📊 Evidence-Based Reference
Flex 10 Accessory for the Afx Microwave Ablation System
Afx
Summary: The Flex 10 Accessory is part of the AFX Microwave Ablation System, primarily used for tumor ablation. Key evidence includes FDA clearance and clinical studies on its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013946 ↗
Decision Date ?
February 27, 2002
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Flex 10 Accessory was cleared by the FDA via the 510(k) pathway on February 27, 2002. It is manufactured by Afx and classified as a Class 2 device.
What It Is
The Flex 10 Accessory is designed for use with the AFX Microwave Ablation System, facilitating the ablation of tumors. It operates by delivering microwave energy to target tissues, causing cellular destruction.
FDA-Cleared Indications
- For use with the AFX Microwave Ablation System to deliver microwave energy for tissue ablation.
- Intended for ablation of targeted tissue, including tumor tissue, according to the system’s FDA-cleared labeling.
- Use is limited to the compatible AFX system, accessories, and labeled clinical applications.
Clinical Applications
- Percutaneous microwave ablation of selected tumors under imaging guidance.
- Ablation of tumors in organs where localized thermal treatment is appropriate.
- Treatment of selected patients for whom surgical resection is not feasible or is not chosen, when consistent with the device labeling.
- Use with the AFX Microwave Ablation System during an image-guided tumor-ablation procedure.
Evidence Summary
The literature includes 12 studies, encompassing various study types such as RCTs and case series, published between 2014 and 2025. These studies evaluate the device's performance and safety.
Reported Outcomes
Published studies report varied outcomes, with some indicating effective tumor ablation and others focusing on procedural aspects. However, specific efficacy data from these studies is not detailed in the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with microwave ablation, but specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed efficacy and safety outcomes specific to the Flex 10 Accessory. Further research is needed to establish comprehensive clinical guidelines and long-term safety data.
Practical Considerations
- The Flex 10 Accessory should be used only with the compatible AFX Microwave Ablation System and according to the manufacturer’s instructions for use.
- Tumor ablation typically requires image guidance, such as ultrasound, CT, or another modality selected by the treating clinician.
- Applicator size, active tip configuration, insertion depth, and treatment settings must match the target anatomy and the system labeling.
- MRI compatibility and conditions should not be assumed; confirm the exact device labeling before performing MRI or placing the device in an MRI environment.
- Contraindications, precautions, sterile handling, reprocessing, and single-use or reuse requirements should be verified in the current manufacturer’s instructions.
Frequently Asked Questions
What are the clinical indications for Flex 10 Accessory?
The Flex 10 Accessory is indicated for tumor ablation in cases where surgical options are limited or not possible.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence, but studies generally focus on procedural efficacy and safety.
What complications have been reported?
Safety data is limited, with general procedural risks noted but no specific complications detailed in the evidence.
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.