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Indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.

The Modified NexSite HD Hemodialysis Catheter for long term use is intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane catheter has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to assist with the direction of the catheter. The catheter is provided in three catheter lengths (32cm, 36cm and 40cm). The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement.

The Modified NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The Modified NexSite HD Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Marvao Modified NexSite™ HD Hemodialysis Catheter:

Important Note: The provided text describes a Special 510(k) Premarket Notification. This type of submission is used when a manufacturer is making a modification to their own legally marketed device and the modification does not affect the device's fundamental scientific technology or principles of operation. As such, the testing approach is different from a de novo submission or a traditional 510(k) for a truly novel device. The focus here is on demonstrating that the modifications do not negatively impact performance compared to the predicate, and that the modified device remains substantially equivalent. Therefore, a "study" in the sense of a clinical trial or a deep algorithmic performance evaluation (like for AI/ML) is not present.

Acceptance Criteria and Reported Device Performance

Given the nature of the Special 510(k) for a modified hemodialysis catheter, the "acceptance criteria" are implied by the comparison testing to the predicate device and the adherence to relevant standards. The "study" largely consists of direct comparison testing of predefined characteristics.

Further Information (Based on provided text):

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

   • Sample Size: Not explicitly stated. The text mentions "proposed finished NexSite™ HD devices and commercial predicate devices (K121933)" were used for comparison testing. However, the number of units tested for visual, dimensional, and pressure/flow analysis is not provided.
   • Data Provenance: Not explicitly stated, but assumed to be from Marvao Medical Devices, Ltd. in Galway, Ireland, where the devices are manufactured. The testing is laboratory-based performance testing of the physical device. The data is prospective for this submission as the testing was done on the "proposed finished" modified devices.

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

   • This is not applicable to the type of device and submission. "Ground truth" in this context refers to engineering specifications and performance standards (like ISO 10555-1), not expert interpretation of medical images or outcomes.

3. Adjudication method for the test set:

   • Not applicable. Performance testing against engineering specifications does not typically involve expert adjudication in the same way clinical or image-based studies do.

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:

   • Not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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" for this device's performance testing is its engineering specifications and international performance standards (e.g., ISO 10555-1) and the performance characteristics of the legally marketed predicate device (K121933).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "design" and "materials" from the predicate device serve as the foundational "knowledge base," but this isn't a training set in the AI sense.

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

   • Not applicable. See point 7. The underlying principles for hemodialysis catheters, materials science, and manufacturing processes, which were established for the predicate device, form the basis for the modified device.

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