Search Results

The XO Cross Coronary is a support catheter intended to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The XO Cross Coronary Support Catheter is a single-lumen support catheter designed to support a guidewire during access of the peripheral or coronary vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross Coronary Support Catheter within the vasculature, while under fluoroscopy. The distal end of the subject catheter is also coated with a hydrophilic coating to reduce surface friction. It is available in various lengths (90cm, 135cm, 175cm), with a diameter of 2 Fr (0.7 mm) and with a tapered polymer tip at its distal end.

The provided text describes a medical device, the XO Cross Coronary Support Catheter, and its 510(k) submission to the FDA for substantial equivalence. However, the document does not contain information about:

• Acceptance criteria for an AI/ML powered device. The device described is a physical catheter, not an AI/ML software.
• A study proving the device meets AI/ML specific acceptance criteria.
• Sample size for test sets or data provenance (these are relevant for AI/ML validation).
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Stand-alone performance of an algorithm.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

The document details the following for the physical catheter device:

Device Performance and Testing:

The document focuses on demonstrating substantial equivalence to a predicate device (Quick Cross Extreme Support Catheter, K092396) and a reference device (XO Cross Support Catheter, K210322). The "performance" assessment is based on functional and safety testing of the catheter, not on specific output metrics typically associated with AI/ML systems (like accuracy, sensitivity, specificity, etc.).

Biocompatibility Testing:

• Tests performed and passed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Endotoxin LAL, Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Blood Platelet and Leukocyte Count.
• Method: In accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (≤ 24hrs) to circulating blood. The device used the same materials and processes as the reference device, with an additional assessment for a new black polymer outer layer.

Design Verification (Performance Bench Testing):

• Tests performed or fulfilled: Tip ID Testing, Tip Tensile Testing, Distal Shaft Kink Testing, Simulated Use.
• Purpose: To ensure the catheter met applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence.

Comparative Analysis (Substantial Equivalence):

The document presents a comparison (Table 2) between the subject device, the predicate device, and the reference device across various attributes like:

• Intended Use
• Indications for Use
• Classification Name
• Single Use
• Fundamental Scientific Technology
• Prescription (Rx Only)
• Anatomical Access
• Design
• Effective Length (cm)
• Distal Tip/Crossing Profile
• Shaft Outer Diameter
• Visibility
• Guidewire Compatibility
• Sheath / Introducer Compatibility
• Max Infusion Pressure
• Sterility
• Biocompatibility

Conclusion:

The submission concludes that the XO Cross Coronary Support Catheter is substantially equivalent in safety and effectiveness to the legally marketed predicate and reference devices. The minor design differences (longer tapered tip, modified strain relief, outer polymer layer color change, minimum kink specifications, minimum tip ID and tensile specifications) were assessed and determined to "raise no additional or different questions of safety or effectiveness."

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (catheter), not an AI/ML-powered device. Therefore, it does not contain the specific information requested regarding AI/ML acceptance criteria and validation studies.

Ask a specific question about this device