(74 days)
The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.
The Bioject Needle-Free Vial Adapter is a device which provides single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter is a one piece, polycarbonate adapter with a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike designed to fit 13 mm outside diameter vial stopper overseals. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications. The Bioject Needle-Free Vial Adapters are sterile, nonpyrogenic, and intended for single-use only. The adapters are individually packaged in a sterile, single-use Tyvek blister pack.
This K963012 document describes a Bioject Needle-Free Vial Adapter. It is a medical device and not an AI/ML-based diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria and studies demonstrating performance in the context of AI/ML are not applicable here.
The document focuses on demonstrating substantial equivalence to existing predicate devices (Baxter Needle*Less™ Drug Vial Adapter and Abbott LifeShield™ Vial Adapter) to gain FDA clearance. This involves showing that the new device has the same intended use, materials, design, and operational principles, and does not raise new questions of safety or effectiveness.
Here's why the provided questions cannot be answered from this document:
- No AI/ML Component: The device is a physical adapter for drug vials; it does not involve any algorithms, image analysis, or decision support based on data.
- No Diagnostic/Prognostic Claim: The device facilitates medication transfer, not diagnosis or prognosis, so performance metrics like sensitivity, specificity, AUC, or reader improvement are irrelevant.
- No "Study Proving Device Meets Acceptance Criteria" in an AI/ML Sense: The "proof" here is the demonstration of substantial equivalence to legally marketed devices, not a clinical trial evaluating AI performance against ground truth.
If this was an AI/ML device submission, the requested information would be crucial. However, for a traditional medical device like a vial adapter, the document instead focuses on:
- Device Description: What it is, what it's made of (polycarbonate), how it works.
- Intended Use/Indications For Use: Its purpose (accessing drug vials without needles for medication transfer, reconstitution).
- Predicate Devices: Identifying similar devices already on the market.
- Substantial Equivalence Argument: Directly comparing key features (intended use, materials, design, operational principles, sterility, single-use) to the predicates to demonstrate it's as safe and effective.
Therefore, I cannot populate the table or answer the specific questions because they pertain to a type of device and evaluation methodology not 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.