Search Results

The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion.

The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

This document is a 510(k) Pre-market Notification for the ELITECROSS Support Catheter. It seeks to demonstrate substantial equivalence to a predicate device, the Cordis Micro Guide Catheter ELITE. Therefore, the information provided focuses on the substantial equivalence and performance testing compared to the predicate, rather than a standalone study proving the device meets de novo acceptance criteria for an AI/ML device.

Because this is a submission for a medical device (catheter) and not an AI/ML device, the typical acceptance criteria and study design elements you've requested for AI/ML performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in the context of this document.

Instead, the "acceptance criteria" for a medical device like this are generally related to its functional performance, physical dimensions, material properties, and biological safety, demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's how to interpret the provided information in relation to your request, keeping in mind the device type:

1. A table of acceptance criteria and the reported device performance

Based on the document, the "acceptance criteria" are implied by the performance characteristics tested, demonstrating equivalence to the predicate and ensuring the device functions as intended. The reported performance is that the device "meets applicable performance requirements" and "continues to meet all previous performance specifications" of the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided document. For physical device testing, sample sizes are typically determined by statistical methods or industry standards but are not usually detailed in this summary section of a 510(k).
• Data Provenance: Not specified nor is it typically relevant for this type of physical device performance testing. The tests are benchtop, laboratory evaluations.

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

• Not Applicable. This is not an AI/ML device where expert consensus on interpretations or diagnoses would be required for ground truth. Ground truth for a catheter involves objective physical and functional measurements (e.g., burst pressure, flow rate, dimensions).

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

• Not Applicable. As above, this is for AI/ML interpretative tasks, not for physical device performance validation.

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/ML diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not Applicable. This is a physical medical device. There is no algorithm or "standalone" performance in the AI/ML sense.

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

• Objective Technical Measurements: The "ground truth" for this type of device testing consists of objective, quantifiable measurements of physical properties and performance characteristics (e.g., dimensions, burst pressure, flow rates, compatibility with other devices). These are typically verified against engineering specifications and industry standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

• Not Applicable. No training set is involved.

Ask a specific question about this device