EMBOTRAP III Revascularization Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the agency's name on the right. The seal features an eagle-like figure, while the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "ADMINISTRATION" appearing in a smaller font size below the rest of the name. July 30, 2021 Neuravi Ltd. Niall Fox Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway H91 K5YD, Ireland Re: K211338 Trade/Device Name: EMBOTRAP III Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 30, 2021 Received: May 3, 2021 Dear Niall Fox: 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. 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You must comply with all the Act's 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 {1}------------------------------------------------ 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 (QS) 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). 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211338 Device Name EMBOTRAP III Revascularization Device ### Indications for Use (Describe) The EMBOTRAP™ III Revascularization Device is intended 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) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:inline-block;"><span style="text-decoration:overline;">☑</span> Recreational Use (Part 21 CFR 201.326 Subject)</div> | <div style="display:inline-block;">□ Over-The-Counter Use (21 CFR 201.66 Subject)</div> | |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER: 510(k) Owner: Neuravi Ltd. Block 3, Ballybrit Business Park, Galway H91 K5YD, Ireland Contact Person: Niall Fox Director of Regulatory Affairs Tel: +353-91-394123 E-mail: nfox5@its.jnj.com Date Prepared: July 28th, 2021 #### DEVICE II. Trade Name of Device: EMBOTRAP™ III Revascularization Device Common Name of Device: Catheter, Thrombus Retriever Classification Name: 21 CFR 870.1250 - Class II Product Code: NRY #### PREDICATE DEVICES III. EmboTrap® II Revascularization Device (K173452) EMBOTRAP™ III Revascularisation Device (5 x 22 mm and 5 x 37 mm models via K193063) Solitaire™ Platinum Revascularization Device (K160641) #### IV. DEVICE DESCRIPTION The EMBOTRAP™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EMBOTRAP™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke. #### V. INDICATIONS FOR USE The EMBOTRAP™ III Revascularization Device is intended 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. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. A summary of the technological characteristics of the EMBOTRAP™ III device in comparison to those of the predicate devices is presented below {4}------------------------------------------------ | Characteristics | Predicate Devices Referenced in this Submission | | | Proposed SE Device | |-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | | EMBOTRAP III<br>(5 x 22 mm and 5 x 37 mm) | EMBOTRAP II | Solitaire™ Platinum | EMBOTRAP III<br>(6.5 x 45 mm) | | Manufacturer | Neuravi Ltd. | Neuravi Ltd. | Covidien/Medtronic | Same as EMBOTRAP II | | 510(k) Number | K193063 | K173452 | K160641 | N/A | | Classification | Class II (21CFR 870.1250) | | | Same | | Device Classification Name | Catheter, Thrombus Retriever | | | Same | | Classification Product Code | NRY | | | Same | | Indication for Use | The EMBOTRAP III Revascularization<br>Device is intended to restore blood<br>flow in the neurovasculature by<br>removing thrombus in patients<br>experiencing ischemic stroke within<br>8 hours of symptom onset. Patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV t-<br>PA) or who fail IV t-PA therapy are<br>candidates for treatment. | The EMBOTRAP II Revascularization<br>Device is intended to restore blood<br>flow in the neurovasculature by<br>removing thrombus in patients<br>experiencing ischemic stroke within<br>8 hours of symptom onset. Patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV t-<br>PA) or who fail IV t-PA therapy are<br>candidates for treatment. | The Solitaire Platinum Revascularization<br>Device is intended to restore blood flow<br>by removing thrombus from a large<br>intracranial vessel in patients<br>experiencing ischemic stroke within 8<br>hours of symptom onset. Patients who<br>are ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or who<br>fail IV t-PA therapy are candidates for<br>treatment. | Same as EMBOTRAP models | | Target Population | Patients with symptoms of an ischemic stroke within 8 hours of symptom onset, who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment | | | Same | | Design/Technological<br>Principles | Retrievable, self-expanding Nitinol shaped section<br>Nitinol guide-wire like shaft | | | Same | | Distal End (Retriever) Design | Bi-layer tubular design with a tapered<br>distal end with tip<br>Image: [5 x 22 mm device]<br>Image: [5 x 37 