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Xplan-2 with Head and Neck Localizer Model Hnl
Radionics
Summary: The xplan-2 with head and neck localizer by Radionics is a device used in the clinical management of head and neck conditions. It is FDA-cleared under 510k K991237. Key evidence includes studies on head and neck cancer management and surgical approaches.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K991237 ↗
Decision Date ?
August 30, 1999
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The xplan-2 with head and neck localizer was cleared by the FDA via the 510k pathway on August 30, 1999. Manufactured by Radionics, it is classified as a Class 2 device under product code MUJ.
What It Is
The xplan-2 with head and neck localizer is a medical device designed to assist in the precise localization and treatment planning for head and neck conditions. It is primarily used in surgical oncology and other head and neck interventions.
FDA-Cleared Indications
- Used for localization and treatment planning in head and neck clinical applications as described by the cleared device labeling.
Clinical Applications
- Preoperative localization and planning for head and neck procedures.
- Supporting surgical planning for head and neck tumors.
- Helping define the location of targeted anatomy during complex head and neck interventions.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, prospective, and retrospective studies. The studies span from 2020 to 2022, focusing on head and neck cancer management and surgical techniques.
Reported Outcomes
Published studies report on the distribution of surgical oncology workforce, the importance of the immune system in head and neck cancer, and the impact of COVID-19 on surgical practices. Outcomes highlight the role of tumor-associated lymphocytes in survival and the challenges in elderly patient management.
Safety Profile
Reported complications include increased risk of adverse outcomes in elderly patients with head and neck cancer during the COVID-19 pandemic. The studies emphasize the need for careful management to minimize infectious risks during surgical procedures.
Evidence Limitations
The evidence is limited by a lack of specific outcome data directly linked to the device itself. Further research is needed to evaluate the device's direct impact on clinical outcomes and to explore its use in diverse patient populations.
Practical Considerations
- The FDA record identifies the device category and intended application but does not provide detailed size, accessory, or compatibility specifications.
- Use requires trained clinical personnel and integration with the applicable imaging, planning, or surgical workflow.
- MRI safety should not be assumed; verify the device's current labeling and the specific localizer configuration before use in or near an MRI system.
- Inspect and handle the localizer according to the manufacturer's instructions, including any requirements for positioning, calibration, cleaning, or sterilization.
- Contraindications, limitations, and compatibility with newer imaging or navigation systems should be confirmed in the current manufacturer documentation.
Frequently Asked Questions
What are the clinical indications for xplan-2 with head and neck localizer?
The device is indicated for use in the planning and localization of head and neck surgical procedures, particularly in oncology settings.
What outcomes have been reported in clinical studies?
Studies report on workforce distribution, immune system roles in cancer, and surgical challenges during the COVID-19 pandemic, with a focus on survival and management strategies.
What complications have been reported?
Safety data indicate increased risks for elderly patients during the pandemic, highlighting the need for multidisciplinary management to mitigate infectious risks.
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.