(58 days)
The modified Baxter blood sets have the same intended use as currently marketed Baxter blood sets. The intended use of these sets is the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
Baxter currently markets a line of intravascular administration sets containing 80 micron and 170 to 260 micron blood filters. These sets are used in blood transfusion procedures for the administration of blood, blood components and solutions. We plan to replace the current 80 micron and 170 to 260 micron filters in these blood sets with a modified filter design. The key differences between the current and proposed blood filters are in the material composition and design of the filter chamber. The current filters are polyester and nylon screen type filters housed in PVC chambers. The new filters will be polyester screen type filters but will be housed in chambers of a different material and design. The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4.
The provided text describes a 510(k) premarket notification for "Modified Blood Administration Sets" and focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.
The document discusses "functional performance" but does not provide details on specific acceptance criteria, reported performance, sample sizes, expert involvement, or comparative effectiveness with human readers.
Therefore, I cannot populate the table or answer the questions based on the provided text. The only piece of information that hints at a standard is: "The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4." However, this is a design specification, not an acceptance criterion with a reported performance outcome.
§ 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.