(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is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.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 < 2.15 EU/device. Packaging must maintain functionality and sterility for the indicated shelf-life. | Pass. Successfully validated electron beam sterilization process achieving a minimum SAL of 10^-9 with bacterial endotoxin < 2.15 EU/device. Shelf-life studies per ASTM F1980 conducted, establishing product and packaging functionality and sterility. |
| Animal Testing (Safety & Performance) | Tissue response, perforation/dissection, and downstream thromboembolic/ischemic injury must be comparable to the predicate device. Devices must be safe and equivalent to the predicate device. | Pass. Histological evaluation showed similar tissue response to test and control devices. No evidence of perforation or dissection. No evidence of downstream thromboembolic or ischemic injury. Chronic study animals remained healthy. Study endpoints met; ERIC devices shown to be safe and equivalent. |
| Clinical Study - Primary Effectiveness Outcome (mTICI 2b-3) | The primary effectiveness outcome (successful reperfusion, mTICI 2b-3) success rate for the ERIC device cohort must be statistically non-inferior to the mTICI rate for the Trevo/Solitaire cohort. | 82.2% (76.9-87.5%) for ERIC (166/202) vs. 80.7% (78.2-83.1%) for Trevo/Solitaire (842/1044). When considering missing subjects/rescue as failures: 63.1% for ERIC (130/206) vs. 60.4% for Trevo/Solitaire (639/1058). Conclusion: Substantially equivalent. |
| Clinical Study - Primary Safety Outcome (sICH within 24-48h) | The rate of occurrence of symptomatic intracerebral hemorrhage (sICH) within 24-48 hours post-procedure for the ERIC device cohort must be statistically non-inferior to the sICH rate for the Trevo/Solitaire cohort. | 4.1% (1.1-7.2%) for ERIC (7/169) vs. 8.4% (6.6-10.2%) for Trevo/Solitaire (81/965). (Note: A higher proportion of missing follow-up CT/MRI in the ERIC group means the actual sICH rate could be higher than the reported CI). Conclusion: Substantially equivalent. |
| Clinical Study - Secondary Outcome (Good Clinical Outcome - 90-day mRS 0-2) (for substantial equivalence support) | The 90-day mRS of the ERIC arm must be substantially equivalent to the control arm based on available follow-up data. | 49.3% (40-57.7%) for ERIC (67/136) vs. 44.9% (41.7-48.2%) for Trevo/Solitaire (413/919). Conclusion: Substantially equivalent. |
II. Sample Size and Data Provenance (Clinical Study)
- Sample Size for Test Set:
- ERIC Device Cohort: N = 206 patients
- Trevo/Solitaire Cohort: N = 1058 patients
- Data Provenance: Prospective, multi-center, observational study (ETIS - Endovascular Treatment in Ischemic Stroke follow-up Evaluation Observational Cohort Study, NCT03776877). Data collected from all 7 active sites from the beginning of the study to September 2018.
- Country of Origin: France.
- Retrospective or Prospective: Prospective.
III. Number of Experts and Qualifications (Clinical Study Ground Truth / Patient Selection)
- "All patients were selected for endovascular thrombectomy based on evaluation by a multi-disciplinary team of physicians including neuroradiologists."
- Number of Experts: Not explicitly stated, but implies a team approach.
- Qualifications of Experts: Included "neuroradiologists." Specific years of experience are not mentioned.
IV. Adjudication Method (Clinical Study Test Set)
- The document does not explicitly describe an adjudication method for the test set outcomes (mTICI, sICH, mRS). This was an observational study based on data collected over time. Outcomes would have been determined by the treating physicians and documented in the study records.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The clinical study compared the performance of the ERIC device against predicate devices (Trevo/Solitaire) in terms of patient outcomes (reperfusion rates, sICH, mRS) as measured in standard clinical practice, not specifically assessing the improvement of human readers with AI assistance. This device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.
VI. Standalone (Algorithm Only) Performance
- Not applicable. This device is a medical device (mechanical thrombectomy device), not an algorithm or AI. The performance metrics presented are for the device's clinical efficacy and safety when used by medical professionals, not a standalone algorithm.
