(77 days)
Elcam Stopcocks and Manifolds with Safe2 Rotator 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.
Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family. The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path. The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.
The provided document describes a 510(k) submission for Elcam Medical Stopcocks and Manifolds with Safe2 Rotator. This is a medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
The document discusses performance data in the context of the device's physical functionality and substantial equivalence to a predicate device.
Here's the relevant information extracted from the document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Functional Requirements of ISO 594-2) | Reported Device Performance |
|---|---|
| Initial twisting force | "demonstrated that it meets its specifications" |
| Secondary twisting force | "demonstrated that it meets its specifications" |
| Liquid pressure resistance | "demonstrated that it meets its specifications" |
| Disconnection force | "demonstrated that it meets its specifications" |
| Overall Conclusion | "modified device is as safe and effective as its predicate" and "meets its specifications" |
2. Sample size used for the test set and the data provenance:
- The document states that "non-clinical tests" were conducted.
- It does not specify the sample sizes used for each test.
- The data provenance (country of origin, retrospective/prospective) is not detailed. However, the manufacturer, Elcam Medical, is based in Israel, so it can be inferred that testing was conducted either internally or by a contracted lab, adhering to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes physical device testing for functionality, not diagnostic/prognostic algorithm performance requiring expert-established ground truth. The "ground truth" here is objective physical measurements against established engineering standards (ISO 594-2).
4. Adjudication method for the test set:
- This question is not applicable for the same reasons as #3.
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 question is not applicable as this is not an AI/ML device.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- This question is not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for this device's performance testing is defined by established engineering standards (specifically ISO 594-2 for various mechanical properties like twisting force, liquid pressure resistance, and disconnection force). These are objective, measurable criteria.
8. The sample size for the training set:
- This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."
9. How the ground truth for the training set was established:
- This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."
Summary of what the study did prove:
The study conducted for the Elcam Medical Stopcocks and Manifolds with Safe2 Rotator involved a series of non-clinical bench tests. These tests were designed to evaluate the physical functionality and safety of the modified device, particularly the new Safe2 Rotator component. The tests demonstrated that the device meets its specifications and complies with the functional requirements outlined in ISO 594-2 for lock fitting (initial twisting force, secondary twisting force, liquid pressure resistance, and disconnection force). Based on these results, the manufacturer concluded that the "modified device is as safe and effective as its predicate."
§ 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.