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510(k) Data Aggregation
(29 days)
Traxcess 7 Mini XSoft 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 indicated for use in coronary arteries.
Traxcess 7 Mini XSoft Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It consists of aproximal coated Stainless Steel core wire, and a distal coated Nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a Platinum/Nickel coil. The Platinum/Nickel coil is 6 cm in length. The distal 1.4 cm of the guidewire is shapeable by the physician.
Traxcess 7 Mini XSoft Guidewire distal and proximal sections are coated with hydrophilic coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. A shaping mandrel, insertion tool, and torque device are also included with the device
The provided text describes the regulatory submission for a medical guidewire (Traxcess 7 Mini XSoft Guidewire). This document primarily details the performance bench testing and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device. It addresses the acceptance criteria and conclusions for these tests, which are typical for medical device regulatory submissions rather than AI/ML device studies.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) are not applicable as this is a physical medical device and not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Performance Bench Testing (Table II) | ||
| Dimensional Inspection (Visual) | Test article should meet specified dimensional requirements for: OD (Distal and Proximal), Overall Length, Length of distal Pt/Ni coil section, Length of hydrophilic coated section, Accessory devices present. | Device met established dimensional specification. |
| Tip Shapeability | Test article should be greater than or equal to existing tip shapeability specification. | Device met established tip shapeability specification. |
| Durability/Lubricity of Hydrophilic Coating | Test article should meet existing durability/lubricity of hydrophilic coating specification. | Device met established durability/lubricity of hydrophilic coating specification. |
| Tensile Strength | Test article should be greater than or equal to existing tensile strength specification for distal tip and proximal joint section. | Device met established distal tip and proximal joint tensile strength specification. |
| Corrosion Resistance | Test article should be corrosion resistant. | Device met established corrosion resistance. |
| Surface Contamination and Defects | Test article when examined at magnification, should meet existing surface contamination and defects specification. | Device met established surface contamination and defects specification. |
| Torque Strength | Test article should be greater than or equal to existing torque strength specification. | Device met established torque strength specification. |
| Torqueability | Test article should be equal to, or better than predicate devices. | Subject device torque response better than predicate devices. |
| Fracture resistance | Test article should not show signs of fracture. There should be no coating flaking off the guidewire. | Device met established fracture resistance specification. |
| Flexing test | Test article should not show signs of defect, fracture or other damage. There should be no coating flaking off the guidewire. | Device met established flexing test specification. |
| Distal Tip flexibility | Test article should be less than existing distal tip specification to deflect the distal tip of guidewire and must be softer than Traxcess 7 Mini. | Device met established distal tip flexibility specification. |
| Particle Testing | Test article should meet established particle testing specification. | Device met established particle test specification. |
| Radiopacity | Test article should be visible under fluoroscopy. | Device met established radiopacity specification. |
| In-Vitro Simulated Use Testing | Test article should meet rating of 3 or greater when tested with compatible microcatheters. | Device met established simulated use testing specification. |
| Biocompatibility Testing (Table III) | (Note: These tests were not repeated on the subject device but relied on data from the reference device, Traxcess® 14 SELECT Guidewire (K153053), due to identical materials, manufacturing, sterilization, and packaging.) | |
| Cytotoxicity - L929 MEM Elution Test | Test article meets the requirements of the test if it does not show greater than a mild reactivity (Grade 2). | Test article exhibited a biological reactivity grade of 0 (on a scale of 0 to 4). (Non-cytotoxic). |
| Sensitization/Irritation - Kligman Maximization Test | Test article meets the requirements of the test if it does not show a positive response in at least 10% of the test animals. | Test article exhibited 0% sensitization. (Non-sensitizer). |
| Sensitization/Irritation - Intracutaneous Injection Test | Test article meets the requirements of the test if it does not produce irritation after intracutaneous injection in New Zealand White rabbits. | Test article did not show a significantly greater biological reaction than sites injected with the control article. The difference of the overall mean score between the test article and the control article was 0.0. (Non-irritant). |
| Hemocompatibility - Hemolysis - Direct and Indirect | Test article meets the requirements of the test if the hemolytic index above the negative control article is <5%. | Hemolysis index was above the negative control of 0.77% via direct contact method and 0.23% via indirect contact method. (Non-hemolytic). |
