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tubing and accessories sets for extracorporeal membrane oxygenation ecmo with balance biosurface
Medtronic
Summary: This device is a tubing and accessories set designed for use in extracorporeal membrane oxygenation (ECMO) procedures. It is used by healthcare professionals in critical care settings to support patients with severe cardiac and respiratory failure.
FDA Clearance Information
Pathway
510K
Number
K223168 ↗
Decision Date
April 19, 2023
Product Code
QWF
Device Class
Class 2
Evidence
0 studies
The tubing and accessories sets for ECMO by Medtronic were cleared through the FDA 510(k) pathway on April 19, 2023. It is classified as a Class 2 medical device.
What It Is
This device comprises tubing and accessory sets specifically designed for ECMO, a life-support technique that oxygenates blood outside the body. The tubing is coated with Balance Biosurface to enhance biocompatibility and reduce complications. It is crucial in managing patients with severe cardiac or respiratory failure by providing temporary support while underlying conditions are treated.
Clinical Applications
These tubing sets are commonly used in intensive care units and specialized cardiac centers. They are essential in procedures involving ECMO, which is often employed in cases of acute respiratory distress syndrome (ARDS), cardiogenic shock, or during cardiac surgery. The device is used by critical care specialists, perfusionists, and cardiothoracic surgeons to stabilize patients who are unresponsive to conventional therapies.
Indications for Use
The FDA-cleared indications suggest this device is for patients requiring ECMO support, typically those with severe heart or lung failure. It is used to maintain oxygenation and circulation in patients who cannot sustain these functions on their own.
Practical Considerations
These tubing sets are available in various sizes to accommodate different patient needs and ECMO configurations. Compatibility with existing ECMO machines should be verified, and clinicians should be trained in ECMO setup and management to ensure optimal outcomes.
Related Literature
The linked study evaluated drug sorption in PVC- and non-PVC-based tubes used in administration sets. It highlighted the importance of understanding drug sorption to ensure safety and efficacy in drug delivery. While the study provided a protocol for evaluating sorption, it did not establish standard regulatory methods, indicating a need for further research.
Frequently Asked Questions
What is tubing and accessories sets for ECMO used for?
It is used in ECMO procedures to support patients with severe cardiac or respiratory failure by oxygenating blood outside the body.
What specialties typically use this device?
Critical care specialists, perfusionists, and cardiothoracic surgeons in intensive care and cardiac centers.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring ECMO support due to severe heart or lung failure.
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.