(91 days)
The Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Traxcess Docking Wire can be used with Traxcess guidewires to facilitate the placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It consists of a stainless steel shaft with a nitinol pipe and is coated with PTFE and silicone.
Acceptance Criteria and Study for Traxcess Docking Wire
Based on the provided 510(k) summary for the Traxcess Docking Wire (K093647), the device's acceptance criteria and the study proving it meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Attachment with docking wire | Pass |
| Docking wire tensile strength | Pass |
| Simulated use testing (Tracking, supportability, microcatheter compatibility/exchange, repositioning) | Pass |
Note: The 510(k) summary only explicitly lists "Pass" as the result for each bench test, without providing numerical thresholds or detailed metrics for the "Pass" criteria. This is typical for 510(k) submissions where the focus is on substantial equivalence to a predicate device, rather than novel performance claims.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing, meaning the "test set" refers to the physical samples of the Traxcess Docking Wire and associated components.
- Sample Size: The document does not specify the exact number of samples (e.g., number of wires or components) used for each bench test.
- Data Provenance: The data provenance is internal to the manufacturer, MicroVention, Inc., based in Tustin, California, U.S.A. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For bench testing of a medical device like a guidewire, the "ground truth" is typically established by engineering specifications, industry standards, and regulatory requirements, not by clinical experts in the same way it would be for an AI diagnostic algorithm.
- Number of Experts: Not applicable in the context of clinical expert consensus for ground truth. The "experts" would be the design engineers, quality control personnel, and regulatory affairs specialists at MicroVention, Inc.
- Qualifications: These individuals would possess engineering, scientific, and regulatory expertise relevant to medical device design, manufacturing, and testing standards.
4. Adjudication Method for the Test Set
For bench testing, "adjudication" (e.g., 2+1, 3+1) is not typically applicable as it refers to reconciling differences in expert opinions for clinical data.
- Adjudication Method: Not applicable. The results are determined by objective measurements and adherence to pre-defined test protocols. Any discrepancies would be resolved through re-testing, investigation of methodology, or review by quality control/engineering.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done?: No. This submission describes a physical medical device (guidewire) and its bench testing, not an AI diagnostic algorithm or a clinical study involving human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done?: No. This question is relevant for AI algorithms, not for physical medical devices undergoing bench testing. The "performance" being evaluated is the physical properties and functionality of the guidewire itself.
7. Type of Ground Truth Used
The ground truth for the bench tests is based on:
- Engineering Specifications: Internal design parameters and performance targets set by MicroVention, Inc.
- Industry Standards: Relevant ASTM, ISO, or other recognized standards for guidewires and medical devices.
- Regulatory Requirements: Compliance with FDA guidelines for device safety and effectiveness, often implicitly linked to the performance of the predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This concept is relevant for machine learning algorithms where a model is "trained" on a dataset. For a physical device, the "training" involves the design and manufacturing processes, which are informed by engineering principles and historical data on similar devices, rather than a quantifiable training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- How the Ground Truth for the Training Set Was Established: Not applicable in the conventional sense of AI/machine learning. The "ground truth" for the design and manufacturing processes would be established through a combination of:
- Prior knowledge and experience: Accumulated expertise from developing previous guidewires and medical devices.
- Research and development: Iterative design and testing phases.
- Performance of the predicate device: The predicate device (Runthrough NS Extension Wire, K080563) serves as a benchmark for established safe and effective performance, influencing the design and performance targets of the Traxcess Docking Wire.
§ 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.