Search Results

The SuperCross Catheter is intended to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries in order to facilitate placement and positioning of other catheters. The SuperCross Catheter is not intended for use in the coronary or cerebral vasculature. The SuperCross Catheter is not intended for use to dilate lesions.

The SuperCross Catheter features a 7 French compatible hydrophilically coated stainless steel braided polyimide and polyurethane shaft, which is attached to a steerable dilator at the distal end of the device. The proximal end of the shaft is connected to a handle and rotating hemostasis valve assembly. The dilator consists of two halves. One half articulates about a hinge pin and the other half is fixed to the shaft. The dilator is actuated by a wire connected to a lever and it may be rotated 360 degrees with the control of the shaft. A guidewire lumen through the device accepts a non-polymer coated 0.018" guide wire.

This document is a 510(k) premarket notification for a medical device (SuperCross™ Catheter). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not present in this type of submission. This document details a modification to an existing device and relies on showing that the new device performs equivalently to the previously cleared predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel functionality.

Here's a breakdown of the information that is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This type of 510(k) submission generally does not present specific "acceptance criteria" in a quantitative performance table like a software device. Instead, the "acceptance criteria" can be broadly understood as demonstrating "substantial equivalence" to the predicate device in terms of:

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

• Not Applicable. This document describes a modification to an existing physical device, not an AI/software algorithm that operates on a "test set" of data. The "testing" referred to is against physical performance and biocompatibility expectations, not a dataset in the context of AI.

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

• Not Applicable. As this is not an AI/software device, there is no "ground truth" derived by experts from a test set of data.

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

• Not Applicable. See point 3.

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 catheter device, not an AI-assisted diagnostic or treatment system.

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

• Not Applicable. This is a physical catheter device, not an algorithm.

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

• Not Applicable. The "ground truth" for this device's performance would be engineering specifications, material science standards, and established clinical performance of the predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI algorithm.

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

• Not Applicable. See point 8.

Summary of the Study (as described in the document):

The study referenced in the document is primarily a "substantial equivalence" justification.

• Nature of the Study: It's a submission of information demonstrating that the modified SuperCross Catheter is substantially equivalent to its previously cleared predicate device (K001856). This involves comparing:
  • Intended Use: Confirmed to be identical.
  • Technological Characteristics: Described device components and features, implying similarity or minor, non-impactful changes from the predicate.
  • Biocompatibility: "Results of scientific testing" ensured materials are biocompatible and no new adverse effects were introduced.
  • Performance Characteristics: "Results of scientific testing" ensured physical properties are appropriate for intended use. This would likely involve bench testing (e.g., tensile strength, steerability, lubricity) but specific details and acceptance ranges are not provided in this summary.

This type of submission focuses on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the predicate, validating its equivalence based on design, materials, and intended function.

Ask a specific question about this device