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Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during cardiopulmonary bypass procedures requiring extracorporeal circulation.
- Use for oxygenation and carbon dioxide removal from blood during cardiac surgery.
- Intended for neonatal and pediatric patients when the required blood flow is within the system's labeled range of approximately 0.1 to 2 L/min.
Clinical Applications
- Cardiopulmonary bypass during neonatal cardiac surgery.
- Cardiopulmonary bypass during infant and pediatric open-heart surgery.
- Extracorporeal blood oxygenation and carbon dioxide removal during cardiac procedures.
- Use with a compatible cardiopulmonary bypass circuit in a hospital cardiac operating room.
Practical Considerations
- The system is intended for small patients and supports blood flow rates of approximately 0.1 to 2 L/min; the circuit configuration must match the patient's size and clinical requirements.
- It must be used by trained cardiac surgeons and perfusionists with compatible cardiopulmonary bypass equipment and according to the manufacturer's instructions.
- The Carmeda BioActive Surface or Balance Biosurface is a device-surface treatment; it does not eliminate the need for appropriate anticoagulation, monitoring, and blood-management practices.
- This is an extracorporeal bypass device, not an implantable device. MRI compatibility is generally not relevant while the system is in use, and the device should not be taken into an MRI environment unless the complete system has been specifically evaluated and cleared for that setting.
- Potential complications relate to cardiopulmonary bypass and extracorporeal circuits, including bleeding, clotting, air or particulate embolism, blood trauma, infection, gas-exchange problems, and equipment or circuit failure.
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.