(29 days)
PhaSeal® closed system for the preparation and administration of parenteral drugs
PhaSeal Infusion Adapter - Intravascular Administration Set: The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.
PhaSeal Protection Cap - Special accessories: The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting.
PhaSeal Secondary Set - Intravascular Administration Set: The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique.
PhaSeal Extension Set - Intravascular Administration Set: The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
PhaSeal is a closed system for preparation and administration of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the administration of the drug to the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component devices is sealed off with an elastomeric membrane cover. The membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.
The provided text is a 510(k) summary for the PhaSeal® closed system for the preparation and administration of parenteral drugs. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted directly from this type of regulatory submission.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria or quantitative performance metrics typically associated with a clinical study. The submission focuses on demonstrating substantial equivalence in function and components to already marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of a performance study. No sample sizes for testing or data provenance (country, retrospective/prospective) are mentioned, as the basis of the submission is a comparison to predicate devices, not a de novo performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or available. Ground truth establishment for a test set implies a performance study (e.g., diagnostic accuracy), which is not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not applicable or available, as no performance study with a test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
This information is not applicable or available. The submission does not detail any comparative effectiveness study, especially one involving human readers with and without AI assistance. The PhaSeal system is a physical medical device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable or available. The PhaSeal system is a physical device, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable or available. The submission doesn't describe establishing ground truth for a performance study. Instead, it relies on the known safety and efficacy of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable or available. There is no mention of a "training set" as this is not an algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or available, as there is no training set described.
Summary of what the document DOES provide, relevant to its purpose:
The document explains the function of the PhaSeal system components (Infusion Adapter, Protection Cap, Secondary Set, Extension Set) and argues for their substantial equivalence to existing predicate devices based on:
- Similar components: "all use similar components"
- Similar function: "provide a pathway to administer fluids from a container to a patient's vascular system" or "a protection and mechanical cover for a connections to IV systems."
This 510(k) submission is a regulatory filing aimed at demonstrating that the new device is as safe and effective as a legally marketed predecessor, not a detailed report of a clinical performance study with specific acceptance criteria.
§ 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.