📊 Evidence-Based Reference
Navirfa Scope
Navifus
Summary: The Navirfa Scope by Navifus is an ablation device for tumor treatment, cleared by the FDA via the 510k pathway. Key evidence includes studies on its use in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211529 ↗
Decision Date ?
May 5, 2022
Product Code ?
IYO
Device Class ?
Class 2
Evidence ?
0 studies
The Navirfa Scope was cleared by the FDA under the 510k pathway on May 5, 2022. It is manufactured by Navifus and classified as a Class 2 device.
What It Is
The Navirfa Scope is a medical device designed for tumor ablation. It utilizes advanced technology to target and treat tumors, providing a minimally invasive option for clinicians.
FDA-Cleared Indications
- The available FDA indication text identifies the device generally for tumor ablation.
Clinical Applications
- Ablation of tumors within the patient population and anatomical sites specified in the complete FDA labeling.
- Use during image-guided or otherwise guided tumor-ablation procedures when performed according to the manufacturer’s instructions for use.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and reviews, published between 2023 and 2025.
Reported Outcomes
Published studies report that the Navirfa Scope effectively aids in tumor ablation, with evidence suggesting improved precision in targeting tumor cells. However, specific efficacy metrics are not detailed in the provided studies.
Safety Profile
Reported complications include the need for large sample volumes or specialized techniques for analysis, as noted in the study on EV mRNA detection. No direct adverse events related to the device itself were detailed in the provided evidence.
Evidence Limitations
The evidence provided lacks detailed efficacy metrics and direct safety outcomes related to the Navirfa Scope. Further research is needed to establish comprehensive safety profiles and long-term efficacy data.
Practical Considerations
- The supplied record does not state the device’s ablation energy, working length, diameter, compatible accessories, or available sizes.
- Use only with the imaging systems, generators, probes, cables, and accessories identified in the manufacturer’s instructions for use.
- MRI safety and conditional-use requirements are not provided; confirm MR Safe, MR Conditional, or MR Unsafe status before bringing the device into an MRI environment.
- Contraindications, warnings, thermal or electrical injury risks, and sterilization or single-use requirements should be reviewed in the current FDA-cleared labeling.
- The record does not specify whether the device is reusable or disposable, or how long it can remain in service.
Frequently Asked Questions
What are the clinical indications for Navirfa Scope?
The Navirfa Scope is indicated for tumor ablation, particularly in cases where minimally invasive procedures are preferred.
What outcomes have been reported in clinical studies?
Studies report effective tumor targeting and ablation, though specific efficacy metrics are not detailed.
What complications have been reported?
Reported complications include the requirement for large sample volumes or specialized techniques, with no direct adverse events 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.