📋 FDA Reference
Affinity Nt Oxygenator with Balance Biosurface Affinity Nt Oxygenator with Balance Biosurface and Uncoated Cardiotomy Venous Reservoir
Summary: The Affinity NT Oxygenator with Balance Biosurface 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 during open-heart surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K191444 ↗
Decision Date ?
September 27, 2019
Product Code ?
DTZ
Device Class ?
Class 2
Evidence ?
0 studies
The Affinity NT Oxygenator was cleared through the FDA 510(k) pathway on September 27, 2019. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity NT Oxygenator is a device designed to replace the function of the lungs during cardiopulmonary bypass procedures. It oxygenates the blood and removes carbon dioxide, ensuring that the patient's tissues receive adequate oxygenation during surgery. The Balance Biosurface coating helps reduce the risk of clotting and inflammation, enhancing biocompatibility.
FDA-Cleared Indications
- Use during cardiopulmonary bypass procedures requiring temporary oxygenation of blood.
- Use during cardiopulmonary bypass procedures requiring removal of carbon dioxide from blood.
- Use as part of an extracorporeal circulation circuit for open-heart surgery, according to the device labeling.
Clinical Applications
- Cardiopulmonary bypass during coronary artery bypass grafting.
- Cardiopulmonary bypass during heart valve repair or replacement.
- Temporary blood oxygenation and carbon dioxide removal during open-heart surgery.
- Use with a compatible cardiopulmonary bypass circuit under the direction of cardiac surgery and perfusion personnel.
Practical Considerations
- The oxygenator and reservoir are single-use extracorporeal circuit components and must be prepared and operated by trained perfusion personnel.
- The selected device size and circuit configuration should match the patient's body size, blood-flow requirements, and the planned procedure.
- The device is used with compatible cardiopulmonary bypass equipment; connections, priming, pressure monitoring, and gas flow require careful setup according to the manufacturer's instructions.
- This is not an implantable device and is not intended for direct placement in the body outside the extracorporeal circuit.
- MRI compatibility is generally not relevant while the device is being used in the operating room circuit; it should not be taken into the MRI environment unless the current manufacturer labeling specifically permits it.
Frequently Asked Questions
What is Affinity NT Oxygenator used for?
It is used to oxygenate and remove carbon dioxide from the blood during cardiopulmonary bypass in open-heart surgeries.
What specialties typically use this device?
Cardiac surgery teams, including cardiac surgeons and perfusionists, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures requiring temporary blood oxygenation and carbon dioxide removal during open-heart surgery.
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.