(28 days)
The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.
The Vial2Bag Advanced® 20mm Admixture Device is a single-use, sterile, needle-less, nonpyrogenic, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is intended to be used with standard drug vials with a 20mm closure and an elastomeric stopper. The Vial2Bag Advanced® 20mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set.
The provided text describes a medical device, the Vial2Bag Advanced® 20mm Admixture Device, and its comparison to a predicate device for substantial equivalence. It is not an AI/ML device, therefore, many of the requested fields are not applicable.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance:
The document outlines performance testing, but the explicit acceptance criteria are not tabulated with specific performance results. Instead, it states that testing was conducted to ensure the device "met the applicable design and performance requirements." For some tests, it mentions the basis for acceptance criteria or sample size, but not the actual criteria set.
| Test | Acceptance Criteria (Explicitly Stated) | Reported Device Performance (Explicitly Stated) |
|---|---|---|
| Vial Adaptor Tensile Detachment Force | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Vial Adaptor Torque Test | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Detachment Force of Vial Adapter from Vial | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Attachment Force of Vial Adapter to the Vial | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Leakage Testing | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Internal Diameter of the Upper Skirt for Vial Adapter | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| 1m Drop Durability | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Fragmentation | Based on EN ISO 8536-2, section 6.2.2 | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Mass Transfer | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Residual Volume | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Dose Concentration | Not explicitly stated (In-house test method) | Met applicable design and performance requirements; subject device is as safe and effective as the predicate. |
| Biocompatibility | In accordance with ISO 10993-1, classified as externally communicating device with prolonged contact duration (>24 hours to 30 days) | Test reports from the reference device (K201415), which uses an identical colorant, were leveraged and deemed applicable to demonstrate biological safety. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Fragmentation Test: "sample size based on EN ISO 7864, Annex B, Section B.4." (Specific number not provided, but the standard is cited.)
- Sample Size for other tests: Not explicitly stated.
- Data Provenance: The tests are in-house, suggesting they were conducted by the manufacturer, West Pharma. Services IL, Ltd., in Ra'anana, Israel. There is no mention of retrospective or prospective data in the context of performance testing on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a physical medical device (fluid transfer device) and not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on a test set. The performance testing is based on engineering and material standards.
4. Adjudication method for the test set:
Not applicable for a physical device's performance testing. The outcomes of the tests are objective measurements against established standards or in-house criteria.
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 is not an AI/ML device, and no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
The performance criteria are established through:
- In-house test methods (presumably based on engineering principles and intended function).
- International standards (e.g., EN ISO 8536-2 for Fragmentation, ISO 10993-1 for Biocompatibility).
- Comparison to a predicate device to demonstrate "substantial equivalence."
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.