(30 days)
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is 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 or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.
This document describes the VascuPuncture™ PICC Guidewire by NeoMetrics, Inc. and its 510(k) premarket notification. However, it does not contain the detailed acceptance criteria or results from a study proving the device meets those criteria in the format explicitly requested for AI/medical device performance evaluation.
The provided text focuses on the device's substantial equivalence to predicate devices based on:
- Functional and performance characteristics demonstrated through equivalence with the predicate device and testing of representative device samples as part of Design Verification Testing.
- Biocompatibility demonstrated through successful completion of Biocompatibility Testing in accordance with ISO 10993.
- Shelf Life demonstrated through successful completion of accelerated aging studies and subsequent testing in accordance with ISO 11070.
This information is typical for a 510(k) submission for a conventional medical device like a guidewire, which relies on demonstrating equivalence to an already legally marketed predicate device rather than on clinical AI performance metrics.
Therefore, I cannot populate the requested table and study details as they are not present in the provided text.
Specifically, the following information is NOT present in the provided document:
- A table of acceptance criteria and the reported device performance: While general areas of testing (functional, performance, biocompatibility, shelf life) are mentioned, specific acceptance criteria (e.g., tensile strength minimum, kink resistance maximum) and their corresponding reported values are absent.
- Sample size used for the test set and the data provenance: No information on the number of guidewires tested or where the test data was generated (e.g., country, retrospective/prospective).
- Number of experts used to establish the ground truth and their qualifications: Not applicable, as this is not an AI device relying on expert-annotated ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable, as this is a physical medical device, not an AI model requiring ground truth for diagnosis/detection.
- The sample size for the training set: Not applicable, as there is no AI model or "training set" for this device.
- How the ground truth for the training set was established: Not applicable.
The document states that the conclusion of substantial equivalence is based upon "functional design, indications for use, principles of operation, risk analysis, and performance characteristics." The "performance characteristics" are demonstrated through "testing of representative device samples as part of Design Verification Testing" and compliance with ISO standards for biocompatibility and shelf life. This indicates that bench testing was performed for mechanical and material properties, rather than clinical studies with human participants for diagnostic performance.
§ 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.