(70 days)
The Traxcess® Pro 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 therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess® Pro 14 Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil. The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician. The coil section of the guidewire and the distal stainless steel section is coated with a hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of these surface coatings is to provide lubricity when the MicroVention guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
This document is a 510(k) summary for the Traxcess® Pro 14 Guidewire, which is a medical device. The information provided is for regulatory purposes to demonstrate substantial equivalence to a predicate device, not a typical study report for an AI/ML device. Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) are not applicable or cannot be extracted directly from this document.
However, I can extract the acceptance criteria and performance data for the device based on the bench and biocompatibility testing.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Dimensional attributes: Device to meet specified dimensional requirements for guidewire OD, overall length, length of Pt/Ni coil section, length of SS section, length of PTFE coated section, length of hydrophilic coated section, length of proximal docking section and accessory devices. | Device met established dimensional specifications (Test articles met specified dimensional requirements for guidewire OD, overall length, length of Pt/Ni coil section, length of SS section, length of PTFE coated section, length of hydrophilic coated section, length of proximal docking section and accessory devices). |
| Tip shapeability: Performance relative to a specific angle retention. | ≥71% average for tip shape percent angle retention. Device met established tip shapeability. |
| Tensile strength: Distal ≥ 3N; Proximal ≥ 70N. | Device met established tensile strength (Tensile strength of distal ≥ 3N; Tensile strength of proximal ≥ 70N). |
| Torque strength: Equivalent or better than predicate (turns to failure). | Device torque strength comparable to predicate (Equivalent or better than predicate (turns to failure)). |
| Torqueability: Torque response equal to or better than predicate. | Device torque response comparable to predicate (Torque response was equal to or better than predicate). |
| Tip flexibility: Force to deflect the distal tip is ≤ predicate. | Device tip flexibility is ≤ predicate (Demonstrated force to deflect the distal tip is ≤ predicate). |
| Fracture resistance and Flexing test: No portion of the guidewire should show signs of defect, fracture or other damage. No coating flaking off the guidewire. | No defects, fractures, damage or signs of coating flaking. |
| Particle Testing: Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns). | Device does not generate particles under use (Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns)). |
| Radiopacity: Distal coil section visible under fluoroscopy. | Device radiopacity was comparable to predicate (Distal coil section visible under fluoroscopy). |
| Coating adherence: Coating adherence maintained after advance/retract cycles. | Durability and lubricity of coating was maintained after advance/retract cycles. |
| In-vitro simulated use testing: Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking. | Device performed as intended under simulated use (Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking). |
| Acceptance Criteria (Biocompatibility) | Reported Device Performance |
|---|---|
| Cytotoxicity - MEM Elution Test (ISO 10993-5): Cell culture exhibited a biological reactivity grade of 0 (on a scale of 0 to 4). No cytotoxic effect. | Non-cytotoxic (Cell culture exhibited a biological reactivity grade of 0 (on a scale of 0 to 4). No cytotoxic effect). |
| Sensitization/Irritation - Kligman Maximization Test (ISO10993-10): | |
| Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10): | Non-sensitizer (Extracts of test article exhibited 0% sensitization). |
| Non-irritant (Extracts of test article did not show a significantly greater biological reaction than sites injected with the control). | |
| Hemocompatibility - Hemolysis (Direct and Indirect) (ISO 10993-4): | Non-hemolytic (Hemolysis index was above the negative control of 0.77% (direct contact)) and 0.23% (indirect contact)). |
| Hemocompatibility - Unactivated Partial Thromboplastin Assay (ISO 10993-4): No statistically significant difference found between plasma exposed to test article, negative control, and untreated control. | No effect on coagulation of human plasma (No statistically significant difference found between plasma exposed to test article, negative control, and untreated control). |
| Hemocompatibility - Complement Activation (ISO 10993-4): The concentration of C3a and SC5b-9 in plasma exposed to test article was not statistically increased than the plasma exposed to negative and untreated controls. | Not considered to have activated the complement system in human plasma (The concentration of C3a and SC5b-9 in plasma exposed to test article was not statistically increased than the plasma exposed to negative and untreated controls). |
| Hemocompatibility - In Vitro Hemocompatibility Test (Direct Contact) (ISO 10993-4): No effect on the WBCs, Platelet concentration and other hematological parameters in comparison to control. | No effect on selected hematological parameters (No effect on the WBCs, Platelet concentration and other hematological parameters in comparison to control). |
| Hemocompatibility - Dog Thrombogenicity (ISO 10993-4): Minimal thrombosis for test article and control sites (Grade 0-1). | No significant thrombosis (Minimal thrombosis for test article and control sites (Grade 0-1)). |
| Systemic toxicity - Systemic Injection Test (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 (Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice). |
| Systemic toxicity - Rabbit Pyrogen Test (ISO 10993-11): Temperature increase was 0.0°C from baseline. | Non-pyrogenic (Temperature increase was 0.0°C from baseline). |
Study Proving Device Meets Acceptance Criteria:
The "Design Verification and Validation Test Summary" (Table II) describes the testing performed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for individual bench or biocompatibility tests. The statement "Test articles" is used, implying multiple units were tested, but the exact number is not provided.
- Data Provenance: Not specified. This is a regulatory submission for a medical device; the tests are typically considered "prospective" in the sense that they are planned experiments conducted to qualify the device. Country of origin for data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This document describes physical and biological performance testing of a medical device, not a diagnostic algorithm that requires expert ground truth labeling. The "ground truth" for these tests comes from objective measurements and standardized protocols (e.g., ISO standards for biocompatibility).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human reader interpretation or 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:
Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established through:
- Objective Measurements: e.g., dimensional attributes, tensile strength, particle counts.
- Standardized Test Protocols: e.g., ISO 10993 series for biocompatibility, and other unspecified internal bench test methods to ensure physical performance.
- Comparison to Predicate Device: For several tests (e.g., torque strength, torqueability, tip flexibility, radiopacity), the performance is assessed as being "comparable to" or "equivalent or better than" the predicate device, implying the predicate device's established performance serves as a benchmark for "ground truth" for those specific characteristics.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set or corresponding ground truth to establish for this type of device.
§ 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.