(98 days)
The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial
The Swabable Vial Adapter is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.
The Swabable Vial Adapter is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a luer connection) is attached to the sub-assembly.
This document is a 510(k) summary for the "Swabable Vial Adapter" by Medimop Medical Projects Ltd. It describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not contain information about a medical device that performs a diagnostic or prognostic function capable of being proven through a study. Therefore, the information needed to answer the comprehensive questions about acceptance criteria and a study proving device performance is not present in the provided text.
Specifically, the document focuses on:
- Device Description: How the Swabable Vial Adapter works (allowing safe and easy transfer of liquid drugs from and into vials).
- Indications for Use: To allow multiple needleless accesses to an injection medication vial for facilitating withdrawal or addition of drugs/solutions.
- Technological Comparison to Predicate Devices: Claims substantial equivalence in indications for use, design, material, sterility, and packaging with predicate devices like the Robertsite Vial Adapter and Smartsite Vented Vial Access Device.
- Safety and Effectiveness: States that finished products are tested to meet required release specifications, including physical testing and visual examination.
- Conclusion: Asserts substantial equivalence to predicate devices and that it introduces no new issues of safety and effectiveness.
Key Missing Information:
The document does not describe:
- Specific acceptance criteria for "performance" as one would for a diagnostic or prognostic device (e.g., sensitivity, specificity, accuracy). The "acceptance criteria" mentioned are related to release specifications for manufacturing and safety (e.g., meeting ISO 10993-1, USP VI, physical testing, visual examination), not clinical performance.
- A study that proves the device meets specific performance criteria related to diagnostic or prognostic capabilities. The "study" mentioned is conformity to safety standards and comparison to predicates for substantial equivalence.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or details about training sets. These are all irrelevant for a device whose primary function is drug transfer and access rather than diagnostic interpretation.
Therefore, I cannot populate the table or provide the requested details about a study focusing on performance metrics like accuracy, sensitivity, or specificity. The provided document concerns a medical device accessory whose "performance" is primarily assessed through engineering, material, and safety standards, and equivalency to existing devices, rather than clinical diagnostic efficacy.
§ 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.