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affinity pixie oxygenation system with carmeda bioactive surface or balance biosurface
Medtronic
Summary: The Affinity Pixie Oxygenation System is a medical device used in cardiopulmonary bypass procedures, particularly for neonatal and pediatric patients. It is utilized by cardiac surgeons and perfusionists in specialized settings.
FDA Clearance Information
Pathway
510K
Number
K100645 ↗
Decision Date
September 14, 2012
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Pixie Oxygenation System, manufactured by Medtronic, was cleared through the FDA 510k pathway on September 14, 2012. It is a Class 2 device under product code DTZ.
What It Is
The Affinity Pixie Oxygenation System is a device designed for use in cardiopulmonary bypass procedures, providing oxygenation and carbon dioxide removal from the blood. It features a Carmeda BioActive Surface or Balance Biosurface, which enhances biocompatibility and reduces inflammatory response. The system is specifically engineered for the unique physiological needs of neonatal and pediatric patients, supporting blood flow rates from 0.1 L/min to 2 L/min.
Clinical Applications
This device is commonly used in pediatric cardiac surgery, particularly in procedures requiring cardiopulmonary bypass, such as open-heart surgeries. It is essential in settings like children's hospitals and specialized cardiac centers. The system is tailored for neonatal and infant patients, addressing their higher cardiac index requirements compared to adults.
Indications for Use
The FDA indications suggest that the Affinity Pixie Oxygenation System is intended for use in cardiopulmonary bypass procedures, specifically targeting neonatal and pediatric patients who require extracorporeal circulation support during cardiac surgery.
Practical Considerations
The device is compatible with standard cardiopulmonary bypass equipment and is available in configurations suitable for small patients. Clinicians should consider the specific blood flow requirements and patient size when selecting the appropriate system setup.
Related Literature
A study conducted at Great Ormond Street Children's Hospital evaluated the Affinity Pixie Oxygenation System in over 500 pediatric cardiac procedures. The findings indicated that the system effectively met the higher cardiac index demands of neonatal and pediatric patients. However, the study was limited to a single center, and broader multi-center trials could provide more generalized data.
Frequently Asked Questions
What is the Affinity Pixie Oxygenation System used for?
It is used for providing oxygenation and carbon dioxide removal during cardiopulmonary bypass in neonatal and pediatric cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in pediatric cardiac surgery settings.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures in neonatal and pediatric patients.
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.