(81 days)
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.
The provided document is a 510(k) summary for the VascuPuncture™ PICC Guidewire, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI/software medical device.
Therefore, much of the requested information cannot be extracted directly from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission for a guidewire.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (guidewire), acceptance criteria and performance are typically related to physical and functional characteristics demonstrating equivalence to existing, legally marketed predicate devices. The document explicitly states:
"Functional and performance characteristics are demonstrated through equivalence with the predicate device and testing of representative device samples."
However, specific quantitative acceptance criteria (e.g., tensile strength > X, lubricity
§ 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.