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510(k) Data Aggregation
(44 days)
The Traxcess™ 14 SELECT Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire 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™ 14 SELECT 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 PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
The provided text describes the acceptance criteria and a study demonstrating that the Traxcess™ 14 SELECT Guidewire meets these criteria. However, it's important to note that this document is for a medical device (guidewire), not an AI/ML powered device. Therefore, many of the requested categories (e.g., ground truth, experts, MRMC study, training set) typically associated with AI/ML device performance evaluation are not applicable or found in this context.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench/Biocompatibility Testing) | Reported Device Performance (Result & Conclusion) |
|---|---|
| Bench Testing: | |
| Physical attributes (dimensional requirements) | Device met established dimensional specifications |
| Surface Contamination (absence of defects/contamination) | Device was free from surface defects and contamination |
| Corrosion Resistance | Device met established corrosion resistance |
| Simulated use testing (prep, introduction, tracking rating ≥ 3) | Device performed as intended under simulated use |
| Guidewire Coating adherence (maintained after advance/retract cycles) | Durability and lubricity of coating was maintained after advance/retract cycles |
| Guidewire fracture resistance (no fracture, no coating flaking) | Device met established fracture resistance specification |
| Particulate Testing (≤ 6000 particles (≥ 10 microns) and ≤ 600 particles (≥ 25 microns)) | Device has comparable particulate results to the predicate device |
| Biocompatibility Testing: | |
| Cytotoxicity (ISO 10993-5:2009) (Scores of grade 0, 1, or 2) | The test articles are non-cytotoxic (grade 0) |
| Sensitization (ISO 10993-10:2010) (Grades of <1) | The test articles are not a sensitizer (grade <1) |
| Irritation (ISO 10993-10:2010) (Difference in mean score ≤ 1.0) | The test articles are considered non-irritating (the score ≤1) |
| Acute Systemic Toxicity (ISO 10993-11:2017) (No significantly greater biological reactivity, no death, no severe reactions, no excessive weight loss) | The test articles meet requirements of the test and it's nontoxic |
| Material-mediated Pyrogenicity (ISO 10993-11:2017) (No animal shows temperature rise ≥ 0.5 °C) | Not pyrogenic (temperature rise < 0.5 °C) |
| Haemo-compatibility - Hemolysis (ISO 10993-4:2017) (< 2.0% hemolytic index for non-hemolytic) | Non-hemolytic (1.48% hemolysis - Extract Method; 0.96% hemolysis - Direct Method) |
| Haemo-compatibility - Coagulation (ISO 10993-4:2017) (No statistically significant decrease in PTT) | The test article meets the requirement of the test and not an activator to the coagulation |
| Haemo-compatibility - Complement Activation (ISO 10993-4:2017) (No statistically significant increase in C3a or SC5b-9a) | The test articles are considered a 'Non-Activator of the Complement System' |
| Haemo-compatibility - Thrombus formation (ISO 10993-4:2017) (Mean percentage value of platelet cell counts 80-120% of negative control and ≥ 30% above positive control, no visible clot) | The test article meets the requirement of the test and does not cause thrombus formation |
| Haemo-compatibility – Thrombogenicity (ISO 10993-4:2017) (Thrombus formation score of 2 or less) | The test articles are considered thromboresistant (score <2) |
2. Sample sized used for the test set and the data provenance:
The document mentions "Test articles" for bench testing and "animals" for biocompatibility testing, but does not specify the exact sample sizes for each test. The provenance of the data is that it was generated from verification and validation testing on the Traxcess™ 14 SELECT Guidewire. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes a physical medical device (guidewire) and its performance through bench and biocompatibility testing, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above. The tests performed are objective laboratory assessments.
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:
This information is not applicable as the document describes a physical medical device (guidewire), not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes a physical medical device (guidewire), 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 based on objective measurements and observations against established specifications and ISO standards for physical and biological properties. This includes dimensional measurements, visual inspection for defects, force resistance, coating integrity, and specific biological responses (e.g., cell viability, immune response, blood compatibility).
8. The sample size for the training set:
This information is not applicable as the document describes a physical medical device and its validation through testing, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
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