(237 days)
The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not intended for use in coronary arteries.
The Traxcess 14 Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The guidewire is coated with a lubricious hydrophilic coating.
Acceptance Criteria and Device Performance for Traxcess 14 Guidewire
This document describes the acceptance criteria and study results for the Traxcess 14 Guidewire, as presented in the provided 510(k) summary. No AI/ML components are mentioned in this submission, therefore, sections related to AI/ML specific criteria (sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The Traxcess 14 Guidewire's performance was evaluated through a series of bench tests and biocompatibility assessments, with the predicate device (Traxcess 0.014" Hydrophilic Guidewire, K080863) serving as the primary benchmark for equivalence.
| Bench Testing Category | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Physical & Dimensional | Meet specified dimensional requirements (OD, overall length, coil, SS, docking sections). | Test articles met specified dimensional requirements for OD, overall length, length of coil section, length of SS section, length of docking section. | Device met established dimensional and physical specifications. |
| Tensile Strength | Distal ≥ 3N; Proximal ≥ 70N | Tensile strength of distal ≥ 3N and of proximal ≥ 70N. | Device met established tensile strength. |
| Tip Flexibility | Force to deflect distal tip ≤ predicate. | Demonstrated force to deflect the distal tip is ≤ predicate. | Device tip flexibility is ≤ predicate. |
| Torque Strength | Equivalent or better than predicate (turns to failure). | Equivalent or better than predicate (turns to failure). | Equivalent to predicate. |
| Coating Adherence | Coating adherence maintained after advance/retract cycles. | Coating adherence maintained after advance/retract cycles. | Durability and lubricity of coating was comparable to predicate. |
| Torqueability | Torque response equal to or better than predicate. | Torque response was equal to or better than predicate. | Torque response was equal to or better than predicate. |
| Flexing & Fracture Resistance | No damage to test articles or coating after flexing and fracture test. | No damage to test articles or coating after flexing and fracture test. | Device able to withstand forces and stress during navigation in vasculature. |
| Radiopacity | Distal coil section visible under fluoroscopy. | Distal coil section visible under fluoroscopy. | Device radiopacity equivalent or better than predicate. |
| Tip Shapeability | Test articles able to maintain tip shape. | Test articles able to maintain tip shape. | Device tip shapeability equivalent or better than predicate. |
| In-vitro Simulated Use | Achieve rating ≥ 3 for prep of device, introduction, and tracking. | Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking. | Device performed as intended under simulated use. |
| Attachment with Docking Wire | Pull force of attachment equivalent or better than predicate. | Pull force of attachment was equivalent or better than predicate. | Device is compatible with docking wire. |
| Particulate Testing | Particle count ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns). | Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns). | Device does not generate particles under use. |
| Biocompatibility - Cytotoxicity | Non-cytotoxic (ISO 10993-5). | Cell culture exhibited slight reactivity (Grade 1). | Non-cytotoxic. |
| Biocompatibility - Sensitization/Irritation (Kligman) | Weak allergenic potential (0% reaction at challenge following induction phase) (ISO 10993-10). | Extracts of test article elicited no reaction at challenge (0%) following induction phase. (Grade 1). | Weak allergenic potential. |
| Biocompatibility - Sensitization/Irritation (Intracutaneous) | Non-irritant (no significantly greater biological reaction than control) (ISO 10993-10). | Extracts of test article did not show a significantly greater biological reaction than sites injected with the control. | Non-irritant. |
| Biocompatibility - Hemolysis | Non-hemolytic (ISO 10993-4). | Hemolysis index was 4.69% (direct) and 0.0% (indirect). | Non-hemolytic. |
| Biocompatibility - Coagulation | No effect on coagulation (no statistically significant difference compared to controls) (ISO 10993-4). | No statistically significant difference found between plasma exposed to test article, negative control, and untreated control. | No effect on coagulation. |
| Biocompatibility - Complement Activation | No effect on complement system (C3a and SC5b-9 not statistically higher than controls) (ISO 10993-4). | C3a and SC5b-9 in plasma exposed to test article was not statistically higher than the plasma exposed to negative and untreated controls. | No effect on complement system. |
| Biocompatibility - Thrombogenicity | No significant thrombosis (Grade 1-2 minimal thrombosis) (ISO 10993-4). | Minimal thrombosis for test article and control sites (Grade 1-2). | No significant thrombosis. |
| Biocompatibility - Systemic Toxicity | No toxic effects (no significantly greater biological reaction than control) (ISO 10993-11). | Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice. | No toxic effects. |
| Biocompatibility - Pyrogenicity | Non-pyrogenic (temperature increase 0.0° C from baseline) (ISO 10993-11). | Temperature increase was 0.0° C from baseline. | Non-pyrogenic. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the exact sample sizes (number of devices) used for each individual bench test or biocompatibility assessment. It refers to "test articles" being evaluated.
The data provenance is not explicitly stated as country of origin, however, the submitting company is MicroVention, Inc., located in Tustin, California, U.S.A., implying the studies were conducted under U.S. regulatory and testing standards. The tests appear to be prospective in nature, as they involve testing newly manufactured devices against predetermined criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a medical device submission based on physical and biological testing, not on the interpretation of data by human experts to establish a "ground truth" in the context of diagnostic performance.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, which is not the case for the bench and biological tests described here. The conclusions are based on quantitative measurements and established ISO standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. No MRMC comparative effectiveness study was conducted as this is a physical medical device, not a diagnostic algorithm.
6. Standalone (Algorithm Only) Performance Study
N/A. This submission is for a physical medical device (guidewire), not a standalone algorithm.
7. Type of Ground Truth Used
For the bench tests, the "ground truth" or reference standard was primarily engineering specifications and established ISO standards for biocompatibility. For comparative tests (e.g., tip flexibility, torque strength, coating adherence, docking wire attachment), the predicate device served as the reference for equivalence.
8. Sample Size for the Training Set
N/A. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
N/A. Correspondingly, there is no ground truth for a training set.
§ 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.