WOLF Thrombectomy System, 6F

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August 27, 2021 DeVoro Medical, Inc. % Roberta Hines Regulatory Consultant Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, Washington 98077 # Re: K210530 Trade/Device Name: WOLF Thrombectomy® System, 6F Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 23, 2021 Received: August 24, 2021 # Dear Roberta Hines: 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). 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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, Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K210530 Device Name WOLF Thrombectomy System, 6F Indications for Use (Describe) The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature. The device is intended for single use only. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## TRADITIONAL 510(k) SUMMARY #### DeVoro Medical, Inc. WOLF Thrombectomy® System, 6F | Submitter | | | |----------------------------|--------------------------------------------------------------------------------------------|--| | Name:<br>Address: | DeVoro Medical, Inc.<br>46724 Lakeview Blvd<br>Fremont, CA 94538, USA | | | Contact: | Roberta Hines, Requlatory Consultant | | | Telephone: | 425-766-0308 | | | Email: | rhines@nwcrg.com | | | Date Prepared: | August 26, 2021 | | | Trade Name of Device: | WOLF Thrombectomy® System, 6F | | | Common or Usual Name: | Embolectomy Catheter | | | Classification Name: | Catheter, Embolectomy | | | Regulation Number: | 21 CFR 870.5150 | | | Product Code: | QEW | | | Primary Predicate Device | 880 Medical, LLC WOLF Thrombectomy Device<br>(K182835) (now owned by DeVoro Medical, Inc.) | | | Secondary Predicate Device | DeVoro Medical, Inc. WOLF Thrombectomy V System<br>(K200101) | | ### Device Description The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use. ### Indication for Use The WOLF Thrombectomy System®, 6F is indicated for the nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. {4}------------------------------------------------ # Summary of Technological Characteristics Comparative Evaluation of the DeVoro Medical WOLF Thrombectomy System, 6F to the Primary and Secondary Predicate Devices | Manufacturer /<br>Device | Device Subject of<br>Traditional 510(k) | Primary Predicate | Secondary Predicate | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device and<br>Manufacturer | WOLF Thrombectomy®<br>System, 6F DeVoro<br>Medical, Inc. | WOLF Thrombectomy Device<br>(6F)880 Medical, Inc. (Now<br>owned by DeVoro Medical,<br>Inc.) | WOLF Thrombectomy V<br>System (10F) DeVoro<br>Medical, Inc. | | 510(k) Number and<br>Description | K210530 | K182835 | K200101 | | Regulation | 21 CFR 870.5150 | 21 CFR 870.5150 | 21 CFR 870.5150 | | Regulation<br>Description | An embolectomy catheter is<br>a balloon-tippedcatheter that<br>is used to remove<br>thromboemboli, i.e., blood<br>clots which have migrated in<br>blood vessels from one site in<br>the vascular tree to another. | An embolectomy catheter is a<br>balloon-tipped catheter that is used<br>to remove thromboemboli, i.e.,<br>blood clots which have migrated in<br>blood vessels from one site in the<br>vascular tree to another. | An embolectomy catheter is a<br>balloon-tipped catheter that is<br>used to remove thromboemboli,<br>i.e., blood clots which have<br>migrated in blood vessels from<br>one site in the vascular tree to<br>another. | | Product Code | QEW | QEW | QEW | | FDA Classification | Class II | Class II | Class II | | Common Name | Embolectomy Catheter | Embolectomy Catheter | Embolectomy Catheter | | Classification Name | Peripheral Mechanical<br>Thrombectomy With<br>Aspiration | Peripheral Mechanical<br>Thrombectomy With Aspiration | Peripheral Mechanical<br>Thrombectomy With<br>Aspiration | | Intended Use | To remove thromboemboli<br>from the peripheral<br>vasculature. | To remove thromboemboli<br>from the peripheral<br>vasculature. | To remove thromboemboli<br>from the peripheral<br>vasculature. | | Indication for Use | The WOLF Thrombectomy<br>Device is indicated for the<br>nonsurgical removal of<br>emboli and thrombi from<br>arterial and venous blood<br>vessels in the peripheral<br>vasculature. | The WOLF Thrombectomy<br>Device is indicated for the<br>nonsurgical removal of emboli<br>and thrombi from arterial blood<br>vessels in the peripheral<br>vasculature. | The WOLF Thrombectomy<br>Device is indicated for the<br>nonsurgical removal of<br>emboli and thrombi from<br>arterial and venous blood<br>vesselsin the peripheral<br>vasculature. | | Design Features and<br>Design Intent | The WOLF Thrombectomy<br>System, 6F consists of a<br>WOLF Catheter with a pre-<br>loaded Devortex shaft which<br>has a nitinol Devortex sleeve<br>attached to the distal end of<br>the Devortex shaft, two (2)<br>Devortex shaft reloads with<br>removable hubs, two (2)<br>grabbing tools and a<br>guidewire loading tool. The<br>WOLF Catheter and Devortex<br>shaft are both single lumen<br>composite catheters which<br>are intended to be loaded<br>coaxially with each other. The<br>Devortex sleeve is fabricated<br>from fine, nitinol wire formed<br>into a desirable shape and<br>attached to the Devortex<br>shaft. | The WOLF Thrombectomy Device<br>is comprised of two coaxial single<br>lumen catheters (WOLF Inner &<br>Outer) designed foruse in<br>removing clot from peripheral<br>vascularvessels. The WOLF<br>Device is delivered with athird<br>coaxial catheter, a Guide Catheter<br>or Sheath.