đź“‹ FDA Reference
Intelliblate Microwave Ablation System Console Ib-Con Intelliblate Microwave Ablation System Mobile Cart Ib-Cart Intelliblate Ximitry Probe Assembly 13g x 15cm Ib-Xpa-1315 Intelliblate Ximitry Probe Assembly 13g x 20cm Ib-Xpa-1320 Intelliblate Ximitry Probe Assembly 13g x 27cm Ib-Xpa-1327
Product: IntelliBlate Ximitry Probe Assembly, 13G x 20cm — all models and sizes
Summary: The Intelliblate Microwave Ablation System is a medical device used for the ablation of tumors. It is primarily used by interventional radiologists and oncologists to treat patients with certain types of tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K240480 ↗
Decision Date ?
July 19, 2024
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Intelliblate Microwave Ablation System was cleared through the FDA 510(k) pathway on July 19, 2024. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code NEY.
What It Is
The Intelliblate Microwave Ablation System is a device designed for the thermal ablation of tumors using microwave energy. It includes a console, a mobile cart, and various probe assemblies that deliver microwave energy to targeted tissue. This system works by generating heat through microwave energy, which destroys tumor cells while sparing surrounding healthy tissue.
FDA-Cleared Indications
- Thermal ablation of soft-tissue tumors.
- Use with percutaneous or laparoscopic approaches when access to the target tissue is appropriate.
Clinical Applications
- Microwave thermal ablation of soft-tissue tumors.
- Image-guided percutaneous tumor ablation when the target can be safely reached with a probe.
- Laparoscopic tumor ablation when a laparoscopic approach is clinically appropriate.
- Treatment planning for tumors that are not suitable for, or require an alternative to, surgical resection.
Practical Considerations
- The listed probe assemblies are 13 gauge and 15 cm, 20 cm, or 27 cm long; probe selection depends on the target depth and planned approach.
- The procedure requires imaging guidance, such as ultrasound, computed tomography, or another clinically appropriate modality, for probe placement and treatment monitoring.
- The system is intended to deliver microwave energy and should not be considered MRI safe unless the specific console, cart, probe, and procedure setup have been evaluated and cleared for MRI use.
- Clinicians should assess the tumor's proximity to major vessels, bile ducts, bowel, nerves, skin, and other heat-sensitive structures before treatment.
- Contraindications and precautions include inability to safely access the target, uncorrected bleeding risk, active infection at the access site, and patient-specific conditions that make anesthesia, sedation, or the planned approach unsafe.
Frequently Asked Questions
What is the Intelliblate Microwave Ablation System used for?
It is used for the thermal ablation of tumors in various organs, including the liver, lung, kidney, and bone.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, particularly when surgical options are limited or not feasible.
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.