ExpressCore Biopsy Device

The ExpressCore Full Core Biopsy Device is a sterile, single-use, handheld biopsy instrument comprised of a plastic handle and three stainless steel needle components that work sequentially to capture full-core tissue samples. It is intended for obtaining biopsies from soft tissues and features variable throw distances (10-30mm), multiple firing modes (semi or automatic), and available gauge sizes from 12ga to 18ga with lengths from 10cm to 25cm.

The subject device differs from the predicate Revolution device in handle composition (ABS/Polycarbonate vs. ABS/TPE/Polyester/Acetal), available needle gauges (12ga, 14ga, 16ga, 18ga vs. 14ga only), needle lengths (10, 15, 20, 25cm vs. 10, 15cm), throw range (10-30mm vs. 13-25mm), and packaging (Tyvek/PE pouch vs. Tyvek/PETG tray). Both use 304 stainless steel needles, ethylene oxide sterilization, dual-stroke arming, and semi/automatic firing modes.

Not stated in this summary.

The subject device is substantially equivalent because it performs the same intended function (obtaining soft tissue biopsies) using the same core operational mechanism and materials as the predicate. Although the subject offers broader gauge and length options and slightly different packaging, these differences do not raise safety or effectiveness concerns because they represent expected design variations within the same device class, as evidenced by the reference devices EliteCore and AccuCore which demonstrate similar variations. Bench performance testing confirmed equivalent usability, biopsy sample collection, tensile strength, and tissue sampling capability.