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surface applicator set
Varian Medical Systems
Summary: The surface applicator set by Varian Medical Systems is used primarily for tumor ablation. Key evidence highlights its role in high-dose-rate brachytherapy and microwave hyperthermia.
FDA Clearance Information
Pathway
510K
Number
K162018 ↗
Decision Date
February 28, 2017
Product Code
JAQ
Device Class
Class 2
Evidence
0 studies
The surface applicator set was cleared by the FDA through the 510(k) pathway on February 28, 2017. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The surface applicator set is designed for the delivery of localized treatment to tumors, particularly through methods like brachytherapy and microwave hyperthermia. It is intended for precise application of therapeutic modalities to targeted areas.
Clinical Applications
Commonly used in scenarios requiring precise tumor ablation, such as skin cancer treatment and high-dose-rate brachytherapy. It is particularly useful in settings where targeted therapy is critical.
Evidence Summary
The literature includes 15 studies, with a mix of RCTs, prospective, and retrospective studies, spanning from 2022 to 2024. These studies explore various applications and dosimetric evaluations of the device.
Reported Outcomes
Published studies report the efficacy of the surface applicator set in delivering high-dose-rate brachytherapy and microwave hyperthermia for tumor treatment. The device has shown promise in improving treatment precision and outcomes in skin cancer therapy.
Safety Profile
Reported complications include potential deviations in dose delivery due to assumptions in treatment planning systems. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of standardized quality assurance protocols in surface brachytherapy. Further research is needed to establish comprehensive safety profiles and optimize treatment planning systems.
Frequently Asked Questions
What are the clinical indications for surface applicator set?
The device is indicated for tumor ablation, particularly in high-dose-rate brachytherapy and microwave hyperthermia for skin cancer.
What outcomes have been reported in clinical studies?
Studies have reported improved precision and efficacy in tumor treatment, particularly in skin cancer therapy using high-dose-rate brachytherapy.
What complications have been reported?
Safety data indicate potential dose delivery deviations due to treatment planning assumptions, but specific adverse events were not detailed.
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.