Search Results

The ERIC Retrieval Device is indicated 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.

Device Description

The ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ERIC Retrieval Device:

I. Acceptance Criteria and Reported Device Performance

Test Description / Outcome	Acceptance Criteria (Implied)	Reported Device Performance
Bench/Verification Testing
Dimensional Testing (Expanded Diameter & Device Overall Length)	Device attributes (overall device length and expanded outer diameter (OD) of the shaped section) must meet specified criteria and not raise new questions regarding safety and efficacy compared to predicate.	Pass. The longer overall length and smaller OD of the subject device offerings do not affect the performance of the device.
Fluoroscopic Guidance Marker Testing (Radiopacity)	Markers must be sufficiently visible under fluoroscopy.	Pass. Both subject and predicate devices are sufficiently visible under fluoroscopy.
Advance/Retraction Force Testing	Advance and retract forces in a tortuous model must be comparable to predicate devices.	Pass. The advance and retract forces of the subject device were comparable with the forces measured for the predicate device.
Re-Sheathing Testing	Ability to re-sheath the device must be comparable to predicate devices.	Pass. The ability to re-sheath the subject device is comparable to that of the predicate device tested.
Radial Force Testing	Radial force must be comparable to predicate devices.	Pass. The radial force of the subject device is comparable to that of the predicate device tested.
Tensile Strength Testing	Peak tensile strength to failure in different sections must be comparable to predicate devices.	Pass. The system tensile strength of the subject device is comparable to that of the predicate device tested.
Kink Resistance Testing	Kink resistance must be equivalent to predicate devices.	Pass. Kink resistance of the subject device is equivalent to that of the predicate device tested.
Austenite Finish (Af) Testing	Af temperature must be less than product use temperature (body temperature) to satisfy clinical application requirements.	Pass. The Af temperature of the subject device is less than the product use temperature (body temperature) and, thus, satisfies requirements for clinical applications.
Simulated Use/Performance Testing	Ability to reliably deploy and use the device in a tortuous benchtop model must be comparable to predicate devices.	Pass. Simulated use testing was comparable with that of the predicate device.
Corrosion Resistance Testing	Metallic components intended for fluid path contact must show no signs of corrosion.	Pass. Corrosion resistance testing of the subject device showed no signs of corrosion.
Particulate Evaluation Testing	Particulate generation in a tortuous benchtop model must be comparable to predicate devices.	Pass. Particulate evaluation was comparable with that of the predicate device.
Torque Response Testing	Core wire of the subject device must rotate freely with the proximal sphere and have equivalent torqueability compared to the predicate device.	Pass. Torque response testing indicated that the core wire of the subject device rotates freely with the proximal sphere and, thus, has equivalent torqueability compared to the predicate device.
Biocompatibility Evaluation	Device must be non-cytotoxic, non-irritating, non-sensitizing, systemically non-toxic, non-pyrogenic, non-hemolytic, non-activating (complement activation), non-thrombogenic, and have no effect on coagulation of human plasma and hematological parameters. (Compliance with ISO 10993-1 and FDA Biocompatibility Guidance)	Pass. Demonstrated non-cytotoxic, non-sensitizer, non-irritating, systemically non-toxic, non-pyrogenic, non-hemolytic, no effect on coagulation of human plasma, non-activating, no effect on hematological parameters, and non-thrombogenic.
Sterilization, Shelf-Life, and Packaging Integrity	Achieve a minimum sterility assurance level (SAL) of 10^-6 for electron beam sterilization (specified as 10^-9) and bacterial endotoxin

Ask a Question

Ask a specific question about this device

Page 1 of 1