(90 days)
The Vial Adapter is indicated for the transfer of drugs contained in a vial.
The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.
The provided text describes a 510(k) premarket notification for a medical device called "Vial Adapter 20mm". This is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria in the typical academic or clinical trial sense.
Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context, as they pertain to clinical or AI/algorithm performance studies. This document focuses on bench testing and regulatory comparisons.
Here's a breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests conducted. For each test, the acceptance criteria are implicitly defined by the referenced standard or the success of the "in-house test method." The reported device performance is indicated by statements like "meets all applicable design and performance requirements," "conforms to applicable external and internal standards," and "successfully conducted." Specific numerical performance data or detailed results are not provided in this summary.
| Test | Test Method/Standard | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fragmentation Test | ISO 8536-2:2010 section 6.2.2 | Compliance with ISO 8536-2:2010 requirements | Meets requirements |
| Particulate Testing | USP 788 | Compliance with USP 788 requirements for particulate matter | Meets requirements |
| Internal Diameter Upper Skirt | ISO 8362-6:2010 Section 4.2 | Compliance with ISO 8362-6:2010 requirements for dimensions | Meets requirements |
| Luer Gauging Test | ISO 594-1:1986 and ISO 594-2:1998 | Compliance with ISO 594-1:1986 and ISO 594-2:1998 for Luer fittings | Meets requirements |
| Luer Stability & compliance (fluid leakage) | ISO 80369-7:2021; ISO 80369-20:2015, Annex B & C | Compliance with ISO 80369-7:2021 and ISO 80369-20:2015 for fluid leakage | Meets requirements |
| Luer Stability & compliance (air leakage) | ISO 80369-7:2021; ISO 80369-20:2015, Annex D & C | Compliance with ISO 80369-7:2021 and ISO 80369-20:2015 for air leakage | Meets requirements |
| Luer Stability & compliance (stress cracking) | ISO 80369-7:2021; ISO 80369-20:2015, Annex E & C | Compliance with ISO 80369-7:2021 and ISO 80369-20:2015 for stress cracking | Meets requirements |
| Luer Stability & compliance (axial load) | ISO 80369-7:2021; ISO 80369-20:2015, Annex F & C | Compliance with ISO 80369-7:2021 and ISO 80369-20:2015 for axial load | Meets requirements |
| Luer Stability & compliance (resistance separation from unscrewing) | ISO 80369-7:2021; ISO 80369-20:2015, Annex G & C | Compliance with ISO 80369-7:2021 and ISO 80369-20:2015 for resistance to unscrewing | Meets requirements |
| Luer Stability & compliance (overriding) | ISO 80369-7:2021; ISO 80369-20:2015, Annex G & C | Compliance with ISO 80369-7:2021 and ISO 80369-20:2015 for overriding | Meets requirements |
| Luer Stability & compliance (dimensions) | ISO 80369-7 Table B.2 and B.5 | Compliance with ISO 80369-7 dimensional requirements | Meets requirements |
| Residual Volume | In-house test method | Meeting internal specifications for residual volume | Meets requirements |
| Device Leakage | In-house test method | Meeting internal specifications for device leakage | Meets requirements |
| Device Leakage under normal use | In-house test method | Meeting internal specifications for device leakage under normal use | Meets requirements |
| Device Total Penetration Force | In-house test method | Meeting internal specifications for penetration force | Meets requirements |
| Vial Adapter Detachment Force | In-house test method | Meeting internal specifications for detachment force | Meets requirements |
| Product Retention in Blister | In-house test method | Meeting internal specifications for product retention (packaging) | Meets requirements |
| Device Removal Force from Blister | In-house test method | Meeting internal specifications for device removal force (packaging) | Meets requirements |
| Tyvek Total Peel Test | In-house test method | Meeting internal specifications for Tyvek peel strength | Meets requirements |
| Functionality according to IFU | In-house test method | Performing as intended according to Instructions for Use | Meets requirements |
| Filter Efficiency | In-house test method | Meeting internal specifications for filter efficiency | Meets requirements |
| Syringe First Orientation | In-house test method | Performing as intended in Syringe First orientation | Meets requirements |
| Product Skirt Position on Vial | In-house test method | Meeting internal specifications for skirt position | Meets requirements |
| Injection Force | In-house test method | Meeting internal specifications for injection force | Meets requirements |
| Aspiration Force | In-house test method | Meeting internal specifications for aspiration force | Meets requirements |
| Label Legibility | In-house test method | Meeting internal specifications for label legibility | Meets requirements |
| Packaging Integrity | In-house test method | Meeting internal specifications for packaging integrity | Meets requirements |
| Biocompatibility (various tests) | ISO 10993-5, -4, -10, -11, -12; ASTM F756 | Compliance with specified ISO and ASTM standards and FDA guidance | Successfully conducted, materials are biologically safe |
| Sterilization (validation) | ISO 11137-1, 11137-2, 13004 | Achieving a Sterility Assurance Level (SAL) of 10-6 | Validated, SAL of 10-6 achieved |
| Bacterial Endotoxin Testing | Limulus Amebocyte Lysate (LAL) | Acceptable levels of bacterial endotoxins | Passed with acceptable levels |
| Shelf life stability | ASTM F1886 | Withstanding a shelf life of 5 years | Determined to withstand 5 years |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: The tests are "non-clinical performance data" and "bench performance tests." The manufacturing facility is in Ra'anana, Israel. The data would be prospective for the purpose of this submission (i.e., new testing done for this device).
3. 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. This is not a study relying on expert interpretation for ground truth. It's an engineering and regulatory compliance submission based on physical and chemical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication of results is described for these bench tests; results are objective measurements against standards.
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 a passive, non-electrical, non-software-enabled mechanical component (Vial Adapter), not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As mentioned above, this is a mechanical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance tests outlined is defined by the specified international and in-house standards (e.g., ISO, USP, ASTM) that the device must comply with. For biocompatibility and sterilization, it's compliance with safety thresholds and validation standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning study, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is irrelevant.
§ 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.