INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK

The INDIGO Aspiration System - Lightning Flash Aspiration Tubing with LINK is a medical device component designed to remove fresh, soft blood clots (emboli and thrombi) from blood vessels in the arms, legs, and lungs. The tubing connects an aspiration catheter to a vacuum pump to facilitate mechanical thrombus removal during interventional procedures.

The subject device includes an alternative internal electrical connector for the solenoid valve, minor dimensional updates to the solenoid valve pinch tubing and proximal tubing, a modified electrical subsystem with wireless radio capability (BLE and USB connectivity), increased memory on the main circuit board, and an updated power delivery cable to enable optional data transfer.

IEC 60601-1, IEC 60601-1-2, ISO 10079-1, ISO 10079-4, ISO 13485, FCC Title 47 CFR Part 15 Subpart B (Unintentional Radiators), and FCC 47 CFR Part 15.247 (Spurious Emissions). Testing included design verification (performance, valve sense, dimensional, durability, tensile), software verification and validation, cybersecurity assessment, biocompatibility, shelf-life, sterilization, and packaging evaluation.

The subject device is substantially equivalent to the predicate (K240030) because it maintains the same intended use, operating principle, design concept, and device performance for removing thrombi from peripheral vessels and treating pulmonary embolism. The new features (wireless connectivity, electrical updates) are modifications that do not alter the fundamental function or safety profile, and all design verification testing met established requirements using the same methods and acceptance criteria as the predicate.