(56 days)
Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.
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This document is a 510(k) clearance letter from the FDA for a medical device called "Millex®- HV, VV, GV Syringe Filter Unit." It is an approval for the device to be marketed, based on its substantial equivalence to a legally marketed predicate device.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) is a premarket notification process that demonstrates a new device is as safe and effective as a legally marketed device (predicate device). It primarily focuses on comparing the new device to an existing one. It does not typically include detailed performance study results, acceptance criteria, or ground truth establishment in the way that would be seen for a new, novel device requiring a PMA (Premarket Approval) or for AI/ML-driven devices.
Therefore, I cannot provide the requested information from this document. The document confirms that the device is intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications, and that it has been deemed substantially equivalent to a predicate device.
§ 868.5130 Anesthesia conduction filter.
(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).