| Hemocompatibility - Unactivated Partial Thromboplastin Time (UPTT) Assay - Direct Contact | Test article meets the requirements of the test if no statistical decrease is found between UPTT of the plasma exposed to the test article and that of plasma exposed to negative control or untreated control. | No statistical decrease is found between UPTT of the plasma exposed to the test article and that of plasma exposed to negative control or untreated control. (Not considered to have an effect on coagulation of human plasma). |
| Hemocompatibility - C3A and SC5B-9 Complement Activation Test - Direct Contact | Test article meets the requirements of the test if the concentration of C3A and SC5B-9 in plasma exposed to test article does not statistically increase than the plasma exposed to negative and untreated controls. | The concentration of C3A and SC5B-9 in plasma exposed to test articles were not statistically increased than the plasma exposed to negative and untreated controls. (Not considered to activate the complement system in human plasma). |
| Hemocompatibility - In Vitro Hemocompatibility Test - Direct Contact | Test article meets the requirements of the test if no statistical decrease (or increase/decrease for hematocrit and Mean corpuscular values) is found between blood exposed to test article and blood exposed to negative control or untreated control. | Test article did not have an effect on the WBCs, Platelet concentration and other hematological parameters in comparison to negative control and untreated control. (No effect on selected hematological parameters). |
| Hemocompatibility - Dog Thrombogenicity | Test article meets the requirements of the test if there is minimal thrombosis for test article (Grade 0-2). | Minimal thrombosis (Grade 0-1) for test article and control sites. (No significant thrombosis). |
| Systemic toxicity - Systemic Injection Test | Test article meets the requirements of the test if it does not induce a significantly greater biological reaction than the animal treated with the control articles when injected into albino mice. | Test article did not induce a significantly greater biological reaction than the control extracts when injected into albino mice. (No toxic effects). |
| Systemic toxicity - Rabbit Pyrogen Test | Test article meets the requirements of the test for the absence of pyrogens, if no rabbit shows an individual temperature rise of 0.5°C or more above the baseline temperature. | Temperature increases for the test animals were all 0.0° C from baseline. (Non-pyrogenic). |
| Packaging Validation | Acceptance criteria for visual inspection, simulated use testing, sterile pouch seal strength testing, dye penetration testing and shipper box testing were met. | The results from packaging testing conducted on Traxcess® 14 SELECT Guidewire (reference device) showed that the acceptance criteria were met. (Not repeated for subject device due to no change in packaging.) |
| Sterilization | Sterilization efficacy and integrity maintained. | Product adoption study performed and documented. (Not repeated for subject device due to no changes in materials or design.) |
| Shelf Life | All acceptance criteria for accelerated shelf life testing (T=3 years accelerated aging) were met. | The accelerated shelf life testing for Traxcess® 14 SELECT Guidewire (reference device) was conducted, and test results confirmed all acceptance criteria were met. (Not repeated for subject device due to no new materials and same degradation rate, concluding a 3-year shelf life). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a numerical value for each test (e.g., how many guidewires for tensile strength). The document refers to "Test article" and "Samples," implying a number sufficient for engineering bench testing which often relies on a small defined number of samples to represent the product (e.g., 3-5 devices per test).
- Data Provenance: This is an engineering bench test and lab-based biocompatibility study. The "country of origin" of data or "retrospective/prospective" nature is not applicable in the same way it would be for a clinical trial or AI study. The manufacturer is MicroVention, Inc., Tustin, California, U.S.A., implying the testing would have been conducted or overseen by them or contracted labs.
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)
- N/A. This is a physical device and not an AI/ML system that relies on expert interpretation of data for ground truth. "Ground truth" here is defined by meeting predefined engineering specifications and biological safety standards, which are evaluated objectively through physical and chemical tests, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective interpretations, often in clinical or image-based studies. These tests are objective pass/fail based on quantitative measurements and established scientific standards.
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
- N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established engineering specifications, material science principles, and international standards for biocompatibility (e.g., ISO 10993 standards). These are objective, quantifiable criteria for physical and biological performance, not subjective expert interpretations or clinical outcomes data in the context of an AI device.
8. The sample size for the training set
- N/A. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set, this is not applicable.
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