(92 days)
Traxcess .007" Mini 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 catheters. This device is not indicated for use in coronary arteries.
Traxcess .007" Mini 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 a proximal 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 .007" Mini 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 document pertains to the 510(k) summary for the Traxcess .007" Mini Guidewire (K161803), which is a medical device. This document describes that the subject device is substantially equivalent to a predicate device, the Traxcess® 14 SELECT Guidewire (K153053). The core of the submission relies on demonstrating this substantial equivalence through various tests.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text, using the specified categories:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | ||
| 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. | 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 device. | Subject device torque response better than predicate device. |
| 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. | 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. |
| Animal Testing | ||
| Trackability, friction and handling | Equal to or better than the predicate device. | Both subject device and predicate device were able to reach desired location in the animal study with no issues. No friction during insertion. Subject device trackability, friction and handling equivalent to predicate device. |
| Radiopacity | Must be visible under fluoroscopy. | Both subject device and predicate device were visible under fluoroscopy. |
| Compatibility with Microcatheter | Must be compatible with microcatheters. | Both subject device and predicate device were compatible with microcatheters. |
| Overall Assessment | Equal to or better than the predicate device. | Performance of both subject device and predicate device was satisfactory. Subject device overall assessment is equivalent to predicate device. |
| Biocompatibility Testing (on Predicate Device) | ||
| 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 (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 |
§ 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.