(15 days)
The ViaLok™ is a stand-alone, single-use, 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 ViaLok™ is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.
The ViaLok™ Non-vented (ViaLok™) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The ViaLok™ is inserted into a stopper of a medication vial. The healthcare provided uses the ViaLok™ to inject or withdrawal fluid from the vial. The ViaLok™ includes four product configurations in this submission:
- ViaLok™ Non-vented, 20mm with female luer .
- ViaLok™ Non-vented, 20mm with male luer .
- ViaLok™ Non-vented, 13mm with female luer
- ViaLok™ Non-vented, 13mm with male luer .
The ViaLok™ is offered in two sizes: 20mm and 13mm. The ViaLokTM is configured to mate with standard medication vial enclosure sizes (20mm and 13mm). Each ViaLok™ size configuration is offered in female and male luer versions.
The ViaLok™ device is made up of a spike, luer access and a shroud. The spike is used to penetrate a standard medication vial stopper and provide a fluid path.
The purpose of the ViaLok™ shroud is to secure the device to a standard medication vial after the stopper is penetrated.
The ViaLok™ is molded methyl methacrylate acrylonitrile butadiene styrene copolymer (MABS). The ViaLok™ may be provided with a cap which is molded from a low density polyethylene (female luer) or a high density polyethylene (male luer). The ViaLok™ and protective caps do not contain natural rubber latex.
This document describes the acceptance criteria and study proving the device meets said criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details performance characteristics that were tested for the ViaLok™ device to demonstrate its substantial equivalence to a predicate device. While specific quantitative acceptance criteria (e.g., minimum attachment force, maximum leak rate) are not explicitly stated, the text implies that the ViaLok™ met all specified requirements. The performance data is presented as a comparative study against a predicate device.
| Test/Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Attachment Force | Equivalent to predicate device K013087 | Tested and results contributed to demonstrating substantial equivalence; deemed "as effective" and "performs at least as safely and effectively." |
| Flow Rate | Equivalent to predicate device K013087 | Tested and results contributed to demonstrating substantial equivalence; deemed "as effective" and "performs at least as safely and effectively." |
| Pressurization Leak Test | Equivalent to predicate device K013087 | Tested and results contributed to demonstrating substantial equivalence; deemed "as effective" and "performs at least as safely and effectively." |
| Vacuum Leak Test | Equivalent to predicate device K013087 | Tested and results contributed to demonstrating substantial equivalence; deemed "as effective" and "performs at least as safely and effectively." |
| Luer Leakage (Air Ingress) | Equivalent to predicate device K013087, and ISO 594-2 compliant | Tested for both predicate comparison and ISO 594-2 compliance; results contributed to demonstrating substantial equivalence. |
| Luer Leakage (Fluid Ingress) | Equivalent to predicate device K013087, and ISO 594-2 compliant | Tested for both predicate comparison and ISO 594-2 compliance; results contributed to demonstrating substantial equivalence. |
| Priming Volume | Equivalent to predicate device K013087 | Tested and results contributed to demonstrating substantial equivalence; deemed "as effective" and "performs at least as safely and effectively." |
| Detachment Force | Equivalent to predicate device K013087 | Tested and results contributed to demonstrating substantial equivalence; deemed "as effective" and "performs at least as safely and effectively." |
| ISO 594-2 Adherence (Luer Attachment, Luer Separation Force, Unscrewing Torque, Resistance to Overriding, Stress Cracking) | Compliant with ISO 594-2 standards | ViaLok™ was tested and deemed to meet these requirements. |
| Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Hemocompatibility) | Compliant with ISO 10993-1, 4, 5, 9, 10, 11 | ViaLok™ was tested and deemed to meet these requirements. |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test or the overall test set. It mentions "samples of the predicate device were tested along with the ViaLok™."
The data provenance is implicit: the studies were conducted as part of a 510(k) submission to the FDA, indicating that the testing was carried out by or for Yukon Medical, LLC, likely in the United States, as the submission is to the U.S. regulatory body. The studies are prospective in nature, as they involve testing newly manufactured devices and a predicate device for the purpose of regulatory clearance.
3. Number of Experts and Qualifications for Ground Truth
This type of information is not applicable to the described study. The tests performed are objective, quantitative performance characteristic evaluations (e.g., force measurements, leak tests, biocompatibility assays). They do not involve subjective interpretation or decision-making by experts to establish a "ground truth" for a diagnosis or classification.
4. Adjudication Method
This information is not applicable for the same reason as point 3. Adjudication methods (like 2+1, 3+1) are used in studies where there is a need for expert consensus on a subjective interpretation, such as image reading or clinical diagnosis. This study relies on objective physical and chemical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The study is focused on the device's physical and biological performance characteristics, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was done in the sense that the ViaLok™ device's performance was evaluated independently against defined standards (like ISO 594-2 and ISO 10993) and through direct comparison with a predicate device. This is not an "algorithm-only" study as it pertains to a physical medical device, but it evaluates the device's inherent performance characteristics without human-in-the-loop interaction in the context of interpretation, but rather human interaction for use.
7. Type of Ground Truth Used
The "ground truth" for this study is based on objective, verifiable measurements against established engineering standards and performance benchmarks, as well as a direct comparison to a legally marketed predicate device. This includes:
- Established industry standards: ISO 594-2 for luer components and ISO 10993 for biocompatibility.
- Performance metrics: Measurable parameters like attachment force, flow rate, leak rates, and priming volume.
- Predicate device performance: The performance of the predicate device (ALARIS Medical Systems, Inc. Single Dose Dispensing Pin) served as a benchmark for comparison.
8. Sample Size for the Training Set
This information is not applicable. The ViaLok™ is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of supervised learning. The testing described is for verification and validation of the device's design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical medical device as described in this document.
§ 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.