(466 days)
The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
The Beacon® Tip Torcon NB® Advantage Catheters are visually identified by a distal radiopaque tip bonded onto a nylon catheter shaft with braided stainless steel. Beacon® Tip Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, and 6.0 French with lengths measuring 40 to 170 centimeters. The catheter inner lumen is manufactured to accept a 0.035 or 0.038 inch diameter wire guide. These devices are manufactured without sideports and in a variety of distal tip configurations.
The Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material and constructed with stainless steel braiding. The Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, 6.0, 7.0 and 8.0 French with lengths measuring 35 to 150 centimeters. The catheter inner lumen is manufactured to accept a 0.025, 0.035, or 0.038 inch diameter wire guide. These devices are manufactured with zero to twelve sideports, depending on the distal curve radius, and are available in a variety of distal tip configurations. These tips may be tapered at the distal endhole, depending upon device specifications. The catheters are also available in a variety of distal tip configurations.
Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Because medical device approval documents do not typically include detailed clinical study reports found in drug approvals, many of the requested data points (e.g., test set sample size and provenance, number and qualifications of experts, adjudication methods, MRMC study details, training set specifics) are not available in the provided text. The document focuses on demonstrating substantial equivalence through engineering and bench testing, rather than human-in-the-loop performance or clinical outcomes.
Here's the partial information based on the provided text:
Acceptance Criteria and Reported Device Performance for Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Dynamic Flow Rate and Burst Pressure Evaluation | No specific acceptance criteria (for characterization purposes) | N/A (characterization study) |
| Static Burst Pressure Testing | Withstood a minimum of 1200 psig static pressure for at least 2 seconds without failure (in accordance with ISO 10555-2:1996(E)). | "The predetermined acceptance criterion was met." (i.e., devices withstood 1200 psig for at least 2 seconds without failure) |
| Evaluation of Dynamic Pressure During Injection after Three Years Accelerated Aging | Achieved a flow rate of at least 12 mL/sec when pressurized to 1215 psig ± 15 psig without failure. | "The predetermined acceptance criterion was met." (i.e., devices achieved ≥ 12 mL/sec flow rate at 1215 psig ± 15 psig without failure) |
| Biocompatibility Testing (Per ISO 10993-1:2009) | Biocompatibility deemed acceptable based on a panel of tests. | "The biocompatibility was deemed acceptable" for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Implantation, Partial Thromboplastin Time, C3a Complement Activation, SC5b-9 Complement Activation, Mutagenicity, Pyrogenicity. |
| Tensile Testing | Peak load values greater than 10N (in accordance with ISO 10555-1:2009). | "The predetermined acceptance criterion was met." (i.e., peak load values > 10N) |
| Liquid Leakage Testing | Maintained a pressure of 300 kPa for 30 seconds without leaking between the catheter shaft and hub (in accordance with ISO 10555-1:2013). | "The predetermined acceptance criterion was met." (i.e., no leaking observed at 300 kPa for 30 seconds) |
| Air Leakage Testing | No leakage of air between the catheter shaft and hub when subjected to a negative pressure for 15 seconds (in accordance with ISO 10555-1:2013). | "The predetermined acceptance criterion was met." (i.e., no air leakage observed under negative pressure for 15 seconds) |
| Particulate Testing | No specific acceptance criteria (for characterization purposes) | N/A (characterization study) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The tests described are bench tests, so the "sample size" refers to the number of physical devices tested in each category.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by Cook Incorporated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these tests is based on objective physical measurements and adherence to international standards (e.g., ISO, FDA regulations) as performed by laboratory technicians/engineers. No expert radiologists/physicians were involved in establishing "ground truth" for the performance of these physical tests.
4. Adjudication method for the test set:
- Not applicable. Performance against acceptance criteria for these bench tests is determined by direct measurement and comparison, not by expert adjudication.
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:
- No MRMC or human-in-the-loop study was done. This device is a physical medical catheter, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm. The "standalone performance" is the device's performance in bench tests as outlined above.
7. The type of ground truth used:
- The "ground truth" for these technical performance tests is based on objective physical measurements and adherence to international standards (e.g., ISO 10555-1, ISO 10555-2, ISO 10993-1).
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this type of device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).