đź“‹ FDA Reference
Affinity AF100 Arterial Filter with Balance Biosurface
Summary: The Affinity AF100 Arterial Filter with Balance Biosurface is a medical device used in cardiac surgery to filter out emboli and other particulates from the blood. It is primarily used by cardiovascular surgeons and perfusionists during cardiopulmonary bypass procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K122760 ↗
Decision Date ?
December 7, 2012
Product Code ?
DTM
Device Class ?
Class 2
Evidence ?
0 studies
The Affinity AF100 Arterial Filter was cleared through the FDA 510(k) pathway on December 7, 2012. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTM.
What It Is
The Affinity AF100 Arterial Filter is a component used in extracorporeal circulation systems during cardiac surgery. It is designed to remove air bubbles and particulate matter from the blood, thus reducing the risk of embolic events. The Balance Biosurface technology helps in minimizing protein adsorption and platelet activation, which can enhance biocompatibility and reduce complications during surgery.
FDA-Cleared Indications
- Filtering blood during cardiopulmonary bypass procedures that require extracorporeal circulation.
- Removing air bubbles and particulate matter from blood circulating through the cardiopulmonary bypass circuit.
Clinical Applications
- Use in cardiopulmonary bypass circuits during coronary artery bypass grafting.
- Use during cardiac valve repair or replacement procedures requiring cardiopulmonary bypass.
- Use during other open cardiac operations requiring extracorporeal circulation.
- Use in hospital operating rooms by cardiac surgical teams and perfusionists as part of the bypass circuit.
Practical Considerations
- The filter must be correctly sized and integrated into a compatible cardiopulmonary bypass circuit according to the manufacturer's instructions.
- Perfusionists should follow the device instructions for priming, flow rates, pressure monitoring, de-airing and management of the filter during bypass.
- This is a single-use extracorporeal circuit component and is not intended for implantation or reuse.
- It is not an MRI device or an implanted device; MRI safety depends on the patient, the complete bypass system and any retained materials.
- Use is limited by the patient's need for cardiopulmonary bypass and by any contraindications or circuit limitations identified in the manufacturer's labeling.
Frequently Asked Questions
What is the Affinity AF100 Arterial Filter used for?
It is used in cardiac surgeries to filter out air bubbles and particulates from the blood during cardiopulmonary bypass procedures.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists typically use this device during cardiac surgeries requiring cardiopulmonary bypass.
What are the FDA-cleared indications?
The device is indicated for use in filtering blood during cardiopulmonary bypass procedures to reduce embolic complications.
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.