(268 days)
The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.
The ProSeal™ Closed System Administration Set is a single use-, disposable-, intravenousadministration set used to deliver fluids from a container into a patient's vascular system. The device comprises an injector, a drip chamber* with a 15-um particulate filter, a roller clamp, flexible IV tubings*, a luer connector and a priming cap with a 3-um air filter. ProSeal™ Closed System Administration Set may be used in combination with standard IV therapy devices widely used throughout the health care industry, e.g. luer lock adaptor and IV extension sets. ProSeal™ Closed System Administration Set is configured to achieve the intended use when used in combination with these aforementioned standard complementary products. Based on the approved microbial testing in K192075, the ProSeal injector can be accessed/used for up to maximum of 5 times in 7 days. * Both the drip chamber and the IV tubings are not made with DEHP (Di (2-ethylhexyl) phthalate (DEHP)).
The provided text is a 510(k) summary for the ProSeal™ Closed System Administration Set. It provides information for a medical device that administers fluids intravenously, and demonstrates its substantial equivalence to a predicate device.
However, the request asks for details related to acceptance criteria, test set, ground truth establishment, MRMC studies, and training set information for an AI/Software as a Medical Device (SaMD).
The provided document does NOT contain information about an AI/SaMD device. It describes a physical medical device (an intravenous administration set). Therefore, it does not include the specific types of data, studies, and performance metrics that would be relevant to an AI model, such as:
- Acceptance criteria in terms of AI performance metrics (e.g., sensitivity, specificity, AUC).
- Test set/training set sizes and provenance for AI model development.
- Number and qualifications of experts for AI ground truth labeling.
- Adjudication methods for ground truth in an AI context.
- MRMC studies for AI assistance.
- Standalone performance of an algorithm.
- Types of ground truth for AI (e.g., pathology, outcomes data).
Therefore, I cannot fulfill the request as the source document pertains to a physical medical device, not an AI/SaMD.
§ 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.