Search Results

The Arrow NextStep® Retrograde Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Retrograde Catheter is inserted percutaneously and is preferentially placed into the internal jugular (JJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow NextStep Retrograde catheter is intended for use in adult patients.

The NextStep Retrograde Chronic Hemodialysis Catheter (herein referred to as the proposed NSR catheter) is a long-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. The catheter is a two-piece, two-lumen, 15 Fr, step-tipped catheter designed for retrograde placement. The catheter is available in multiple lengths.

The catheters will be packaged sterile with various components to facilitate insertion.

The provided text describes a 510(k) premarket notification for a medical device, the NextStep Retrograde Chronic Hemodialysis Catheter. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would.

Instead, the document focuses on demonstrating substantial equivalence to previously approved predicate devices. This means the manufacturer is arguing that their new device is as safe and effective as existing legally marketed devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, many of the requested elements (like "acceptance criteria" in the sense of performance metrics, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth for test/training sets) are not applicable or not provided in this type of regulatory submission. The document explicitly states: "Clinical performance data was not used to determine substantial equivalence."

Here's the breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criteria" for a 510(k) submission are that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. This is achieved by demonstrating similar technological characteristics, intended use, and functional performance, backed by non-clinical testing. Specific performance metrics are compared against those of the predicate.

• Reported Device Performance (Non-clinical):

  • Dialysis Flow Rate: Performed for longer length catheters.
  • Hemolysis: Performed for longer length catheters.
  • Additional Testing: Complies with Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis (for longer length catheters).
  • Bench Testing: Previously completed on predicate NextStep Retrograde catheters in accordance with ISO 10555-1 and 10555-3.
  • Biocompatibility: In accordance with ISO 10993-1.

  Note: The document states what tests were performed, but does not provide the specific numerical results or target values (acceptance criteria) for these tests within this summary.

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

• Not applicable / Not provided. The document states "Clinical performance data was not used to determine substantial equivalence." Non-clinical bench testing was performed, but specific "test set" sample sizes or data provenance (e.g., country of origin) for these bench tests are not detailed in this summary.

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

• Not applicable / Not provided. No clinical "ground truth" establishment by experts for a test set is discussed, as clinical data was not used.

4. Adjudication method for the test set:

• Not applicable / Not provided. Not relevant due to the lack of clinical test set and expert review.

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 device is a chronic hemodialysis catheter, not an AI-assisted diagnostic or imaging device, so MRMC studies or AI assistance are not relevant.

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

• Not applicable. This device is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.

7. The type of ground truth used:

• Non-clinical Performance Standards/Predicate Device Performance: The "ground truth" for this submission largely relies on established international standards (e.g., ISO 10555-1, 10555-3, 10993-1) for medical device performance and biocompatibility, as well as the known performance characteristics of the predicate devices. The aim is to show the new device performs acceptably against these standards and is equivalent to the predicate.

8. The sample size for the training set:

• Not applicable / Not provided. No "training set" in the context of machine learning or AI is relevant here. For non-clinical bench testing, the sample sizes for the specific tests are not disclosed in this summary.

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

• Not applicable / Not provided. Similar to point 8, no training set or its ground truth establishment is relevant or described for this device and submission type.

Ask a specific question about this device