(267 days)
For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
Millex - MP Sterilizing Filter Unit
I am sorry, but based on the provided document excerpts, there is no information available regarding acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the "Millex® - MP Filter Unit," which primarily addresses the substantial equivalence of the device to a predicate device for its intended use.
The letter and the enclosed "Indications for Use Statement" do not contain details about:
- Specific performance metrics or acceptance criteria for the filter.
- Any performance study results (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
- Details about training sets or their ground truth establishment.
The document states the device's indications for use: "For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications." The FDA's clearance is based on its determination of substantial equivalence, which implies that the device performs as intended and is as safe and effective as a legally marketed predicate device, but the specific data proving this from a primary study are not included in these excerpts.
§ 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).