<br>The Inner catheter is attached<br>to the nitinol weave structure<br>which when pulled, ingests the<br>clot into the Outer catheter<br>which is pulled into the Guide<br>Catheter upon its removal. | The WOLF Thrombectomy<br>Device is comprised of two<br>coaxial single lumen catheters<br>(WOLF Inner & Outer) designed<br>for use in removing clot from<br>peripheral vascular vessels. The<br>WOLFDevice is delivered with a<br>third coaxial catheter, a Sheath.<br>The Inner catheter is attached<br>to the nitinol weave structure<br>which when pulled, ingests the<br>clot into the Outer catheter<br>which is pulled into the sheath<br>upon its removal. The Outer<br>catheter has a braided funnel<br>attached to its distal end. The<br>funnel assists the weave in<br>removing larger volumes of<br>clot, seen in larger blood<br>vessels (>4mm diam). Three | | | If further clot ingestion is<br>required, the Devortex shaft<br>is fully removed from the<br>WOLF Catheter and<br>additional Devortex shafts<br>(Reloads) are reloaded into<br>the distalend of the WOLF<br>Catheter by the user, as<br>needed.<br><br>A Devortex Reload Kit is<br>packaged separately. The Kit<br>includes three (3) WOLF<br>Devortex Reloads placed into a<br>packaging hoop on a hoop<br>card. The additional Reloads<br>enable further clot ingestion if<br>desired. | | size funnel devices are offered;<br>4mm, 6mm and 8mm OD<br>funnels. | | | Visualization: Radiopaque<br>marker bands on fluoroscopy<br>Effective Length: 110cm,<br>140cm<br>Devortex Reload Kit: 140cm | Visualization: Radiopaque<br>marker bands on fluoroscopy<br>Effective Length: 152cm | Visualization: Radiopaque<br>marker bands on fluoroscopy<br>Effective Length: 110cm, 130cm | | | Catheter Outer Diameter: 6F<br>Vessel Compatibility: vessels | Catheter Outer Diameter: 6F<br>Vessel Compatibility: vessels | Catheter Outer Diameter: 10F | | Technological<br>Characteristics | larger 1.8mm | larger 1.8mm | Vessel Compatibility: vessels<br>that are larger than the funnel<br>OD for the specific device (4, 6<br>or 8mm) | | | Materials:<br>Devortex sleeve: nitinol wire<br>structure with urethane<br>tungsten polymer and on its<br>end. No hydrophilic coating<br>on sleeve. | Materials:<br>Weave: nitinol wire structure<br>with urethane tungsten<br>polymer and on its end &<br>hydrophilic coating on<br>weave. | Materials:<br>Weave: nitinol wire structure &<br>a urethane polymer on its end.<br>No hydrophilic coating on<br>weave. | | | Devortex shaft: stainless<br>steel, Technora, Pebax<br>polymers, colorant,<br>Tungsten polymer, TPU Ink<br>hydrophilic coating,<br>polytetrafluoroethylene<br>(PTFE), UV adhesive /<br>cyanoacrylate. | Inner Catheter: stainless steel,<br>platinum iridium, Technora, UV<br>epoxy, Pebax polymers, colorant,<br>urethane polymers, Vestamid<br>polymer, hydrophilic coating,<br>polytetrafluoroethylene (PTFE), UV<br>adhesive & cyanoacrylate. | Inner Catheter: stainless steel,<br>platinum iridium, HDPE, LDPE<br>and Pebax polymers,<br>polytetrafluoroethylene (PTFE),<br>UV adhesive / cyanoacrylate.<br>Outer Catheter: stainless steel,<br>Pebax polymers, nylon polymer,<br>hydrophilic coating, PTFE,<br>platinum iridium. | | | WOLF Catheter: stainless<br>steel, Pebax polymers,<br>nylon polymer, hydrophilic<br>coating, TPU Ink, PTFE,<br>platinum iridium. Three<br>added colorants: white<br>(titanium dioxide), yellow<br>(iron oxide) & black (iron<br>oxide). | Outer Catheter: nitinol, stainless<br>steel, Pebaxpolymers, urethane<br>polymers, nylon polymer,<br>colorant, hydrophilic coating,<br>PTFE, platinum iridium, solder<br>flux.<br>Hub Materials: Stainless steel, TPU<br>Ink solder, flux, UV epoxy, silicone<br>polycarbonate, cyanoacrylate | Hub Materials: Polycarbonate,<br>silicone, UV adhesive /<br>cyanoacrylate.