ClearCount Medical Solutions, a Pittsburgh-based company focused on improving surgical safety, has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SmartWand-DTX handheld device, an RFID-enabled tool that can be used to find surgical sponges embedded with RFID chips if they’ve been inadvertently left inside a patient during surgery. During the 510(k) process, the FDA determines whether a device is equivalent to an instrument previously cleared by the FDA, or marketed before 1976. The 510(k) submitter explains the similarity between the new device being submitted for clearance and any previously approved tools it may replace, outlining why any differences between them should be acceptable. Having received 510(k) clearance, ClearCount can now market and commercially distribute its SmartWand-DTX system in the United States. The company had previously received 501(k) clearance for its RFID-enabled sponges, called SmartSponges, in 2007 (see RFID-enabled Surgical Sponges a Step Closer to OR). ClearCount’s system leverages Texas Instruments’ Tag-it HF-I passive 13.56 MHz RFID tags, which support the ISO 15693 and 18000-3 standards. In addition to the SmartWand-DTX handheld reader, the firm’s SmartSponge system can be configured with a built-in RFID interrogator that, at the start of an operation, records the number of tagged sponges in pre-packs as workers set them on a tray fitted with an interrogator antenna. After an operation, used sponges are then discarded into a bucket, also fitted with an interrogator antenna, to record the number of sponges that are discarded. A small LCD screen displays the counts, confirming whether there’s a match. The SmartWand-DTX enables surgical teams to scan a patient during postoperative safety checks, and to locate any sponges mistakenly left behind. ClearCount has also announced that it has redesigned its SmartSponge system so that hospitals can use the SmartWand-DTX, with the RFID-enabled sponges, as a stand-alone, less expensive system, or invest in the fixed reader, console and sponges for a more comprehensive system. “This clearance to market is a significant milestone for our customers, employees and investors,” said ClearCount’s CEO, David Palmer, in a prepared statement. “We are commercializing a detection system that offers broad advantages over current offerings. SmartWand-DTX, in addition to our award-winning SmartSponge System, for the first time provides hospitals a choice of devices to best address the unique conditions of each O.R.”