mm device] | Bi-layer tubular design with a tapered<br>distal end with tip<br>Image: [device] | | Same as EMBOTRAP II | | Principal Device Materials | | | | | | Shaped Section & Shaft Wire | Nitinol | Nitinol | Nitinol | Same as EMBOTRAP II | | Distal Marker/Coil | Platinum/Tungsten Coil | Platinum/Tungsten Coil | Platinum/Iridium | Same as EMBOTRAP II | | Proximal Marker/Coil | Platinum/Tungsten Coil | Platinum/Tungsten Coil | Platinum/Iridium | Same as EMBOTRAP II | | Shaft Coating | Hydrophobic<br>PTFE Coating | Hydrophobic<br>PTFE Coating | | Same as EMBOTRAP II | | Design Characteristics & Technology | | | | | | Size(s) Offered<br>(Retriever Diameter ×<br>Length) | 5×22mm, 5×37mm, | 5×21 mm, 5×33 mm | 6x40 mm | 6.5x45 mm | | Device Length | 194 cm, 195 cm<br>(Labeled Overall length) | 194 cm, 195 cm<br>(Labeled Overall length) | 180 cm<br>(Labeled Push Wire Length) | 196 cm<br>(Labeled Overall length) | | Minimum Microcatheter ID | 0.021"-0.027" | 0.021" | 0.027" (6 mm diameter size) | 0.021"-0.027" | | Key Principles of Operation | The device is used in the neurovasculature to restore blood flow in patients experiencing ischemic stroke | | | Same | {5}------------------------------------------------ | No. of passes/device IFU | 3 / Device & Vessel | 3 / Device & Vessel | 3 / Device & Vessel | Same | | | | | |----------------------------|---------------------|---------------------|---------------------|------|--|--|--|--| | Additional Characteristics | | | | | | | | | | How supplied | Sterile/Single Use | Sterile/Single Use | Sterile/Single Use | Same | | | | | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same | | | | | {6}------------------------------------------------ # VII. PERFORMANCE DATA # Biocompatibility Testing: The biocompatibility evaluation for the EMBOTRAP™ III Revascularization Device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA (Recognition Number 2-156) and FDA Biocompatibility Guidance (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 16, 2016). Per ISO 10993-1, the EMBOTRAP™ III device is categorized as an external communicating device with limited exposure, i.e. whose contact with circulating blood is less than 24 hours. | Test | Results | Conclusions | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Cytotoxicity Study | The test article extract showed no<br>evidence of causing cell lysis or<br>toxicity. The test article extract<br>met the requirements of the test.<br>Based on the percentage viability<br>values for the test article extract<br>dilutions, the device is non-<br>cytotoxic. | Device is non-cytotoxic per the<br>Cytotoxicity Studies conducted | | ISO Guinea Pig Maximization<br>Sensitization Test | Test article extracts showed no<br>evidence of causing delayed<br>dermal contact sensitization in the<br>guinea pig. | Device is not considered a<br>sensitizer per the Guinea Pig<br>Maximization Test | | ISO Intracutaneous Study in<br>Rabbits | The difference between the test<br>extract overall mean score and the<br>corresponding control overall<br>mean score was 1.0 or less. | Device is not an irritant when<br>injected intracutaneously per the<br>ISO Intracutaneous Study in<br>Rabbits | | ISO Systemic Toxicity Study in<br>Mice | There was no mortality or evidence<br>of systemic toxicity from the<br>extracts injected into mice. Each<br>test article extract met the<br>requirements of the study. | Device is non-toxic per the ISO<br>Systemic Toxicity Study in Mice | The biocompatibility evaluation included the following tests: {7}------------------------------------------------ | Test | Results | Conclusions | |----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | USP Rabbit Pyrogen Study,<br>Material Mediated | No individual rabbit showed a rise<br>in temperature of ≥ 0.5°C above its<br>baseline temperature and the total<br>maximum temperature rise of all<br>three animals was within<br>acceptable USP limits.<br><br>The total rise of rabbit<br>temperatures during the 3-hour<br>observation period was within<br>acceptable USP requirements. The<br>test article met the requirements<br>for the absence of pyrogens. | Device is non-pyrogenic per the<br>Material Mediated Rabbit Pyrogen<br>Study | | ASTM Hemolysis | Both the test article in direct<br>contact with blood and the test<br>article extract were non-hemolytic. | Device is non-hemolytic per the<br>ASTM Hemolysis Test | | Complement Activation Assay<br>Studies<br>SC5b-9 Complement Activation<br>Assay Study | The C3a and SC5b-9<br>concentrations of the test article<br>samples were acceptable. All test<br>method acceptance criteria were<br>met. | Levels of C3a and SC5b-9 were<br>acceptable. | | In Vivo Thromboresistance Study<br>in Sheep – Jugular Vein, Acute<br>(Thrombogenicity) | The implantation procedure was<br>routine and there were no<br>difficulties encountered with<br>insertion or placement of the test<br>device. There was no evidence of<br>bleeding or complications during<br>the post-operative implant period.