(15 days)
The Vented Single Vial Access Device is a stand-alone, singleuse, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.
The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.
The Vented Single Vial Access Device (ViaLokTM / Universal) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. These devices are inserted into a stopper of a medication vial. The healthcare provider uses the Vented Single Vial Access Device to transfer and mix drugs contained in standard medication vials. The Vented Single Vial Access Device includes three product configurations in this submission:
- ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer .
- . ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer
- . Universal Single Vial Access Device, Vented, Female Luer
The 20mm and 13mm product configurations are intended to mate with standard medication vial enclosure sizes (20mm and 13mm, respectively). The Universal device does not contain a shroud and can be used independent of enclosure size. Each Vented Single Vial Access Device configuration is offered with a female luer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" with pass/fail values. Instead, it lists various performance tests conducted to demonstrate equivalency to predicate devices. The reported device performance for each test is generally stated as "meets all specified requirements" or "is as safe and effective as the legally marketed devices."
| Performance Characteristic | Acceptance Criteria (Implicit from Equivalency) | Reported Device Performance |
|---|---|---|
| Attachment Force | Equivalent to predicate devices | Meets all specified requirements |
| Flow Rate | Equivalent to predicate devices | Meets all specified requirements |
| Pressurization Leak Test | Equivalent to predicate devices | Meets all specified requirements |
| Vacuum Leak Test | Equivalent to predicate devices | Meets all specified requirements |
| Priming Volume | Equivalent to predicate devices | Meets all specified requirements |
| Detachment Force | Equivalent to predicate devices | Meets all specified requirements |
| Filter Integrity | Provides equivalent air filtration to predicate | Meets all specified requirements |
| Septum Coring | Equivalent to predicate devices | Meets all specified requirements |
| Multiple Access | Equivalent to predicate devices | Meets all specified requirements |
| ISO 594-2 Test Methods | Compliance with ISO 594-2 standards | Meets all specified requirements |
| - Luer Leakage (Air Ingress) | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| - Luer Leakage (Fluid Ingress) | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| - Luer Attachment | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| - Luer Separation Force | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| - Unscrewing Torque | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| - Resistance to Overriding | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| - Stress Cracking | (Implicitly tested against ISO 594-2) | Meets all specified requirements |
| Biocompatibility (ISO 10993) | Compliance with ISO 10993 standards | Meets all biological requirements |
| - Cytotoxicity by Elution Test | (Implicitly tested against ISO 10993) | Meets all biological requirements |
| - Intracutaneous Reactivity | (Implicitly tested against ISO 10993) | Meets all biological requirements |
| - Maximization Test for Delayed Hypersensitivity | (Implicitly tested against ISO 10993) | Meets all biological requirements |
| - Acute Systemic Toxicity | (Implicitly tested against ISO 10993) | Meets all biological requirements |
| - Evaluation of Hemocompatibility | (Implicitly tested against ISO 10993) | Meets all biological requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each performance test. It only mentions that "samples of the predicate device were tested along with the Vented Single Vial Access Device" where performance data for a predicate was unavailable.
The data provenance is from Yukon Medical, LLC's internal testing as part of their 510(k) submission. It is a prospective study in the sense that the new device was manufactured and then subjected to these performance tests. The country of origin of the data is not specified, but the submission is to the US FDA, implying US regulatory standards and potentially US-based testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical device (Vented Single Vial Access Device), not an AI/software-based diagnostic tool. Ground truth in this context refers to objective physical and chemical properties and performance, not expert interpretation of data. The "ground truth" is established by the specifications and standards for medical device performance.
4. Adjudication Method for the Test Set
This is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation (e.g., of medical images) needs consensus. For device performance, the results are objectively measured against established standards.
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 is not applicable. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI to improve their performance. The Vented Single Vial Access Device is a physical, non-AI medical device.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable. This question refers to the performance of an AI algorithm in isolation. The Vented Single Vial Access Device is a physical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted on the Vented Single Vial Access Device is primarily based on:
- Established industry standards: Such as ISO 594-2 for luer connections and ISO 10993 series for biocompatibility.
- Performance characteristics of legally marketed predicate devices: The new device's performance is compared to that of existing, cleared predicate devices (Yukon Medical's ViaLok™ Non-vented and Medimop Medical Projects' Vented Vial Adapter Transfer Device). The implicit ground truth is that the predicate devices are safe and effective.
- Engineering specifications and design requirements: While not explicitly detailed in the summary, underlying the tests are specific engineering targets for flow rates, leak resistance, etc., which define acceptable performance.
8. The Sample Size for the Training Set
This is not applicable. A "training set" refers to data used to train an AI algorithm. The Vented Single Vial Access Device is a physical medical device and does not involve AI.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated in point 8.
§ 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.