SmartClip Secure Soft Tissue Marker

The SmartClip Secure Soft Tissue Marker is a sterile, single-use implantable device composed of ethylene oxide-sterilized material, approximately 8mm long and 1.25mm wide. It is designed to be placed within soft tissue and is visible using radiography (including mammography), ultrasound, and MRI. The device is indicated for radiographic marking of sites in soft tissue and for marking soft tissue sites that need to be identified for future medical procedures.

The SmartClip Secure differs from the predicate device in two primary ways: it features a PEEK retention mechanism that securely attaches to the glass vial component via PET heat-shrink wrap, whereas the predicate uses PET retention; and the subject device has a luer lock nut on the distal end designed to fasten to a transbronchial access tool or 17ga needle, whereas the predicate has an introducer needle affixed to the hub. Both devices share identical principles of operation, visualization compatibility, permanent implant duration, and sterilization methods.

ISO 10993-1 (biocompatibility), ISO 11607-1 (packaging), ISO 11135 (sterilization), and simulated use testing, mechanical integrity testing, imaging assessment, and MR compatibility testing.

The subject device is substantially equivalent because the fundamental technology, indications for use, principle of operation (electromagnetic signature emission detected by EnVisio System), visualization methods, permanent implant duration, and sterilization approach are unchanged from the predicate. The modifications—the PEEK retention feature and the luer lock design—represent refinements to the delivery mechanism and material attachment that do not alter the core clinical function of marking soft tissue for radiographic visualization and identification. All necessary testing demonstrates the device performs as intended with equivalent safety and effectiveness to the predicate device.