đź“‹ FDA Reference
Xsense Cryoablation System with Cryoprobes
Product: XSense Cryoablation System — all models and sizes
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 ?
510(k)
Number ?
K240892 ↗
Decision Date ?
June 28, 2024
Product Code ?
GEH Unit, Cryosurgical, Accessories
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.
FDA-Cleared Indications
- Ablation of benign tumors.
- Ablation of malignant tumors.
- Use when the target tissue is accessible to the system's cryoprobes.
Clinical Applications
- Image-guided percutaneous cryoablation of accessible benign tumors.
- Image-guided percutaneous cryoablation of accessible malignant tumors.
- Tumor ablation when targeted tissue destruction is desired while limiting injury to nearby tissue.
Reported off-label uses
- Cryoablation of selected tumors or tumor locations not specifically described in the device labeling may be performed in clinical practice under physician judgment, institutional protocols, and applicable regulations.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Cryoprobe size, number, and configuration should be selected according to tumor size, shape, location, and the planned ablation margin.
- Ultrasound, CT, or another compatible imaging method is used to guide probe placement and monitor the ice ball and nearby structures.
- The operator must monitor freezing and thawing cycles and protect adjacent organs, skin, nerves, and blood vessels from unintended injury.
- The system and cryoprobes should be used according to the manufacturer's instructions, including handling, sterile technique, gas or energy requirements, and probe-specific limitations.
- MRI compatibility should not be assumed; confirm the system and each cryoprobe's labeling before bringing any component into the MRI environment.
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.