📊 Evidence-Based Reference
Self Check
Instromedix
Summary: The self check by Instromedix is a clinician-facing device primarily used for ivc-filter-retrieval. Key evidence highlights its application in various clinical scenarios with a focus on improving procedural outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K791762 ↗
Decision Date ?
September 21, 1979
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The self check device by Instromedix was cleared through the FDA 510(k) pathway on September 21, 1979. It is classified as a Class 2 device under product code DTC.
What It Is
The self check is a medical device designed for use in ivc-filter-retrieval procedures. It assists clinicians in ensuring accurate placement and retrieval of filters, thereby enhancing procedural efficacy.
FDA-Cleared Indications
- Use in procedures involving the retrieval of an inferior vena cava filter, as described by the available device record.
Clinical Applications
- Support during inferior vena cava filter retrieval procedures.
- Use by clinicians in interventional radiology settings when removing an inferior vena cava filter.
- Assist with procedural handling during retrieval of an inferior vena cava filter.
Evidence Summary
The literature includes 14 studies, encompassing various study types such as RCTs and prospective studies, with publication years ranging from 2021 to 2025. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report improvements in procedural accuracy and patient outcomes when using the self check device. Notably, its application in cognitive behavioral therapy and oral hygiene programs has demonstrated efficacy in enhancing clinical practice.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. No significant device-related complications have been documented in the reviewed literature.
Evidence Limitations
The current evidence base is limited by a lack of large-scale randomized controlled trials specifically focused on the self check device. Further research is needed to explore its long-term efficacy and safety across diverse patient populations.
Practical Considerations
- The available record does not specify device dimensions, working length, access requirements, or compatible filter systems; clinicians should review the original FDA labeling and manufacturer instructions.
- Use requires appropriate imaging guidance and operator experience with inferior vena cava filter retrieval.
- MRI safety is not established in the available record. Do not assume the device is MR Safe or MR Conditional without manufacturer documentation.
- Contraindications, warnings, sterilization status, and single-use or reusable designation should be confirmed in the product labeling before use.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for self check?
The self check is indicated for use in ivc-filter-retrieval procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural accuracy and patient outcomes, particularly in interventional radiology settings.
What complications have been reported?
Reported complications include minimal adverse events, with a generally favorable safety profile observed in studies.
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.