<br><br>Minimal thrombus formation was<br>associated with the control article<br>and minimal to slight thrombus<br>formation was associated with the<br>test article. | Under the conditions of this study,<br>both test and control articles were<br>considered thromboresistant. | All biocompatibility tests completed met the pre-assigned acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards. # Sterilization and Shelf Life: The EMBOTRAP™ III device is labelled as a single-use, sterile device, with a shelf life of 3 years. The sterilization process for the EMBOTRAP™ III device has been successfully validated and process monitoring controls are in place to assure that the device is EO-sterilized to achieve a minimum SAL of 10-6. Shelf life studies have been conducted for the EMBOTRAP™ III device and establish that the product and packaging remain functional and sterile for the shelf life period of 3 years. # In Vitro (Bench) Testing: The results of design verification and validation testing conducted on the EMBOTRAP™ III device demonstrate that it performs as designed, fulfils all pre-determined product performance {8}------------------------------------------------ specification requirements, and is suitable for its intended use. The verification and validation test results demonstrate that EMBOTRAP™ III is substantially equivalent to the predicate devices. | Characteristic/Test | Method | Conclusions | |-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System Dimensions | A range of device dimensions were measured using specified measurement tools to verify that the required dimensional specifications were met for the subject device models. | All required specifications were met.<br>Device dimensions are comparable to legally-marketed mechanical thrombectomy devices. The subject device includes a longer overall length and larger diameter. | | Radial Force Testing | Radial force of the subject device models was measured within a range of lumen diameters applicable to the intended vasculature to verify that the device performance specifications have been met. | All required specifications were met.<br>Radial force performance of the subject device is comparable to that of the predicate device. | | Outer Cage Recovery | Expansion characteristics of the self-expanding portion of a representative (worst-case) device model were evaluated by measurement post-multiple loading and deployment cycles. | All required specifications were met.<br>Outer cage recovery performance is comparable to that of the predicate. | | Durability Testing | Damage was evaluated after delivery and withdrawal of the subject device models beyond the recommended number of passes and re-sheathings recommended in the instructions for use. | All required specifications were met.<br>Durability performance of the subject device is comparable to that of the predicate device. | | Full Unit (System) Tensile Testing | The system (full unit) tensile strength of the proximal/distal sections of the device was evaluated post-simulated use. | All required specifications were met.<br>The system tensile strength of the subject device is comparable to that of the predicate device. | | Marker Push Out Force | Evaluated the force required to dislodge riveted markers from a representative device model post-simulated use (all marker locations and push-out directions were assessed). | All required specifications were met. | | Flexibility & Kink Resistance | Kink resistance of the entire device (shaft and shaped section) was evaluated using a representative worst-case device model, which was wrapped around a series of mandrels of decreasing radii until permanent deformation was observed or until the smallest radius was used. | All required specifications were met.<br>Kink resistance of the subject device is comparable to that of the predicate device. | | Coating Integrity | Coating integrity of the subject device was evaluated on a representative (worst-case) device model by examining the shaft coating | All required specifications were met.<br>Coating integrity of the subject device is comparable to that of the predicate | | Torque Durability<br>(Strength) | The effects of torquing the subject<br>device were evaluated using a<br>representative (worst-case) device<br>model post-simulated use with the<br>device positioned as follows (distal<br>end constrained): (a) within the<br>microcatheter in a simulated vessel;<br>and (b) with the shaped section of<br>the device deployed in a simulated<br>vessel following retraction of the<br>microcatheter. | All required specifications were met.