đź“‹ FDA Reference
Icesphere 1 5 Cx Cryoablation Needle
Summary: The IceSphere 1.5 CX Cryoablation Needle is a medical device used for cryoablation procedures to treat tumors. It is commonly used by interventional radiologists and oncologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181741 ↗
Decision Date ?
July 30, 2018
Product Code ?
GEH Unit, Cryosurgical, Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The IceSphere 1.5 CX Cryoablation Needle received FDA clearance through the 510(k) pathway on July 30, 2018. Manufactured by Galil Medical, it is a Class 2 medical device.
What It Is
The IceSphere 1.5 CX Cryoablation Needle is a specialized tool designed for the cryoablation of tumors. It works by delivering extreme cold to targeted tissues, causing cellular destruction through freezing. This minimally invasive technique is often used in oncology to treat solid tumors by inducing cell death while preserving surrounding healthy tissue.
FDA-Cleared Indications
- Use as an accessory for cryosurgical systems during the cryoablation of tissue.
- Use for percutaneous or surgical placement when cryogenic destruction of targeted tissue is indicated.
- Use with compatible cryoablation equipment and imaging guidance according to the device labeling and system instructions.
Clinical Applications
- Image-guided percutaneous cryoablation of selected solid tumors.
- Placement through the skin under CT, ultrasound, or other appropriate imaging guidance.
- Use during cryosurgical procedures in which controlled freezing and thawing are used to destroy targeted tissue.
- Use with a compatible Galil Medical cryoablation system as part of a complete cryotherapy setup.
Reported off-label uses
- Cryoablation of tumors in organs or locations not specifically described in the applicable system labeling.
- Cryoablation of selected benign or non-tumor conditions reported in clinical practice.
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
- The 1.5 mm needle diameter and CX configuration should be selected based on the target size, location, desired ice-ball geometry, and the compatible cryoablation system.
- Placement is typically performed under CT, ultrasound, or another suitable imaging modality; multiple needles may be required for adequate treatment coverage.
- The needle is intended for use by clinicians trained in image-guided cryoablation and requires adherence to the system’s instructions for use.
- MRI compatibility and conditional-use requirements should be confirmed in the current device labeling before MRI use; a cryoablation needle should not be assumed to be MR safe.
- Potential limitations include inability to safely access the target, proximity to critical structures, bleeding or infection risk, and contraindications related to the patient or planned anesthesia.
Frequently Asked Questions
What is IceSphere 1.5 CX Cryoablation Needle used for?
It is used for the cryoablation of solid tumors, providing a minimally invasive treatment option for patients.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in the treatment of tumors.
What are the FDA-cleared indications?
The device is cleared for the treatment of solid tumors through cryoablation, 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.