đź“‹ FDA Reference
Epidural Minifilter Luer 80369-7 Epidural Minifilter Nrfit 80369-6
Pajunk Gmbh Medizintechnologie
Summary: The Epidural Minifilter Luer and NRFit are medical devices used for filtering medications in epidural procedures. They are typically utilized by anesthesiologists and pain management specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190663 ↗
Decision Date ?
June 17, 2019
Product Code ?
BSN
Device Class ?
Class 2
Evidence ?
0 studies
The Epidural Minifilter, manufactured by Pajunk Gmbh Medizintechnologie, received FDA clearance through the 510k pathway on June 17, 2019. It is classified as a Class 2 device under product code BSN.
What It Is
The Epidural Minifilter is a specialized filter designed for use in epidural procedures to ensure the purity of medications administered. It connects to epidural catheters via Luer or NRFit connectors, which are standardized to prevent misconnections. The device helps reduce the risk of particulate contamination during drug delivery in epidural spaces.
FDA-Cleared Indications
- Filtering medications administered through epidural catheters.
- Use with epidural analgesia or anesthesia medication-delivery systems.
- Use with compatible Luer or NRFit epidural connections, as applicable to the model.
Clinical Applications
- Filtering medication during continuous epidural infusions.
- Filtering medication during intermittent epidural injections.
- Use during epidural analgesia or anesthesia in hospital-based care.
- Use with compatible epidural catheters and administration equipment using Luer or NRFit connections.
Practical Considerations
- Select the correct configuration: the Luer model uses a Luer connection, while the NRFit model uses an ISO 80369-6 neuraxial connection designed to reduce misconnections.
- Confirm compatibility with the epidural catheter, tubing, syringes, pumps and other components before use.
- Use aseptic technique and inspect the package and filter for damage, leakage or obstruction before connection.
- Follow the product labeling for priming, flow limits, replacement and single-use requirements; do not reuse unless the labeling specifically permits it.
- MRI compatibility should be confirmed in the current manufacturer labeling. Do not assume an implanted or connected epidural system is MRI safe solely because the filter is used for epidural medication delivery.
Frequently Asked Questions
What is the Epidural Minifilter used for?
It is used to filter medications administered through epidural catheters to ensure they are free from particulates.
What specialties typically use this device?
Anesthesiologists and pain management specialists commonly use this device during epidural procedures.
What are the FDA-cleared indications?
The device is indicated for filtering medications in epidural anesthesia or analgesia procedures to ensure purity and safety.
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.