Inspections, Compliance, Enforcement, and Criminal Investigations
Hemcon Medical Technologies, Inc. 5/20/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
May 20, 2014
In reply refer to Warning Letter SEA 14-13
Barry S. Starkman
President and CEO
HemCon Medical Technologies, Inc.
10575 SW Cascade Avenue, Suite 130
Portland, Oregon 97223-4363
Dear Mr. Starkman:
During an inspection of your firm located in Portland, Oregon, on December 4, 2013, through December 18, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following hemostasis bandage products: the Bandage PRO, Patch PRO, Strip PRO, Strip FIRST AID, GuardaCare PRO 2 in x 2 in 8 ply, and ChitoGauze PRO 3 in x 4 yrds. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 are intended to affect the structure or any function of the body.
We received a response from you dated January 9, 2014, concerning our investigator’s observations noted and discussed with you at the conclusion of the December 4, 2013, through December 18, 2013, inspection. We address this response below, following the noted violations.
During the inspection, FDA collected labeling, including promotional materials and website information, for your hemostasis bandage products. Our review of the material revealed that the Bandage PRO, Patch PRO, Strip PRO, Strip FIRST AID, GuardaCare PRO 2 in x 2 in 8 ply, and ChitoGauze PRO 3 in x 4 yrds 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 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Bandage PRO, Patch PRO, Strip PRO, Strip FIRST AID, GuardaCare PRO 2 in x 2 in 8 ply, and ChitoGauze PRO 3 in x 4 yrds are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution in that a notice or other information respecting the new intended use of the devices was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). Specifically, these devices were cleared with the following indications:
K023298, K043050 - HemCon Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon Bandage also controls bleeding in patients following hemodialysis.
K030946, K072486 - The HemCon Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
K080818 - HemCon ChitoFlex Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.
K092357 - (Rx) ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds. (OTC) ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts, and minor abrasions.
However, you are marketing these devices for the following indications including but not limited to:
· Shortens long bleeding times associated with blood thinners.
· Uses for anti-coagulant patients; effective on anticoagulated patients; ideal for anticoagulated patients.
· Reduces time to hemostasis, even for patients on anticoagulants; ideal for people on anticoagulant medications.
· Barrier may help prevent the risk of infection; barrier may help decrease the risk of hospital acquired infection.
· Offer antibacterial properties when applied to a wound.
Of the statements identified on the website, the only statement that is consistent with your firm’s cleared 510(k)s are bandages and dressings having antibacterial properties to have a preservative effect on the device. All other statements claimed are not consistent with the above clearances and were not reviewed or cleared through the 510(k)s mentioned in this Warning Letter and a new 510(k) is required.
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 the device is described on the Internet at http://www.fda.gov/MedicalDevices/ %20DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.
The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
We received your response dated January 9, 2014, and find that your response is inadequate to address the noted violations. The above claims were not specifically listed on the cleared product labeling or in the 510(k) indications for use.
You refer to various statements within your 510(k) submissions that have been substantiated by data in your 510(k) applications such as: mitigation of hospital acquired infections, regarding the effectiveness of the device in anti-coagulated patients, and mitigation of emboli formation. You state that these claims were supported by data that was included within your 510(k). However, in order for you to be able to market these claims, these claims also have to be included in your indication for use statement to ensure these claims when administered by your device are reviewed to be as safe and effective as similar claims by the predicate device. Therefore, you are only permitted to promote and distribute your devices with the specific indications for use cleared in your 510(k)s.
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/or 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 awarding 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 (which must address systemic problems) 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 Patricia A. Pinkerton, Compliance Officer, Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about the content of this letter please contact Ms. Pinkerton at (425) 302-0428.
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. The specific violations noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.
Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Miriam R. Burbach