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510(k) Data Aggregation
(109 days)
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown.
The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing.
The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.
Catheters longer than 40cm are intended for femoral vein insertion.
Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated).
The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.
Acceptance Criteria and Study for 15.5Fr Decathlon Coated Catheters (K060155)
The provided documentation describes the acceptance criteria and supporting studies for the 15.5Fr Decathlon Coated Catheters, which incorporate a Carmeda® BioActive Surface (CBAS®) coating to reduce thrombus formation.
The "device performance" in this context refers to the coating's ability to maintain bioactivity and reduce thrombus. The acceptance criteria are implicitly derived from the product claims and the results of the performed in-vitro and animal studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Coating Durability/Bioactivity | Heparin's bioactive properties maintained for a minimum of 90 days. | Heparin bioactivity remained essentially constant throughout the 90-day test period in saline. |
| Thrombus Reduction (In-vitro) | Significant reduction in total thrombus accumulation compared to uncoated catheters. | 96% reduction in thrombus accumulation in a two-hour in-vitro thromboresistance study (radiolabeled measurements). |
| Thrombus Reduction (In-vivo/Animal) | Significant reduction in total thrombus accumulation compared to uncoated catheters. | 94% reduction in total thrombus accumulation in an ovine model (thrombus weight measurements). |
| Qualitative Thrombus Reduction | Improved thromboresistance based on visual evaluation and mitigation of disturbed flow-mediated thrombosis and fibrin sheath propagation. | Visual evaluation of catheters showed improved thromboresistance. The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft). Optical and scanning electron microscopy showed differences in thrombus accumulation. |
| Catheter Functionality | No adverse impact on blood flow through the catheter. | Pressure increase in the arterial lumen was used as a criterion to determine coating effects, implying that acceptable flow dynamics were maintained. |
| Biocompatibility | Meets requirements for a permanent contact device. | Biocompatibility testing demonstrated that the device meets the requirements for a permanent contact device per ISO 10993. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- In-vitro Thromboresistance Study: Not explicitly stated, but implies multiple coated and uncoated catheters were tested as part of the "circulation of bovine blood through an outer loop."
- Animal (Ovine) Studies: 3 animals were used for evaluation. Within each animal, one coated and one uncoated catheter were evaluated.
- 90-day Durability Tests: Not explicitly stated how many catheters were tested, but "coated catheters" were used.
- Data Provenance: The studies were conducted by Spire Biomedical, Inc. (submitter). The country of origin for the studies is not explicitly stated but is implied to be in the USA where the company is located. The studies are prospective in nature as they are specifically designed to test the performance of the new coated catheter.
3. Number of Experts and Qualifications for Ground Truth
- No information provided regarding the number or qualifications of experts involved in establishing ground truth for the provided studies.
- For the animal studies, examination "using optical and scanning electron microscopy" would likely involve trained histologists or pathologists, but their specific qualifications are not detailed.
- Visual evaluations in the in-vitro study and interpretation of mechanical/biological data would also involve expert judgment, but again, details are absent.
4. Adjudication Method for the Test Set
- No information provided regarding a specific adjudication method (e.g., 2+1, 3+1). The studies appear to be quantitative (e.g., radiolabeled measurements, thrombus weight) and qualitative (visual evaluation, microscopy) assessments. Expert consensus or arbitration related to the interpretation of results is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was performed. The described studies are focused on the device's inherent biological and physical performance attributes, not on human reader performance with or without AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.
6. Standalone Performance Study
- Yes, standalone performance studies were done. All described studies (in-vitro, animal, durability, biocompatibility, mechanical properties) evaluate the performance of the catheter itself, without human intervention as part of the primary performance metric. The "algorithm" in this context is the CBAS® coating technology applied to the catheter, and its performance is evaluated directly.
7. Type of Ground Truth Used
- Experimental/Objective Measurements:
- In-vitro Thrombus Reduction: Radiolabeled measurements (objective quantitative data) and visual evaluation (qualitative observation).
- In-vivo Thrombus Reduction (Animal Study): Thrombus weight measurements (objective quantitative data), optical microscopy, and scanning electron microscopy (qualitative and semi-quantitative analysis).
- Coating Durability: Surface-bound heparin bioactivity (pmol/cm2) measurements over time (objective quantitative data).
- Biocompatibility: Conformance to ISO 10993 requirements.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device (catheter) with a bioactive coating, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The coating technology itself is the "algorithm" and its performance is characterized through direct experimentation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained in point 8, there is no "training set" for this device. The ground truth for the device's performance claims is established through the specific experimental methodologies and measurements described in the in-vitro and animal studies.
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