(101 days)
The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor). The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.
The provided text includes a 510(k) summary for the EQUASHIELD™ System, a closed drug transfer system. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study design with reported performance metrics, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications as requested.
The document only states that:
- "A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance."
- "A simulated clinical test was performed in order to evaluate the Plastmed EQUASHIELD™ System and to ensure it performs its intended use as a closed drug transfer system. The simulated test has demonstrated that the EQUASHIELD™ system performs its intended use."
- "Both bench tests and simulated clinical test have shown that the device performs its intended use."
Without further details, it is impossible to populate the requested table and information points accurately.
Here's a breakdown of what cannot be extracted from the provided text:
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Table of Acceptance Criteria and Reported Device Performance: No specific quantitative or qualitative acceptance criteria are listed, nor are any performance metrics and their results reported. The document only offers general statements of "satisfactory performance" and "performs its intended use."
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing involves bench and simulated clinical tests, but it's unclear if "experts" were involved in establishing ground truth (e.g., for contamination assessment).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a closed drug transfer system, not an AI-assisted diagnostic or imaging device for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Again, this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For bench and simulated clinical tests, ground truth would typically refer to established standards or verifiable measurements of containment or drug transfer accuracy.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document only offers a high-level overview of performance validation, stating that tests were performed and results were satisfactory. It lacks the granular detail required to complete the requested information.
§ 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.