đź“Š Evidence-Based Reference
Catheter Surface Flap Applicator Set GM11011830
Summary: The catheter surface flap applicator set GM11011830 by Varian Medical Systems is primarily used for high-dose-rate brachytherapy in treating non-melanoma skin cancer. Key evidence highlights its efficacy in delivering targeted radiation therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K241965 ↗
Decision Date ?
October 29, 2024
Product Code ?
JAQ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on October 29, 2024. It is manufactured by Varian Medical Systems and classified as a Class 2 medical device.
What It Is
The catheter surface flap applicator set GM11011830 is designed for high-dose-rate brachytherapy, specifically targeting non-melanoma skin cancers. It allows precise radiation delivery to the skin surface, enhancing treatment efficacy.
FDA-Cleared Indications
- Use in high-dose-rate brachytherapy for localized radiation treatment of non-melanoma skin cancer.
- Application of a radiation-delivery catheter or surface applicator over the skin treatment area.
Clinical Applications
- Surface-based high-dose-rate brachytherapy for selected non-melanoma skin cancers.
- Localized radiation delivery to superficial skin lesions.
- Positioning and stabilizing the treatment catheter over the prescribed skin target during brachytherapy.
Evidence Summary
The available literature includes three studies published between 2021 and 2025. These studies encompass various research types, including prospective and retrospective analyses, focusing on the device's application in skin cancer treatment.
Reported Outcomes
Published studies report that the catheter surface flap applicator set is effective in delivering high-dose-rate brachytherapy for non-melanoma skin cancer. The device facilitates precise radiation delivery, potentially improving treatment outcomes.
Safety Profile
Reported complications include potential deviations in planned versus delivered doses due to assumptions in treatment planning systems. No specific adverse events were detailed in the provided studies.
Evidence Limitations
Current evidence is limited by the lack of standardized quality assurance protocols in surface brachytherapy. Further research is needed to validate the long-term efficacy and safety of the device in diverse clinical settings.
Practical Considerations
- The applicator must be selected and positioned according to the treatment plan, lesion size, lesion shape, and prescribed radiation dose.
- It is used with compatible high-dose-rate brachytherapy equipment and treatment-planning systems; users should verify compatibility before treatment.
- The device is applied to the skin surface and should be handled according to the manufacturer’s instructions for placement, fixation, and connection to the brachytherapy system.
- MRI safety status, including MR Safe, MR Conditional, or MR Unsafe labeling, should be confirmed in the current manufacturer’s documentation before MRI exposure.
- Contraindications, skin condition requirements, sterilization or single-use status, and any size limitations should be confirmed in the current instructions for use.
Frequently Asked Questions
What are the clinical indications for catheter surface flap applicator set GM11011830?
The device is indicated for high-dose-rate brachytherapy in the treatment of non-melanoma skin cancer.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective radiation delivery and potential improvements in treatment outcomes for non-melanoma skin cancer.
What complications have been reported?
Reported complications include potential deviations in dose delivery due to assumptions in treatment planning systems.
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.