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The HYBRID 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 or therapeutic catheters. This device is not intended for use in the coronary arteries.

Device Description

HYBRID 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 is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.

HYBRID Guidewire 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 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle).

The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device.

AI/ML Overview

The HYBRID Guidewire is a Class II device intended for general intravascular use, including neuro and peripheral vasculature, to facilitate the selective placement of diagnostic or therapeutic catheters. It is not intended for use in coronary arteries.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Visual and Dimensional Inspection	External surface free from process and surface defects; dimensions (overall length, radiopaque length, outer diameter, distal shape) per product specification.	All test samples passed testing.
Catheter Compatibility & Simulated Use	In vitro performance under simulated use conditions using a worst-case tortuous ICA vessel model.	All test samples passed testing.
Coating Integrity and Adherence	Coating quality (after dyeing and simulated use) inspected under a microscope.	All test samples passed testing.
Tensile Strength	Minimum force to break the guidewire meets ISO 11070. Tensile strength comparable to the predicate device.	All test samples passed testing. Tensile strength was comparable to predicate devices.
Corrosion Resistance	No visual evidence of corrosion after immersion in sodium chloride solution and boiling distilled/deionized water.	All test samples passed testing.
Torque Strength	Number of turns-to-failures comparable to the predicate device.	All test samples passed testing. The torque strength of the subject device is equivalent to the predicate device.
Torqueability	Rotational input to output ratio comparable to the predicate device.	All test samples passed testing. The torqueability value of the subject device is equivalent to the predicate device.
Fracture Resistance and Flexing Test	Resistance to damage by flexing and resistance to fracture per ISO 11070.	All test samples passed testing.
Tip Flexibility	Force required to deflect the distal tip (45° and 90°) comparable to the predicate device.	All test samples passed testing. The tip flexibility of the subject device is equivalent to the predicate device.
Particulate Matter Characterization	Particulate matter in injections quantified after simulated use comparable to the predicate device.	All test samples passed testing. Particulate matter characterization was comparable to predicate device.
Design Verification and Packaging Validation	Device design and packaging design meet product specification requirements at t=1 year time-point after exposure to 1x EtO sterilization.	All test samples passed testing.
Packaging Integrity (Visual Inspection)	Packaging free of damage; all seals free of incomplete seals, voids, channels, wrinkles, foreign material, and/or over-heated sections. Labels legible, intact, no damage or delamination.	All test samples met the acceptance criteria.
Packaging Integrity (Bubble Leak Test)	No leaks per ASTM F2096-11.	All test samples met the acceptance criteria.
Packaging Integrity (Seal Strength)	Meets seal strength per ASTM F88/F88M-15.	All test samples met the acceptance criteria.
Animal Testing (GLP)	In vivo performance in an acute porcine model: Trackability, handling, radiopacity, and microcatheter compatibility comparable to predicate devices.	All test samples passed testing. Trackability and handling of the guidewire, radiopacity, and compatibility with microcatheter were comparable to predicate device.
Biocompatibility (Cytotoxicity)	Non-cytotoxic (percent viability of test article not less than 70% compared to cells exposed to control).	The percent viability of the test article was 110.6%. Non-cytotoxic.
Biocompatibility (Sensitization)	Did not induce delayed sensitization.	Did not elicit sensitization response.
Biocompatibility (Irritation)	Non-irritant.	Non-irritant.
Biocompatibility (Acute Systemic Toxicity)	No evidence of significant systemic toxicity or mortality.	Non-toxic.
Biocompatibility (Pyrogenicity)	Non-pyrogenic (rabbit temperature rise not exceeding 0.5°C).	Non-pyrogenic.
Biocompatibility (Hemolysis)	Non-hemolytic (mean hemolytic index for direct contact and extract not exceeding 2%).	Non-Hemolytic. (Mean hemolytic index for direct contact was 0.71%; for extract was 0.61%).
Biocompatibility (Thrombogenicity)	Minimal thrombus formation; similar thromboresistance characteristics as control devices.	Passed. Minimal thrombus formation associated with test devices; neither animal's clotting abilities were compromised. Similar thromboresistance characteristics to control devices.
Biocompatibility (Complement Activation)	Statistically similar to negative control data.	Passed. Statistically similar to the reference negative control data (p > 0.050).
Biocompatibility (Partial Thromboplastin Time)	Within the same thrombogenicity category (minimal activator); responses considered similar to predicate.	Passed. Test article and predicate percent plasma control values fell within the same thrombogenicity category (minimal activator). Responses considered similar.
Biocompatibility (Platelet and Leukocyte Counts)	Test article comparable to reference control and comparison article (not statistically significant, p > 0.05).	Passed. Test article results for leukocyte and platelet counts showed 100.6-105.6% of negative control. Not statistically significant (p > 0.05) when compared to reference material or comparison article. Comparable to both.
Shelf Life (Accelerated Aging)	All acceptance criteria met at T=1 year accelerated aging, no new questions of safety or effectiveness raised. Performs as intended to Design Specification.	All acceptance criteria were met. Concluded that the HYBRID Guidewire will perform as intended to the Design Specification. Labeled for 1-year shelf life.
Sterilization Validation	Achieves a minimum Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2007.	The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria.
EO and ECH Residuals	Residual traces of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) below limits specified in ISO 10993-7:2008.	The residual traces of EO and ECH for the worst-case device were well below the limits specified in ISO 10993-7.
Bacterial Endotoxin Levels	Below 2.15 EU/device, in accordance with FDA guidance, USP , and European Pharmacopeia BET 2.6.14.

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