(42 days)
With drawal cannula for single use sterile transfer of liquid from a syrings vial and vice versa. Air enters and exits the through a hydrophobic membrane which avoide extraneous contamination of the vist and syringe contents and prevents liquid aerosols from escaping into the environment. The integrated fluid filter provides for reliable filtration o particles and ensures a high degree of safety patient.
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This document is a 510(k) clearance letter from the FDA for a device called "Taky-Spike Plus". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it predates the widespread use of such detailed AI/ML study reporting in regulatory submissions.
Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on confirming the device's substantial equivalence to a legally marketed predicate device and outlining general regulatory obligations.
The device itself, "Taky-Spike Plus," is described as a "withdrawal cannula for single use sterile transfer of liquid from a syringe to a vial and vice versa." It features a hydrophobic membrane for air exchange and an integrated fluid filter. This description clearly indicates it is a physical medical device, not an AI/ML-driven software or diagnostic tool that would typically have the kind of performance metrics and study details you're asking for.
§ 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.