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U.S. Department of Health and Human Services

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Enforcement Actions

Augustine Biomedical & Design, LLC 7/24/12

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993
 

JUL 24, 2012

WARNING LETTER
 

Via United Parcel Service

Scott Augustine, M.D.
Chief Executive Officer
Augustine Biomedical & Design, LLC
6581 City West Parkway
Eden Prairie, Minnesota 55344

Refer to CPT1 200003 when replying to this letter.

Dear Dr. Augustine:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Hot Dog Patient Warming System in the United States. The product is a device within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C.§ 321 (h), because it is intended for use in the diagnosis of disease or other conditions or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. As explained below, this device is being marketed without the required clearance or approval in violation of the Act.

Your firm obtained the following clearances for this system under section 510(k) of the Act, 21 U.S.C. § 360(k): the Hot Dog Patient Warming System (K052392), the Hot Dog Patient Warming Mattress System (K092807), the Hot Dog Multifunction Controller (K094056), and the Hot Dog Patient Warming System (K112488), each of which is " intended to prevent or treat hypothermia and to provide warmth to patients," and is " intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery and emergency rooms and on medical/surgical floors." The Hot Dog Patient Warming System was most recently cleared in K112488 for use with adult and pediatric patients.

The Office of Compliance in FDA's Center for Devices and Radiological Health, reviewed your firm's website, www.hotdog-usa.com on May 24, 2012. Although none of your firm's 510(k)s for the Hot Dog Patient Warming System are cleared to reduce infection rates, your firm's web site includes several claims of infection reduction from use of this device during surgical procedures. For example, a page on your firm's website, www.hotdog-usa.com/guarantee.php, titled "REFUND GUARANTEE," contains statements about air-free Hot Dog warming being associated with infection reduction. On this page, your firm states that, " unlike forced-air, air-free HotDog warming doesn't generate waste heat that can contaminate the sterile field (even with laminar flow ventilation). Hospitals that have switched to HotDog report significant reduction in deep joint SSIs. For example, a # 1 rated hospital in Minnesota experienced an 81% reduction after switching to air-free warming." The claim of reduced infection is a clinical claim; submission of clinical data would be needed to support such a claim.

On your web site there is another page, www.hotdog-usa.com/safer.php, titled "HOTDOG IS SAFER." Below that caption is a summary of an article from the November 2011 issue of the Journal of Bone and Joint Surgery Br. Your firm's web page summarizes the article as concluding, "74% reduction in implant infections: Orthopedic surgeons reduced infections after switching to air-free Hot Dog patient warming (1437 patients over 2.5 years). Bair Hugger contaminates sterile field: Waste hot air convection currents transport contaminated air into the surgical site. Air-free warming has no such effect. Researchers concluded: 'Airfree warming, therefore, is recommended over forced-air warming for orthopedic procedures."'

Statements such as the ones cited above represent a major change or modification in the intended use of your firm's device, which requires a new premarket notification. 21 CFR 807.81(a)(3)(ii). Therefore, the Hot Dog Patient Warming System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360(e)(a), or an approved application for an investigational device exemption (IDE) under section 520(b) of the Act, 21 U.S.C. § 360j (g). The Hot Dog Patient Warming System is 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 device into commercial distribution for infection reduction, 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, 21 U.S.C. § 360(k), 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 its device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.

The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps that 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.

Your firm 's response should be sent to:

Damia Jackson
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire A venue
W066-3500
Silver Spring, MD 20993

Finally, you should know that the violations discussed in this letter do not necessarily constitute and exhaustive list. It is your firm's responsibility to ensure compliance with each applicable requirement of the Act and FDA implementing regulations. 

Sincerely,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health