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510(k) Data Aggregation
(119 days)
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.
Here's a breakdown of the acceptance criteria and the study information for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™):
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming substantial equivalence to a predicate device (Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip, K043272). The primary modification is the addition of a silver-impregnated sleeve. Therefore, the acceptance criteria and performance are focused on demonstrating that this modification is safe and effective, and that the new device remains substantially equivalent.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (General) | Device is substantially equivalent in intended use, materials, physical characteristics, and performance characteristics to the predicate. | The sponsor states the device is "substantially equivalent to the Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (K043272) in intended use, materials, physical characteristics, and performance characteristics." The silver-impregnated sleeve itself is deemed substantially equivalent in intended use and performance to the legally marketed VitaGuard™ silver impregnated cuff (K861563). |
| Safety and Catheter Performance (General) | The presence of the silver-impregnated sleeve does not negatively affect the safety and catheter performance. | "Testing conducted on the proposed device confirmed that the presence of the silver impregnated sleeve did not affect the safety and catheter performance of the device." This was verified using standard tests applicable to intravascular catheters published by ASTM, ISO, and KDOQI guidelines. |
| Biocompatibility | Biocompatibility at the highest level of silver loading. | Biocompatibility testing was performed at the "highest level of silver loading." |
| Silver Amount (Safety) | Total silver amount in the sleeve is within safety versus toxicity and exposure limits. | Determination of "total silver amount in sleeve to confirm safety versus toxicity and exposure limits" was conducted. Specific values are not provided, but the outcome is that it confirmed safety. |
| Silver Elution | Demonstrates controlled release of silver. | Silver elution testing was performed "to demonstrate controlled release." |
| Microbial Colonization Reduction (In-vitro) | Significant reduction in microbial colonization on the silver-impregnated sleeve after repeated challenges with specified microorganisms. | "In-vitro studies demonstrating a significant reduction, between 2.1 and 5.5 log10 reductions, in the amount of microbial colonization on the silver impregnated sleeve after repeated challenges with Staphylococcus aureus, Coagulase-negative Staphylococcus, Candida albicans, and Escherichia coli (all clinical isolates)." |
| Microbial Colonization Reduction (In-vivo - Animal Model) | Significant reduction in microbial colonization on the silver-impregnated sleeve after repeated subcutaneous inoculation of Staphylococcus aureus in a rabbit infection model, with the performance lasting for up to 30 days. | "In-vivo studies demonstrating a significant reduction, between 2.5 and 4.9 log10 reduction in the amount of microbial colonization on the silver impregnated sleeve after repeated subcutaneous inoculation of Staphylococcus aureus (clinical isolate) in a rabbit infection model." The indication states, "The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- In-vitro studies: Not explicitly stated how many samples were used for each microorganism or how many repeated challenges were performed.
- In-vivo studies: Not explicitly stated how many rabbits were used in the infection model.
- Data Provenance: The studies were prospective bench and animal testing conducted specifically for this device submission. The clinical isolates used for in-vitro and in-vivo testing indicate a connection to real-world pathogen strains, but the testing itself was performed in a controlled laboratory/animal environment. There is no mention of human clinical data from any country in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Falls outside the scope of this document. This submission details bench and animal testing. There are no human "readers" or "experts" establishing ground truth in the context of diagnostic interpretation, as this is a medical device for placement within the body, not a diagnostic imaging or AI product. The ground truth for the microbial studies would be objective laboratory measurements (e.g., colony-forming unit counts).
4. Adjudication Method for the Test Set
Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary.
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. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device with a modified component. The "standalone" performance here refers to the device's inherent physical and antimicrobial properties, which were tested in a controlled environment without human intervention during the measurement phase.
7. The Type of Ground Truth Used
- Biocompatibility, Silver Amount, Silver Elution: Objective laboratory measurements against established standards and limits.
- Microbial Colonization Reduction (In-vitro & In-vivo): Quantitative microbiological methods (e.g., colony-forming unit counts) that directly measure the reduction in microbial load. This is an objective, empirical ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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