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510(k) Data Aggregation
(56 days)
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.
The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.
The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.
The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) 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 heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also 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.
The provided document describes a Special 510(k) submission for a device modification: the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™). The modification involves adding a silver impregnated sleeve to an existing device (Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating - Palindrome™ Emerald™).
Here's an analysis of the acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Heparin Coating Performance | ||
| Platelet Adhesion Reduction (in-vitro) | ≥ 60% reduction in platelet adhesion | 60% reduction in platelet adhesion (p<0.05) |
| Heparin Activity (Coating Durability) | Maintain heparin activity levels at twice the minimum required for 60% reduction of platelet adhesion. | Maintained heparin activity levels at above the minimum efficacy threshold (which is 43% of initial activity) for 720 hours of simulated dialysis, with 60-70% of initial activity remaining. |
| Thrombus Formation Reduction (in-vivo) | Significant reduction in thrombus formation | 82% reduction in total thrombus formation (p<0.05) over 24 days |
| Silver Impregnated Sleeve Performance | ||
| Microbial Colonization Reduction (in-vitro) | Significant reduction in microbial colonization | Between 2.1 and 5.5 log10 reductions against S. aureus, Coagulase-negative Staphylococcus, C. albicans, E. coli |
| Microbial Colonization Reduction (in-vivo) | Significant reduction in microbial colonization | Between 2.5 and 4.9 log10 reduction against S. aureus (clinical isolate) |
| Silver Loading / Biocompatibility | Safe levels of silver loading for biocompatibility and non-toxicity; controlled release. | Biocompatibility testing at highest silver loading passed; total silver amount confirmed safe versus toxicity/exposure limits; silver elution demonstrated controlled release. |
| No Impact on Catheter Performance | Silver sleeve should not negatively affect catheter safety and performance. | Confirmed that the presence of the silver impregnated sleeve did not affect the safety and catheter performance. |
2. Sample Size and Data Provenance
Test Set (for Heparin Coating Performance):
- In-vitro circulating blood loop test: Sample size not explicitly stated for individual catheters, but "uncoated control" implies multiple comparisons. Data provenance is a bench test using fresh heparinized bovine blood.
- Coating durability test: Sample size not explicitly stated, but "the catheter was subjected to 720 hours of simulated dialysis". Data provenance is an in-vitro simulation.
- In-vivo ovine model: Six sheep. Each sheep had both a coated and non-coated catheter. Data provenance is prospective animal testing (ovine model).
Test Set (for Silver Impregnated Sleeve Performance):
- Biocompatibility testing: Not specified, but typically involves a battery of tests with multiple samples. Data provenance not specified (likely lab-based).
- Total silver amount in sleeve determination: Not specified. Data provenance not specified (likely lab-based).
- Silver elution: Not specified, but likely multiple samples over time. Data provenance not specified (likely lab-based).
- In-vitro studies (microbial colonization): Sample size not specified for each microbial challenge, but tests were "after repeated challenges". Data provenance is in-vitro laboratory testing with clinical isolates.
- In-vivo studies (microbial colonization): Not specified (e.g., number of rabbits or catheters). Data provenance is prospective animal testing (rabbit infection model) with a clinical isolate.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The reported studies are primarily bench and animal testing, not human user studies requiring expert adjudication or ground truth establishment in the clinical sense.
4. Adjudication Method for the Test Set:
Not applicable for these types of studies. The end results are quantitative measurements (e.g., platelet counts, thrombus weight, microbial log reduction, heparin activity).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The studies are focused on the device's functional performance in bench and animal models, not on human reader performance, with or without AI assistance, or direct human clinical outcomes.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Studies:
Not applicable. This device is a medical catheter, not an AI algorithm. The performance evaluation is for the physical device and its coatings.
7. Type of Ground Truth Used:
- For Heparin Coating:
- In-vitro platelet adhesion: Quantitative measurement of radiolabeled platelet counts on catheter surfaces.
- In-vivo thrombus formation: Gravimetric analysis of extracted thrombus from catheter surfaces.
- Heparin activity: Chemical assay to measure heparin levels.
- For Silver Impregnated Sleeve:
- Microbial colonization: Quantitative measurement of microbial load (e.g., colony-forming units, reported as log10 reduction).
- Biocompatibility: Standardized toxicological endpoints (e.g., cytotoxicity, sensitization, irritation).
- Silver elution/content: Analytical chemistry techniques.
8. Sample Size for the Training Set:
Not applicable. This is a medical device and its coatings undergoing performance testing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a machine learning model.
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