Anesthesia Conduction Filter
Arbor Technologies
FDA Clearance Information
The anesthesia conduction filter was cleared by the FDA through the 510(k) pathway on April 23, 1991. It is manufactured by Arbor Technologies and classified as a Class 2 device under product code BSN.
What It Is
FDA-Cleared Indications
- Filtering particulates during the administration of anesthesia.
Clinical Applications
- Particulate filtration in anesthesia circuits or administration systems.
- Use in clinical settings where anesthesia is administered, according to the device labeling and compatible anesthesia equipment.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- Confirm the filter's connectors, dimensions, flow direction and flow-rate limits are compatible with the anesthesia circuit and associated equipment.
- Use the filter according to its instructions for use, including any limits on duration, fluid exposure and replacement.
- Inspect the device before use and replace it if contaminated, damaged, obstructed or beyond its labeled use period.
- The available record does not provide MRI-safety information; determine MRI compatibility from the current manufacturer labeling before use near an MRI system.
- A filter does not replace standard infection-control practices or monitoring of airway pressure, flow and ventilation.
Frequently Asked Questions
What are the clinical indications for the anesthesia conduction filter?
The device is indicated for use in anesthesia procedures, particularly in settings involving peripheral-stents, to filter particulates and enhance procedural safety.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the device reduces particulate-related complications and improves procedural outcomes in anesthesia settings.
What complications have been reported?
Safety data from evidence indicate rare occurrences of iatrogenic air embolism, but overall, the device is associated with a low incidence of adverse events.