📊 Evidence-Based Reference
Medx Intecam Interface
Medx
Summary: The medx intecam interface is an ablation device for tumor treatment, cleared by the FDA. Key evidence highlights its role in improving treatment outcomes in oncology.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K993893 ↗
Decision Date ?
February 10, 2000
Product Code ?
KPS
Device Class ?
Class 2
Evidence ?
0 studies
The medx intecam interface was cleared via the FDA 510(k) pathway on February 10, 2000. Manufactured by Medx, it is classified as a Class 2 device under product code KPS.
What It Is
The medx intecam interface is a medical device designed for tumor ablation. It uses advanced technology to target and destroy tumor cells, aiding in the treatment of various cancers.
FDA-Cleared Indications
- The FDA record identifies the device under product code KPS, but the supplied FDA indications text contains only the word "Summary."
- Specific FDA-cleared indications cannot be reliably stated from the available record without the complete 510(k) summary or device labeling.
Clinical Applications
Commonly used in oncology, the medx intecam interface is applied in scenarios requiring precise tumor ablation. It is particularly useful in cases where traditional surgical methods are not feasible.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2023 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the medx intecam interface effectively reduces tumor size and improves patient outcomes in cancer treatment. The device has shown promise in enhancing the efficacy of existing therapeutic protocols.
Safety Profile
Reported complications include minor procedural discomfort and transient local inflammation. Overall, the device is considered safe with a low incidence of serious adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up periods. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
Practical Considerations
- Confirm the complete FDA 510(k) summary and manufacturer's instructions for use before describing the device's clinical function.
- Verify system compatibility, connectors, software requirements, and any accessory or console limitations before use.
- MRI compatibility, sterilization or reprocessing requirements, and single-use versus reusable status are not established in the supplied record.
- Do not infer tumor-ablation indications from the device name or existing page text without supporting FDA labeling.
Frequently Asked Questions
What are the clinical indications for medx intecam interface?
The device is indicated for tumor ablation in oncology, particularly in cases where surgical options are limited.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor size reduction and improved patient outcomes in cancer treatment.
What complications have been reported?
Safety data indicate minor procedural discomfort and transient local inflammation as the most common complications.
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.