(140 days)
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Modified Trevo ProVue Retriever consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and new radiopaque markers on the new truncated distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel. The Modified Trevo ProVue Retriever is offered in two sizes.
The provided text describes a 510(k) submission for a Modified Trevo ProVue Retriever, a medical device intended to remove thrombus in patients experiencing ischemic stroke. The submission focuses on demonstrating substantial equivalence to a predicate device (Concentric Trevo ProVue Retriever K122478) rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted or inferred from the provided text, with an explanation of why other requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Met | "Dimensional verification meets acceptance criteria." |
| Retriever Proximal Joint Tensile Strength | Met | "Retriever Proximal Joint Tensile Strength meets acceptance criteria." |
| Retriever Mid Joint Tensile Strength | Met | "Retriever Mid Joint Tensile Strength meets acceptance criteria." |
| Retriever Tip Tensile Strength | Met | "Retriever Tip Tensile Strength meets acceptance criteria." |
| Retriever Shaped Section Radial Force | Met | "Retriever Shaped Section Radial Force meets acceptance criteria." |
| Retriever/Vessel Interaction (Tip Flexibility) | Met | "Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria." |
| Retriever Torque Tensile Durability | Met | "Retriever Torque Tensile Durability meets acceptance criteria." |
| Retriever Platinum Wire Joint Strength | Met | "Retriever Platinum Wire Joint Strength meets acceptance criteria." |
| Retriever Platinum Wire and Joint Durability | Met | "Retriever Platinum Wire and Joint Durability meets acceptance criteria." |
| Radiopacity | Assessed based on visual assessment of the device being used under fluoroscopy. | "Radiopacity meets acceptance criteria." |
| Retriever/Microcatheter Deliverability | Met | "Retriever/Microcatheter Deliverability meets acceptance criteria." |
| Proximal Curl Resistance | Met | "Proximal Curl Resistance meets acceptance criteria." |
| Simulated Use | Demonstrated successful performance in a silicone neurovascular model with simulated thrombus. | "Simulated Use meets acceptance criteria." |
| Biocompatibility (Cytotoxicity - ISO Elution Method) | Non-cytotoxic (Dilutions: Undiluted (3 - Moderate reactivity - noted as consistent with historical data), 50%, 25%, 12.5%, 6.25%, 3.13% - 0 reactivity) | Pass for all dilutions, with specific note on historical consistency for undiluted moderate reactivity. |
| Biocompatibility (ASTM Hemolysis) | Non-Hemolytic | Pass. Hemolytic index: 0.0% (direct contact) and 0.4% (extract) |
| Biocompatibility (Physicochemical Tests Plastics) | No heavy metals or leachables (Non-volatile residue: 2 mg, Residue on ignition: ≤ 2 mg, Heavy metal: |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).