(132 days)
The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
The Formulation Prepration Device. The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.
The provided text describes a medical device called the "Formulation Preparation Device" and its substantial equivalence to another device. However, it does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, study details, or ground truth establishment.
The document is a 510(k) summary for a relatively old device (1995) and focuses on demonstrating substantial equivalence to a predicate device based on materials, form, and intended use. It mentions that "All finished products are tested and must meet all required release specifications before distribution" and refers to "physical testing" and "visual examination," but it does not specify what those specifications or the results of those tests are.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth that you've asked for. The information simply isn't present in 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.