| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue |
Department of Health and Human Services
JAN 21 2011
WARNING LETTER
VIA United Parcel Service {and FACSIMILE}
Jan Keltjens
President and Chief Executive Officer
Angiodynamics, Incorporated
14 Plaza Drive
Latham, New York 12110
Re: NanoKnife/Oncobionic System
Refer to: CON1017413
Dear Mr. Keltjens:
The Food and Drug Administration (FDA) has learned that your firm is marketing the NanoKnife/Oncobionic System (NanoKnife) device in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act). The product is a device within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(h), because it is 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.
Your firm has obtained the following 510(k) clearances for this device, each of which is indicated “for surgical ablation of soft tissue”: the Oncobionic System (K080376), the Oncobionic System with 6 probe output (K080202), and the Oncobionic Bipolar Electrode (K080287), which “is intended to be used only with the Oncobionic System.”
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website at www.angiodynamics.com/products/nanoknife for the NanoKnife device on January 4, 2010. Although the NanoKnife is not cleared for the treatment of any specific disease or condition, on your website under the “Products” link there is an option to select “Oncology/Surgery,” which leads the reader to information regarding the NanoKnife. The webpage for the NanoKnife contains a link to a promotional brochure that includes the following testimonial from a physician whose identified specialty is general oncologic surgery:
“NanoKnife IRE therapy is a novel ablative modality which may allow us to treat patients who we could not otherwise treat, such as patients with locally advanced disease which is unresectable due to location. As a surgeon, I see value in utilizing IRE as an adjunct to surgery to widen my field of treatment at or near critical structures to increase resectability and/or accentuate margin.”
On the same page of the promotional brochure there is another testimonial by a physician whose identified specialty is vascular interventional radiology, which states:
“NanoKnife IRE… destroys tissue at the cellular level, enabling us to treat lesions at or near critical structures without collateral damage to blood vessels and bile ducts. With the NanoKnife IRE System, we can reach and treat lesions in difficult locations-which cannot be treated effectively with thermal ablative therapies. This allows me to offer a treatment option to some patients who have no other recourse.”
On page 4 of the same brochure you make the following claims “Ablate at or near vital structures (e.g., blood vessels, bile ducts, and other tissues containing collagen/elastin); Potential to spare critical structures - vasculature and ducts remain intact; Ablated tissue removed by the body's natural processes within weeks - mimics natural cell death; and Minimal to no post-procedural pain compared to other traditional modalities.”
Throughout your promotional brochure and instructions for use, also available on your website via the “Oncology/Surgery” link, you repeatedly use the words “treat,” “treatment,” and “therapy” to imply that your device should be used as therapy for a particular disease or condition. Prior to the clearance of your device, the FDA reviewer requested that you remove the terms “treatment” and “therapy” and replace them with the word ”ablation” throughout the labeling for the device, and you agreed to do so. The quotations attributed to you in the October 5, 2010 Wall Street Journal article titled, “Some Doctors Question New Cancer Treatment,” suggest that you are aware that your device has not received the required clearance or approval for such treatment claims: “We have not done randomized, controlled clinical trials, the so-called gold-standard studies…We think this is a very promising technology for treating cancer that is otherwise untreatable.”
Statements such as the ones cited above represent a major change or modification in the intended use of your device that requires a new premarket notification. 21 CFR 807.81(a)(3)(ii). Therefore, the NanoKnife device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C.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 device is 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 it into commercial distribution for the intended uses discussed above, 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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is available through the Internet at http://www.fda.gov/cdrh/deviceadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Office of Compliance requests that Angiodynamics, Inc. immediately cease marketing the NanoKnife for unapproved uses such as those described above. 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 Food and Drug Administration without further notice. Such action includes, but is not limited to seizure, injunction, and/or civil money penalties. U.S. 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. Request for Certificates to Foreign Government will not be granted until the violations related to the subject device are corrected.
We also note that you use the term “irreversible electroporation” or “IRE” throughout your materials to describe the indicated use of the device. You did not explicitly use this term in your 510(k) submissions. We request that you provide us a precise definition of this term.
Please notify this office in writing within fifteen (15) working days from the date your receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentations of the corrective actions you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review. Your response should be sent to:
Terri T. Garvin
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3521
Silver Spring, MD 20993
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt steps to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Steve D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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