(29 days)
The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.
PhaSeal is a closed system for handling 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 drug, the administration of the drug to the patient, and waste handling.
All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric 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 Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the administration and disposal processes.
This document is a 510(k) summary for the PhaSeal Y-site Line, an intravascular administration set. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K980381) rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report as one might find for a novel device undergoing extensive clinical trials.
Therefore, the requested information elements related to specific acceptance criteria, detailed study design, expert ground truth, and AI-specific metrics (like MRMC studies) are not fully present in the provided text because this type of submission is for a device deemed substantially equivalent to an already approved one.
However, I can extract the available information and point out where the requested details are absent.
Description of Device and Comparison to Predicate
The PhaSeal Y-site Line is a component of the PhaSeal closed system for handling parenteral drugs, particularly cytotoxic drugs. It serves as a port for IV administration when a Luer Lock fitting is not available in the patient's IV line. It uses a built-in connector that works with the PhaSeal Injector, utilizing a double membrane technique designed to prevent leakage of hazardous drug aerosols and spills.
The device is considered substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381. This claim of substantial equivalence replaces the need for extensive de novo performance studies in this specific 510(k) submission. Therefore, detailed acceptance criteria and a specific performance study in the manner requested are not explicitly outlined for this particular submission entry (K060866) beyond the general safety and efficacy implied by substantial equivalence to its predicate.
Requested Information Based on Provided Document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (based on documentation) |
|---|---|
| Prevention of leakage/spills: (Central to PhaSeal system functionality) | "Leakage of drug into the environment is effectively avoided during all three phases of drug handling..." |
| Safe handling of medications: (General objective) | "These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs." |
| Functionality with PhaSeal Injector: (Device-specific) | "The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique." |
| Material/Component Compatibility & Biocompatibility: (Standard for medical devices) | Not explicitly detailed in this summary, but required for predicate. |
| Sterility: (Standard for intravascular devices) | Not explicitly detailed in this summary, but required for predicate. |
| Durability/Integrity: (Functionality over time) | Not explicitly detailed in this summary, but required for predicate. |
Note: The document states, "The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381." This means the foundational acceptance criteria and performance data would have been established and met by the predicate device. This specific 510(k) (K060866) relies on demonstrating that the Y-site Line performs equivalently.
2. Sample size used for the test set and the data provenance
- Not explicitly stated in this 510(k) summary. Since this is a substantial equivalence submission, a new, independent performance study with a specific "test set" and sample size as described for a de novo device is not presented. The "data" refers to the established performance of the predicate device (K980381).
- Data Provenance: The predicate device (PhaSeal system) was developed by Carmel Pharma AB (Molndal, Goteborg, Sweden). The provided text does not specify the country of origin of testing data for the predicate, nor whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not explicitly stated in this 510(k) summary. This type of information is typically for diagnostic devices, particularly those involving image interpretation where expert consensus is needed to establish "ground truth." This device is an administration set. The "ground truth" for its safety and effectiveness would be established through engineering validation, material testing, and potentially clinical use data of the predicate, as opposed to expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not explicitly stated in this 510(k) summary. This concept is generally applied to diagnostic studies where multiple readers interpret data and discrepancies are adjudicated.
5. 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 an intravascular administration set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm, so "standalone" performance in this context is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device (intravascular administration set), the "ground truth" for its performance, safety, and effectiveness would be established through a combination of:
- Engineering specifications and tests: Demonstrating the physical integrity of the component, the sealing mechanism (double membrane), burst pressure, leak tests, and flow rates.
- Biocompatibility testing: Compliance with ISO 10993 standards.
- Sterilization validation: Ensuring the device is sterile.
- Clinical performance data (for the predicate): Evidence from the predicate device (K980381) demonstrating its effectiveness in preventing drug exposure during preparation, administration, and waste handling in actual use, likely supported by observational studies or post-market surveillance.
- None of these specific details are provided in this 510(k) summary. The summary relies on the overarching claim of substantial equivalence to K980381.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is involved.
§ 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.