(28 days)
The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.
The 20mm SmartSite™ Vented Vial Access Device is a stand-alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite™ needle-free valve.
The SmartSite™ Vented Vial Access Device is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the SmartSite™ Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to 7 days.
The provided text is a 510(k) summary for the "SmartSite™ Vented Vial Access Device" and does not contain any information about a study proving the device meets specific acceptance criteria using a test set of medical images or other data that would involve ground truth established by experts.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (SmartSite® Vented Vial Access Device, K151963) through comparisons of intended use, design, technology, materials, and performance characteristics.
The "testing" mentioned in the document refers to engineering and biocompatibility tests for the physical device, not an AI/algorithm-based performance study. For example:
- Human Factors Engineering/Usability Engineering Study: This relates to how users interact with the physical device, not an algorithm's performance on data.
- Particulate Contamination Testing, Fragmentation Testing, Attachment force, Flow rate, Shelf life, etc.: These are physical performance tests of the device itself.
- Chemical Characterization Testing: Relates to the material properties of the device.
- Biocompatibility Testing: Relates to the device's interaction with the body (e.g., cytotoxicity, irritation).
Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/algorithm-based device and its performance metrics against a ground truth. The document does not describe such a study.
§ 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.