Inspections, Compliance, Enforcement, and Criminal Investigations
Siemens Medical Solutions, Ultrasound Division 17-Dec-07
Department of Health and Human Services
Public Health Service
9200 Corporate Boulevard
VIA FEDERAL EXPRESS
Mr. Klaus W. Hambuechen
Siemens Medical Solutions, Ultrasound Division
1230 Shorebird Way
Mountain View, CA 94039-7393
Re: Syngo® Arterial Health Package
Dear Mr. Hambuechen:
The Office of Compliance(OC) in the Center for Devices and Radiological Health (CDRH) reviewed information on your web site: www.usa.siemens.com and press releases for the syngo® Arterial Health Package (AHP) which is promoted for use with several of your ultrasound systems (ACUSON SequoiaTM C512, X500, X300 and CV 70) and the syngo® US Workplace. Under section 201(h) of the Food, Drug, and Cosmetic Act (the Act), 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 intended to affect the structure or function of the body, 21 U.S .C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
Your Siemens web site and the press releases contain statements and claims that the syngo® Arterial Health Package, which is intended for use with your above-referenced ultrasound systems and syngo US Workplace, features a semi-automated carotid intima-media thickness (CIMT) measurement with vascular age risk assessment and Framingham Risk Factors. A PDF brochure for the AHP, available on your website, further states that the AHP provides "vascular risk assessment" in a simple package that is a "reliable, noninvasive assessment tool [that] empowers physicians and patients to address atherosclerosis in its earliest stages by optimizing proactive treatment and preventive care." The brochure further indicates that the syngo AHP:
• Derives a semi-automated CIMT measurement incorporated into patient database
• Calculates a Vascular Age with individualized results
• Calculates a Distensibility and Elasticity measurements
• Derives a Framingham Risk Factors assessment based on calculated vascular age
• Validated for adult patients, 40-70 years of age with no prior history of cardiovascular disease
The brochure indicates that through use of the AHP, "Color-coded 'at risk' areas are highlighted on clinical images." The brochure also indicates that the AHP enables treatment of "subclinical atherosclerotic disease," "facilitates monitoring and long-term patient management," and provides feedback to patients to encourage them to make and maintain changes to "potentially avoid myocardial infarction and stroke."
A review of our records reveals that you did not obtain marketing approval or clearance for the AHP before you began offering that product for sale for use with your ultrasound systems and syngo® US Workplace. Although you did previously obtain premarket clearance for the ultrasound systems themselves, your statements regarding the uses and capabilities of the AHP do not fall within the cleared indications for use of those ultrasound devices. (See K063085, K061980, K071036 and K050240). (If the addition of the AHP and associated claims is viewed as a change to the underlying ultrasound systems, it constitutes a significant change in both components and intended use that would require the submission of a new premarket notification, in accordance with 21 CFR 807.81(a)(1).) The claims for the AHP are also beyond the scope of the cleared indications for the syngo® US Workplace device, which is used to view post processed ultrasound image to store and print images, and to manipulate and make measurements on images using a PC or a compatible DICOM. (See K061964). None of your cleared 510(k)s contained data to support the claims of vascular risk assessment you are now making in conjunction with use of the AHP.
Because you lack clearance or approval, marketing your devices for this intended use is a violation of the law. Specifically, your devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C.3 51(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). Your devices are also misbranded under section 502(o) 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.htm1. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct these deviations. Specifically, FDA requests that you cease distribution of the syngo Arterial Health Package and cease dissemination of promotional materials for your ultrasound systems ACUSON SequoiaTM C512, X500, X300 and CV 70 and the syngo® US Workplace, for use with the syngo® AHP and/or for use in vascular risk assessment. Failure to promptly correct these deviations 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/or 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.
Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. Please include a list of all promotional materials for ACUSON SequoiaTM Ultrasound Systems, syngo® US Workplace, and syngo® AHP the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to: Ms. Fleadia Farrah at the Food and Drug Administration, 9200 Corporate Blvd., (HFZ-340), Rockville, Maryland 20850, facsimile at 240.276.0129.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only~ the issue of premarket review for your devices and does not necessarily address other obligations you have under the law.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and