VII. Type of Ground Truth Used (Clinical Study)
- Clinical Outcomes/Expert Assessment and Imaging:
- Successful reperfusion (mTICI 2b-3): Based on angiographic imaging assessed by clinical experts (likely neuroradiologists or interventionalists within the clinical setting).
- Symptomatic Intracerebral Hemorrhage (sICH): Based on clinical assessment and follow-up CT scan/MRI, interpreted by medical professionals.
- Good Clinical Outcome (90-day mRS 0-2): Modified Rankin Scale (mRS) score assessed clinically by medical professionals at 90 days.
VIII. Sample Size for Training Set
- Not applicable. The ERIC Retrieval Device is a hardware medical device, not an AI/ML algorithm that requires a training set. The clinical study investigated its performance against established predicate devices.
IX. How the Ground Truth for the Training Set Was Established
- Not applicable. As described above, there is no training set for this type of hardware medical device.
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March 31, 2022
Image /page/0/Picture/11 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MicroVention, Inc. Sapna Singh Director, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656
Re: K211120
Trade/Device Name: ERIC Retrieval Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 25, 2022 Received: March 28, 2022
Dear Sapna Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211120
Device Name ERIC Retrieval Device
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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K211120 510(k) Summary
| Trade Name: | ERIC™ Retrieval Device |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | II, 21 CFR 870.1250, NRY |
| Submitted By: | MicroVention, Inc. |
| 35 Enterprise | |
| Aliso Viejo, California, USA | |
| Contact: | Sapna Singh |
| Director, Regulatory Affairs | |
| MicroVention, Inc. | |
| Sapna.Singh@MicroVention.com | |
| Tel: (714) 247-8000 x 8162 | |
| Date: | March 29, 2022 |
| Predicate Device: | Trevo XP ProVue Retriever (6x25 mm), K143077 |
| Trevo XP ProVue Retriever (4x30mm), K150616 | |
| Modified Trevo ProVue Retriever (3x20 mm and 4x20 mm), K132641 | |
| Reference Device: | Solitaire™ FR Revascularization Device (K113455) |
| 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. | |
| Indications for Use: | The ERIC™ Retrieval Device is indicated to restore blood flow in the |
| neurovasculature by removing thrombus in patients experiencing ischemic |
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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.
Comparison of Technological Characteristics with the Predicate Device:
The subject device, ERIC™ Retrieval Device, is substantially equivalent to the predicate device in terms of intended use, scientific technology, and fundamental design. A tabular comparison of the technological characteristics between the predicate device and subject device is provided below.
Table 1: Technological Characteristics Comparison
| DeviceCharacteristics | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Trevo XP ProVue (6x25 mm, K143077 and 4x30 mm, K150616)Modified Trevo ProVueRetriever (3x20 mm and 4x20 mm K132641) | ERIC™ Retrieval Device | ||
| Manufacturer | Stryker | MicroVention | N/A |
| Classification | 21 CFR 870.1250, Class II | 21 CFR 870.1250, Class II | Same |
| DeviceClassificationName | Catheter, ThrombusRetriever | Catheter, Thrombus Retriever | Same |
| Product Code | NRY | NRY | Same |
| Indications for Use | The Trevo XP ProVueRetriever is intended torestore blood flow inthe neurovasculature byremoving thrombusin patients experiencingischemic stroke within 8hours of symptom onset.Patients who are ineligiblefor intravenoustissue plasminogen activator(IV t-PA) or who fail IV t-PA therapy are candidatesfor treatment. | The ERIC Retrieval Device isindicated to restore bloodflow in the neurovasculatureby removing thrombus inpatients experiencingischemic stroke within 8 hoursof symptom onset. Patientswho are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment. | Same |
| Target Population | Patients with symptoms of an ischemic stroke | Patients with symptoms of an ischemic stroke | Same |
| Anatomical Sites | Neurovasculature | Neurovasculature | Same |
| DeviceCharacteristics | Predicate Device | Subject Device | Comparison |
| Trevo XP ProVue (6x25 mm, K143077 and 4x30 mm, K150616)Modified Trevo ProVueRetriever (3x20 mm and4x20 mm K132641) | ERIC™ Retrieval Device | ||
| Principal Device Dimensions & Materials | |||
