VitalFlow Console

The VitalFlow Console is a control unit for extracorporeal membrane oxygenation (ECMO) that regulates blood flow through a centrifugal pump during heart-lung bypass procedures. It is intended for adult patients with acute respiratory or cardiopulmonary failure when other treatment options have failed and death is imminent. The console adjusts pump speed, monitors flow and detects bubbles via ultrasound, displays alarms visually and audibly, and allows data download for circuit information only.

The modified device maintains identical design parameters, materials, packaging, and sterilization status as the predicate. The key change is addition of USB port capability for field software upgrades by Medtronic service personnel, whereas the predicate required opening the console and connecting a laptop to individual boards. The upgrade feature includes cybersecurity measures and mitigation strategies for the upgrade process.

The document states the device 'continues to meet international standards for safety' but does not explicitly name specific ISO, IEC, or ASTM standards in this summary.

Substantial equivalence is based on: (1) identical intended use for ECMO support; (2) same operating principle and performance characteristics; (3) same design features, materials, and packaging as the predicate; and (4) software verification with cybersecurity testing demonstrates the upgrade-over-USB change does not alter the device's core functionality or raise new safety concerns. The addition of USB upgrade capability is a process improvement that does not change what the device does clinically or introduce new hazards beyond those already cleared in the predicate.