(54 days)
Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.
The CLEARLINK 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 syringefluer 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 antiscptic before each connection.
The hard surfaces of the CLEARLINK Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may destroy or inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially compromised.
The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing legally marketed devices rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for a novel device or AI algorithm.
Due to the nature of a 510(k) summary, which often relies on non-clinical testing and comparison to predicates, many of the requested details (like sample sizes for test/training sets, expert qualifications, MRMC studies, and detailed quantitative performance metrics) are not present in the provided document.
Here's an analysis based on the available information:
1. Table of acceptance criteria and reported device performance:
The document broadly states: "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." However, it does not specify what those acceptance criteria are, nor does it provide quantitative reported device performance against those criteria. It focuses on the presence of an antimicrobial agent (metallic silver) and its intended function to inhibit microbial growth on coated surfaces.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." |
| Reduced possibility of microbial contamination on coated surfaces | Device contains metallic silver intended to inhibit growth of microorganisms on coated surfaces, thereby reducing microbial contamination. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "nonclinical tests" but does not provide details on the number of units tested.
- Data Provenance: Not specified, but given it's a 510(k) for a physical medical device (IV administration set), the testing would likely be performed in a laboratory setting by the manufacturer, or contracted labs, rather than involving patient data in the typical sense of a clinical study for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a study requiring expert-established ground truth in the context of diagnostic interpretation (e.g., radiology reads). The "testing" referred to is non-clinical, likely engineering and microbiology testing.
4. Adjudication method for the test set:
- Not applicable. This type of non-clinical testing typically involves objective measurements against established standards, not interpretation or adjudication by human experts for a "ground truth" derived from consensus.
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 an AI/software device that would involve human readers or MRMC studies. The device is a physical IV administration set with an antimicrobial coating.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For the antimicrobial aspect, the "ground truth" would be established through microbiological assays demonstrating the inhibition of microbial growth on the coated surfaces under controlled laboratory conditions, likely comparing against non-coated versions or established controls.
- For the functional aspects (e.g., fluid administration, luer activation), the ground truth would be established through engineering and performance standards for IV administration sets to ensure proper sealing, flow rates, and connection integrity.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" in the context of this device, as it is a physical medical device and not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable for the reason above.
In summary:
The provided 510(k) summary for the CLEARLINK Antimicrobial Luer Activated Device and Extension Sets focuses on demonstrating substantial equivalence through non-clinical risk analyses and design verification tests. While it states that acceptance criteria were met, it lacks the detailed quantitative performance metrics, sample sizes, expert qualifications, or study designs often associated with clinical trials or AI/software validation studies. This is typical for a 510(k) submission for a physical device where the primary change is the addition of a well-understood feature (antimicrobial coating) similar to those already cleared in predicate devices.
§ 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.