Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

The Zoom 7X Catheter is a single-lumen, reinforced catheter designed to remove blood clots from blood vessels in the brain during acute ischemic stroke treatment. It connects to an aspiration pump via tubing to create suction that retrieves clots. The device is indicated for revascularization of patients with large vessel occlusive disease in the brain within 8 hours of symptom onset, particularly for those ineligible for or unresponsive to intravenous thrombolytic therapy.

The Zoom 7X Catheter has identical dimensions, materials, and construction to its predicate (ZOOM 71): same inner/outer diameters, 137 cm working length, hydrophilic coating, beveled soft tip, and metal-reinforced polymer shaft. The main differences are a pre-shaped distal tip (versus unshaped) and allowance for up to two EO sterilization cycles (versus one). The Zoom POD Aspiration Tubing adds a new in-line clot filter and longer working length (117″ vs. 104″) compared to the standard Zoom Aspiration Tubing.

ISO 10555-1 (catheter performance), ISO 11135 (ethylene oxide sterilization), ISO 80369-7 (luer compatibility), ASTM F1980 (accelerated aging), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis), and ASTM F756-17 (indirect hemolysis).

The subject devices share identical intended use, indications, and regulatory classification (Class II, product code NRY) with the predicate ZOOM 71. Bench testing demonstrates all performance parameters—trackability, compatibility, burst strength, flexibility, clot retrieval, and vacuum delivery—are equivalent or comparable to the predicate. The minor design differences (pre-shaped tip, dual sterilization cycles, in-line filter in POD variant) do not introduce new safety or effectiveness risks and are supported by targeted testing. Biocompatibility remains unchanged for the catheter; new materials in the introducer sheath and POD filter passed standard biocompatibility testing. The predicate has established safety and effectiveness in the same clinical application, so equivalent performance supports substantial equivalence without clinical data.