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The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.

Device Description

Scientia Cardio Access's CrossTorg™ 14 Guidewire is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 300cm.

The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.

The guidewire is provided with a shaping mandrel (to shape the flexible tip of the guidewire), an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "CrossTorq 14 Guidewire". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the acceptance criteria and study described are geared towards demonstrating this equivalence through non-clinical performance and functional testing.

Here's a breakdown based on your requested information:

1. A table of acceptance criteria and the reported device performance

The document lists various tests with associated "Results." For substantial equivalence, the "acceptance criteria" are implicitly that the new device performs "as well as the predicate devices and/or meets requirements of relevant standards" or that any differences "do not raise different questions of safety and effectiveness."

Test Category	Specific Test	Acceptance Criteria (Implicit from context)	Reported Device Performance/Results
Biocompatibility	General Biocompatibility	Identical materials and processing to reference devices (Aristotle 18 Guidewire K183608, Aristotle 14 Guidewire K173235) such that dimensional change does not alter chemical/physical properties or involve new biological interactions. Low and acceptable biological and toxicological risk.	The materials and processing are identical to the reference Aristotle 18 Guidewire (K183608) in formulation, processing, sterilization, and geometry, with only a smaller outer diameter. This dimensional change does not alter chemical/physical properties, allowing results from the Aristotle 18 Guidewire to be applied. No additional biological evaluations were deemed necessary as the design presents a low and acceptable biological risk.
	Radiopacity	Acceptable radiopacity for physician visualization in human cadaver.	Guidewires exhibited acceptable radiopacity.
	Corrosion Resistance	No signs of corrosion after soaking in typical end-use solutions (per ISO 11070).	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
	Chemical Compatibility	No signs of degradation, corrosion, or physical decomposition after exposure to saline and contrast agent/saline solutions.	All guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
	Latex	No detectable traces of latex proteins (per ASTM D6499-07).	No detectable traces of latex were found.
	Accessories Testing	Acceptance criteria of all tests (biocompatibility, visual inspection, corrosion resistance, tensile testing, luer taper dimensions) for torque device and shaping mandrel were met.	Acceptance criteria of all tests were met.
	Package Integrity	All sterile barrier pouches maintained integrity and labeling remained affixed and legible after simulated transportation (per ASTM D 4169:16). Seal strength (ASTM F 88-15) and leak tests (ASTM F 2096-11) criteria met.	Following exposure to typical storage and transportation conditions, all sterile barrier pouches maintained their integrity and labeling remained affixed and legible.
	Sterilization Validation	SAL of at least 10^-6, results justified adoption into EO sterilization processing group. PCDs more difficult to sterilize than devices. Bioburden Enumeration and Extraction Efficiency, and Bacteriostasis/Fungistasis test results demonstrated.	Results justified adoption into the EO sterilization processing group: Comparative and Bioburden Resistance study results demonstrated that PCDs are more difficult to sterilize than devices; Bioburden Enumeration and Extraction Efficiency tests were used to enumerate the CFUs present on devices; and Bacteriostasis/Fungistasis test results demonstrated that the product does not inhibit the growth of organisms.
	Sterilization Validation: EO and ECH Residuals	Residual traces of EO and ECH well below limits specified in ISO 10993-7.	The residual traces of EO and ECH remaining in the CrossTorq 14 Guidewire after exposure to the EO sterilization process are well below the limits specified in ISO 10993-7.
	Sterilization Validation: Bacterial Endotoxin Levels	, and USP ).

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