(434 days)
The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a continuous piece of wire extending from the distal tip to the proximal shaft. The distal tip is tapered to provide flexibility and softness. The distal tip is composed of gold plated tungsten wire. The guidewire is coated with a hydrophilic coating to enhance lubricity.
I am sorry, but there is not enough information in the provided text to describe the acceptance criteria and the study that proves the device meets those criteria, as detailed in your request.
The text is a 510(k) summary for a medical device called "The 'HyTek' Hydrophilic Guidewire." While it mentions "Functional/Safety Testing" and states that "The HyTek Guidewire successfully underwent all functional and safety testing," it does not provide:
- Specific acceptance criteria: It doesn't list defined thresholds or benchmarks that the device needed to meet (e.g., "tensile strength must be >X Newtons").
- Reported device performance: It doesn't provide the actual measured results of these tests (e.g., "tensile strength was Y Newtons").
- Details about the study design: It lacks information on sample sizes, data provenance, ground truth establishment, expert involvement, or any comparative effectiveness studies.
The document primarily focuses on establishing substantial equivalence to predicate devices based on the successful completion of functional testing, rather than detailing the specific performance metrics and methodologies used in those tests.
§ 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.