(217 days)
The Glidewire® GT is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
The Glidewire® GT is a guide wire which is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. The Glidewire® GT consists of a core wire of a Nickel Titanium superelastic alloy and has a flexible radiopaque gold coil around the distal tip of the core wire. The Glidewire® GT is offered with two distal tip types: Shapeable and Preshaped. The wire distal segment comes in angled or straight configurations. Physicians choose the guide wire types depending upon their personal preference and the type of interventional procedure being performed. Other considerations may include: anatomy, difficulty of access, and the interventional device used for procedure. The device is packaged in a plastic holder that is contained within an individual package. A guide wire inserter, torque device and mandrel (Shapeable type only) are contained within the individual package to assist with the manipulation of the guide wire. Following the guide wire insertion, the guide wire inserter is removed from the proximal portion of guide wire.
The provided document is a 510(k) summary for the Glidewire GT and describes non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets an acceptance criterion for an AI/ML device.
Here's an analysis based on the structure of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several performance tests. It states that "All samples tested met the applicable acceptance criteria, and no new issues of safety and effectiveness were raised by the testing performed." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each test. Instead, it refers to ISO standards, FDA guidance documents, and in-house standards.
General Summary of Performance Testing:
| Test Item | Reference Standard/Guidance | Reported Performance |
|---|---|---|
| Surface | Sec. 4.3 of ISO 11070: 2014 | Met applicable acceptance criteria |
| Radiodetectability | Sec. 4.5 of ISO 11070: 2014, ASTM F640-12 | Met applicable acceptance criteria |
| Fracture Test | Sec. 8.4 of ISO 11070: 2014 | Met applicable acceptance criteria |
| Flexing Test | Sec. 8.5 of ISO 11070: 2014 | Met applicable acceptance criteria |
| Peak Tensile Force of guidewire (ISO Standard) | Sec. 8.6 of ISO 11070: 2014 | Met applicable acceptance criteria |
| Peak Tensile Force of guidewire (FDA Guidance) | 3.a of FDA Guidance, In-house Standard | Met applicable acceptance criteria |
| Torque strength | 3.b of FDA Guidance, In-house Standard | Met applicable acceptance criteria |
| Torqueability | 3.c of FDA Guidance, In-house Standard | Met applicable acceptance criteria |
| Tip flexibility | 3.d of FDA Guidance, In-house Standard | Met applicable acceptance criteria |
| Sliding resistance/Coating integrity (Product appearance) | 3.e of FDA Guidance, In-house Standard | Met applicable acceptance criteria |
| Particulate evaluation | VIII.A.13 of FDA Guidance, USP , In-house Standard | Met applicable acceptance criteria |
| Product dimension | In-house Standard | Met applicable acceptance criteria |
| Shaping test | In-house Standard | Met applicable acceptance criteria |
Biocompatibility: The device is classified as Externally Communicating Devices, Circulating blood, Limited Contact (
§ 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.