<br>Peelaway Sheath: PTFE, poly-<br>lactic acid, UV adhesive /<br>cyanoacrylate. | | | Hub Materials:<br>Polycarbonate, silicone, UV<br>adhesive / Cyanoacrylate,<br>Cyanoacrylate, polyolefin<br>Peelaway Sheath: PTFE, | Peelaway Sheath: PTFE | | | | Cyanoacrylate<br>Performance: equivalent to<br>predicate devices | Performance: meets product<br>specifications for its intended<br>use | Performance: meets product<br>specifications for its intended<br>use | {5}------------------------------------------------ {6}------------------------------------------------ | Guidewire compatibility:<br>0.014" | Guidewire compatibility: 0.014" | Guidewire compatibility: 0.035" | |-------------------------------------------|-------------------------------------------|-------------------------------------------| | Sterilization Method: EO and nonpyrogenic | Sterilization Method: EO and nonpyrogenic | Sterilization Method: EO and nonpyrogenic | The technical features of the WOLF Thrombectomy® System, 6F and the primary predicate device, the WOLF Thrombectomy Device (6F), are the same or similar including design components and the mechanism of action. Both devices have the same materials and come in multiple sleeves (weaves) and usable lenqths, are quidewire and sheath compatible with saline and contrast, are provided sterile and have the same sterilization method. Both devices are radiopague, have similar packaging, and are biocompatible for human use. Several studies conducted on the primary and secondary predicate devices apply to the subject device based on the similarities between them, including stability over time, pre-clinical safety and performance, compatibility with saline and contrast and some functional and simulated use testing. Both the WOLF subject device and both predicate devices are delivered through the femoral artery and contain radiopaque markers for visualization under fluoroscopy. The subject device reloads within the package are the secondary predicate device. Funnels, which are a design feature of the secondary predicate, are intended to treat larger vessels 4mm and larger. Since the 6F device is intended to treat 1.8mm or larger vessels, funnels are not required. #### Performance Data Bench studies indicate that the DeVoro Medical WOLF Thrombectomy® System, 6F performs as intended. The following testing was repeated in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included dimensional and functional design verification/validation (durability and integrity, kink resistance, torsion and tensile strength, air and liquid leak testing, catheter tip durability, simulated use validation, coating integrity, particulate testing, and corrosion resistance). Sterilization validation for the subject device through the Product Adoption method. Transit and package integrity testing, shelf life testing were also repeated on the subject device and its packaging. Supporting data from the acute and chronic animal study for the secondary predicate device apply to the subject device basedon substantial equivalence between the devices; therefore, this repeat testing was not required. ### Biocompatibility Testing Biocompatibility for the WOLF Thrombectomy® System, 6F was repeated due to the addition of three colorants (white (titanium dioxide), yellow (iron oxide), and one new manufacturing process change replacing a soldering joint process with a laser welding process. The following tests were conducted per the ISO-10993-1 standard including: - Cytotoxicity - MEM Elution - Sensitization - Guinea Pig Maximization Test, 2 extracts - . Irritation or Intracutaneous Reactivity - . Material Mediated Pyrogenicity - . Acute Systemic toxicity - . Direct and indirect hemolysis - . Complement activation assay - . Heparinized Platelet and Leukocyte Count Assay, with comparison Article {7}------------------------------------------------ - . Partial thromboplastin time - . Thrombogenicity – In Vitro Blood Loop test In addition to the biocompatibility tests listed above, testing for extractables was conducted on the WOLF Thrombectomy System, 6F. The tests concluded that there are no chemical, toxicological, or safety risks from the WOLF Thrombectomy® System, 6F components, manufacturing procedures and sterilization process and the device is considered biocompatible for its intended use as ISO 10993-1 category: externally communicating device, limited < 24 hour contact with circulating blood exposure. ### Sterilization Validation Sterilization validation testing verified with a high degree of assurance that Ethylene Oxide sterilization is effective in achieving sterility of the WOLF Thrombectomy® System, 6F at a sterility assurance level of 10-6. ## Package Integrity After Aging and Distribution Packaging was verified to protect the WOLF Thrombectomy® System, 6F adequately to ensure product function throughout the claimed shelf life and after exposure to the storage and distribution environment. ### Animal Testing Previous pre-clinical studies for the device's primary and secondary predicates support the safety and performance of the WOLF Thrombectomy® System, 6F. Pre-clinical testing was not repeated for the subject device. ### Conclusions Based on a comparison of the intended use/indications for use, technological characteristics, and the results from a series of non-clinical tests, the WOLF Thrombectomy® System, 6F has demonstrated substantial equivalence to the predicate device. The differences between the devices and its expanded Indication for Use do not raise new questions of safety or effectiveness.