| Size(RetrieverDiameter × Length)(mm) | 3×204×204×306×25 | 3×153×203×254×184×244×304×364×426×266×356×44 | Bench and animal testinghave demonstrated that thedifferent overall lengths ofthe subject deviceofferings do not raise newquestions regarding safetyand efficacy. |
| Stent & Core Wire(Shaft) | Nitinol | Nitinol | Same |
| Stent RadiopaqueWire | Platinum/Tungsten | None | Minor difference does notraise new questionsregarding safety andefficacy. Bothdevices have radiopaquecharacteristics. |
| Distal Marker/Coil | Platinum/Tungsten | Tantalum | Similar. Both arecommonly used medicalgrade materials. Materialdifference does not raisenew questions of safety andefficacy. |
| ProximalMarker/Coil | 304 Stainless Steel | Tantalum | Similar. Both arecommonly used medicalgrade materials. Materialdifference does not raisenew questions of safety andefficacy. |
| Solder | Gold/Tin | N/A | Minor difference does notraise new questionsregarding safety andefficacy. |
| HydrophilicCoating | Sodium Hyaluronate Mixture | None | Difference does not raisenew questions of safety andefficacy. Hydrophiliccoatings are commonlyused to |
| DeviceCharacteristics | Predicate Device | Subject Device | Comparison |
| Trevo XP ProVue (6x25 mm, K143077 and 4x30 mm, K150616)Modified Trevo ProVue Retriever (3x20 mm and 4x20 mm K132641) | ERIC™ Retrieval Device | ||
| lubricate some vascular devices. | |||
| Pusher ShrinkTubing | None | Polyethylene | Polyethylene is acommonly used medical grade plastic. Difference does not raise new questions of safety and efficacy. |
| Additional Characteristics | |||
| PackagingMaterials andConfiguration | Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film Pouch, HDPE Tubing Clips, Chipboard carton | Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film Pouch, HDPE Tubing Clips, Bleached Sulfate carton | Minor difference does not raise new questions regarding safety and efficacy. |
| Supplied As | Sterile/Single Use | Sterile/Single Use | Same |
| SterilizationMethod | Ethylene Oxide | Electron Beam | Minor difference in method does not raise new questions regarding safety and efficacy. Both devices demonstrate a SAL of 10-6 |
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Verification Test Summary:
The results of verification and validation testing conducted on the subject device demonstrate that it performs
as intended and are summarized as follows:
Table 2: Verification and Validation Testing
| Test Description | Test Method | Result | Conclusions |
|---|---|---|---|
| Dimensional Testing(Expanded Diameter &Device Overall Length) | Device attributes (overall devicelength and expanded outerdiameter (OD) of the shapedsection) were measured. | Pass | The longer overall length andsmaller OD of the subjectdevice offerings does notaffect the performance of thedevice. |
| Test Description | Test Method | Result | Conclusions |
| Fluoroscopic GuidanceMarker Testing | The radiopacity of devicemarkers were assessed underfluoroscopy during non-clinicaltesting. | Pass | Both subject and predicatedevices are sufficiently visibleunder fluoroscopy. |
| Advance/Retraction ForceTesting | The advance and retract forcesof the subject device in atortuous model were comparedwith the forces measured for oneor more predicate devices. | Pass | The advance and retractforces of the subject devicewere comparable with theforces measured for thepredicate device. |
| Re-Sheathing Testing | The ability to re-sheath thedevice was evaluated comparedwith the predicate device. | Pass | The ability to re-sheath thesubject device is comparableto that of the predicate devicetested. |
| Radial Force Testing | The radial force of the subjectdevice was measured by radiallycompressing the device and wascompared with the radial forcesmeasured for predicate device. | Pass | The radial force of the subjectdevice is comparable to thatof the predicate device tested. |
| Tensile Strength Testing | The peak tensile strength tofailure in different sections ofthe subject device was evaluatedand compared with thatmeasured for the predicatedevice. | Pass | The system tensile strength ofthe subject device iscomparable to that of thepredicate device tested. |
| Kink Resistance Testing | Kink resistance of the subjectdevice was evaluated whenwrapped around a series ofmandrels of decreasing radiiuntil permanent deformation wasobserved or until the smallestradius was used. | Pass | Kink resistance of the subjectdevice is equivalent to that ofthe predicate device tested. |
