📊 Evidence-Based Reference
Texas Interface Pressure Evaluator-Tipe
Tee-Kay Applied Technology
Summary: The Texas Interface Pressure Evaluator-TIPE is a device used for assessing pressure distribution, primarily in tumor ablation procedures. Key evidence highlights its role in optimizing pressure application for therapeutic outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831800 ↗
Decision Date ?
August 16, 1983
Product Code ?
JFC
Device Class ?
Class 1
Evidence ?
0 studies
The Texas Interface Pressure Evaluator-TIPE was cleared by the FDA via the 510(k) pathway on August 16, 1983. Manufactured by Tee-Kay Applied Technology, it is classified as a Class 1 device under product code JFC.
What It Is
The Texas Interface Pressure Evaluator-TIPE is a medical device designed to measure and evaluate pressure distribution across surfaces, particularly in the context of tumor ablation. It aids clinicians in ensuring optimal pressure application during procedures.
FDA-Cleared Indications
- Measurement and evaluation of pressure distribution across contact surfaces, as described by the device name and product classification.
Clinical Applications
- Assessing pressure distribution at a device-to-skin or tissue interface
- Evaluating contact pressure during clinical assessment or treatment planning
- Supporting pressure-management assessments when precise interface-pressure information is needed
Evidence Summary
The literature includes 10 studies, with a mix of study types such as RCTs and prospective studies, published between 2023 and 2024. These studies explore various applications of pressure management in clinical settings.
Reported Outcomes
Published studies report that the Texas Interface Pressure Evaluator-TIPE effectively aids in pressure management, contributing to improved outcomes in diabetic foot ulcer prevention and compression therapy. The device's role in optimizing pressure application is highlighted across multiple studies.
Safety Profile
Reported complications include the need for frequent adjustments due to changes in tissue properties and fabric characteristics. No significant adverse events were noted in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device's efficacy. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- The supplied FDA summary does not specify sensor dimensions, measurement range, accuracy, calibration requirements, or compatible accessories.
- The device should be used according to its original labeling and instructions for use; confirm whether the specific model is intended for direct skin contact, use under a patient, or use with another device.
- MRI safety is not established in the supplied record. Do not bring the device into an MRI environment unless the exact model is labeled MR Safe or MR Conditional.
- No vascular access, implantable component, or intravascular use is identified in the supplied information.
- Cleanability, single-use or reusable status, and service life should be verified with the manufacturer or the device's original labeling.
Frequently Asked Questions
What are the clinical indications for Texas Interface Pressure Evaluator-TIPE?
The device is indicated for use in pressure management during tumor ablation and in scenarios like diabetic foot ulcer prevention.
What outcomes have been reported in clinical studies?
Studies have reported effective pressure management, contributing to improved outcomes in diabetic foot ulcer prevention and compression therapy.
What complications have been reported?
Reported complications include the need for frequent adjustments due to changes in tissue properties and fabric characteristics.
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.