đź“‹ FDA Reference
Barrx Flex Rfa Energy Generator
Summary: The Barrx Flex RFA Energy Generator is a medical device used for radiofrequency ablation, primarily by gastroenterologists to treat conditions like Barrett's esophagus. It is designed to deliver controlled energy to ablate diseased tissue.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K160360 ↗
Decision Date ?
April 5, 2016
Product Code ?
GEI
Device Class ?
Class 2
Evidence ?
0 studies
The Barrx Flex RFA Energy Generator was cleared through the FDA 510k pathway on April 5, 2016. Manufactured by Covidien, it is a Class 2 medical device under product code GEI.
What It Is
The Barrx Flex RFA Energy Generator is a device that delivers radiofrequency energy for the ablation of diseased tissue. It works by generating heat to remove or destroy abnormal cells, particularly in the esophagus. This device is part of a treatment strategy for conditions like Barrett's esophagus, where it helps prevent progression to esophageal cancer.
FDA-Cleared Indications
- Use with compatible Barrx radiofrequency ablation catheters to ablate esophageal tissue in patients with Barrett's esophagus.
- Deliver controlled radiofrequency energy for endoscopic ablation of diseased esophageal mucosa.
Clinical Applications
- Endoscopic radiofrequency ablation of Barrett's esophagus.
- Treatment of abnormal or precancerous esophageal lining associated with Barrett's esophagus.
- Use during outpatient or endoscopy-suite ablation procedures with compatible Barrx ablation catheters.
Practical Considerations
- The generator must be used with compatible radiofrequency ablation catheters and accessories; it is not used as a standalone ablation device.
- The endoscopist selects the catheter size, energy settings and treatment sequence based on the anatomy and the device labeling.
- The procedure generally requires endoscopic visualization and appropriate sedation or anesthesia, with trained staff available to manage esophageal complications.
- Radiofrequency ablation can cause chest discomfort, swallowing difficulty, bleeding, stricture or, rarely, perforation; patient selection and post-procedure monitoring are important.
- MRI safety depends on the specific generator, catheter and accessories. The equipment should not be brought into the MRI environment unless its labeling confirms MRI compatibility.
Frequently Asked Questions
What is Barrx Flex RFA Energy Generator used for?
It is used for radiofrequency ablation of diseased tissue in conditions like Barrett's esophagus.
What specialties typically use this device?
Gastroenterologists primarily use this device in endoscopic procedures.
What are the FDA-cleared indications?
The device is indicated for the ablation of Barrett's esophagus to prevent progression to esophageal cancer.
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.