The AHP is an assessment tool with Siemens’ Acuson Sequoia C512. Source: Siemens Medical Solutions

The FDA’s Center for Devices and Radiological Health on Wednesday sent a warning letter to Siemens Medical Solutions ultrasound division president, Klaus W. Hambuechen, concerning its syngo Arterial Health Package (AHP) assessment tool that the company sells with some ultrasound systems needs to have separate regulatory approval.

The agency said that Siemens is promoting AHP for use with several of Siemens ultrasound systems, including the Acuson Sequoia C512, X500, X300 and CV 70, and its syngo US Workplace.

Kristen Saponaro, manager of corporate affairs at Siemens Medical, told Health Imaging News that Siemens has received the letter and the company is corroborating with the FDA to resolve the issue. When asked if Siemens would seek FDA approval for AHP, she said the company was not prepared to answer that at this point, so soon after receiving the warning letter.

The FDA said that under section 201(h) of the Food, Drug, and Cosmetic Act, the 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.”

The agency also called into question the manner in which AHP is advertised, specifically pointing to the Siemens website, press releases and PDF brochure for the AHP, and stating that the promotional language does not coincide with its current regulatory indications. The warning letter stated the company “did previously obtain premarket clearance for the ultrasound systems themselves,” yet the letter continued that “your statements regarding the uses and capabilities of the AHP do not fall within the cleared indications for use of those ultrasound devices.”  The letter added that 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 images, to store and print images, and to manipulate and make measurements on images using a PC or a compatible DICOM.”
 
The letter concluded that the manner in which Siemens is marketing AHP “for this intended use is a violation of the law.”

FDA urged that the company “should take prompt action to correct these deviations. Specifically, FDA requests that you cease distribution of the syngo AHP and cease dissemination of promotional materials for your ultrasound systems Acuson Sequoia 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.”

The FDA gave Siemens 15 working days to let the agency know what steps they have taken to “correct the problem.” They also requested that Siemens provide a plan to prevent this type of violation from happening in the future.