STERIS (NYSE:STE) has obtained 510(k) clearance from the U.S. Food and Drug Administration on two new sterilization devices and one clearance for a minor enhancement on an existing product.
Details of the new products were fairly sketchy, as a STERIS spokesman declined to provide much information until after the products are launched at an unspecified time. But a look at a list of September 510(k) clearances on the FDA’s website provided a few details.
One new product is a small steam sterilizer called the Chimeron that’s part of the Mentor, Ohio, company’s Amsco product line. The device was assigned to an FDA gastroenterology and urology advisory committee.
The other new device is called the “Verify biological indicator challenge pack,” and is intended for use with a vaporized hydrogen peroxide sterilizer. Steris sells several types of biological indicators, which are sterilization monitoring tools that detect bacteria on medical equipment.
STERIS has been awaiting FDA clearance of a biological indicator for its System 1E liquid chemical sterilization device, which is a newer version of its flagship product. The biological indicator for the System 1E is being reviewed under the FDA’s de novo process, which is intended for devices for which there is no existing “substantial equivalent” on the market. It doesn’t appear that the recently cleared biological indicator is intended for use with the System 1E.
The company’s third 510(k) clearance in September applied to two previously cleared sterilizers, the Amsco V-PRO 1 and V-PRO 1 Plus systems. The V-PRO systems are designed to quickly sterilize high volumes of heat- and moisture-sensitive devices. The new 510(k) clearance for the devices “included minor changes to enhance device usability,” the STERIS spokesman said.
In 1996, STERIS acquired Amsco, a maker of operating room and sterilization equipment, and has maintained the brand name on several product lines.
