (ODE) and require a new 510(k). The brochure also promotes reduced risk of hypersensitivity for the Dover® Catheters; however, although silicone catheters do not carry the risk of latex sensitivity, the silver-coated catheters do pose the risk of allergic or hypersensitivity responses to individuals who are sensitive to silver.

Additionally, your firm submitted a 510(k), [redacted] seeking claims of antimicrobial effectiveness based upon laboratory studies for the Dover® Catheters. The devices were found to be not substantially equivalent in November 2004, due to lack of performance data. Marketing your product for the above-stated intended uses is a violation of the law. In legal terms, these products are'. adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved Premarket Approval Application (PMA) to demonstrate that these devices are safe and effective for the new uses for which you are marketing them: In addition, the devices are misbranded under section 502(o) of the Act, 21 U.S.C. 352(o) because you did not submit a section 510(k) premarket notification to notify the agency of your intent to introduce the device into commercial distribution for these new uses. For a device or use requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).

The kind of information you need to submit in order to obtain marketing clearance or approval is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate this information and decide whether your products may be legally marketed.

Conclusion and Requested Action

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Kendall Dover® Silver Hydrogel Coated Silicone Foley Cathetor comply with each applicable requirement of the Act and FDA implementing regulations.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice: These actions include, but are not limited to; seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

The OC in CDRH requests that your firm (1) immediately cease the dissemination of violative promotional materials for the Kendall Dover® Silver Hydrogel Coated Silicone Foley Catheters for the uncleared/unapproved clinical benefits described above, and (2) revise the violative portions of your website. Please submit a written response to this letter within fifteen (15) working days of receipt of this letter, describing your intent to comply with this request, and explaining your plan for discontinuing claims for such clinical benefits. Please direct your response to Mr. Paul Tilton, Chief, Ob/Gyn, Gastroenterology & Urology Devices Branch, at the Food and Drug Administration, 2098 Gaither Road (HFZ-332), Rockville, Maryland 20850, or by facsimile at (240) 276-0114. We remind you that only written communications are considered official.

Sincerely yours,

/S/

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