(235 days)
Vials Adapters Ø20 mm and Ø13mm are indicated for the transfer and mixing of drugs contained in vials.
The vial Adapters (VA) Ø20mm and Ø13mm are sterile polycarbonated devices which 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 a 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 two Ø20 mm and Ø13mm diameter to accommodate respective size of drug vials and is available in 3 configurations, no filter, in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Vial Adapter Ø20 mm, Vial Adapter Ø13 mm". It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.
However, the request asks for information relevant to the acceptance criteria and study proving a device meets those criteria for an AI/ML-enabled medical device. The document provided pertains to a traditional physical medical device (Vial Adapter) and, as explicitly stated in section "10. Clinical Testing", no clinical testing was required or performed, and the device is not an AI/ML-enabled device.
Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this document.
The document focuses on non-clinical performance testing (mechanical, flow, packaging, filtration, Luer Lock) and biocompatibility for a physical device.
N.B.: Since the core premise of the request (AI/ML device testing) is not met by the provided document, I cannot fulfill most of the specific numbered points. The below response will address only what is present in the document related to acceptance criteria and testing for this physical device.
Acceptance Criteria and Study for Vial Adapter (Physical Device)
The document describes non-clinical performance testing for the Vial Adapter to demonstrate substantial equivalence to a predicate device, rather than an AI/ML system's performance. The acceptance criteria for these tests are implicitly that the device performs as expected according to the specified standards or internal performance criteria.
1. A table of acceptance criteria and the reported device performance
The document provides a "Non-Clinical/Performance testing Summary" table listing various tests and the testing standards used. It then states in section "9. Summary of Non-Clinical Testing" and "Performance Testing Summary" that:
- "All testing met the required acceptance criteria."
- "The performance testing of the filters met required acceptable criteria."
The specific quantitative acceptance criteria values (e.g., minimum snapping force, maximum leak rate) and the reported device performance values (e.g., actual snapping force measured, actual leak rate) are not detailed in this summary document. Only the statement that they "met the required acceptance criteria" is provided.
| Test Category | Specific Test | Testing Standard | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|---|---|
| A: Packaging | A1: Seal integrity test by dye penetration | ISO 11607-1 | Met required acceptance criteria | Met acceptance criteria |
| A2: Sealing strength (resistance) | ISO 11607-1 | Met required acceptance criteria | Met acceptance criteria | |
| A3: Peeling open characteristics test | ISO 11607-1 | Met required acceptance criteria | Met acceptance criteria | |
| A4: VA Extraction force from blister | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| A6: Blister Dimensional Control | According Drawings | Met required acceptance criteria | Met acceptance criteria | |
| B: Mechanical tests and leaks | B1: VA Snapping force | Internal performance standards | Met required acceptance criteria | Met acceptance criteria |
| B2: VA Unsnapping force | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| B3: Leak Spike/Vial | ISO 8871-5:2016(F) | Met required acceptance criteria | Met acceptance criteria | |
| B6: Spike ductility | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| D: Fluid flow | D1: Flow injection from syringe to Vial | Internal performance standards | Met required acceptance criteria | Met acceptance criteria |
| D2: Flow aspiration from Vial to syringe | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| D3: Dead volume | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| E: Filter | E1: Filter integrity | Internal performance standards | Met required acceptance criteria | Met acceptance criteria |
| E2: Filter holding force / VA | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| E3: Leak external filter / internal VA | Internal performance standards | Met required acceptance criteria | Met acceptance criteria | |
| E4: Particle Filtration Efficiency (Particulate) | Internal specification | Met required acceptance criteria | Met acceptance criteria | |
| F: Luer Lock | F1: Gauging | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria |
| F2: Liquid leak Checking of the liquid-tightness of the cone Luer | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| F3: Air leak Checking of the air-tightness of the cone Luer | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| F4: Separation force | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| F5: Unscrewing torque force | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| F6: Friendly assembly | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| F7: Thread resistance | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| F8: Cracks and change color | ISO 80369-7 | Met required acceptance criteria | Met acceptance criteria | |
| Other | Particulate Testing (Vial Adapters with filters) | USP | Met required acceptance criteria | Met acceptance criteria |
| Biocompatibility (Cytotoxicity, Sensitization, Hemolysis, etc.) | ISO 10993-1, ISO 10993-5, etc. | Successfully completed | Successfully completed |
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 summary for any of the non-clinical tests.
- Data Provenance: Not applicable in the context of this physical device's non-clinical performance testing. The tests are laboratory-based. The submitter is Avenir Performance Européenne Medical (APEM), located in France, suggesting the testing likely occurred in France or a European testing facility.
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 device is a physical product, not an AI/ML system requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Ground truth and adjudication methods are not relevant for these non-clinical performance tests.
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
- No. This is a physical device, and no AI/ML component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for a physical device's performance tests would be the established scientific/engineering standard for what constitutes acceptable performance (e.g., maximum allowable leak rate, minimum force for a secure connection). These are determined by regulatory standards (e.g., ISO) or internal specifications.
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
§ 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.