Device Information
Device Specifications:
The CentriMag System is a temporary mechanical circulatory support system. It includes a blood pump, motor, console, and flow probes. The system controls blood flow in extracorporeal membrane oxygenation (ECMO) circuits. It uses MagLev technology to rotate the pump’s impeller and control blood flow. This helps manage acute circulatory failure in patients during surgeries or in critical care situations.
Indications
The CentriMag System is used for cardiopulmonary and circulatory bypass in surgeries involving the heart or great vessels. It supports blood flow in cases of acute respiratory or cardiopulmonary failure when other treatments have failed.
Intended Use
The CentriMag System is intended for use in adults with acute cardiopulmonary or respiratory failure. It is designed for use by healthcare professionals in a hospital setting. It provides circulatory support during surgeries and emergency treatments.
Availability
This device is available by prescription only.
Study Results
- Clinical Testing: Not performed for the redesigned motor locking feature. The change does not impact clinical performance.
- Nonclinical Testing: The CentriMag System underwent mechanical, durability, and cleaning tests. Usability validation was also performed. The testing confirmed that the snap-in locking mechanism does not affect device safety or performance.
Regulatory Information
- Regulation Number: 21 CFR 870.4100
- Regulatory Class: Class II
- Product Code: QNR, DWA
- 510(k) Number: K234118
The device must comply with various FDA regulations, including quality system regulations (21 CFR Part 820), labeling, and adverse event reporting.
Manufacturer Information
- Name: Abbott Medical
- Address: 6035 Stoneridge Drive, Pleasanton, CA 94588
- Contact Person: Manas Lele, Senior Manager, Regulatory Affairs
Predicate Device Information
- Primary Predicate Device: CentriMag Acute Circulatory Support System (K200306), CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System (K222038)
The current device is a modified version of the predicate device, featuring a snap-in motor locking feature instead of the previous screw-locking mechanism. This change does not affect the device’s safety or effectiveness.
Implications
The CentriMag System can provide critical support for patients with circulatory failure during surgery or other procedures. It represents an option for temporary blood flow control when standard treatments are insufficient.
References
- CentriMag™ Acute Circulatory Support System. 510(k) Number K234118. FDA Summary https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K234118
- Manufacturer website:https://www.abbott.com
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