WOLF Thrombectomy V System

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April 27, 2020 DeVoro Medical, Inc. % Roberta Hines Regulatory Consultant Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, Washington 98077 # Re: K200101 Trade/Device Name: WOLF Thrombectomy V System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: March 30, 2020 Received: March 31, 2020 # Dear Ms. 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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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) K200101 Device Name Wolf Thrombectomy V System Indications for Use (Describe) The WOLF Thrombectomy V System is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | ☑ Residential Use (R-1, SFR, MH, Select District) | ☐ Other: This Space Intentionally Left Blank | |---------------------------------------------------|----------------------------------------------| |---------------------------------------------------|----------------------------------------------| X 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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WOLF Thrombectomy™ V System ## K200101 #### General Company Information | Name: | DeVoro Medical, Inc. | |------------|--------------------------------------| | Address: | 48389 Fremont Blvd., Suite 114 | | | Fremont, CA 94538, USA | | Contact: | Roberta Hines, Regulatory Consultant | | Telephone: | 425-766-0308 | | Email: | rhines@nwcrg.com | #### Date Prepared March 30, 2020 #### General Device Information Product Name: WOLF Thrombectomy "" V System Common Name: Embolectomy Catheter Classification: Catheter, Embolectomy (21 CFR 870.5150, Product Code: QEW) #### Predicate Devices 880 Medical, LLC WOLF Thrombectomy Device (K182835) (Primary) #### Reference Device | Edwards LifeSciences | Fogarty Venous Thrombectomy Catheter (510K number unknown) | |----------------------|------------------------------------------------------------| |----------------------|------------------------------------------------------------| #### Description The WOLF Thrombectomy V System is comprised of two single lumen composite, variable stiffness catheters. Both devices have a distal radiopague marker for recognition under fluoroscopy. The WOLF Outer device has a collapsible braided funnel formed at its distal end. The purpose of the funnel is to enable more efficient ingestion of clot in larger vessels. The system includes a preloaded weave and additional reloadable weave and reloadable weave are fabricated from fine nitinol wire formed into a desirable tubular shape and attached to the WOLF Inner Catheter. The end of both weaves that are not attached to the WOLF Inner Catheter are cuffed with a radiopaque polymer. The WOLF outer catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The WOLF inner catheter has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The outer catheter has two sets of radiopague markers. The distal most marker bands reside in the distal end of the funnel to facilitate visualization of the second marker band is located at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion. The reloadable weaves can be used for additional clot removal. A WOLF Thrombectomy V System used with a reloadable weave has the same principle of operation of action as the system packaged with the preloaded weave. {4}------------------------------------------------ ## Indication for Use The WOLF Thrombectorny V System is indicated for the nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. ## Substantial Equivalence The data presented in this submission demonstrates the technological similarity of the WOLF Thrombectomy V System compared with the primary predicate device, the WOLF Thrombectomy Device. The devices have the same intended use (peribheral vascular), use the same mechanism of action, incorporate similar components, use similar construction and materials, are compatible with a quide sheath and are packaged and sterilized using the same processes. The 10F size is considered a line extension to offer the physician an additional option for treatment of larger peripheral blood vessels. The review and analysis of the data demonstrate that the WOLF Thrombectomy V System, 10F is similar in intended use, benefits, risks, safety, and performance to the WOLF Thrombectomy Device, 6F and the reference device in the 10F size. Based on the design similarities between the 6F and 10F WOLF thrombectomy devices and the test results in the acute and chronic animal study using arterial and venous vessels, the devices are substantially equivalent. Biocompatibility, performance testing, simulated use testing, and animal testing demonstrate that the device has appropriate properties for its intended use. No new questions of safety are raised for the WOLF Thrombectomy V System. ## Performance Data Bench studies indicate that the DeVoro Medical WOLF Thrombectomy V System performs as intended. The following testing was performance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testinq included dimensional and functional design verification/validation (durability and integrity, kink radius, torsion and tensile strength, air and liguid leak testing, clot retrievability, resheathability, surface condition, coating integrity, particulate testing, corrosion resistance), sterilization, transit and package integrity testing, shelf life testing, acute and chronic animal safety testing, biocompatibility testing, simulated use testing, and comparative performance analysis with the predicate device. In addition, comparative testing of the Fogarty Venous Thrombectomy Catheter was conducted in the acute and chronic animal study in, both, arteries and veins. #### Technical Comparison The technical features of the WOLF Thrombectomy V System and the WOLF Thrombectomy Device are the same or similar for both the design components and the mechanism of action. Both devices are also provided sterile and are sterilized by the same method (EO). Both devices are made of similar materials and come in similar configurations (shape, diameter and lengths). The WOLF 10F is offered in additional configurations (funnel diameters and lengths). The Weave/Clot Grabber component in both devices is a tubular weave structure formed from nitinol wire and is attached to the Inner Catheter. The Weave/Clot Grabber is the component that integrates and aids in ingesting the clot. The WOLF 10F package offers reloadable weaves attached to inner catheters. The reloadable weaves retain the same construction and are made of the same materials as the preloaded weave. Therefore, the reloadable weaves have the same construction to the preloaded weaves. Also, for both Inner and Outer Catheters are coaxial single lumen metallic/polymeric composites. The WOLF Thrombectomy V System does not require an aspiration source to engage the clot. Both the WOLF Thrombectomy V System and the WOLF device are delivered through the femoral artery or vein or other targeted vessel, provide delivery of contrast, and contain radiopague markers for visualization under fluoroscopy. Both devices are used with introducer sheaths and the WOLF Thrombectomy V System has been tested for compatibility with the appropriate accessories in preclinical (animal) testing and simulated use design validation testing. ## Biocompatibility Testing The WOLF Thrombectomy V System was subjected to the following biocompatibility testing per the ISO-10993-1 standard: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, hemolysis, complement activation and thromboresistance. The results showed that the WOLF Thrombectomy V System meets biocompatibility requirements of the ISO standard. {5}------------------------------------------------ ## 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 V System at a sterility assurance level of 10°. #### Package Integrity After Aging and Distribution Packaging was verified to protect the WOLF Thrombectomy V System adequately to ensure product function throuqhout the claimed shelf life and after exposure to the storage and distribution environment. #### Animal Testing The WOLF Thrombectomy V System was subjected to acute and chronic animal study to compare the safety of the WOLF device to a control device. The study was conducted per the US Food and Drug Administration, 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. The purpose of this study was to assess the following safety endpoints: 1. The angiographic assessment of the vessel (presence or absence of dissection or perforation) due to use of the test article in the treated vessels. 2. The histopathological assessment of the vessel (degree of trauma and healing) due to use of the test article compared to vessels treated with the control. The device passed all acceptance criteria outlined in the study protocol and should be deemed acceptable for clinical use. ## Conclusions The WOLF Thrombectomy V System and its predicate device have the same intended use and similar technological characteristics. The differences do not raise new questions of safety or effectiveness. Performance testing further demonstrates that the device is substantially equivalent to the predicate for its intended use.