(139 days)
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The Aspiration Catheter and Tenzing 7 Delivery Catheter comprise the Route 92 Medical Full Length 070 Reperfusion System. The Route 92 Medical Full Length 070 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 7 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. 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, along with a legally marketed canister and accessories kit.
The provided document, a 510(k) K223530 Premarket Notification for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, does not contain information about an AI-powered device or a study involving AI assistance for human readers. It describes a medical device (a catheter system for stroke treatment) and a series of non-clinical, benchtop, and animal studies to demonstrate its safety and effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance, as the document does not pertain to an AI device.
However, I can provide a summary of the acceptance criteria and the studies conducted for the medical device described in the document, as it meets the general structure of the request for device performance and testing.
Acceptance Criteria and Study for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
This document describes the testing and acceptance criteria for a physical medical device, not an AI-powered one. The studies focus on the physical and functional performance of the catheter system.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests and their corresponding results, with the acceptance criterion implicitly being "PASS" for all samples meeting pre-determined criteria.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Shelf Life & Sterility | Sterilization Verification | Sterility Assurance Level of 1 x 10-6 | Verified |
| Aging Studies (Packaging & Functionality) | Remain functional for labeled expiration date | Met acceptance criteria | |
| Biocompatibility | Cytotoxicity - ISO MEM Elution | Test article non-cytotoxic (grade less than 2) | Non-cytotoxic |
| Sensitization - ISO Guinea Pig Maximization | No delayed dermal contact sensitization | Did not elicit sensitization | |
| Irritation - ISO Intracutaneous Reactivity | Differences in mean scores |
§ 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).