(71 days)
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in vials.
The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.
The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.
The provided text describes a 510(k) submission for a medical device called the "Vented Vial Adapter Transfer Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study related to strict acceptance criteria and performance metrics in the way one might for a diagnostic AI device.
Therefore, many of the requested categories for AI device studies (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable to this type of medical device submission.
Here's an adaptation of the requested information based on the provided document:
Acceptance Criteria and Device Performance for the Vented Vial Adapter Transfer Device
The "acceptance criteria" for this device, within the context of a 510(k) submission, are primarily focused on demonstrating substantial equivalence to already cleared predicate devices regarding its intended use, technological characteristics, and safety and effectiveness. The "study" proving this largely relies on comparisons, material testing, and manufacturing quality controls.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated through Equivalence) | Reported Device Performance / Justification |
|---|---|
| Indications for Use: Transferring and mixing drugs contained in vials. | Met: "The Vented Vial Adapter Transfer Device has Indications for Use similar to the predicate devices – all are intended for transferring and mixing drugs and diluents contained in vials." |
| Technological Characteristics: Similar design principle, specifically enabling direct passage to and from vials in a sterile manner, and allowing connection to standard luer accessories. | Met: "All products have piercing spikes, which enable the users to create a direct passage to and from vials, in a sterile manner." "The Vented Vial Adapter Transfer Device allows the connection any standard accessory with a luer connection to be connected to a vial." |
| Material Safety (Biocompatibility): Materials suitable for intended use. | Met: "The Vented Vial Adapter Transfer Device is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP V1 requirements and were determined suitable for the Indications for Use of this product." |
| Sterility: Packaged sterile. | Met: "All devices are packaged sterile..." (mentioned for the predicate devices and implied for the proposed device through equivalence). |
| Safety and Effectiveness (General): No new issues of safety and effectiveness compared to predicates. | Met: "The Vented Vial Adapter Transfer Device is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness." This is supported by the technological comparison and the fact that "All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing, visual examination (in-process and finished product)." |
| Ergonomics: Designed ergonomically. | Met: Mentioned for predicate devices ("All devices are... designed ergonomically.") and implied for the proposed device through equivalence. |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A): This submission is for a medical device, not an AI/diagnostic software. There isn't a "test set" in the sense of a dataset for algorithm evaluation. Instead, the "testing" refers to manufacturing quality control and material biocompatibility.
- Data Provenance: The device is manufactured by Medimop Medical Projects Ltd. in Ra'anana, Israel. The material testing (ISO 10993-1 and USP V1) would generate data, but specific details on the provenance of these material tests beyond the standards themselves are not provided. The comparison is retrospective to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A: Not relevant for this type of device submission. Ground truth as typically understood for AI models is not established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: Not relevant for this type of device submission.
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
- N/A: Not relevant for this type of device submission. This is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: Not relevant for this type of device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A (Indirectly): The "ground truth" for this type of device is implicitly the established safety and effectiveness of its predicate devices, as well as adherence to recognized material and manufacturing standards (ISO 10993-1, USP V1, internal release specifications). The FDA's substantial equivalence determination acts as the validation.
8. The sample size for the training set
- N/A: Not relevant for this type of device submission.
9. How the ground truth for the training set was established
- N/A: Not relevant for this type of device submission.
§ 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.