| Austenite Finish (Af)Testing | Af temperature testing of thesubject device determined atwhat temperature the shaperecovery transformation iscomplete upon heating and is aproperty of the pseudoelasticmaterial used. | Pass | The Af temperature of thesubject device is less than theproduct use temperature(body temperature) and, thus,satisfies requirements forclinical applications. |
| Simulated Use/Performance Testing | The ability to reliably deployand use the subject device in atortuous benchtop model wasevaluated and compared withone or more predicate devices. | Pass | Simulated use testing wascomparable with that of thepredicate device. |
| Test Description | Test Method | Result | Conclusions |
| Corrosion ResistanceTesting | Metallic components intendedfor fluid path contact wereevaluated for signs of corrosion. | Pass | Corrosion resistance testing ofthe subject device showed nosigns of corrosion. |
| Particulate EvaluationTesting | Particulate evaluation testing ofthe subject device was evaluatedin a tortuous benchtop modeland was compared with that ofthe predicate device. | Pass | Particulate evaluation wascomparable with that of thepredicate device. |
| Torque Response Testing | The torque ability of the subjectdevice in a tortuous benchtopmodel was evaluated andcompared with the predicatedevice. | Pass | Torque response testingindicated that the core wire ofthe subject device rotatesfreely with the proximalsphere and, thus, hasequivalent torqueabilitycompared to the predicatedevice. |
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Biocompatibility Evaluation:
The in vitro and in vivo biocompatibility safety studies performed on the terminally sterilized ERIC™ Retrieval Device have demonstrated the biocompatibility of the proposed device and support compliance with ISO 10993-1, 'Biological Evaluation of Medical Devices,' and the FDA Biocompatibility Guidance.
Per ISO 10993-1, the ERIC™ Retrieval device is categorized as an external communicating device with limited exposure. The device was determined to be non-cytotoxic, non-irritating, non-irritating, non-toxic, nonpyrogenic, non-hemolytic, non-activating, and has no effect on coagulation of human plasma and hematological parameters. The biocompatibility evaluation are summarized as follows:
| Table 3: Biocompatibility Testing | ||
|---|---|---|
| -- | ----------------------------------- | -- |
| Test | Test Summary | Conclusions |
|---|---|---|
| Cytotoxicity: L929 MEMElusion Test | There was no biological reactivity (Grade 0) ofthe cells exposed to the test article extract. | Non-cytotoxic |
| Sensitization: KligmanMaximization Test inGuinea Pigs | The test article extracts elicited no reaction at thechallenge (0% sensitization) following aninduction phase. | Non-sensitizer |
| Intracutaneous Reactivity inWhite Rabbits | No evidence of irritation (score 0.0). | Non-irritating |
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| Test | Test Summary | Conclusions |
|---|---|---|
| Systemic Injection Test inMice | No biologically significant weight loss,mortality, or evidence of systemic toxicity fromthe extract exposure to the mice was observed. | Systemically non-toxic |
| Rabbit Pyrogen Test(Material Mediated) | No rabbit showed an individual rise intemperature of 0.5 °C. The temperature increasesfor the test animals were 0.0 °C. | Non-pyrogenic |
| ASTM Blood Compatibility- Direct and Indirect ContactHemolysis | The test article demonstrated 0.12% hemolysisin direct contact and 0.00% hemolysis in indirectcontact. | Non-hemolytic |
| Unactivated PartialThromboplastin Time Test | An average coagulation time of the test articleshowed no significant difference from thecontrol. | No effect on coagulationof human plasma |
| Complement ActivationTest (Direct Contact) | The plasma exposed to the test article for 90minutes was found to exhibit no statisticallysignificant increase in C3 and SC5b-9. | Non-activating |
| Platelet and LeukocyteCount Assay (DirectContact) | The concentration of White Blood Cells (WBC)and Platelets (Plt) in human blood exposed to thetest article was not statistically significantlydecreased. | No effect onhematologicalparameters |
| Thrombogenicity | The test article had a thrombus formation scoreof "2" and was considered thromboresistant. | Non-thrombogenic |
Sterilization, Shelf-Life, and Packaging Integrity:
The ERIC™ Retrieval Device is labeled as a single-use, sterile device. The sterilization process for the ERIC™ Retrieval Device has been successfully validated and process monitoring controls are in place to assure that the device is electron beam sterilized to achieve a minimum SAL of 10-9 with bacterial endotoxin < 2.15 EU/device.
