(250 days)
The Tractus CSC is intended to be used during interventional procedures in the peripheral vasculature 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 and sheath sizes as well as effective lengths. The subject device is a 0.035" guidewire compatible catheter with a 4.5 Fr crossing profile and available effective lengths of 90, 135, 155, and 170 cm. The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire crossing of discrete lesions of the vasculature. The catheters are also used to allow for quidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
The CSC consists of an outer, inner, and center tubing configuration. The outer tubing of the CSC consists of Pebax with hydrophilic coating on the distal end of the catheter to reduce frictional forces and enhance tracking. The inner tubing consists of a PTFE liner and Pebax. The center tubing is spiral laser cut stainless steel. This design provides catheter flexibility, kink resistance and torsional strength while also providing axial stability to support a guidewire and allow for quidewire placement across discrete lesions for further percutaneous intervention, such as angioplasty or stent placement. The distal tip of the catheter, which is stainless steel covered with Pebax and is continuous with the stainless steel center tubing of the catheter, has a smooth, rounded, and tapered profile that provides a seamless catheter-to-guidewire transition.
All effective lengths of the CSC include three radiopaque marker bands that are evenly spaced 10cm apart along the distal end of the catheter including one radiopaque marker band within 4mm of the distal end of the catheter for fluoroscopic visualization of the distal tip. In addition to providing hub-to-tip visualization of the catheter, the marker bands assist in catheter positioning and aide in estimating geometry within the vascular system for subsequent therapies, such as PTA and/or stenting. The proximal end of the catheter includes a luer hub to allow for quidewire passage, flushing saline solution or contrast media through the inner lumen of the catheter, and to facilitate guidewire exchanges.
To use the device, the inner lumen of the catheter is flushed with saline until the solution exits the distal end of the device prior to use. The appropriate size quidewire is inserted into the distal end of the catheter and the catheter is advanced over the guidewire and through a sheath using standard interventional techniques. Under fluoroscopic guidance, the catheter is tracked to the target site within the vasculature and utilized to support guidewire access across discrete areas of the vasculature using standard interventional techniques. For guidewire exchanges, standard interventional techniques are used. Saline or contrast media can be infused into the catheter during operation for flushing and fluoroscopic visualization. Once quidewire access across the target lesion is gained, the catheter is withdrawn using standard interventional techniques.
This document is a 510(k) Premarket Notification for a medical device. It focuses on demonstrating "substantially equivalent" to predicate devices, rather than establishing acceptance criteria and providing performance data of a new and novel device in the format of a typical clinical study report for an AI/ML device.
Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, sample sizes for test and training sets, expert consensus details, or results of MRMC studies, is not present in this document.
This submission relies on nonclinical testing and comparison to predicates to demonstrate substantial equivalence, rather than a clinical performance study with human subjects, especially not one involving AI/ML.
Here's how this document addresses the performance and acceptance criteria, adapted to the context of a 510(k) submission for a non-AI/ML medical device:
Acceptance Criteria and Device Performance (in the context of a 510(k) for a physical device)
The concept of "acceptance criteria" in this document is primarily focused on the device successfully passing various nonclinical (bench and biocompatibility) tests, demonstrating functionality and safety comparable to legally marketed predicate devices. The "performance" is the successful completion of these tests as intended.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a table with quantitative performance metrics (like those for an AI/ML device), the acceptance criteria here are qualitative (the device functioned as intended) for a series of nonclinical tests.
| Acceptance Criteria (What was tested for) | Reported Device Performance (Test Outcome) |
|---|---|
| Biocompatibility: | |
| Acute Systemic Toxicity | Functioned as intended (Passed) |
| Materials-Mediated Pyrogenicity | Functioned as intended (Passed) |
| Intracutaneous Irritation | Functioned as intended (Passed) |
| Maximization Sensitization | Functioned as intended (Passed) |
| MEM Elution | Functioned as intended (Passed) |
| Hemolysis - Extract Method | Functioned as intended (Passed) |
| Hemolysis - Direct Contact Method | Functioned as intended (Passed) |
| Nonanticoagulated Canine Thrombogenicity | Functioned as intended (Passed) |
| Anticoagulated Porcine Thrombogenicity | Functioned as intended (Passed) |
| Complement Activation (SC5b-9) | Functioned as intended (Passed) |
| Physical/Functional Performance: | |
| Simulated Use Testing | Functioned as intended (Passed) |
| Flexibility | Functioned as intended (Passed) |
| Trackability | Functioned as intended (Passed) |
| Guidewire Compatibility | Functioned as intended (Passed) |
| Torque Tolerance | Functioned as intended (Passed) |
| Tensile Strength | Functioned as intended (Passed) |
| Bond Strength | Functioned as intended (Passed) |
| Coating Integrity (Blue Dye Test, Lubricity) | Functioned as intended (Passed) |
| Radiopacity | Functioned as intended (Passed) |
| Particulate Emission | Functioned as intended (Passed) |
| Flow Rate | Functioned as intended (Passed) |
| Corrosion Resistance | Functioned as intended (Passed) |
| Packaging/Sterilization: | |
| Package Integrity | Functioned as intended (Passed) |
| Shipping Simulation | Functioned as intended (Passed) |
| Environmental Conditioning | Functioned as intended (Passed) |
| Bubble Leak | Functioned as intended (Passed) |
| Seal Strength | Functioned as intended (Passed) |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: For nonclinical bench testing, the "sample size" refers to the number of devices or components tested for each specific test. This information is not explicitly stated in this summary document.
- Data Provenance: The data provenance is from nonclinical bench testing and biocompatibility testing of the Tractus Crossing Support Catheter itself, conducted by the manufacturer, Tractus Vascular LLC. There is no indication of country of origin for data as it's not patient data. It is inherently "prospective" in the sense that the new device was subjected to these tests.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable in the context of this 510(k) submission. Ground truth for these nonclinical tests is established by standardized testing protocols and comparison to engineering specifications or regulatory standards, not by human experts interpreting clinical images.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop assessments, typically in reader studies for diagnostic devices. For bench testing, the results are typically objectively measured and pass/fail criteria are pre-defined.
5. MRMC Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating the impact of an AI/ML diagnostic tool on human reader performance. This device is a physical medical device (catheter), not an AI/ML diagnostic.
6. Standalone Performance
- This concept is applicable to AI/ML algorithms. For a physical device, its "standalone performance" is demonstrated through the successful completion of the nonclinical tests listed, showing it functions as intended in laboratory settings.
7. Type of Ground Truth Used
- The "ground truth" for the nonclinical testing is based on pre-defined engineering specifications, international/national standards (e.g., ISO, ASTM for material properties, sterility, etc.), and the successful completion of established biocompatibility protocols.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML model that requires training data.
9. How Ground Truth for the Training Set was Established
- Not applicable. As above, no training set for an AI/ML model is involved.
§ 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).