(183 days)
The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the connection of a standard Luer syringe for the reconstitution and removal of the contents of the drug vial. The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter to accommodate respective size of drug vials.
This is a 510(k) Premarket Notification for a medical device called "Vial Adapter". The document describes the device, its intended use, and the evidence provided to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the acceptance criteria and study information, as requested:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative format for specific performance metrics in the way a clinical trial might, but rather lists various tests performed and reports a "Pass" result for each. These effectively serve as the acceptance criteria for ensuring the device's functional integrity and safety.
| Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Particulate | Pass |
| Tensile strength | Pass |
| Leakage | Pass |
| Unobstructed | Pass |
| Piercing Spike | Pass |
| Puncture force | Pass |
| Chips after puncture | Pass |
| Housing | Pass |
| Luer Connector (ISO 80369-7 compliant) | Pass |
| Detachment force | Pass |
| Spike tip ductility | Pass |
| Reducing substances (easy oxides) | Pass |
| Metal ions | Pass |
| pH | Pass |
| Evaporation residues | Pass |
| UV absorbance | Pass |
| Sterile (SAL 10-6) | Pass |
| Bacterial endotoxin | Pass |
| Biocompatibility (Cytotoxicity) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Skin sensitization) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Hemolysis) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Intracutaneous reactivity) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Acute systemic toxicity) | Performed (Result Implied Pass for safety) |
| Biocompatibility (Pyrogenicity) | Performed (Result Implied Pass for safety) |
| Sterilization validation (ISO 11137-1, 11137-2) | Validated to SAL 10-6 |
| Shelf life | 3 years (Verified by stability study, aging test per ISO 11607-1, ISO 11607-2, ASTM F1980-16) |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for individual performance tests (e.g., how many devices were tested for leakage or puncture force). The tests are described generally and report a "Pass" result. Data provenance is not explicitly stated beyond being "internal performance standards" and compliance with international standards (ISO, ASTM). It is implied these are lab-based tests, not human/patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes non-clinical performance testing of a physical medical device. Ground truth, in the sense of expert consensus on medical conditions or image interpretation, is not relevant here. The "ground truth" for the performance tests would be the established scientific and engineering principles and standards against which the device's physical properties and functionality are measured.
4. Adjudication method for the test set:
This information is not applicable as the document describes non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers.
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:
This information is not applicable. This submission is for a physical medical device (Vial Adapter) and does not involve AI or any form of human-in-the-loop performance evaluation. A MRMC comparative effectiveness study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical Vial Adapter; there is no algorithm or software component for which standalone performance would be relevant.
7. The type of ground truth used:
For the performance tests, the "ground truth" implicitly refers to:
- Established industry standards: Such as ISO 80369-7 for Luer connectors, ISO 11137-1/2 for sterilization, ISO 10993-1/4/5/10/11 for biocompatibility, and ISO 11607-1/2 and ASTM F1980-16 for shelf life and packaging.
- Internal performance standards: These are criteria developed by the manufacturer to ensure the device meets its design specifications, based on engineering principles and intended use.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML product.
9. How the ground truth for the training set was established:
This information is not applicable. Since there is no training set, there is no ground truth to establish for it.
§ 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.