<br>Torque durability of the subject device<br>is comparable to that of the predicate<br>device. | | Corrosion Resistance | Representative (worst-case) device<br>models were subjected to corrosion<br>testing to determine resistance to<br>corrosion. | All required specifications were met.<br>Corrosion resistance of the subject<br>device is comparable to that of the<br>predicate device. | | Tip Flexibility | Tip flexibility was evaluated by<br>measuring the deflection force of the<br>device tip when advanced through a<br>microcatheter past its tip and<br>deflected against contact plates at<br>pre-specified angles. | All required specifications were met.<br>Tip flexibility of the subject device is<br>comparable to that of the predicate<br>device. | | Re-sheathing Force | A representative (worst-case) device<br>model was evaluated in a 0.021"<br>microcatheter to determine the force<br>required to re-sheath the device. | All required specifications were met.<br>Re-sheathing force is comparable to<br>those recorded for the predicate<br>devices. | | Deliverability Force | A representative (worst-case) device<br>model was evaluated in a tortuous<br>track model to determine the force<br>required to deliver the subject device<br>in a 0.021" microcatheter. | All required specifications were met. | | Radiopacity | The worst-case subject device (least<br>number of radiopaque markers) was<br>evaluated in a skull phantom model<br>using fluoroscopy. | All required specifications were met.<br>Radiopacity of the subject device is<br>equivalent to, or better than, that of<br>the predicate devices tested. | | Clot retrieval and<br>performance<br>(Simulated Use/Ease of<br>Use) | Device performance and ease of use<br>attributes (including clot retrieval<br>performance) were evaluated in<br>simulated anatomy for the subject<br>devices in relation to the key steps<br>involved in the clinical procedure. | All required ease of use performance<br>specifications were met.<br>The subject device effectively<br>retrieved clot and restored flow in the<br>test model.<br>Performance of the subject device<br>(including loading, delivery,<br>deployment and retrieval) was<br>comparable to that of the predicate<br>devices tested in an in vitro tortuous<br>path anatomical model. | | Physician Usability Study | Device performance and ease of use<br>attributes were evaluated in<br>simulated anatomy for the worst-<br>case (largest) subject device model in<br>relation to the key steps involved in<br>the clinical procedure.<br>Performance was compared with the<br>predicate device. | The physician usability study<br>demonstrated that the subject device<br>met user needs.<br><br>Device performance was comparable<br>to that of the predicate device. | | Delivery and re-sheathing<br>force during simulated<br>use<br>(in a clinically-<br>representative, full-length<br>anatomical model) | Delivery and re-sheathing forces<br>were measured during simulated use<br>of a representative (worst-case)<br>device model device in a full-length<br>anatomical model and compared<br>with the forces measured for one or<br>more predicate devices. | Delivery and re-sheathing<br>performance of the subject device are<br>comparable to that of the predicate<br>device. | | Kink Resistance –<br>Deployed Shaped Section | Kink resistance of the deployed<br>shaped section of a representative<br>(worst-case) device model was<br>evaluated in a series of bend radii<br>within a range of vessel lumen<br>diameters. | Kink resistance of the deployed<br>shaped section was comparable to<br>that of the predicate device. | Specifically, the following in vitro bench tests were performed on the subject device: simulated use. {9}------------------------------------------------ {10}------------------------------------------------ ### In Vivo (Animal) Studies: Acute and chronic animal studies have been performed to assess the usability, effectiveness and safety of the EMBOTRAP™ III device compared to the predicate devices in the swine model. Acute performance evaluated on Day 0 showed that the usability and performance of the EMBOTRAP™ III device was equivalent to that of the predicate device tested. Histological evaluation performed on treated vessels after 3 and 28 days demonstrated that the local and end organ tissue response was comparable between the EMBOTRAP™ III device and the predicate devices tested. ### Clinical Studies: No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device. Substantial equivalence of the subject device has been established to the predicate device through the results of bench and animal testing. ### CONCLUSIONS Non-clinical studies demonstrate that the EMBOTRAP™ III Revascularization Device is substantially equivalent to the predicate devices.