(99 days)
The CenterCross ULTRA Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
The CenterCross Ultra Catheter is a sterile, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Ultra Catheter in and of itself does not provide therapeutic beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.
This document is a 510(k) premarket notification for the Roxwood Medical CenterCross Ultra Catheter. As such, it is focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study where acceptance criteria for a novel device performance were established and met.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC study, training set information, and direct effect size of AI improvement) are not applicable to the information provided in this document. This document describes bench testing for performance and characterization, not clinical study results evaluating diagnostic accuracy or reader performance with an AI device.
Here's an extraction of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in a manner typical for a clinical study with specific metrics like sensitivity, specificity, or reader improvement. Instead, it states that "All testing was performed in accordance with recognized standards" and the "collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."
The types of testing performed and confirmed to meet specifications are:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Inspection | Met established specifications |
| Expansion Force | Met established specifications |
| Simulated Use | Met established specifications |
| Hydrophilic Coating | Met established specifications |
| Leak | Met established specifications |
| Contrast Flush Injection | Met established specifications |
| Tip Flexibility & Kink Resistance | Met established specifications |
| Torque Strength | Met established specifications |
| Tensile Strength | Met established specifications |
| Particulate | Met established specifications |
| Radiopacity | Met established specifications |
| Corrosion | Met established specifications |
| LAL (Limulus Amebocyte Lysate) | Met established specifications |
| EO Residuals (Ethylene Oxide) | Met established specifications |
| Packaging and Shelf-Life | Met established specifications |
| Biocompatibility | Met established specifications |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document refers to bench testing of a medical device, not a study involving human subjects or data collected from patients. Therefore, there is no "test set" in the context of patient data, nor data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a device's physical and mechanical performance is established through engineering specifications and recognized testing standards, rather than expert consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to human reader studies where disagreement needs to be resolved.
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 conventional medical device (catheter), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the device performance is based on established engineering specifications, recognized industry standards, and relevant regulatory requirements for the physical, mechanical, and biological properties of percutaneous catheters. This includes objective measurements of dimensions, forces, material integrity, and biological safety as detailed in the testing categories.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).