(48 days)
The Traxcess Guidewire and Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess 14EX Guidewire consists of a 0.014" stainless steel shaft and a tapered The Traxcess 14EA Guidewire consisted organism and stainless steel coils. The distal coil minton the contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE and silicone.
The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It The Traxess Docking Which an use assist with a nitinol pipe and is coated with PTFE and silicone.
This is a 510(k) premarket notification for a medical device, the Traxcess 14EX Guidewire and Traxcess Docking Wire. The provided document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific performance metrics and acceptance criteria for a new AI/software-based device.
Therefore, the requested information elements related to AI device performance studies, such as sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies, are not applicable to this submission.
Here's the summary of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Testing | Acceptance Criteria (Implied: Pass) | Reported Device Performance |
|---|---|---|
| Physical attributes | Pass | Pass |
| Distal tip tensile strength | Pass | Pass |
| Tip flexibility | Pass | Pass |
| Distal tip torque strength | Pass | Pass |
| Coating adherence | Pass | Pass |
| Torqueability | Pass | Pass |
| Attachment with docking wire | Pass | Pass |
| Docking wire tensile strength | Pass | Pass |
Note: The document states "Result" and lists "Pass" for each test. The implicit acceptance criterion for each test is that the device must "Pass". Specific quantitative acceptance ranges (e.g., "tensile strength > X N") are not detailed in this summary document.
2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of a physical medical device, not a performance study of an AI/software device using a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of expert review for AI performance, is not relevant to bench testing of a guidewire.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guidewires, against which the device's physical attributes and mechanical properties were measured.
8. The sample size for the training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed in the "Verification and Test Summary Table" provided in the document. This section lists various bench tests conducted on the Traxcess 14EX Guidewire and Traxcess Docking Wire.
Study Type: Bench Testing
Objective: To demonstrate the technological similarity and equivalency of the Traxcess 14EX Guidewire and Traxcess Docking Wire with predicate devices by verifying its physical and mechanical properties.
Methods: The device underwent a series of standard bench tests that assessed critical performance characteristics for a guidewire. These tests included:
- Physical attributes
- Distal tip tensile strength
- Tip flexibility
- Distal tip torque strength
- Coating adherence
- Torqueability
- Attachment with docking wire
- Docking wire tensile strength
Results: For all listed bench tests, the device "Passed," indicating that it met the pre-defined (though not explicitly detailed in quantitative terms in this summary) acceptance criteria for each test.
Conclusion: Based on these successful bench test results, the submission concludes that the Traxcess 14EX Guidewire and Traxcess Docking Wire are substantially equivalent to the predicate devices, sharing the same intended use, operating principle, basic design, similar construction and materials, and using the same packaging and sterilization processes.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.