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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. Catheters longer than 40cm are intended for femoral vein insertion.

The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

Here's a summary of the acceptance criteria and the studies related to the Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter, based on the provided text:

Acceptance Criteria and Reported Device Performance

• Pressure increase in the arterial lumen
• Visual evaluation of the catheters
• End-point thrombus accumulation | "Results show improved thromboresistance using each of these criteria for Decathlon Coated catheters vs. uncoated catheters." |
  | Mitigation of Specific Thrombus Types | Effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft). | "The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft)." |
  | Mechanical/Physical/Biocompatibility | The device's small change (angle between distal end lumens) is not expected to alter the characteristics of the catheter, therefore predicate device data is acceptable. | "Mechanical, physical, and biocompatibility tests were conducted on the predicate device. These tests were not repeated for this submission since this small change (angle between distal end lumens) does not alter any of the characteristics of the catheter. Test data from the predicate device is contained in this application." (Predicate device: Spire Biomedical, Inc.'s (K060155) 15.5Fr Decathlon™ Gold Twin Lumen Hemodialysis Catheter with Separated Tips). |

Study Information

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • 90-day durability tests (Heparin Coating Bioactivity): The sample size isn't explicitly stated for this particular part. It mentions "coated catheters" in saline, with measurements at "7 regular intervals." The study type appears to be prospective (in-vitro). No country of origin is mentioned.
   • In-vitro thromboresistance study: One coated and one uncoated catheter per test. The study involved circulation of bovine blood. This is an in-vitro, prospective study. No country of origin is mentioned.
   • Animal study (Ovine Model): "One coated and one uncoated catheter was evaluated in each of three animals (ovine)." This is an animal study, prospective. No country of origin is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • The document does not mention the use of human experts to establish ground truth for the performance studies. The ground truth appears to be objective laboratory measurements (heparin bioactivity, thrombus accumulation via radiolabeled measurements and weight measurements, visual evaluation, pressure increase).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable, as human expert adjudication is not mentioned for establishing ground truth in these performance studies.

4. 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

   • No MRMC comparative effectiveness study was done. This device is a medical catheter, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The ground truth used for performance evaluation was based on objective laboratory measurements and animal study observations/measurements:
     • Heparin bioactivity (in pmol/cm').
     • Total thrombus accumulation (radiolabeled measurements, thrombus weight measurements).
     • Pressure increase in the arterial lumen (in-vitro).
     • Visual evaluation of catheters (in-vitro and animal study).
     • Optical and scanning electron microscopy (animal study).

7. The sample size for the training set

   • Not applicable. This is a physical medical device, not an AI model that requires a training set.

8. How the ground truth for the training set was established

   • Not applicable.

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Spire Biomedical Inc's Alta Gold, Coated Twin Lumen Chronic Indications for Use: Hemodialysis Catheter with fixed tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter is 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 Alta Gold, Heparin Coated Catheter is fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the ends of the distal tips; the cuff is not coated).

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

Acceptance Criteria and Study for K063441: 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter

This document describes the acceptance criteria and the study that proves the Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The primary performance studies for the Alta Gold catheter leveraged data from previously cleared devices, particularly the 15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter (K060155), due to identical material, outside dimensions, and coating.

• In-vitro durability test (90-day bioactivity): Not explicitly stated, but performed on "coated catheters in saline."
• In-vitro thromboresistance study (2-hour blood loop): Involved "circulation of bovine blood" through an outer loop with "coated or uncoated catheter." The number of catheters tested is not specified but it's a comparative study. This study was performed on the Alta Gold catheters, while other tests were performed on the predicate Decathlon Gold catheters.
• Biocompatibility Testing: Conducted on the 15.5Fr Decathlon coated catheter. Number of samples not explicitly stated but implied to be sufficient for ISO 10993 compliance.

Data Provenance:
All studies mentioned are in-vitro laboratory studies, and thus the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the same way as for clinical trials with human subjects. The studies were conducted by Spire Biomedical, Inc. (or their contractors) in support of regulatory submission in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This submission does not involve a standard clinical study with expert interpretation of cases. The "ground truth" for the performance claims is established through objective, quantitative, in-vitro scientific measurements and validated international standards (e.g., ISO 10993). Therefore, there were no "experts" in the traditional sense establishing a diagnostic ground truth for a test set of medical images or patient data. The scientists and technicians conducting the laboratory tests provided the data.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used as this was not a study involving human interpretation of medical data requiring consensus or arbitration. The performance data was derived from laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a medical device (catheter) and not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a chronic hemodialysis catheter, not an algorithm or AI system. Its performance is inherent to the device's material properties and coating, not dependent on an algorithm.

7. Type of Ground Truth Used

The ground truth used for performance validation was based on:

• Quantitative In-vitro Measurements: Direct measurements of heparin bioactivity (pmol/cm²), thrombus accumulation (radiolabeled measurements), pressure increase, and visual evaluation in controlled laboratory settings.
• Adherence to Standards: Compliance with established physical and mechanical test methods, and international biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore no "training set" was used. The device's design and performance are based on engineering principles and established biological interactions, not data training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

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