(271 days)
The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system.
The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system. This device is not made with natural rubber latex. The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, drip chamber, Y-site, tubing, flow regulator, clamp, needless injection site and luer connection. The set may include two unique components: 1. Spike: The Spike is intended for connection to the spike port of an infusion bag. In cases when a drug needs to be introduced, a septum enables connection to the Tevadaptor™ Syringe Adaptor for withdrawal of diluents or introduction of drug. 2. ULTRASITE In Injection site (cleared under 510(k) No. K031923). The Ultrasite Valve is a needle-free, cap less positive displacement valve to be use in place of needles for the administration of fluids. The ULTRASITE™ Valve may be accessed with standard male luer connectors and requires no special accessories devices. The Ultrasite device eliminates the use of needles to access the set during IV administration and aids in the prevention of needle stick injuries. Teva Medical Migada Plant offers both standard and custom sets with tubing of various lengths to meet customer requirements and specifications.
The provided text is a 510(k) summary for an I.V. Administration Set, which is a medical device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., performance metrics, ground truth, expert adjudication, MRMC studies, standalone performance) does not apply.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance of an AI/ML algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document describes a traditional medical device and its regulatory submission, not an AI/ML product.
§ 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.