(259 days)
Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.
The vial adapter (VA) are sterile polycarbonate molded devices that allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of the vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in Ø20mm to accommodate Ø20 drug vials and is available in 3 configurations, no filter, inline 5-micron or 15-micron disc filter sub- assembly for particulate filtration.
Based on the provided document, the device in question is a "Vial Adapter Ø20 mm", which is a medical device for transferring and mixing drugs contained in vials. The document is a 510(k) summary submitted to the FDA for market clearance.
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document describes non-clinical testing to demonstrate performance and substantial equivalence to a predicate device. There are no specific "acceptance criteria" presented in a table with numerical goals and actual performance values for each, but rather the document states that "All testing met the required acceptance criteria." The tests performed are primarily related to mechanical function, fluid dynamics, filter performance (for some configurations), and Luer lock characteristics.
Here is a table summarizing the tests, standards, and the general statement of performance:
| Category | Test | Testing Standard | Reported Device Performance |
|---|---|---|---|
| A: Packaging | A1: Seal integrity test by dye penetration | ISO 11607-1 | Met required criteria |
| A2: Sealing strength (resistance) | ISO 11607-1 | Met required criteria | |
| A3: Peeling open characteristics test | ISO 11607-1 | Met required criteria | |
| B: Mechanical tests and leaks | B1: VA Snapping force | Internal performance standards | Met required criteria |
| B2: VA Unsnapping force | Internal performance standards | Met required criteria | |
| B3: Leak Spike/Vial | ISO 8871-5:2016(F) | Met required criteria | |
| B6: Spike ductility | Internal performance standards | Met required criteria | |
| D: Fluid flow | D1: Flow injection from syringe to Vial | Internal performance standards | Met required criteria |
| D2: Flow aspiration from Vial to syringe | Internal performance standards | Met required criteria | |
| D3: Dead volume | Internal performance standards | Met required criteria | |
| E: Filter | E1: Filter integrity | Internal performance standards | Met required criteria |
| E2: Filter holding force / VA | Internal performance standards | Met required criteria | |
| E3: Leak external filter / internal VA | Internal performance standards | Met required criteria | |
| E3: Particle Filtration Efficiency (Particulate) | Internal specification | Met required criteria | |
| F: Luer Lock | F1: Gauging | ISO 80369-7 | Met required criteria |
| F2: Liquid leak checking of the liquid-tightness of the cone Luer | ISO 80369-7 | Met required criteria | |
| F3: Air leak checking of the air-tightness of the cone Luer | ISO 80369-7 | Met required criteria | |
| F4: Separation force | ISO 80369-7 | Met required criteria | |
| F5: Unscrewing torque force | ISO 80369-7 | Met required criteria | |
| F6: Friendly assembly | ISO 80369-7 | Met required criteria | |
| F7: Thread resistance | ISO 80369-7 | Met required criteria | |
| F8: Cracks and change color | ISO 80369-7 | Met required criteria | |
| Other | Particulate Testing | USP | Met required criteria |
| Biocompatibility (Cytotoxicity, Sensitization, Hemolysis, Intracutaneous Reactivity, Systemic Toxicity, Rabbit Pyrogen Test) | ISO 10993 series, ASTM F756 | Successfully completed | |
| Sterilization Validation | ISO 11137-1, ISO 11137-2, AAMI TIR 33 | Validated to minimum SAL 10-6 | |
| LAL Testing (Bacterial Endotoxin) | Validated LAL method | Successfully tested |
Study Details:
This document describes a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy trials. The "study" here refers to the non-clinical testing performed to support this claim.
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (N) for each of the non-clinical tests performed. It only lists the types of tests conducted.
- Data Provenance: The submitter is Avenir Performance Européenne Medical (APEM), located in Château Landon, France. The testing standards are international (ISO, ASTM) and US-based (USP). The document does not explicitly state whether the data is retrospective or prospective, but for device testing, it would generally be prospective (tests conducted specifically for this submission).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. The "ground truth" for the non-clinical performance of a device like a vial adapter is established through standardized engineering and laboratory testing protocols, not through expert consensus or clinical interpretation of data. The "acceptance criteria" are derived from these standards or internal specifications, not expert diagnostic agreement.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for establishing ground truth in image analysis or diagnostic tasks where human interpretation is involved and subject to variability. For engineering performance testing of a physical device, the outcome is measured against predefined physical/chemical standards, not adjudicated by experts.
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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:
- This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a mechanical vial adapter, not an AI diagnostic tool.
- The document explicitly states: "There was no clinical testing required to support the medical device as the Indications for Use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a mechanical adapter, not an algorithm or AI. The tests performed are on the physical device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering and medical device standards (ISO, USP, ASTM) and internal performance specifications. For example, "Leak Spike/Vial" is tested against ISO 8871-5:2016(F), and "Particulate Testing" against USP . Biocompatibility is tested against ISO 10993. These standards define the acceptable range or limits for specific performance parameters.
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The sample size for the training set:
- This is not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a mechanical medical device, not an AI.
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How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.
§ 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.