(247 days)
The Tractus CSC is intended to be used during interventional procedures in the coronary and peripheral vasculatures to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
The CSC consists of a family of single-lumen, over-the-wire catheters offered in a variety of sizes for compatibility with a range of guidewire as well as effective lengths. The catheters are used to navigate tortuous peripheral and coronary vasculatures while providing axial stability to enhance quidewire crossing of discrete lesions of the vasculature. The catheters are also used to allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
This document concerns a 510(k) premarket notification for a medical device called the Tractus Crossing Support Catheter (CSC). The information provided is for a traditional medical device and not an AI/ML powered device. As such, the requested information about AI model performance, multi-reader multi-case studies, standalone algorithm performance, and training/test set details related to AI/ML are not applicable.
However, I can provide the relevant information for the nonclinical performance testing conducted for this traditional medical device.
1. A table of acceptance criteria and the reported device performance
The document states that "Functional bench testing was conducted (including demonstrated compliance with relevant standards such as ISO 10555-1 and ISO 594-1)" and "Simulated Use Testing was completed to demonstrate functional performance specifications were met." While specific numerical acceptance criteria and performance results are not detailed in this summary, the overall statement is that the device met these specifications and functioned as intended.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Established in accordance with ISO 10993 | Established (passed) |
| Thromboresistance | Acceptable thromboresistance (porcine study) | Anticoagulated porcine thromboresistance study completed |
| Packaging & Sterility | Maintain sterility and integrity | Shipping simulation, environmental conditioning, and package integrity studies completed |
| Functional Bench Testing | Compliance with ISO 10555-1 and ISO 594-1; Met functional performance specifications | Conducted and compliant; Functional specifications met |
| Simulated Use Testing | Met functional performance specifications | Completed and functions as intended |
| Coating Integrity | Acceptable coating integrity (e.g., no delamination, good lubricity) | Coating Integrity (Blue Dye Test, Lubricity) completed |
| Radiopacity | Visible under fluoroscopy | Radiopacity Testing completed |
| Particulate | Below specified limits | Particulate Testing completed |
| Flexibility | Met flexibility requirements | Flexibility Testing completed |
| Trackability | Acceptable tracking performance | Trackability completed |
| Guidewire Compatibility | Compatible with specified guidewire sizes | Guidewire Compatibility completed |
| Retraction | Acceptable retraction performance | Retraction Testing completed |
| Torque Testing | Acceptable torque transfer and performance | Torque Testing completed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for each test. The tests listed are primarily bench tests and an in-vitro animal study (porcine). Data provenance typical for clinical studies (country of origin, retrospective/prospective) is not applicable here as these are nonclinical performance studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device notification is for a traditional catheter, and performance data is based on nonclinical (bench and animal) testing, not on human expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies involving human interpretation or consensus, which is not the nature of the tests performed for this device.
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 not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the nonclinical tests, the "ground truth" is defined by established engineering and biological standards, measurement methods (e.g., ISO standards), and physical performance specifications. For instance, biocompatibility is assessed against ISO 10993, and functional performance against defined engineering parameters.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
§ 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).