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surface applicator set with leipzig-style cone
Varian Medical Systems
Summary: The surface applicator set with Leipzig-style cone by Varian Medical Systems is a medical device used for tumor ablation. It is typically employed by radiation oncologists for surface brachytherapy treatments.
FDA Clearance Information
Pathway
510K
Number
K123815 ↗
Decision Date
March 11, 2013
Product Code
JAQ
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on March 11, 2013. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code JAQ.
What It Is
The surface applicator set with Leipzig-style cone is a specialized device used in brachytherapy, a form of radiation therapy. It is designed to deliver precise doses of radiation to superficial tumors, leveraging its unique cone shape to focus the radiation on the target area while sparing surrounding tissues. The device accommodates multiple dwell positions to enhance dose uniformity and coverage.
Clinical Applications
This device is commonly used in the treatment of superficial tumors, such as those found in the skin or shallow tissues. It is particularly useful in radiation oncology settings, where precise dose delivery is critical. Patients with non-melanoma skin cancers or other superficial malignancies are typical candidates for treatment with this device.
Indications for Use
The FDA indications suggest that this device is intended for the ablation of superficial tumors. It is particularly suited for patients with skin cancers or other tumors located close to the surface of the body.
Practical Considerations
The Leipzig-style cone applicator is available in various sizes to accommodate different treatment areas. It is compatible with 192Ir sources and requires careful planning to ensure accurate dose delivery. Clinicians should be familiar with model-based dose calculation algorithms for optimal use.
Related Literature
The linked study explored the use of multidwell positions within Leipzig-style applicators to improve dose uniformity in surface brachytherapy. It highlighted the need for model-based dose calculation algorithms due to the complex geometry of these applicators. The study provided template plans to assist users without access to advanced calculation tools, though it noted limitations in generalizability due to specific equipment configurations.
Frequently Asked Questions
What is the surface applicator set with Leipzig-style cone used for?
It is used for delivering precise radiation doses to superficial tumors, often in the context of skin cancer treatment.
What specialties typically use this device?
Radiation oncologists primarily use this device in oncology settings for brachytherapy treatments.
What are the FDA-cleared indications?
The device is cleared for the ablation of superficial tumors, particularly those located close to the skin's surface.
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.