(69 days)
Elcam Antimicrobial Closed Stopcocks (DSS and TSS) are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Both configurations have a feature of an antimicrobial agent using a compound containing silver.
The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.
The device is NOT intended to be used as a treatment for patient infections.
Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described:
The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock.
The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants.
This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve.
The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines:
(1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.
The provided text describes a Special 510(k) summary for Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS). This is a regulatory submission, not a research study, and therefore it does not contain the information typically found in a study proving device performance against acceptance criteria relating to diagnostic accuracy for AI/ML devices.
The document states that the modified device was tested in accordance with Elcam's legally marketed device specifications and "all acceptance criteria were met." However, it does not detail what those specific acceptance criteria were, nor does it provide a full study report with data to prove meeting them.
Here's a breakdown of the requested information based on the provided text, and where the information is not available because this is not a diagnostic AI/ML study:
1. A table of acceptance criteria and the reported device performance
A table of specific acceptance criteria and reported device performance is not provided in the document. The text states:
- "Design verification tests results are supporting all labeling claims and substantial equivalency."
- "The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met."
However, the actual criteria and results are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This document describes a medical device in the context of a 510(k) submission, not an AI/ML algorithm or a diagnostic test involving patient data. The "tests" mentioned are likely performance tests for fluid flow, antimicrobial properties, material compatibility, and structural integrity, not a test set of patient cases.
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. As this is not an AI/ML diagnostic study, there is no "test set" requiring expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. There is no test set or adjudication process described.
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
Not applicable/Not provided. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. Elcam's Antimicrobial Closed Stopcocks are physical medical devices, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the types of tests indicated (biocompatibility, chemical, material characterization, risk assessment, and device specifications), the "ground truth" would be established by relevant industry standards, material properties, and engineering specifications, not by medical expert consensus or patient outcomes in the context of a diagnostic test.
8. The sample size for the training set
Not applicable/Not provided. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. This is not an AI/ML algorithm that requires a training set with established ground truth.
In summary, the provided document is a regulatory submission for a physical medical device (stopcocks), not a study demonstrating the performance of an AI/ML diagnostic device. Therefore, most of the requested information regarding acceptance criteria and study details for AI/ML performance is not present. The document broadly states that "all acceptance criteria were met" for design verification tests, but does not provide the specifics of these tests or criteria.
§ 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.