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Microwave Ablation Generator Ky-2000a Ky-2100a
Product: Microwave Ablation Generator — all models and sizes
Summary: The KY-2000A and KY-2100A are microwave ablation generators used primarily for tumor ablation. Key evidence highlights their application in treating malignant central airway obstruction and liver tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K241827 ↗
Decision Date ?
September 26, 2024
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The KY-2000A and KY-2100A, manufactured by Canyon Medical, received FDA clearance via the 510(k) pathway on September 26, 2024. They are classified as Class 2 devices under product code NEY.
What It Is
The KY-2000A and KY-2100A are microwave ablation generators designed to deliver electromagnetic energy to heat and destroy target tissues. They are intended for use in the ablation of tumors and other pathological tissues.
FDA-Cleared Indications
- Ablation of tumors and other pathological tissue using microwave energy.
- Use with compatible microwave ablation accessories as part of a microwave ablation system.
Clinical Applications
- Percutaneous microwave ablation of selected liver tumors.
- Microwave ablation of other appropriately selected tumors when performed according to the device labeling and compatible accessory instructions.
- Ablation of targeted pathological tissue under image guidance, such as ultrasound, computed tomography, or another appropriate imaging method.
- Use during minimally invasive tumor-ablation procedures when the treating team determines that microwave ablation is appropriate.
Reported off-label uses
- Ablation of malignant central airway obstruction has been described in clinical practice and literature, but the specific indication and accessory configuration should be confirmed against the current Canyon Medical labeling before use.
- Microwave ablation of selected nonmalignant lesions has been reported for some device systems, but these applications may be off label and should not be inferred as FDA-cleared indications for the KY-2000A or KY-2100A.
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.
Evidence Summary
The available literature includes 10 studies, ranging from pilot studies to comprehensive reviews, published between 2019 and 2022. These studies explore the efficacy and safety of microwave ablation in various clinical contexts.
Reported Outcomes
Published studies report that microwave ablation is effective in reducing tumor size and alleviating symptoms in patients with malignant central airway obstruction and liver tumors. The technology offers a viable alternative to surgical interventions in certain cases.
Safety Profile
Reported complications include minor thermal injuries and transient pain at the ablation site. Overall, the safety profile is favorable, with low rates of severe adverse events.
Evidence Limitations
The evidence base is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish standardized protocols and to evaluate long-term outcomes.
Practical Considerations
- The generator must be used with compatible microwave ablation antennas, cables, and accessories specified by the manufacturer; accessory size, shaft length, active tip length, and power limits vary by model.
- Procedures require image guidance and careful planning to avoid injury to adjacent organs, vessels, ducts, airways, skin, and other heat-sensitive structures.
- The generator itself is not the implanted treatment component. The antenna is placed for the duration of the ablation and then removed after treatment.
- MRI compatibility depends on the specific antenna, cable, and other accessories. Do not assume the complete system is safe for use in an MRI environment; verify the manufacturer's MRI labeling.
- Important risks and contraindications depend on the treatment site and patient condition and may include bleeding, infection, thermal injury, damage to nearby structures, smoke or gas-related complications, and inability to safely access the target.
Frequently Asked Questions
What are the clinical indications for microwave ablation generator KY-2000A KY-2100A?
The device is indicated for the ablation of tumors, particularly in cases of malignant central airway obstruction and liver tumors.
What outcomes have been reported in clinical studies?
Studies report effective tumor size reduction and symptom relief, with microwave ablation serving as a minimally invasive alternative to surgery.
What complications have been reported?
Safety data indicate minor thermal injuries and transient pain, with a generally favorable safety profile.
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.