(73 days)
PhaSeal® closed system for the preparation and administration of parenteral drugs.
PhaSeal Protector 20 - Drug Vial Transfer Adapter: The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 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 membranes to minimize exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal processes.
PhaSeal Injector Luer - Drug Transfer Needle Device: The Injector Luer has an encapsulated cannula that is permanently locked onto a syringe using a Luer fitting. Sealed transfer of diluent, drug or air, between the single-use syringe and the various components in the system can be made via the Injector Luer in both the preparation and administration phases.
PhaSeal Connector Luer-Lock - Luer Lock Device: The Connector Luer Lock ensures a sealed connection between the single-use syringe and Injector Luer and the patient's IV line. With the help of the Connector Luer Lock, injections can be made without drug spillage.
PhaSeal Infusion Set - Intravascular Administration Set: The Infusion Set is a non-vented infusion device that has a built-in connector to be used as a way of making additions of parenteral drugs to infusion fluids in a closed system. The Infusion Set may be used to administer the infusion fluid.
The PhaSeal™ closed system for preparation and administration of parenteral drugs has four component devices that 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 drug, the administration of the drug to the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each element 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 elements of the system are separated after transfer, the membranes act as tight seals that prevent leakage. PhaSeal utilizes a built-in, patented pressure equalization technique. Air passes from the vial into a special expansion chamber. Neither excess pressure nor vacuum can occur during drug preparation. This effectively prevents aerosol leakage.
This document, a 510(k) summary for the Carmel Pharma AB PhaSeal® closed system, primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It does not contain a study that proves the device meets specific acceptance criteria in the sense of a performance study with quantitative metrics.
Instead, the document asserts the device's function and safety based on its design and comparison to existing, legally marketed devices. Therefore, I cannot generate a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these types of performance studies are not present in the provided text.
The core of the document's argument for safety and effectiveness relies on:
Product Description, Function, Safety and Efficacy (as stated in the document)
The PhaSeal™ closed system for preparation and administration of parenteral drugs has four component devices that 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 drug, the administration of the drug to the patient, and waste handling.
All drug transferring utilizes a patented double membrane technique. Each element 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 elements of the system are separated after transfer, the membranes act as tight seals that prevent leakage.
PhaSeal utilizes a built-in, patented pressure equalization technique. Air passes from the vial into a special expansion chamber. Neither excess pressure nor vacuum can occur during drug preparation. This effectively prevents aerosol leakage.
Comparison of Predicate Devices/Equivalence
The document then provides a section comparing each component of the PhaSeal system to a predicate device, asserting "substantial equivalence" based on shared function and mechanism to minimize or eliminate exposure to hazardous drugs. This is the primary 'proof' in a 510(k) submission – demonstrating that the new device is as safe and effective as a legally marketed predicate device.
To directly answer your numbered questions based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not present quantitative performance data or specific acceptance criteria in the manner of a clinical or performance study. Its "performance" is implicitly asserted through its design and comparison to predicate devices, focusing on the prevention of leakage and aerosol creation.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set or associated sample size is mentioned. This is not a performance study that tested a specific number of devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth establishment by experts is described in the context of a performance test.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is described.
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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 medical device for drug preparation/administration, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicit ground truth: The "ground truth" for this 510(k) submission is the performance of the predicate devices (CytoGuard® Drug Reconstitution Device, SafetyGlide™ Shielding IM Injection Needle, Monoject® Luer Adapter, IV Administration Set Catalog #443). The PhaSeal system is deemed safe and effective if it functions "substantially equivalently" to these legally marketed devices in preventing leakage and aerosolization.
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The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set is discussed.
In summary, the provided document is a regulatory submission focused on establishing substantial equivalence for a physical medical device. It does not describe a performance study with distinct acceptance criteria, test sets, or ground truth establishment in the way one would analyze a diagnostic or AI-driven device. Its "proof" lies in its detailed description of function and direct comparison to existing, cleared devices.
§ 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.