(350 days)
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.
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is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.
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 |
§ 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).