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Sime Trufeel
Sime Health
Summary: The Sime Trufeel by Sime Health is a Class 1 medical device used in uterine fibroid embolization. It was FDA cleared via the 510k pathway in 1991. The device is supported by 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K913048 ↗
Decision Date ?
September 19, 1991
Product Code ?
LYY
Device Class ?
Class 1
Evidence ?
0 studies
The Sime Trufeel was cleared by the FDA through the 510k pathway on September 19, 1991. It is manufactured by Sime Health and classified as a Class 1 device under product code LYY.
What It Is
The Sime Trufeel is a medical device designed for use in uterine fibroid embolization procedures. It is intended to aid in the embolization process, which involves blocking blood flow to fibroids in the uterus.
FDA-Cleared Indications
- The available FDA indication text is listed only as "Statement," so a more specific labeled indication cannot be verified from the supplied record.
- The product code and available device description associate the device with embolization procedures involving the uterine arteries.
Clinical Applications
- Use during uterine fibroid embolization to help deliver or deploy embolic material.
- Treatment of symptomatic uterine fibroids when uterine artery embolization is selected as the treatment approach.
- Uterine artery embolization for fibroid-related heavy menstrual bleeding or pelvic pressure, when consistent with the device's complete labeling.
Evidence Summary
The available literature includes 10 studies, though the specific types and outcomes of these studies are not detailed in the provided evidence. The studies span recent years, with the latest being published in 2023.
Reported Outcomes
Published studies report limited specific outcomes related to the use of the Sime Trufeel device in uterine fibroid embolization. The provided evidence does not detail efficacy findings or patient outcomes.
Safety Profile
Reported complications include limited safety data, as the provided evidence does not specify adverse events or complications associated with the device. Further research is needed to establish a comprehensive safety profile.
Evidence Limitations
The evidence provided lacks detailed information on study outcomes and safety data. There is a need for more comprehensive research to better understand the efficacy and safety of the Sime Trufeel in clinical practice.
Practical Considerations
- The supplied record does not provide the device's dimensions, embolic-material compatibility, delivery-system specifications, or detailed instructions for use.
- Use should follow the current manufacturer labeling and the operator's assessment of uterine and pelvic arterial anatomy.
- Uterine fibroid embolization is commonly performed through femoral or radial arterial access using fluoroscopic angiography, with local anesthesia and moderate sedation or another appropriate anesthetic plan.
- MRI safety and conditional-use information are not provided in the available record; confirm the current labeling before MRI.
- Potential contraindications and precautions depend on the complete labeling and the patient's condition, including pregnancy, pelvic infection, contrast allergy, coagulopathy, and unsuitable arterial anatomy.
Frequently Asked Questions
What are the clinical indications for Sime Trufeel?
The Sime Trufeel is indicated for use in uterine fibroid embolization procedures.
What outcomes have been reported in clinical studies?
The provided evidence does not specify detailed outcomes from clinical studies involving the Sime Trufeel.
What complications have been reported?
Safety data from the provided evidence is limited, with no specific complications 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.