đź“‹ FDA Reference
Affinity Pixie Arterial Filter with Balance Biosurface
Summary: The Affinity Pixie Arterial Filter with Balance Biosurface is a medical device used to filter blood during cardiovascular procedures. It is primarily used by cardiac surgeons and perfusionists in pediatric and adult cardiac surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K100646 ↗
Decision Date ?
December 16, 2010
Product Code ?
DTM
Device Class ?
Class 2
Evidence ?
0 studies
The Affinity Pixie Arterial Filter was cleared through the FDA 510(k) pathway on December 16, 2010. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTM.
What It Is
The Affinity Pixie Arterial Filter is designed to remove air bubbles and particulate matter from the blood during extracorporeal circulation in cardiac surgeries. It features the Balance Biosurface, which helps minimize blood activation and improves biocompatibility. This device is crucial in maintaining blood purity and preventing embolic events during surgery.
FDA-Cleared Indications
- Filtering blood during extracorporeal circulation in cardiac surgery.
- Use in cardiopulmonary bypass circuits to help remove air and particulate matter from circulating blood.
Clinical Applications
- Blood filtration during cardiac surgery requiring cardiopulmonary bypass.
- Use in extracorporeal circulation circuits for pediatric cardiac surgery.
- Use in extracorporeal circulation circuits for adult cardiac surgery.
- Filtration of blood within a compatible cardiopulmonary bypass circuit during procedures such as valve surgery or coronary artery bypass surgery, when consistent with the device labeling.
Practical Considerations
- The filter is intended for integration into an extracorporeal circulation or cardiopulmonary bypass circuit, not direct placement in a patient's artery.
- Select the appropriate configuration and size for the patient, circuit, blood-flow requirements, and institutional perfusion protocol.
- Follow the manufacturer's instructions for priming, connection, de-airing, pressure monitoring, and management of possible clot or particulate accumulation.
- The device is used in the operating room by trained cardiac surgical and perfusion teams; it should not be used outside its labeled circuit application.
- MRI safety information is not established by the FDA clearance summary; consult the current manufacturer's labeling before bringing the device or connected circuit into an MRI environment.
Frequently Asked Questions
What is the Affinity Pixie Arterial Filter used for?
It is used to filter blood during cardiac surgeries, removing air bubbles and particulates to prevent embolic events.
What specialties typically use this device?
Cardiac surgeons and perfusionists primarily use this device during cardiopulmonary bypass procedures.
What are the FDA-cleared indications?
The device is indicated for filtering blood during extracorporeal circulation in cardiac surgeries to ensure the removal of air and particulates.
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.