(73 days)
Elcam Closed Swabable Stopcock and MRVLS is 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.
Elcam Medical's Closed Swabable Stopcock and MRVLS is a similar version of Elcam legally marketed stopcock. cleared under 510(k) number K022895.
The Closed Swabable Stopcock includes an addition of a component that functions as a closed luer-activated valve.
The valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap, in order to avoid leakage and/or port's contamination. Once a male luer is introduced into the closed port the fluid path automatically opens to allow injection or blood sampling. Once the male luer is taken out, the female port is automatically closed.
The valve actually serves as a needleless injection site integrated in the stopcock. The only change from the end user point of view is the need to swab the valve's top (injection site) with aseptic fluid such as alcohol prior to male luer insertion.
The MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) feature, is an additional option that can be added to the Closed Swabable Stopcock, described above, and provides a stopcock with a minimal residual volume.
Conventional stopcocks are made of a body and a handle with a fluid path bore that allows the fluid to flow only through the handle. Therefore, it leaves other areas in the stopcock without a continuous flow through the stopcock fluid path and especially through the side port female luer. The MRVLS feature enables fluid flow around the handle so the fluid constant flow accesses the entire stopcock's internal volume and enables a continuous flow through the stopcock fluid path and through the side female luer during the medical procedure. This feature significantly reduces the "residual volume" in the stopcock and helps to keep the cleanliness of the stopcock's fluid path when it is in use.
The feature of minimal residual volume is achieved thanks to a modification in the stopcock handle design, which changes the fluid path and a flow guide formed therein.
The minimal residual volume design, together with the luer-activated valve creates the Minimal Residual Volume Luer-activated Swabable-stopcock (MRVLS).
This document outlines a Special 510(k) Summary for Elcam Medical's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than an independent performance study of a new medical device with explicit acceptance criteria and corresponding study results in the traditional sense.
Therefore, the requested information categories may not directly apply as they would for a novel device where diagnostic performance (e.g., sensitivity, specificity) is being evaluated. This submission focuses on non-clinical performance data to show the modified device is as safe and effective as its predicate.
Here's an attempt to populate the requested table and answer the questions based solely on the provided document, acknowledging the limitations for an "acceptance criteria" and "study" as typically understood for diagnostic AI/ML devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied from text) | Reported Device Performance (Summary from text) |
|---|---|---|
| Biocompatibility | Compliance with FDA's Memorandum – #G95-1 (May 1, 1995) and ISO 10993-1:2003. | All body/fluid contact materials were tested and showed "acceptable results." |
| Material Characterization | Validation of colorant/raw materials for intended use; Evaluation for biocompatibility. | Colorant and raw materials are "all validated to their intended use and evaluated for biocompatibility." |
| Risk Assessment | Satisfactory risk assessment (implied). | Risk assessment performed on patient-contact and fluid path materials showed "satisfactory results." |
| Functional Performance | Device meets Elcam's legally marketed device specification for the modified stopcock. | "The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met." |
| Substantial Equivalence | Device is as safe and as effective as the predicate device (K022895) and does not affect its intended use or alter fundamental scientific technology. | "The evaluation... demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device. Therefore, we believe it is substantially equivalent..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the non-clinical tests (biocompatibility, material characterization, functional performance, risk assessment). These are typically bench tests or material tests, not observational or interventional studies with patient data.
Data provenance (country of origin, retrospective/prospective) is not applicable or specified since the tests described are non-clinical, likely conducted in a laboratory setting. The company is based in Israel.
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)
This is not applicable. The device is a medical accessory (stopcock), not a diagnostic device where expert ground truth would be established from patient data. Performance is evaluated against engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The described tests are non-clinical and rely on objective measurements and established protocols.
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 evaluating the performance of AI-assisted diagnostic tools. This submission is for a medical device (stopcock) and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical accessory, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Biocompatibility: Ground truth is established by adherence to and successful completion of tests outlined in ISO 10993-1:2003 and FDA guidance, with acceptable results.
- Material Characterization: Ground truth is established by material specifications and validation against intended use.
- Functional Performance: Ground truth is the device meeting Elcam's own "legally marketed device specification."
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The tests performed are for the physical device's non-clinical performance.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/ML device.
§ 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.