(155 days)
Elcam Antimicrobial Stopcock [or Manifold] 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 Antimicrobial Stopcock [or Manifold] has 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 Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission.
Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path.
Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device.
The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970.
All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and biocompatibility in accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.
The Elcam Antimicrobial Stopcock [or Manifold] received 510(k) clearance (K053405) based on its substantial equivalence to predicate devices and performance in non-clinical testing.
Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Antimicrobial Effectiveness | Significant reduction of bacteria levels (at least 2 log reduction). | Demonstrated significant reduction of bacteria levels (at least 2 log reduction) with a variety of organisms. |
| Mechanical Functionality | Meet Elcam conventional stopcock specifications. | Performed according to Elcam conventional stopcock specification with acceptable results. |
| Biocompatibility & Chemical | Acceptable results in accordance with FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003. | All body/fluid contact materials and fluid path materials were tested and showed satisfactory results. |
| Labeling Claims Support | Tests should support all labeling claims. | Tests results are supporting all labeling claims. |
| Risk Assessment | Satisfactory risk assessment performed. | Risk assessment was performed with satisfactory results. |
| Substantial Equivalence | Demonstrate substantial equivalence to predicate devices. | Determined substantially equivalent to Elcam's conventional stopcocks (K022895) and Medex's antimicrobial stopcock (K954970). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact numerical sample sizes for the antimicrobial effectiveness tests or mechanical tests. It states "Extensive tests were performed with a variety of organisms" for antimicrobial effectiveness and "Mechanical tests were performed according to Elcam conventional stopcock specification."
- Data Provenance: The studies were conducted by Elcam Medical (Israel). The data is retrospective in the sense that it was collected and submitted for the 510(k) application, but the tests themselves would have been prospective experiments designed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic imaging studies. The assessment of the device's performance was based on laboratory testing against established specifications and standards (e.g., "at least 2 log reduction" for antimicrobial effectiveness, "according to Elcam conventional stopcock specification" for mechanical, and ISO 10993-1:2003 for biocompatibility). The "ground truth" for these types of devices is typically defined by the objective results of these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "truth" for these non-clinical performance studies is derived from objective laboratory testing against pre-defined criteria, not from expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging AI devices where human readers interpret medical images, and the AI assists or performs the interpretation. The Elcam Antimicrobial Stopcock is a physical medical device, and its effectiveness is determined through laboratory performance tests, not through human reader interpretation.
6. Standalone Performance Study (Algorithm Only)
Yes, in essence, the "non-clinical performance data" described (mechanically and microbiologically) constitutes a standalone performance study of the device. The antimicrobial stopcock's effectiveness in preventing/reducing bacterial colonization and its mechanical functionality were tested independently of human intervention during its operation in a simulated environment. The device's antimicrobial feature is an inherent property of its material composition, not an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on objective laboratory test results against predefined performance specifications and industry standards. Specifically:
- For antimicrobial effectiveness, the ground truth was a "significant reduction of bacteria levels (at least 2 log)."
- For mechanical functionality, the ground truth was "Elcam conventional stopcock specification."
- For biocompatibility and chemical properties, the ground truth was compliance with "FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003."
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its performance is due to its physical design, materials, and the incorporation of an antimicrobial agent. Development and optimization of a physical device would involve design iterations and testing, but not in the sense of an algorithm training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical 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.