(224 days)
This product is intended for the aspiration and preparation of medical fluid, not including injection.
The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).
The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.
The provided text describes the 510(k) premarket notification for a "Filter Needle for Single Use" (K233277) and its substantial equivalence to a predicate device. However, it does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it refer to performance metrics typically associated with AI/SaMD (e.g., sensitivity, specificity, AUC).
The document focuses on the substantial equivalence of a physical medical device (a filter needle) based on material, design, performance, biocompatibility, sterilization, and shelf-life testing, primarily against established international standards.
Therefore, I cannot extract the requested information regarding AI/SaMD acceptance criteria and studies from this document. The tables and study details you've asked for (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth establishment for training and test sets) are relevant to the validation of AI/SaMD, but are not present in this clearance document for a conventional medical device.
To directly answer your request based on the provided text, I must state that the information is not available.
§ 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.