đź“‹ FDA Reference
Rfa-1717dig Rfa-1717dic
Astel
Summary: The rfa-1717dig and rfa-1717dic are tumor ablation devices used primarily by oncologists and interventional radiologists for treating tumors. They offer a minimally invasive option for tumor management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K212051 ↗
Decision Date ?
August 25, 2021
Product Code ?
MQB
Device Class ?
Class 2
Evidence ?
0 studies
The rfa-1717dig and rfa-1717dic, manufactured by Astel, received FDA 510k clearance on August 25, 2021. These devices are classified as Class 2 under product code MQB.
What It Is
The rfa-1717dig and rfa-1717dic are radiofrequency ablation devices designed for the treatment of tumors. They work by delivering high-frequency electrical currents to generate heat, which destroys cancerous tissue. This minimally invasive approach allows for precise targeting of tumors while sparing surrounding healthy tissue.
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
Clinical Applications
- Image-guided radiofrequency ablation of soft-tissue tumors.
- Thermal destruction of targeted tumor tissue through percutaneous probe placement.
- Treatment of tumors when a minimally invasive ablation approach is selected instead of, or in addition to, other treatment options.
Practical Considerations
- The rfa-1717dig and rfa-1717dic are different device configurations; clinicians should verify the applicable labeling, probe specifications and accessories before use.
- The procedure is generally performed with ultrasound, computed tomography or another appropriate imaging modality for probe placement and treatment monitoring.
- Radiofrequency ablation requires careful assessment of tumor location, nearby organs and critical structures because heat can injure adjacent tissue.
- MRI compatibility should not be assumed. Confirm the device and accessory labeling before bringing any component into the MRI environment.
- Contraindications and precautions may include factors such as inability to safely access the tumor, uncontrolled bleeding risk, infection at the access site or inability to tolerate the required anesthesia or sedation.
Frequently Asked Questions
What is rfa-1717dig/rfa-1717dic used for?
These devices are used for the ablation of tumors, providing a minimally invasive treatment option for cancer patients.
What specialties typically use this device?
Oncologists and interventional radiologists primarily use these devices in clinical practice.
What are the FDA-cleared indications?
The devices are indicated for the ablation of soft tissue tumors, suitable for patients needing minimally invasive treatment.
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.