đź“‹ FDA Reference
Pmt Truscan Surface Electrode
Pmt
Summary: The PMT TruScan Surface Electrode is a medical device used for tumor ablation. It is primarily utilized by oncologists and surgeons in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K122376 ↗
Decision Date ?
December 19, 2012
Product Code ?
GXY
Device Class ?
Class 2
Evidence ?
0 studies
The PMT TruScan Surface Electrode was cleared through the FDA 510(k) pathway on December 19, 2012. It is manufactured by PMT and classified as a Class 2 medical device.
What It Is
The PMT TruScan Surface Electrode is a device designed for the ablation of tumors. It works by delivering electrical energy to target tissue, causing thermal destruction of tumor cells. This device is particularly useful in minimally invasive procedures where precision and control are paramount.
FDA-Cleared Indications
- Used for tumor ablation with an appropriate ablation generator.
- Intended for use when electrical energy is applied through a surface electrode to produce therapeutic tissue destruction.
Clinical Applications
- Surface-electrode application during tumor-ablation procedures.
- Use with compatible ablation equipment in a hospital, surgical, or oncology setting.
- Treatment of tumors that are accessible for placement of the electrode on or near the target tissue.
Practical Considerations
- The device should be used only with compatible equipment and according to the manufacturer’s instructions.
- Electrode size and placement must be selected for the target anatomy, treatment area, and planned energy delivery.
- The FDA record provided does not establish MRI safety; MRI use should be avoided unless the specific device labeling identifies it as MR Safe or MR Conditional.
- Use requires clinicians trained in electrode positioning, energy delivery, skin protection, and management of thermal injury risks.
- Contraindications, warnings, sterilization or single-use status, and compatibility details should be confirmed in the current manufacturer’s labeling.
Frequently Asked Questions
What is the PMT TruScan Surface Electrode used for?
It is used for the ablation of tumors, delivering electrical energy to destroy tumor cells.
What specialties typically use this device?
Oncology and surgical specialties typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for tumor ablation in patients where tumor reduction or removal is needed.
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.