Inspections, Compliance, Enforcement, and Criminal Investigations
Storz Medical, AG
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Silver Spring, MD 20993|
APR 8, 2010
Storz Medical Ag
RE: D-Actor® 50 and D-Actor® 200 devices
Refer to GEN 0901321 when replying to this letter.
The Food and Drug Administration (FDA) has learned that your firm is marketing the D-Actor® 50 and D-Actor® 200 devices in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website at www.storzmedical.com for the D-Actor® 50 and D-Actor® 200 devices on April 5, 2010. The products are devices within the meaning of section 201(h) of 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 is intended to affect the structure or function of the body.
The D-Actor® 50 devices 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 devices 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, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
The D-Actor® 200 devices were cleared in 510(k) K072809 for the following indications: to relieve minor muscle aches and pains, and for the temporary increase in local blood circulation. However, your website states under “Facts and figures” for the D-Actor 200:
- “tissue is purified”; and
- “the interaction between the central and peripheral nervous systems is improved.”
These statements represent a major change or modification in the intended use of your device that require a new premarket notification. 21 CFR 807.81(a)(3)(ii). Therefore, the D-Actor® 200 devices 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 devices 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 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/devadvice/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 Storz Medical immediately cease marketing the D-Actor® 50 and D-Actor® 200 devices 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. Your device is also subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that it appears to be adulterated and misbranded. As a result, FDA may issue an Import Alert, whereby FDA may detain your devices without physical examination upon entry into the United States until the corrections are completed.
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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you 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 documentation of the corrective action 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:
Chief, Orthopedic and Physical
Medicine Devices Branch
Center for Devices and
WO 66, Room 3621
10903 New Hampshire Avenue
Silver Spring, MD 20903-0002
If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or fax number (301) 847-8138.
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 actions to correct the violations and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and