đź“‹ FDA Reference
Affinity Pixie Oxygenator with Balance Biosurface Affinity Pixie Oxygenator with Cardiotomy Venous Reservoir and Balance Biosurface Affinity Pixie Oxygenator with Cortiva Bioactive Surface Affinity Fusion Oxygenator with Cardiotomy Venous Reservoir and Cortiva Bioactive Surface
Summary: The Affinity Pixie Oxygenator is a medical device used in cardiopulmonary bypass procedures to oxygenate and remove carbon dioxide from the blood. It is primarily used by cardiac surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172984 ↗
Decision Date ?
November 20, 2017
Product Code ?
DTZ
Device Class ?
Class 2
Evidence ?
0 studies
The Affinity Pixie Oxygenator by Medtronic was cleared via the FDA 510k pathway on November 20, 2017. It is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity Pixie Oxygenator is a component of the cardiopulmonary bypass circuit, designed to oxygenate blood and remove carbon dioxide during cardiac surgery. It features Balance Biosurface and Cortiva Bioactive Surface technologies to enhance biocompatibility and reduce inflammatory response. The device is crucial in maintaining adequate gas exchange and blood flow during procedures where the heart and lungs are temporarily bypassed.
FDA-Cleared Indications
- Use during cardiopulmonary bypass procedures to oxygenate blood and remove carbon dioxide.
- Use as part of a cardiopulmonary bypass system during cardiac surgical procedures.
- Available configurations include an oxygenator with a cardiotomy venous reservoir.
Clinical Applications
- Cardiac surgery requiring cardiopulmonary bypass
- Valve repair or replacement procedures requiring temporary heart-lung support
- Repair of congenital heart defects requiring cardiopulmonary bypass
- Procedures in which controlled oxygenation and carbon dioxide removal are needed during extracorporeal circulation
Practical Considerations
- The oxygenator is used by a perfusion team as part of a complete cardiopulmonary bypass circuit, not as a standalone treatment.
- Configuration and size must be selected for the patient, blood-flow requirements, and circuit setup.
- The device requires priming, connection, monitoring, and management according to the manufacturer’s instructions and institutional perfusion protocols.
- MRI compatibility should not be assumed; the oxygenator and the complete bypass circuit should be kept out of the MRI environment unless current labeling specifically permits otherwise.
- Potential complications relate to cardiopulmonary bypass and circuit use, including bleeding, clotting, air or gas embolism, inadequate gas exchange, blood trauma, infection, and inflammatory reactions.
Frequently Asked Questions
What is the Affinity Pixie Oxygenator used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass procedures in cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the field of cardiac surgery typically use this device.
What are the FDA-cleared indications?
It is indicated for use in cardiopulmonary bypass procedures during cardiac surgeries.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.