(80 days)
The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.
The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.
The provided text describes the 510(k) summary for the Vial2Bag™ Direct Connect device, focusing on its substantial equivalence to predicate devices based on performance testing and biocompatibility assessments. Here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. It simply states that they "passed."
| Acceptance Criteria (Not explicitly quantified in text) | Reported Device Performance |
|---|---|
| Air leakage test: Established acceptance criteria | Passed |
| Vial adapter detachment force from Vial2Bag™ body: Established acceptance criteria | Passed |
| Vial adapter breaking torque: Established acceptance criteria | Passed |
| Vial adapter total vial penetration force: Established acceptance criteria | Passed |
| Vial adapter detachment force from vial: Established acceptance criteria | Passed |
| Vial adapter spike damage: Established acceptance criteria | Passed |
| Cytotoxicity (MEM Elution - ISO): Established acceptance criteria | Passed |
| Sensitization (ISO Guinea Pig Maximization Sensitization Test): Established acceptance criteria | Passed |
| Irritation / Intracutaneous (ISO Intracutaneous Study in Rabbits): Established acceptance criteria | Passed |
| Hemocompatibility (In Vitro Hemolysis Study Extraction Method): Established acceptance criteria | Passed |
| Acute Systemic Toxicity (ISO Systemic Toxicity Study in Mice): Established acceptance criteria | Passed |
| Material Mediated Pyrogenicity (USP Rabbit Pyrogen Extraction Method): Established acceptance criteria | Passed |
| Bacterial Pyrogenicity (LAL Test Method): Established acceptance criteria | Passed |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each of the performance and biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective), but it can be inferred that the testing was conducted by or on behalf of Medimop Medical Projects Ltd. in Israel, as they are the company proposing the device. These tests are typically prospective, meaning they are designed and executed specifically for regulatory submission.
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 and not provided in the context of device performance and biocompatibility testing for this type of medical device (IV administration set). "Ground truth" and expert consensus typically apply to diagnostic or AI-driven devices where human interpretation or a gold standard diagnosis is compared against the device's output. Here, the tests are objective, laboratory-based measurements against pre-defined engineering and biological safety standards.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically relate to conflicting expert opinions in diagnostic studies, which is not relevant here. The evaluation of test results against acceptance criteria is usually a straightforward pass/fail assessment.
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
An MRMC study is not applicable and was not performed or mentioned for the Vial2Bag™ Direct Connect device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in conjunction with AI. The Vial2Bag™ Direct Connect is an IV administration set and does not involve "readers" or AI assistance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance tests, the "ground truth" is defined by established engineering specifications and physical properties that the device must meet, often based on recognized standards (e.g., ISO for biocompatibility). For biocompatibility, the ground truth is the biological response observed in standardized in vitro and in vivo animal models compared against internationally recognized safety thresholds. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it would be for a diagnostic tool.
8. The Sample Size for the Training Set
This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device. It does not employ machine learning or AI, and therefore does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this device.
§ 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.