(125 days)
The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended 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 and 0.018 inches and in lengths ranging from 45 to 145 cm.
The provided text describes a 510(k) submission for the VascuPuncture PICC Guidewire, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria in the same way a clinical trial for a new drug or novel device might.
Based on the provided text, the specific information requested in your prompt is not present for the following reasons:
- No detailed acceptance criteria or performance metrics are explicitly stated in the provided text. The submission aims to show substantial equivalence, implying that the device performs similarly to predicate devices rather than meeting a specific set of quantitative criteria.
- The "study" refers to bench testing, not a clinical trial with human subjects. Clinical studies, sample sizes for test/training sets, expert involvement, and ground truth establishment are not described.
- The document explicitly states "Functional and Safety Testing: Representative samples of the device underwent bench testing to demonstrate appropriate functional and performance characteristics compared to the predicate device." This indicates bench testing (in-vitro) was performed, not an in-vivo study involving human subjects or clinical data in the manner typically associated with the questions asked.
Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer the questions regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this type of information is simply not included in this 510(k) summary.
The conclusion of the 510(k) summary states: "The VascuPuncture PICC Guidewire modified as proposed in this submission, is substantially equivalent to the predicate devices. This conclusion is based upon the similarity in design, principles of operation, materials, and performance and of the modified device compared to the originally, cleared device."
This heavily implies that the "acceptance criteria" were met by demonstrating that the device's functional and safety characteristics (as evaluated through bench testing) were comparable to the predicate devices, thereby ensuring it met the same safety and effectiveness standards.
§ 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.