(89 days)
Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.
The V-Link Antimicrobial Luer Activated Device consists of a clear housing encasing a gland and center post. The gland functions as the valve that provides a seal against the syringe/luer connector when the device is being used. The gland has a slit that opens when activated by the syringe/Luer connector. The gland also provides a surface that can be easily swabbed with antiseptic before each connection.
The hard surfaces of the V-Link Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may reduce the growth of microorganisms on the coated surfaces of the V-Link device.
The provided text describes a 510(k) summary for a medical device called the "V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report for the current device's performance against those criteria.
Therefore, the requested information, particularly regarding specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth establishment, is largely not present in the provided text. The document refers to "supplemental data on the efficacy and durability of the antimicrobial coating" and states that "All test results meet the acceptance criteria," but it does not elaborate on what those criteria or results actually are.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in the document for this submission) | Reported Device Performance (As stated in the document) |
|---|---|
| Implied: Efficacy and durability of the antimicrobial coating. | "All test results meet the acceptance criteria" |
| Implied: Substantial equivalence to the predicate device in terms of safety and effectiveness. | "The V-Link Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed V-Link Antimicrobial Luer Activated Device cleared November 6, 2007 (K072576)." |
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 for the test set: Not provided in the document.
- Data provenance: Not provided in the document. The general nature of 510(k) submissions suggests the data would likely be from pre-clinical testing (lab-based) rather than clinical studies, and therefore country of origin is typically less relevant unless a clinical trial was conducted.
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/Not provided. The "ground truth" concept is more relevant for diagnostic or image-based AI devices where human experts define the truth. For this device (an IV administration set with an antimicrobial coating), "ground truth" would be established through laboratory testing and engineering specifications by qualified personnel (e.g., microbiologists, engineers), but the details are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like "2+1" are typically used for establishing ground truth in clinical trials or image interpretation studies, not for the type of testing described (efficacy and durability of an antimicrobial coating on an IV set).
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 not applicable to the V-Link Antimicrobial Luer Activated Device. This device is an IV administration set, not an AI-assisted diagnostic tool or system requiring human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in the context of an "algorithm." This device is a physical medical device, not a software algorithm. The "efficacy and durability of the antimicrobial coating" would have been evaluated directly through laboratory tests (e.g., microbiological assays, material durability tests) which are "standalone" in the sense that they evaluate the device itself without human-in-the-loop performance in the way an AI diagnostic tool would be assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but based on the device description, the "ground truth" for the "efficacy and durability of the antimicrobial coating" would have been established through pre-defined laboratory test standards and methods. This would involve:
- Microbiological assays: To determine the reduction in microbial growth on coated surfaces.
- Durability testing: To assess how long the coating remains effective under simulated use conditions.
- These tests adhere to established scientific protocols and acceptance criteria relevant to antimicrobial claims.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. This device is not an AI/machine learning device that uses a "training set."
In summary, the provided 510(k) document is a summary of substantial equivalence for a physical medical device. It states that non-clinical tests were conducted and met acceptance criteria, especially concerning the antimicrobial coating's efficacy and durability, but it does not provide the specific details of those tests, the acceptance criteria, or the results in a manner that would answer the detailed questions about sample sizes, expert involvement, or ground truth establishment relevant to AI/diagnostic studies.
§ 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.