đź“Š Evidence-Based Reference
Surface Applicator Set
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 ?
510(k)
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.
FDA-Cleared Indications
- Used as a surface applicator for localized treatment delivery to targeted body-surface areas.
- Intended for use with compatible therapeutic systems for applications described in the manufacturer’s labeling.
- FDA clearance: 510(k) K162018, decided February 28, 2017; product code JAQ.
Clinical Applications
- Positioning a treatment applicator over a superficial tumor or other targeted body-surface region.
- Supporting localized high-dose-rate brachytherapy delivery when used with the compatible radiation therapy system.
- Supporting localized microwave hyperthermia treatment when used with the compatible hyperthermia system.
- Delivering treatment to superficial lesions where a surface applicator is clinically appropriate and covered by the system’s labeling.
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.
Practical Considerations
- Use is limited to the compatible treatment equipment, applicator configuration, and instructions specified by the manufacturer.
- Applicator size, shape, and contact with the treatment surface must be selected to match the target area and treatment plan.
- The device should be inspected for damage, contamination, or loss of positioning integrity before use and handled according to the manufacturer’s reprocessing or single-use instructions.
- MRI safety is not established from the available FDA summary; do not bring the applicator into an MRI environment unless its exact model and configuration are confirmed as MR Safe or MR Conditional.
- Contraindications, treatment-planning limits, radiation precautions, and hyperthermia precautions depend on the connected therapy system and its labeling.
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.