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Spire Biomedical, Inc.'s Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

Device Description

The Decathlon™ 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 venous lumen at the catheter's distal end. The catheter has a felt cuff and dual extensions. Each extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter:

Summary of Device and Context:

The "Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter with Separated Tips" is a radiopaque polyurethane catheter designed for chronic hemodialysis and apheresis. It is intended for percutaneous insertion. This 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). The key difference in the proposed device is a "small angle" divergence of the lumens at the distal end, compared to the predicate's "substantially parallel" lumens.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type/Evidence
Material Composition	Identical polyurethane resin to predicate	Identical polyurethane resin used	Comparison to predicate device specifications
Physical Design	Similar hub-lumen-extension tubes, luer connections, kit components, packaging, sterilization, and product labeling to predicate.	Identical hub-lumen-extension tubes design, luer connections, kit components, packaging and sterilization, and product labeling.	Comparison to predicate device specifications
Functional Performance (Flow Rates)	Identical flow rates to predicate	Identical flow rates	Comparison to predicate device specifications
Functional Performance (Priming Volumes)	Identical priming volumes to predicate	Identical priming volumes	Comparison to predicate device specifications
Biocompatibility	Meets standards for medical devices	(Implicit: Predicate device passed, and this subtle change won't affect it)	Reference to predicate device test data
Mechanical/Physical Properties	Meets standards for medical devices	(Implicit: Predicate device passed, and this subtle change won't affect it)	Reference to predicate device test data

Note: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device. The core argument is that the single design change (angle of distal lumen divergence) is minor enough not to alter the established safety and effectiveness characteristics of the predicate.

Study Information:

The provided document describes a comparison study to a legally marketed predicate device, rather than a de novo clinical or extensive performance study.

2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a separate test set. The submission relies on data from the predicate device. If "test set" refers to the new device itself, there's no mention of a specific number of new devices being tested for this submission.
- Data Provenance: The data provenance is from the predicate device (Spire Biomedical, Inc.'s 15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). It appears to be retrospective in the sense that existing data from a previously cleared device is being leveraged. The country of origin of the data is not specified, but the submitter is based in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This was not a study requiring expert-established ground truth in the typical sense (e.g., for diagnostic accuracy). The comparison is against engineering specifications and existing regulatory clearance of a predicate device.
4. Adjudication Method for the Test Set:
- Not applicable. There was no specific "adjudication" (e.g., expert consensus on clinical cases) for a test set. The review process was a regulatory submission evaluated by the FDA.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device, not an AI or diagnostic imaging tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study in the context of an algorithm or AI was not done. This is not an algorithmic device.
7. Type of Ground Truth Used:
- The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device, as demonstrated through its mechanical, physical, and biocompatibility tests that led to its previous FDA clearance (K032061, K042858). The manufacturer is asserting that the minor design change in the new device does not alter this established ground truth.
8. Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/machine learning model. The underlying "ground truth" for the predicate device would have been established through a combination of engineering specifications, material testing, mechanical testing, and biocompatibility studies conducted according to relevant standards at the time of its original clearance.

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