(270 days)
The IV Administration Sets with 200um Blood Filter are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.
The IV Administration Sets with 200um Blood Filter are single use, disposable, intravenous administration sets used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system, rapidly through the use of a hand pump, or through gravity flow. The sets include tubing, a 60 cm filter with a 200 micron pore size, bag spike, luer connector, roller clamp and slide clamp. The sets may be equipped with a manually activated hand pump, stopcocks, manifolds, and/or luer access devices.
I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for an IV Administration Set with a blood filter, primarily focused on establishing substantial equivalence to a predicate device.
Here's what is missing that would be needed to fulfill your request:
- Specific acceptance criteria values: While the document mentions utilizing acceptance criteria from ISO 1135-4 for "Blood Filter Surface Area" and "Blood Filter Composition," it does not explicitly state what those acceptance criteria values are.
- Reported device performance values: Similarly, it lists types of performance tests conducted (e.g., "Flow rate under gravity," "Blood Filter Mesh Efficiency Test"), but it does not provide the actual numerical results or performance metrics achieved by the device for these tests.
- Details about the study and its results: The document broadly states that "functional performance testing was completed" and "performance data were provided in support of the substantial equivalence determination," but it does not detail the methodology, sample sizes, data provenance, ground truth establishment, or multi-reader studies for these performance tests.
Without these specific details about the acceptance criteria and the quantitative results of the performance testing, I cannot create the requested table or describe the study in the manner you specified. This document focuses more on what tests were done and why they were done (to prove substantial equivalence) rather than the precise results of those tests.
§ 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.