(223 days)
The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The proposed device consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, drip chamber, drip tube, flow regulator, flexible tube, and conical fitting. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile, single use.
The provided document is a 510(k) Summary for a medical device (Infusion Sets for Single Use) and not a study describing the acceptance criteria and performance of an AI/ML powered device. Therefore, the requested information regarding AI/ML device performance, acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, and training set details cannot be extracted from this document.
The document discusses the substantial equivalence of the proposed device to a predicate device, focusing on material, physical characteristics, and compliance with various ISO and ASTM standards relevant to infusion sets (e.g., sterilization, biocompatibility, seal strength, flow rates). It explicitly states:
- No clinical study is included in this submission. This means there is no data on human-in-the-loop performance, standalone algorithm performance, or the benefits of AI assistance.
- The device being reviewed is a physical medical device (Infusion Sets for Single Use), not an AI/ML algorithm or system.
Therefore, I cannot fulfill your request using the provided text.
§ 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.