đź“‹ FDA Reference
xsense cryoablation system with cryoprobes
Icecure Medical
Summary: The xsense cryoablation system is a medical device used for tumor ablation. It's primarily used by interventional radiologists and oncologists for minimally invasive procedures.
FDA Clearance Information
Pathway 510K
Number K240892 ↗
Decision Date June 28, 2024
Product Code GEH
Device Class Class 2
Evidence 0 studies
The xsense cryoablation system by Icecure Medical received FDA 510k clearance (K240892) on June 28, 2024. It is a Class 2 medical device.
What It Is
The xsense cryoablation system is a medical device designed to destroy tissue using extreme cold. It utilizes cryoprobes to deliver cryogenic temperatures directly to the target tissue, causing cellular destruction. This technology is particularly useful in treating tumors by inducing cell death through freezing, offering a minimally invasive alternative to surgical resection.
Clinical Applications
This device is commonly used in the treatment of small to medium-sized tumors, particularly in the breast, liver, and kidneys. It is often employed in outpatient settings or specialized centers by interventional radiologists and oncologists. The system is suitable for patients who are not ideal candidates for surgery due to age, comorbidities, or tumor location.
Indications for Use
The FDA indications for the xsense cryoablation system include its use in ablating benign and malignant tumors. It is particularly indicated for patients with tumors that are accessible by the cryoprobes and where preservation of surrounding tissue is desired.
Practical Considerations
The system typically includes various sizes of cryoprobes to accommodate different tumor sizes and locations. Compatibility with imaging systems like ultrasound or CT is crucial for precise probe placement. Proper technique involves careful monitoring of freezing cycles to ensure complete ablation while minimizing damage to surrounding tissues.
Frequently Asked Questions
What is xsense cryoablation system used for?
It is used for the ablation of benign and malignant tumors through cryogenic freezing.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of benign and malignant tumors, particularly in patients where surgical options are limited.
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.