Shelf-life studies per ASTM F1980 have been conducted for the ERIC™ Retrieval Device and establish that the product and packaging remain functional and sterile for the shelf-life period indicated on the label.
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Animal Testing Summary:
Acute and chronic in vivo testing was conducted in a porcine model to evaluate safety and performance characteristics of the ERIC Retrieval Device in comparison to the predicate device, Trevo XP ProVue Retriever. Histological evaluation demonstrated that the tissue response to both test and control devices were similar. There was no evidence of perforation or dissection in vessels treated with either the test or control devices. There was no evidence of downstream thromboembolic or ischemic injury. Chronic study animals remained healthy, gained weight, and survived to scheduled termination. Study endpoints were met, and ERIC Retrieval Devices were shown to be safe and equivalent to the predicate device.
Clinical Study Data:
To support the substantial equivalence of the ERIC™ Retrieval Device (ERIC) to its predicate device cleared in the US [Trevo XP ProVue Retriever, Trevo], the clinical data collected from Endovascular Treatment in Ischemic Stroke follow-up Evaluation (ETIS) Observational Cohort Study (NCT03776877) was collected and analyzed.
ETIS is a prospective, multi-center, observational, Good Clinical Practice (GCP) compliant study conducted in France assessing the angiographic and clinical outcomes associated with the use of CE-marked thrombectomy devices [including the ERIC™ device, Trevo and Solitaire FR Revascularization Device (Solitaire)] that are intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. This ongoing ETIS study was initiated in 2011 and has enrolled more than 14,000 subjects as of January 2022. The data presents an analysis population that is a subset of the ETIS study and includes all consecutive subjects treated by the ERIC™ device. Solitaire and Trevo at all 7 active sites from the beginning of the study to September 2018. The data analysis included the clinical, angiographic, and functional outcomes of two hundred six (N=206) patients treated with the ERIC™ device in comparison to N=1058 patients treated with Trevo or Solitaire. The angiographic and clinical outcomes demonstrate that the ERIC™ device performs similarly to the Trevo and Solitaire in terms of successful reperfusion rate and good clinical outcome (mRS 0-2) at 90 days based on available follow-up data in the two analysis groups. The ERIC™ device also exhibits a comparable safety profile, including similar rates of procedural complications, sICH, and 90-day all-cause mortality based on available follow-up data in the two analysis groups. One of the limitations of the ETIS study due to its design is the number of subjects with
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missing data; therefore, the conclusions made from the ETIS study in support of this 510(k) are based on subjects with available follow-up data in both analysis groups.
All patients were selected for endovascular thrombectomy based on evaluation by a multi-disciplinary team of physicians including neuroradiologists. Selection included patients with acute ischemic stroke (AIS), in relation to an occlusion of a large caliber intracranial artery of the anterior circulation, visible in imaging within a period of 6 hours after the onset of symptoms, either initially in combination with intravenous thrombolysis (IVT), or as recourse technique: after failure of treatment with IVT, or alone in case of contraindication to IVT. Both arms of the study included the use of thrombolytics. The ETIS study was conducted in accordance with the GCP guidelines and applicable regulatory requirements (FR, ICH E3-E6. ISO14155).
Primary Outcomes:
Primary Effectiveness Outcome
The primary effectiveness outcome was defined as achievement of an mTICI score of 2b or greater in the target vessel. The success criterion for this analysis is that the primary effectiveness outcome success rate for the ERIC device cohort is statistically non-inferior to the mTICI rate for the Trevo/Solitaire cohort.
Primary Safety Outcome
The primary safety outcome was defined as the occurrence of symptomatic intracerebral hemorthage (sICH) within 24 hours post-procedure. The success criterion for this analysis is that the rate of occurrence of the primary safety outcome for the ERIC device cohort is statistically non-inferior to the sICH rate for the Trevo/Solitaire cohort.
