| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
MAR 23 2010
WARNING LETTER
VIA FEDERAL EXPRESS
(b)(6)
President
Dornier MedTech America, Inc.
1155 Roberts Boulevard
Kennesaw, GA 30144
RE: Dornier Opus II UIMS Digital Urology Imaging System
Dear (b)(6):
Refer to CTS Number GEN0900257 when replying to this letter.
The Food and Drug Administration (FDA) has learned that your firm is marketing in the United States the Dornier Opus II UIMS Digital Urology Imaging System without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance in the Center for Devices and Radiological Health (CDRH) reviewed your website, http://www.dornier.com. for the Dornier Opus II UIMS Digital Urology Imaging System. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device 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 510(k) clearance for the TCA 5R / 5S Image Intensified Fluoroscopic Imaging Mobile C-Arm Systems, K070123, which have the following Indications for Use: "The TCA 5R /5S C-arm systems are designed for x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to: traumatology, pediatrics. simple interventional radiology, pacemaker implantation, operating room procedures, intensive care, and respiratory and skeleton procedures."
However, based on a review of your website, the Dornier Opus II UIMS Digital Urology Imaging System, with digital flat panel detector, provides fully digital imaging capabilities, including utilization of digital flat panel detector technology. This device has not been cleared or approved. Specifically, your website, http://www.dornier.com. contains the following information related to the Dornier Opus II UIMS Digital Urology Imaging System:
• Your website indicates that "The state-of-the-art Opus II urology imaging table is a fully digital imaging system with enhanced patient access, exceptional imaging and advanced patient data management system. The sleek system has the smallest footprint in the industry providing unsurpassed access for both urologist and anesthesiologist and can be changed to either a right- or left- hand configuration in a matter of seconds by simply exchanging the bead and foot pieces. The Opus II offers Dornier's next generation of digital imaging, data management and connectivity platform with UIMS, Urology Information Management System."
• Additionally, the same website link indicates in the "Exceptional Imaging" section that "The Opus II offers exceptional imaging capabilities. The simple-to-use digital system provides zero-bladder cutoff with unique overscan ideal for brachytherapy, enabling physicians to obtain high quality fluoroscopic images to the very end of the table and visualize the entire urological tract. The system is equipped with a realtime, 16" quad mode or 9"/12" tri mode image intensifier and features fluoroscopic and digital radiographic imaging modes."
• The website link to the brochure entitled "The Domier Opus 11 UIMS Digital Urology Imaging System" indicates in the Digital Imaging section that "As a completely digital imaging system, the Opus II UIMS provides unsurpassed imaging flexibility. The real-time, quad-mode image intensifier captures high quality digital and fluoroscopic images in a high resolution pixel format The system offers a dose reducing pulsed fluoroscopy that also supports a special high-level boost mode for larger patients."
The device is 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 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 the device 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, 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 you need to submit in order to obtain approval or clearance for your 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.
The Office of Compliance requests that Domier MedTech America, Inc. immediately cease the dissemination of promotional materials for the Domier Opus II UIMS Digital Urology Imaging System, with digital flat panel detector, including any promotional materials that are the same as or similar to those described above. This includes the removal of such materials from your website http://www.dornier.com.
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. These actions include, but are not limited to, seizure, injunction, and lor civil money penalties. Also, 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 device have been corrected.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing 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 your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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. Additionally, in your response. please describe your intent to comply with our request that you immediately cease the dissemination of promotional materials for the Domier Opus II UIMS Digital Urology Imaging System. with digital flat panel detector. list all promotional materials for the device, including any that are the same as or similar to those described above, and explain your plan for discontinuing use of such materials. Please direct your response to the Food and Drug Administration, Jennifer R. Medicus, Chief, Radiology, Anesthesiology, and Neurology Devices Branch. Office of Compliance, Center for Devices and Radiological Health, 10903 New Hampshire Avenue. W066/2626. Silver Spring. MD 20993. facsimile at 301-847-8128. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is our responsibility to ensure compliance with applicable requirements of the Act and FDA implementing regulations.
Sincerely,
/s/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
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