INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing

The INDIGO Aspiration System with Lightning Flash and Lightning Bolt Aspiration Tubing is designed to remove blood clots (thrombi and emboli) from peripheral arteries, veins, and pulmonary vessels using mechanical aspiration. The tubing connects the aspiration catheter to the Penumbra Aspiration Pump to facilitate vacuum-based thrombus removal, with the Lightning Bolt variant providing modulated aspiration by alternating between pump suction and ambient pressure saline.

The subject devices are mostly identical in materials and dimensions to the predicate, with the Lightning Bolt variant offering larger tubing diameters and a shorter 12-month shelf-life compared to the predicate's 36 months. Material differences are supported by biocompatibility and shelf-life testing. Both variants use the same sterilization method (ethylene oxide), packaging materials, and single-use disposable design.

Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and AIM 7351731 for electrical safety and EMC testing. Biocompatibility testing per ISO standards for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility. Software verification and validation per FDA guidance on device software functions (June 14, 2023).

The subject devices are substantially equivalent to the predicate because they share identical intended use, operating principle, design concept, sterilization and packaging processes. Bench-top testing (dimensional inspection, pressurization, compatibility, durability, valve, and tensile testing) demonstrates equivalent performance. Material differences are supported by biocompatibility data, and the shorter shelf-life for the Bolt variant is justified by accelerated aging studies using the same methods as the predicate.