SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. May 29, 2024 DeVoro Medical, Inc. Aaron Lynch Regulatory Affairs Specialist II 10700 Bren Rd W Minnetonka, Minnesota 55343 Re: K241207 Trade/Device Name: SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: April 30, 2024 Received: April 30, 2024 Dear Aaron Lynch: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Gregory Gregorv W. W. O'connell -S Date: 2024.05.29 15:54:50 O'connell -S 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) K241207 #### Device Name SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01); SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) Indications for Use (Describe) The SmartClaw Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature. 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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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}------------------------------------------------ ## 510(k) Summary for K241207 Per 21 CFR §807.92 | Sponsor | DeVoro Medical, Inc.<br>10700 Bren Rd W<br>Minnetonka, MN 55343-9679 | |-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and<br>Information | Aaron Lynch<br>Regulatory Affairs Specialist II<br>One Scimed Place<br>Maple Grove, MN 55311-1566 Phone: (508) 521-4235<br>Email: aaron.lynch@bsci.com | | Date Prepared | May 24, 2024 | | Proprietary Name | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01),<br>SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) | | Common Name | Catheter, Embolectomy<br>Peripheral Mechanical Thrombectomy with Aspiration | | Primary Product<br>Code | QEW | | Classification | Class II, 21 CFR Part 870.5150 | | Predicate Device | WOLF Thrombectomy™ SmartClaw Catheter (K221391), cleared on<br>November 10, 2022 | | Device Description | The SmartClaw™ Thrombectomy Catheter is a mechanical<br>thrombectomy catheter designed to work with commercially available<br>sheaths sized 8F or larger. The device consists of an inner catheter<br>shaft, outer catheter shaft, heat set nitinol braid, and an actuation<br>handle attached to the proximal ends of the shafts. There are two<br>device configurations that differ only in length of the expandable nitinol<br>braided basket. The two configurations are identified by the maximum<br>diameter of the expanded basket (20 mm, 32 mm).<br>The SmartClaw™ Thrombectomy Catheter is introduced through a<br>commercially available sheath sized 8F or larger and delivered to the<br>targeted vessel location under fluoroscopy and standard endovascular<br>techniques using a commercially available guidewire. After it is<br>delivered to the targeted vessel location, the catheter's distal nitinol<br>basket is expanded by moving the handle slider proximally.<br>Fluoroscopic guidance is used to ensure the expanded basket achieves<br>a 1:1 ratio with the vessel diameter. Subsequently, the SmartClaw™<br>Thrombectomy Catheter is retracted proximally to pull loosened clot<br>towards the sheath. Then, the clot is removed from the patient via<br>aspiration or another commercially available clot removal method as<br>appropriate for procedure requirements. After the clot is removed, the<br>catheter's distal nitinol basket is collapsed, and the SmartClaw™<br>Thrombectomy Catheter is withdrawn from the targeted vessel location<br>through the sheath. | | Intended Use of<br>Device | Removal of thromboemboli from the peripheral vasculature | | Indications for Use | The SmartClaw™ Thrombectomy Catheter is indicated for the non-<br>surgical removal of thrombi and emboli from the peripheral vasculature. | | Device Technology<br>Characteristics and<br>Comparison to<br>Predicate Device | The SmartClaw™ Thrombectomy Catheter incorporates substantially<br>equivalent design, packaging, fundamental technology, and intended<br>use as those featured in the predicate, the WOLF Thrombectomy™<br>SmartClaw Catheter (K221391). The subject device's indications for<br>use are being modified to remove reference to the WOLF<br>Thrombectomy Aspiration Sheath, 14F (K210911), thereby allowing the<br>SmartClaw™ Thrombectomy Catheter to be used with commercially<br>available sheaths sized 8F or larger. | {4}------------------------------------------------ | Characteristic | Subject