đź“‹ FDA Reference
Headphones Patient Alert Standalone Interface
Neocoil
Summary: The headphones patient alert standalone interface by Neocoil is a device used to alert patients during medical procedures, particularly in tumor ablation. It is primarily used by clinicians in radiology and oncology settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133670 ↗
Decision Date ?
July 24, 2014
Product Code ?
LNH
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on July 24, 2014. Manufactured by Neocoil, it is classified as a Class 2 device under product code LNH.
What It Is
The headphones patient alert standalone interface is designed to provide auditory alerts to patients during medical procedures. It serves as a communication tool, ensuring patients can receive important instructions or alerts from clinicians, particularly during procedures where patient movement must be minimized. The device is standalone, meaning it does not require integration with other systems, making it versatile for various clinical environments.
FDA-Cleared Indications
- Providing auditory alerts and communication to patients during medical procedures
- Supporting communication during procedures in which patient movement must be minimized
- Use in clinical settings such as interventional radiology and oncology procedures, including tumor ablation
Clinical Applications
- Patient communication during image-guided tumor ablation
- Auditory instructions during interventional radiology procedures
- Auditory alerts when maintaining patient stillness is important
- Communication with patients during oncology procedures
Practical Considerations
- Confirm that the headphones fit the patient comfortably and remain securely positioned throughout the procedure.
- Verify compatibility with the facility's audio or communication equipment before use.
- The available record does not specify headphone sizes, replacement intervals, or battery requirements; consult the manufacturer's instructions for use.
- MRI compatibility is not established by the information provided. Confirm MR safety or conditional status with the labeling before use in an MRI environment.
- The device is a communication interface and does not replace direct clinical monitoring, emergency communication methods, or procedural sedation when those are indicated.
Frequently Asked Questions
What is the headphones patient alert standalone interface used for?
It is used to provide auditory alerts to patients during medical procedures, ensuring communication and safety, particularly in tumor ablation.
What specialties typically use this device?
The device is primarily used in radiology and oncology, especially during interventional procedures like tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring patient alertness and communication, particularly in tumor ablation contexts.
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.