(243 days)
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. 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 duration of therapy.
IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.
The provided document is a 510(k) summary for an IV Administration Set, not an AI-powered medical device. Therefore, the information required to answer your query (acceptance criteria and study details for an AI/algorithm-based device) is not present in the given text.
The document focuses on demonstrating substantial equivalence of a conventional medical device (IV administration set) to a predicate device, based on:
- Similar indications for use and intended use.
- Similar principle of operation and fundamental scientific technology.
- Similar component types and materials (with specific testing for material differences).
- Compliance with recognized performance standards (e.g., ISO 8536-4, ISO 10993-1).
- Successful completion of non-clinical performance and biocompatibility testing.
The concept of "acceptance criteria" in this context refers to meeting the performance specifications outlined in the relevant ISO standards and the functional and performance tests listed. There is no mention of an algorithm, AI, or comparative effectiveness studies involving human readers and AI assistance.
To summarize why I cannot provide the requested information:
- Nature of the Device: The device is a physical medical administration set, not a software or AI-based diagnostic/assistive tool.
- Type of Submission: This is a 510(k) premarket notification for substantial equivalence, not a de novo or PMA submission that would typically involve extensive clinical performance data for novel AI devices.
- No AI/Algorithm Mentioned: The document does not describe any AI component, algorithm, or software functionality.
- No Human-in-the-Loop Study: Since there's no AI, there's no MRMC study, no human reader improvement data, and no standalone algorithm performance.
- No Ground Truth Establishment: The concept of "ground truth" for diagnostic accuracy is not applicable to a physical IV administration set.
Therefore, I cannot populate the table or answer the specific questions related to AI device evaluation based on 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.