Inspections, Compliance, Enforcement, and Criminal Investigations
Argentum Medical LLC 5/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
MAY 29 2012
VIA UNITED PARCEL SERVICE
Chairman and Chief Executive Officer
Argentum Medical, LLC
3700 North Lake Shore Drive, #106
Chicago, Illinois 60613
Refer to CMS # 297258 when replying to this letter.
Dear Mr. Silver:
The Office of Compliance in the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health has learned that Argentum Medical, LLC, is marketing in the United States the Silverlon products cited below. These products are devices within the meaning of section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 to affect the structure or any function of the body. As explained below, these devices are being marketed without required clearance or approval in violation of the Act.
A review of our records show that your firm obtained under section 510(k) of the Act, 21 U.S.C. § 360(k), the following clearances for the Silverlon wound and burn care product line:
• Silverlon CA Antimicrobial Calcium Alginate Dressing (K053590) is indicated "as an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon CA Antimicrobial Calcium Alginate Dressing is indicated for external use only."
• Silverlon Wound Contact Dressing products (K023612) were cleared to include the following: Antimicrobial Barrier Wound Contact Dressing, Antimicrobial Barrier Burn Wrap Dressing, Antimicrobial Barrier Burn Contact Dressing, and Silverlon Acute Burn Glove. For over-the-counter use, the Silverlon Wound Contact Dressing is indicated as "[f]irst aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns." As prescription devices, the Silverlon Wound Contact Dressing products are indicated as an "effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic)."
• Silverlon Adhesive Strip (K023609) has the following professional indications: "for vascular access, central, arterial and venous IV sites, IM injections sites, abrasions, lacerations, partial thickness burns, wound drain sites and surgical incisions." Silverlon Adhesive Strip also has the following over-the-counter indications: "First aid to help in minor cuts, scrapes, abrasions and burns."
• Silverlon Wound Packing Strips (K984210) are sterile, non-adherent silver wound dressings. They are indicated for professional prescription use in the "[c]ontrol of local wound bleeding and nasal hemorrhage, to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a 'wet-to-dry' packing."
• Silverlon Contact Wound Dressing (K981299) is indicated as "sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic)."
On May 9, 2012, OC reviewed your website at www.silverlon.com/body.htm and observed promotional claims for the following cleared wound-dressing products:
• Silverlon Calcium Alginate Dressing
• Silverlon Wound Contact Dressing
• Silverlon Burn Contact Dressing
• Silverlon Burn Wrap Dressing
• Silverlon Acute Burn Glove
• Silverlon Adhesive Strip
• Silverton Wound Packing Strips
• Silverlon Contact Wound Dressing
The website includes many claims that are not within the cleared intended use for the above-listed products, including the following:
• "[a] flexible fabric delivers more safe, pure ionic silver to the wound site"
• "an effective treatment against stubborn MRSA infections and other Superbug Bacterial Infections"
• "Silverton delivers a speedy and sustained kill against MRSA bacteria."
• "Versatile Silverton Dressings help wounds heal up to 50% faster"
• "Patients report significant pain reduction and reduced scarring"
The Silverton Wound Dressings promoted with the intended uses described above are adulterated under section 501(f)(1)(8) of the Act, 21 U.S.C. § 351(f)(1)(8), because your firm does not have for any of those uses an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C.§ 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C.§ 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency, 21 CFR § 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
The Office of Compliance requests that Argentum immediately cease marketing the Silverton products for unapproved uses such as those described above. Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Additionally, we reviewed promotional materials for the following devices: Silverlon Negative Pressure Dressing, Silverton Island Dressing, Silverton Burn Pad Dressing, Silverton Wound Pad Dressing, and the Silverlon Lifesaver IV/Catheter Wound Dressing. We have conducted a review of our files and have been unable to identify any FDA clearance numbers for these devices: We request that you provide us with the FDA clearance number for the devices. If you do not believe that you are required to obtain FDA clearance for these devices, please provide us with the basis for that determination.
Your firm's response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
Silver Spring, MD 20993
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and