đź“‹ FDA Reference
visual-ice cryoablation system software revision 1 3 1
Galil Medical
Summary: The Visual-ICE Cryoablation System by Galil Medical is a medical device used for cryoablation, a procedure to destroy tissue using extreme cold. It is primarily used by interventional radiologists and oncologists for tumor ablation.
FDA Clearance Information
Pathway
510K
Number
K143564 ↗
Decision Date
March 5, 2015
Product Code
GEH
Device Class
Class 2
Evidence
0 studies
The Visual-ICE Cryoablation System, manufactured by Galil Medical, was cleared by the FDA under 510k pathway (K143564) on March 5, 2015. It is classified as a Class 2 medical device.
What It Is
The Visual-ICE Cryoablation System is a medical device designed to perform cryoablation, a technique that uses extreme cold to destroy abnormal tissues, such as tumors. It operates by delivering argon gas through a cryoprobe, creating an ice ball that freezes and destroys targeted cells. This system is equipped with software that allows precise control and monitoring of the ablation process, ensuring effective treatment while minimizing damage to surrounding healthy tissue.
Clinical Applications
This device is commonly used in interventional radiology and oncology for the treatment of various tumors, including those in the kidney, liver, lung, and bone. It is particularly useful in patients who are not candidates for surgical resection due to the location of the tumor or their overall health status. The procedure is typically performed in a hospital or outpatient setting, often under imaging guidance such as ultrasound or CT to ensure accurate probe placement.
Indications for Use
The FDA-cleared indications for the Visual-ICE Cryoablation System include the ablation of soft tissue tumors. It is suitable for patients with tumors that are difficult to access surgically or for those who prefer a minimally invasive approach.
Practical Considerations
The Visual-ICE system is compatible with various cryoprobes, allowing for flexibility in treating different tumor sizes and locations. Clinicians should be familiar with the imaging techniques required for probe placement and monitoring during the procedure. Proper training in cryoablation techniques is essential to maximize efficacy and minimize complications.
Frequently Asked Questions
What is the Visual-ICE Cryoablation System used for?
It is used for cryoablation, a procedure to destroy tumors using extreme cold.
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 soft tissue tumors.
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.