đź“‹ FDA Reference
affinity pixie oxygenator with balance biosurface model bbp211 affinity pixie oxygenator and cardiotomy venous reservoir with balance biosurface model bbp241 affinity pixie oxygenator with cortiva bioactive surface model cbp211 affinity pixie oxygenator and cardiotomy venous reservoir with cortiva bioactive surface model cbp241
Medtronic
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 during heart surgeries.
FDA Clearance Information
Pathway
510K
Number
K183511 ↗
Decision Date
March 18, 2019
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Pixie Oxygenator by Medtronic was cleared through the FDA 510(k) pathway on March 18, 2019. It is a Class 2 device under product code DTZ.
What It Is
The Affinity Pixie Oxygenator is a compact device designed for use in cardiopulmonary bypass procedures. It functions by oxygenating blood and removing carbon dioxide, mimicking the gas exchange process of the lungs. The device incorporates Balance Biosurface and Cortiva BioActive Surface technologies to enhance biocompatibility and reduce blood activation during use.
Clinical Applications
This device is commonly used in cardiac surgeries, particularly in pediatric and neonatal patients due to its smaller size and efficient performance. It is utilized in operating rooms and specialized cardiac centers by cardiac surgeons and perfusionists to maintain patient oxygenation during procedures that require temporary cessation of heart and lung function.
Indications for Use
The Affinity Pixie Oxygenator is indicated for use in patients undergoing cardiopulmonary bypass procedures, where it aids in oxygenating the blood and removing carbon dioxide. It is suitable for patients requiring temporary support of heart and lung function during surgery.
Practical Considerations
The device is available in various models to accommodate different patient sizes and surgical needs. It is compatible with standard cardiopulmonary bypass systems and requires careful handling and setup by trained perfusionists to ensure optimal performance and patient safety.
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 heart surgeries.
What specialties typically use this device?
Cardiac surgery and perfusion teams in operating rooms and specialized cardiac centers.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures to support heart and lung function temporarily.
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.