Other vendors must also file PMAs for applicationThe Food and Drug Administration has granted ATL supplementalpremarket approval for use of its HDI 3000 ultrasound scannerto determine when suspected breast cancer cases should be biopsied.The Dec.
Other vendors must also file PMAs for application
The Food and Drug Administration has granted ATL supplementalpremarket approval for use of its HDI 3000 ultrasound scannerto determine when suspected breast cancer cases should be biopsied.
The Dec. 23 approval extends to ATL's top-of-the-line scannerthe same marketing rights the FDA issued in April 1996 for itsUltramark 9 High-Definition Imaging (HDI) ultrasound scanner (SCAN4/24/96). Ultramark 9 HDI production ceased three months afterthe PMA was issued, when it was replaced by HDI 3000 as ATL'sfeatured high-performance scanner.
The PMA permits the Bothell, WA, company to advertise that HDI3000, equipped with an L10-5 scanhead, can be used as a follow-upbreast cancer test, according to Terrence Sweeney, vice presidentof regulatory affairs. The examination is designed to increasea physician's confidence that differential results from previousx-ray mammography tests and physical breast exams show that thepatient should be biopsied. The PMA also allows the vendor toteach physicians how to perform and interpret results from thecomplex imaging procedure.
The approval culminates a five-year, $2 million effort by ATLto expand the clinical role of its ultrasound scanners in breastcancer diagnosis, according to Sweeney. In general, ultrasound'sdiagnostic role in breast cancer examination is otherwise limitedby the FDA to determining whether abnormalities are solid or cystic.
The clinical efficacy of the new technique was demonstrated ina 14-site clinical trial involving more than 1000 women and 431suspicious breast lesions selected for analysis, Sweeney said.The study found that the number of unnecessary breast biopsiesis reduced by 40% when equivocal cases are examined with the ATLequipment, he said.
Faced with the prospect of repeating the clinical trial for HDI3000, ATL and the FDA developed a custom test to demonstrate productequivalency, according to Sweeney. It involves comparative clinicalimaging and bench tests of the two systems using an FDA-designedphantom.
"It is very accurate and reproducible, without interoperatorvariance, so you have a very accurate way of comparing the actualperformance of the two products," he said.
While the test is good enough for comparing HDI 3000 with Ultramark9 HDI, it is not appropriate for establishing equivalency betweenscanners from ATL's competitors and the HDI series for the specializedbreast cancer application, Sweeney said.
Sweeney, who also serves as ultrasound section chairperson ofthe National Electrical Manufacturers Association, said that othermanufacturers must go through the PMA processincluding costlyclinical trialsto show that their equipment performs wellenough to play this clinical role.
"There are many factors behind image contrast involved withthe actual performance of the device. Doppler performance, scanheadsetup, and focusing capabilities, for example, also need to beevaluated and critiqued," he said.
The expensive PMA process prompted Acuson to file a citizen'spetition asking the FDA to clarify when vendors must file PMAsinstead of 510(k) applications that demonstrate equivalency withpreviously approved techniques and hardware. Other ATL competitorscite high costs and low potential economic returns for choosingnot to pursue PMAs for their equipment.
It is hard to measure in monetary terms whether ATL's $2 millioninvestment has yet paid off, Sweeney said. The 200 clinicianstrained by ATL to use the breast cancer protocol since April 1996provide a rough measure of clinical acceptance thus far, he said.
Another 1000 customers will be taught how to use the techniqueat five seminars planned this year, according to Cass Diaz, seniorvice president of worldwide sales and marketing. Ongoing ATL outcomeresearch efforts are examining the economics of ultrasound breastimaging and the clinical efficacy of high-performance ultrasoundin dense breast evaluations, according to Richard Tabbutt, directorof market development.