pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are mechanical thrombectomy devices designed to restore blood flow in the neurovasculature by removing blood clots in patients experiencing acute ischemic stroke. The devices are indicated for use within 6–8 hours of symptom onset in large intracranial vessels, for patients who have received or are ineligible for thrombolytic therapy.

The subject devices are substantially identical to the predicate devices (pRESET and pRESET LITE, K222848 and K231539) in classification (Class II), intended use, device sizes (4×20 mm, 5×40 mm, 6×30 mm, 4×20 mm LITE, 3×20 mm LITE), materials (nitinol retrieval structure, platinum/iridium markers, stainless steel or nitinol push-wire, PTFE shrink tubing), sterilization method (ethylene oxide), shelf life (3 years), and packaging. The subject devices maintain the same operating principle and are supplied sterile for single use.

ISO 10993-1 (biocompatibility evaluation framework), ISO 10993-5 (cytotoxicity), ISO 10993-4 (hemocompatibility), EN ISO 11135:2014 & A1:2019 (sterilization validation), AAMI TIR28:2016 (sterilization standards), ASTM F640-23 (radiopacity testing), and FDA guidance documents on non-clinical bench performance testing and human factors engineering.

The devices are substantially equivalent because they have identical intended uses, identical design sizes, identical materials composition, the same sterilization and shelf-life specifications, and employ the same operating principle as the predicate devices. Bench performance testing (deployment, retraction, clot retrieval, compatibility with ancillary devices, dimensional specifications, and radiopacity) all passed acceptance criteria comparable to the predicate. Biocompatibility testing confirmed non-cytotoxicity and no hemolysis. No animal or clinical testing was required because the technological characteristics and performance data were substantially equivalent to the already-cleared predicates.