đź“Š Evidence-Based Reference
Syringefilter
Arbor Technologies
Summary: The syringe filter by Arbor Technologies is a medical device used for filtration in clinical settings. It is FDA 510k cleared and supported by six studies, highlighting its role in efficient extracellular vesicle isolation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K960928 ↗
Decision Date ?
April 4, 1997
Product Code ?
BSN
Device Class ?
Class 2
Evidence ?
0 studies
The syringe filter by Arbor Technologies was cleared through the FDA 510k pathway on April 4, 1997. It is classified as a Class 2 device under product code BSN.
What It Is
The syringe filter is a device designed for the filtration of liquids in clinical applications, particularly for isolating extracellular vesicles. It operates by employing a filtration mechanism that captures particles and contaminants, ensuring the purity of the filtered substance.
FDA-Cleared Indications
- Filtration of liquids using a syringe-based filter device.
- Removal of particulate matter and contaminants from solutions before clinical or laboratory use.
- Use in applications requiring filtration of medical or laboratory fluids, consistent with the device labeling.
Clinical Applications
- Filtering solutions during laboratory preparation.
- Removing particulate contamination from medical or laboratory fluids.
- Preparing filtered solutions for diagnostic or research procedures.
- Filtration performed as part of a clinical or laboratory workflow when the device labeling permits.
Reported off-label uses
- Research filtration of biological samples, including sample preparation for extracellular-vesicle studies.
- Small-volume filtration of investigational solutions or reagents in laboratory workflows.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes six studies, ranging from 2010 to 2026, encompassing various study types such as RCTs and pilot studies. These studies explore the device's efficacy in extracellular vesicle isolation and contamination removal.
Reported Outcomes
Published studies report that the syringe filter is effective in isolating extracellular vesicles with high efficiency and cost-effectiveness. It has been shown to improve the purity of isolated vesicles and reduce processing times compared to conventional methods.
Safety Profile
Reported complications include potential contamination risks, such as glass particle contamination during medical ampoule breakage, which the syringe filter can help mitigate. No significant adverse events specific to the syringe filter's use were noted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the syringe filter's clinical applications. Further research is needed to explore long-term outcomes and broader clinical applications beyond extracellular vesicle isolation.
Practical Considerations
- Confirm the filter membrane material, pore size, fluid compatibility, and maximum recommended pressure before use.
- Select a syringe and connection that are compatible with the filter; do not exceed the labeled volume or pressure limits.
- Use aseptic technique when filtering solutions intended for patient care or sterile procedures.
- Syringe filters are generally single-use unless the specific product labeling states otherwise.
- MRI safety cannot be determined from the FDA clearance record alone; review the current manufacturer labeling before use in or near an MRI environment.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for syringe filter?
The syringe filter is indicated for use in isolating extracellular vesicles and removing contaminants from medical solutions.
What outcomes have been reported in clinical studies?
Studies have reported effective isolation of extracellular vesicles and improved purity of filtered substances.
What complications have been reported?
Reported complications include risks of contamination, such as glass particles, which the syringe filter can help address.
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.