(121 days)
The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.
The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.
The provided text is for a 510(k) premarket notification for a medical device called the "ArteriA Blood Filter," which is a blood administration filter. It describes the device, its intended use, and states its substantial equivalence to a predicate device.
*However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the purpose of demonstrating performance.
The 510(k) summary provided here focuses on administrative details, device description, intended use, and comparison to a predicate device to establish substantial equivalence based on design, materials, and function, rather than a detailed performance study proving specific acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document states: "The basic technologies, design and function of ArteriA Medical Science, Inc.'s ArteriA Blood Filter are substantially equivalent in design, materials of construction, and intended us to the predicate device." This indicates that the regulatory submission primarily relied on demonstrating equivalence to an already approved device rather than a de novo performance study against specific acceptance criteria.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.