Device<br>SmartClaw™ Thrombectomy Catheter | Predicate Device<br>WOLF Thrombectomy™ SmartClaw<br>Catheter (K221391) | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Removal of thromboemboli from the<br>peripheral vasculature | Identical | | Indications for Use | The SmartClaw™ Thrombectomy Catheter<br>is indicated for the non-surgical removal of<br>thrombi and emboli from the peripheral<br>vasculature. | The WOLF Thrombectomy™ SmartClaw<br>Catheter, in conjunction with the WOLF<br>Thrombectomy Aspiration Sheath, 14F, is<br>indicated for:<br>The non-surgical removal of thrombi<br>and emboli from arterial and venous<br>blood vessels in the peripheral<br>vasculature.Injection, infusion, and/or aspiration of<br>contrast media and other fluids into or<br>from a blood vessel. | | Device Class | Class II per 21 CFR 870.5150 | Identical | | Catheter Design | Outer catheter shaft, inner catheter shaft,<br>heat set nitinol braid, and actuation handle | Identical | | Effective Length | 145 cm | 115 cm | | How provided | Sterile, single use | Identical | | Sheath<br>Compatibility | Commercially available sheaths sized 8F or<br>larger | WOLF Thrombectomy Aspiration Sheath,<br>14F (K210911) | | Guidewire<br>Compatibility | Compatible with 0.035 in (0.89 mm)<br>guidewire | Identical | {5}------------------------------------------------ | Characteristic | Subject Device<br>SmartClaw™ Thrombectomy Catheter | Predicate Device<br>WOLF Thrombectomy™ SmartClaw<br>Catheter (K221391) | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operating Principle/<br>Mechanism of<br>Action | The SmartClaw™ Thrombectomy Catheter<br>is delivered through a commercially<br>available sheath of appropriate size (≥ 8F)<br>into or beyond the clot. The SmartClaw™<br>Thrombectomy Catheter is expanded to the<br>vessel diameter via actuation of the handle<br>slider. The SmartClaw™ Thrombectomy<br>Catheter is retracted proximally to pull<br>loosened clot towards the sheath. Then, the<br>clot is removed from the patient via<br>aspiration or another commercially available<br>clot removal method as appropriate for<br>procedure requirements. | The WOLF Thrombectomy™ SmartClaw<br>Catheter is delivered through the WOLF<br>Sheath past the clot location. The WOLF<br>Thrombectomy™ SmartClaw Catheter is<br>expanded to the vessel diameter via<br>actuation of the handle slider. The WOLF<br>Thrombectomy™ SmartClaw Catheter is<br>pulled moving the thrombus towards the<br>WOLF Sheath. The clot is removed via the<br>WOLF Sheath and/or the WOLF<br>Thrombectomy System. | | Visualization | Radiopaque marker band, basket visible<br>under fluoroscopy | Identical | | Non-clinical<br>Performance Data | Determination of substantial equivalence is based on an assessment<br>of non-clinical performance data. | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Non-clinical performance data includes bench-top performance<br>evaluations and packaging validations. | | | <b>Bench Testing:</b><br>Bench testing was performed to evaluate physical integrity,<br>functionality and performance of the catheter. Performance criteria<br>includes: visual inspection; dimension requirements; mechanical<br>integrity; fluid leakage; kink resistance; torsion; and guidewire and<br>sheath compatibility. | | | <b>Packaging Validation:</b><br>The integrity of the packaging configuration was evaluated in<br>accordance with ISO 11607-1 and ISO 11607-2. Testing was<br>conducted on fully packaged units after ethylene oxide sterilization,<br>climatic conditioning, and distribution challenge conditioning. | | | The results of these tests demonstrate the subject device has been<br>designed and tested to assure conformance to the requirements for<br>its intended use. No new safety or performance issues were raised<br>during the testing. | | Clinical Testing | Clinical studies are not required to demonstrate substantial<br>equivalence of the SmartClaw Thrombectomy Catheter. | | Conclusion | Based on the indications for use, technological characteristics, and<br>performance testing, the SmartClaw Thrombectomy Catheter has<br>been shown to be appropriate for its intended use and is considered<br>substantially equivalent to the WOLF Thrombectomy SmartClaw<br>Catheter (K221391). |