(30 days)
The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor contractions outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.
The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liguid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liquid. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.
The PhaSeal Protector is one component of the PhaSeal system. It is a drug vial adapter that is fitted to the drug vial and is used as a docking station between the drug vial and the BD PhaSeal Injector. In addition the Protector equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.
The provided 510(k) summary (K130197) does not contain information related to acceptance criteria, device performance, or any studies involving human readers or AI algorithms.
This document describes a medical device called the "BD PhaSeal Closed System Transfer Device - P55," which is a sterile, single-use closed system drug transfer device. The 510(k) summary focuses on the device's description, intended use, and substantial equivalence to a predicate device (BD PhaSeal® Connector, Injector, Protector - K123213).
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document describes the function of the device (airtight, leakproof, prevents transfer of contaminants, etc.) but does not quantify performance against specific criteria.
- Sample size used for the test set and the data provenance: Not applicable as no such study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
- Adjudication method for the test set: Not applicable as no such study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool.
- If a standalone performance study was done: While there would undoubtedly be internal testing by the manufacturer for a device of this type (e.g., leak tests, microbial ingress tests), the provided 510(k) summary does not detail these studies' acceptance criteria, methodologies, or results. The summary focuses on the regulatory submission process.
- The type of ground truth used: Not applicable as no ground truth for diagnostic or interpretative accuracy is relevant or discussed for this device.
- The sample size for the training set: Not applicable as this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable as this is not a machine learning device.
In summary, the provided text details a regulatory submission for a physical medical device and does not include the type of performance study data or acceptance criteria typically associated with AI/ML devices or diagnostic tools.
§ 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.