Coronary artery claims may push 510(k) device to PMA status.

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Statements in a brochure, press releases and Internet sites regarding screening for coronary artery disease overstepped the 510(k) cleared for Imatron's Ultrafast Computed Tomography Scanner, according to a May 4 warning letter to the South San Francisco company. Although originally cleared via 510(k), the new intended use sounded more like a PMA candidate, FDA said.

"Because of the serious nature of a claim related to coronary artery disease, FDA's Office of Device Evaluation would probably require that Imatron obtain approval of a premarket application," the warning letter stated.

FDA said the 510(k) represented the intended use as "to produce cross sectional images...of the human anatomy." The submission added that, like some of its predicate devices, the Scanner also could be used in "clinical situations requiring determination of specific quantitative information," according to the warning letter.

This did not cover specific diagnostic claims, FDA said. The agency referred to a brochure, submitted to CDRH in 1996, containing "explicit diagnostic claims," particularly for coronary artery scanning, along with a press release referencing the use of the coronary artery scan in the National Heart, Lung and Blood Institute's multicenter study on cardiovascular disease progression. Similar claims appeared on Imatron's Web site, along with a link to another Web site for HeartScan Imaging, an Imatron subsidiary, which discussed scanning for coronary artery disease.

The Imatron site also contained claims for "other specific diagnostic capabilities," such as lung and colon screening, plus more links to other Web addresses in the U.S. and elsewhere, with names referring to coronary scanning, FDA said. 510(k), O-L Use, Web