(179 days)
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System.
The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set.
The Route 92 Medical Base Camp Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8 French (F) or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
The provided text describes a 510(k) clearance for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set. This is a medical device for treating acute ischemic stroke, not an AI/software device. Therefore, the requested information regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details for an AI model cannot be extracted from this document, as it does not pertain to an AI device.
The document focuses on non-clinical and clinical studies (SUMMIT MAX trial) to demonstrate the safety and effectiveness and substantial equivalence of the mechanical device to a predicate device.
However, I can provide the acceptance criteria and performance data for the mechanical device as presented in the document:
Device: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Study: SUMMIT MAX, a prospective, multi-center, randomized, controlled, interventional, open-label clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Endpoint) | Target/Threshold for Non-Inferiority | Reported Device Performance (Route 92 Medical) | Reported Predicate Performance (AXS Vecta) | Result (Difference, 95% CI) | P-value |
|---|---|---|---|---|---|
| Primary Effectiveness Endpoint: Successful arterial revascularization (mTICI ≥ 2b) using only the assigned study device (adjunctive therapy considered a failure). | Non-inferiority margin of 12.5% vs. predicate | 77.5% (69/89) | 50.6% (39/77) | 26.9% (12.7%, 41.0%) |
§ 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).