Inclusion Criteria:
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- Age 18 and older (i.e., candidates must have had their 18th birthday)
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- Neuroimaging demonstrates acute ischemic stroke in a large vessel indicated for use with neurothrombectomy devices intended to restore blood flow
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- No upper or lower limits of the neurological severity at baseline (NIHSS)
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- With or without intravenous thrombolysis
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- Oral informed consent (patient and/or trustworthy person)
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Exclusion Criteria:
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- Pregnant or breast-feeding women
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- Patient benefiting from a legal protection
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- Non-membership of a national insurance scheme
Study Results:
The study assessed the efficacy and safety of the ERIC™ Retrieval Device using marketed devices used in usual clinical practice in comparison to the predicate device, Trevo XP ProVue, and reference device, Solitaire.
Table 4: ETIS Study Outcomes: ERIC vs Trevo/Solitaire Cohort
| ETIS Study Results | ERIC Device Cohort(N=206) | Trevo/Solitaire Cohort(N=1058) | ||
|---|---|---|---|---|
| n/N | ValueRate (CI) | n/N | ValueRate (CI) | |
| Primary Effectiveness Outcome | ||||
| Successful reperfusion at endof procedure (mTICI 2b-3) | 166/202 | 82.2%(76.9-87.5%) | 842/1044 | 80.7%(78.2-83.1%) |
| Primary Safety Outcome | ||||
| Occurrence of sICH within24h-48h* | 7/169 | 4.1%(1.1-7.2%) | 81/965 | 8.4%(6.6-10.2%) |
*59 ERIC-treated patients and 37 Trevo/Solitaire patients without follow-up CT scan/MRI due to absence of symptoms (per site hospital usual care) were treated as absence of symptomatic intracerebral hemorrhage. The number of missing patients without follow-up CT/MRI in the ERIC-treated group is proportionally higher than the number of missing patients without follow-up CT/MRI in the Trevo/Solitaire-treated group. Therefore, the occurrence of sICH within 24-48 hours with the ERIC-treated patients could be higher than the confidence intervals presented in this table.
The primary effectiveness outcome results generated by treating the subjects with rescue mechanical thrombectomy device after failure of the primary intended device to achieve mTICI 2b or greater and missing subjects as failures are shown below.
Table 5: Primary Effectiveness Endpoint (mTICI 2b-3) – ERIC Device vs Trevo/Solitaire: Use of Rescue Mechanical Thrombectomy Device Considered Treatment Failure
| Primary EffectivenessEndpoint | ERIC(N=206) | Trevo/Solitaire(N=1058) | ||
|---|---|---|---|---|
| n/N | Value | n/N | Value |
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| Successful reperfusion atend of procedure (mTICI2b-3)* | 130/206 | 63.1% | 639/1058 | 60.4% |
|---|---|---|---|---|
| ---------------------------------------------------------------- | --------- | ------- | ---------- | ------- |
*The effectiveness outcomes were considered as failures for missing subjects as well as those subjects with use of rescue mechanical thrombectomy device.
The secondary outcome for good clinical outcome (90-day mRS 0-2) is shown in the table below. The results of this analysis demonstrate that the 90-day mRS of the ERIC arm and the control arm are substantially equivalent based on available follow-up data.
Table 6: Secondary Outcome (90-day mRS) - ERIC vs Trevo/Solitaire
| ERIC(N=206) | Trevo/Solitaire(N=1058) | |||
|---|---|---|---|---|
| n/N | Value | n/N | Value | |
| Secondary OutcomeGood ClinicalOutcome (90-daymRS 0-2) | 67/136 | 49.3%(40-57.7%) | 413/919 | 44.9%(41.7-48.2%) |
Comparison of the primary safety and effectiveness outcomes and secondary outcome for the ERIC cohort versus the Trevo/Solitaire cohort from the ETIS study demonstrated that the ERIC device is substantially equivalent to the predicate device.
Conclusion:
The information presented in this 510(k) demonstrates the substantial equivalence between the predicate and the ERIC" Retrieval Device regarding the design, construction materials, operating principle, bench testing, animal testing and clinical performance for the intended use.
§ 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).