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The UltraStream Chronic Hemodialysis Catheter is designed for chronic hemodialysis and apheresis.

The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. The device is used in the same manner as the predicate device and other substantially equivalent 510(k) cleared devices.

This document describes a Special 510(k) submission for a device modification, the UltraStream Chronic Hemodialysis Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the Hemo-Stream™ True Over the Wire Dialysis Catheter (K071422).

Here's the analysis based on your request, but please note that this document is for a medical device modification and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria related to AI/SaMD studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission. The provided document details a comparison of physical and functional characteristics of the new catheter with its predicate, supported by non-clinical testing.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for a Special 510(k) of this nature is demonstrating substantial equivalence to a previously cleared predicate device, meaning the new device is as safe and effective as the predicate. This is achieved by showing that the new device has similar technological characteristics and the non-clinical testing supports that there are no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a device modification, the "acceptance criteria" is essentially the successful demonstration of substantial equivalence to the predicate device, based on the non-clinical tests performed. The "reported device performance" is that these tests revealed the subject device to be substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance:

• Not applicable for this type of medical device modification. The submission relies on non-clinical comparative functional and material testing, performed in a lab setting, not on patient data or clinical datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No expert ground truth establishment for a test set in the context of an AI/SaMD product. The ground truth for device performance is established via standardized engineering and material testing protocols.

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

• Not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Performance is determined by engineering measurements and observations.

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 a physical medical device (catheter), not an AI/SaMD product. MRMC studies are used for evaluating AI-assisted diagnostic tools.

6. 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.

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

• The "ground truth" for this device modification is the established performance and safety profiles of the predicate device, as determined by previous clearances and regulatory standards (e.g., ISO standards, FDA guidance documents). The new device is evaluated against these benchmarks through bench testing and material testing.

8. The sample size for the training set:

• Not applicable. No training set exists as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. No training set exists.

Summary of what was done (based on the provided text):

• Type of Study: Non-clinical comparative functional testing and material testing.
• Purpose: To demonstrate substantial equivalence of the modified UltraStream Chronic Hemodialysis Catheter to its predicate, the Hemo-Stream™ True Over the Wire Dialysis Catheter (K071422).
• Methods:
  • Functional Testing: Performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. This would involve specific tests to measure flow rates, pressure resistance, strength, durability, etc., in a lab setting.
  • Material Testing: Included ISO 10993 Biocompatibility Testing to ensure the materials used are safe for human contact.
  • Bench Testing: A general term for laboratory testing of the device's physical and mechanical properties.
• Results/Conclusion: "Testing results revealed the subject device to be substantially equivalent to the predicate device." The submission concluded that there were "not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness."
• Clinical Studies: "Not applicable as there are no new indications for use which must be supported by clinical data." This confirms that no human clinical trials were performed or required for this particular modification.

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