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Barrx Anorectal Rfa Wand
Summary: The Barrx Anorectal RFA Wand is a medical device used for radiofrequency ablation of anal canal lesions, particularly high-grade anal intraepithelial neoplasia. It is primarily used by colorectal surgeons and gastroenterologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150251 ↗
Decision Date ?
July 28, 2015
Product Code ?
GEI
Device Class ?
Class 2
Evidence ?
0 studies
The Barrx Anorectal RFA Wand was cleared through the FDA 510(k) pathway on July 28, 2015. Manufactured by Covidien, it is classified as a Class 2 device under product code GEI.
What It Is
The Barrx Anorectal RFA Wand is a specialized device designed for the ablation of anal canal lesions using radiofrequency energy. It works by delivering controlled thermal energy to targeted tissue, causing cellular destruction while minimizing damage to surrounding areas. This device is particularly useful for treating high-grade anal intraepithelial neoplasia, a precancerous condition.
FDA-Cleared Indications
- Treatment of high-grade anal intraepithelial neoplasia (AIN).
Clinical Applications
- Radiofrequency ablation of high-grade anal intraepithelial neoplasia in the anal canal.
- Endoscopic treatment of localized precancerous anal canal lesions.
- Outpatient ablation procedures performed by appropriately trained colorectal or gastrointestinal specialists.
Practical Considerations
- The wand should be used by clinicians trained in anorectal examination and radiofrequency ablation techniques.
- Appropriate wand sizing and positioning are important for contact with the target mucosa and protection of surrounding tissue.
- The device is used with compatible ablation-system components and visualization or endoscopic equipment according to the manufacturer’s instructions.
- MRI safety should be confirmed in the current device labeling before an examination; do not assume that an electrosurgical or radiofrequency device is MRI safe.
- Contraindications, precautions, energy settings, cleaning or reuse status, and other handling requirements should be checked in the current instructions for use.
Related Literature
The linked study investigated the safety and efficacy of circumferential anal canal radiofrequency ablation using the Barrx Anorectal Wand for high-grade anal intraepithelial neoplasia. Although the abstract is not available, the study likely focused on evaluating the device's ability to effectively ablate targeted lesions while minimizing complications. Limitations may include the lack of long-term outcome data and a small sample size.
Frequently Asked Questions
What is Barrx Anorectal RFA Wand used for?
It is used for the radiofrequency ablation of high-grade anal intraepithelial neoplasia to prevent progression to anal cancer.
What specialties typically use this device?
Colorectal surgeons and gastroenterologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of high-grade anal intraepithelial neoplasia.
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.