Tigertriever 17 Ultra Revascularization Device

{0} FDA U.S. FOOD & DRUG ADMINISTRATION October 6, 2025 Rapid Medical Ltd. Ina Gutman QA/RA Senior Director Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel Re: K251603 Trade/Device Name: Tigertriever 17 Ultra Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 4, 2025 Received: September 4, 2025 Dear Ina Gutman: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251603 - Ina Gutman Page 2 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). 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 QS 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 (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-reporting-combination-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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K251603 - Ina Gutman Page 3 assistance/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 -S Naira Muradyan, PhD 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 {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251603 | | | Device Name Tigertriever 17 Ultra Revascularization Device | | | Indications for Use (Describe) The Tigertriever 17 Ultra Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug 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) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." | | {4} Rapid Medical # 510(k) Summary K251603 ## Submission Sponsor Rapid Medical Ltd. Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel Company Phone No.: +972-72-250-3331 ## Contacts Ina Gutman, QA/RA Senior Director Email: ina.gutman@rapid-medical.com Ronen Eckhouse, CEO Email: ronen@rapid-medical.com ## Date Prepared August 26, 2025 ## Device Identification Trade/Proprietary Name: Tigertriever 17 Ultra Revascularization Device Common/Usual Name: Catheter, Thrombus Retriever Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY Device Class: II Classification Panel: Neurology ## Legally Marketed Predicate and Reference Devices Predicate Device: Tigertriever 17 Revascularization Device (K203592) Reference Device: Solitaire X Revascularization Device (K203358) ## Indications for Use Statement The Tigertriever 17 Ultra Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. {5} Rapid Medical # Device Description The Tigertriever 17 Ultra Revascularization Device (TRPP7266) is a line extension of the existing Tigertriever 17 Revascularization Device (TRPP7166) cleared under K203592. The Tigertriever 17 Ultra Revascularization Device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 17 Ultra Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke. # Comparison of Technological Characteristics The subject device has the same principles of operation and indication for use as the predicate device. The subject device has different technological characteristics compared to the predicate device, the Tigertriever 17 Revascularization Device, namely a longer mesh length and a slightly larger microcatheter compatibility. Both stentriever models are comprised of a nitinol braided mesh, stainless steel shaft, nitinol core wire, and a handle. The table below compares the indications for use, principles of operation, technological characteristics, and materials of the Tigertriever 17 Ultra Revascularization Device with that of the predicate device (the Tigertriever 17 Revascularization Device). The technological differences of the Tigertriever 17 Ultra Revascularization Device do not raise any new questions of safety or effectiveness compared to the predicate device. | | Tigertriever 17 Ultra Revascularization Device (TRPP7266, Subject Device) | Tigertriever 17 Revascularization Device (TRPP7166, Predicate Device) | | --- | --- | --- | | 510(k) Number | K251603 | K203592 | | Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 | | Product Code | NRY | NRY | {6} Rapid Medical | | Tigertriever 17 Ultra Revascularization Device (TRPP7266, Subject Device) | Tigertriever 17 Revascularization Device (TRPP7166, Predicate Device) | | --- | --- | --- | | Indications for Use | The Tigertriever 17 Ultra Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. | The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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. | | Anatomical Location | Neurovasculature | Neurovasculature | | Mode of Operation | Manual expansion of the braided distal portion into the clot using the handle component | Manual expansion of the braided distal portion into the clot using the handle component | | Design of Distal Portion | Close end braided nitinol mesh, manually expandable | Close end braided nitinol mesh, manually expandable | | Stent Length (Unexpanded Configuration) | 32 mm | 23 mm | | Stent Distal OD (Unexpended and Expanded Configurations) | Unexpanded configuration 0.5 mm Expanded configuration 3 mm | Unexpanded configuration 0.5 mm Expanded configuration 3 mm | | Overall Length | 224 cm | 200 cm | | Microcatheter Compatibility | Microcatheter with a minimum inner diameter of 0.017 inches | Microcatheter with a minimum inner diameter of 0.0165 inches | | Accessory Devices | Two insertion loading sheaths are provided, one is located on the device mesh and one is provided within the product package. | Three insertion loading sheaths are provided, one is located on the device mesh and two are provided within product package. | | Stent (Mesh) Material | Nitinol | Nitinol | | Markers Material | 90% Platinum/ 10% Iridium | 90% Platinum/ 10% Iridium | | Core Wire Material | Nitinol core wire coated with Green Lubriskin PTFE | Nitinol core wire coated with Green Lubriskin PTFE | 3 {7} Rapid Medical | | Tigertriever 17 Ultra Revascularization Device (TRPP7266, Subject Device) | Tigertriever 17 Revascularization Device (TRPP7166, Predicate Device) | | --- | --- | --- | | Shaft Material | 304 Stainless Steel | 304 Stainless Steel | | Insertion Loading Sheath Material | PTFE (Natural color) | PTFE (Natural color) | | Sterilization Method | Ethylene oxide | Ethylene oxide | | Single Use | Yes | Yes | | Packaging | Placed into a Dispenser hoop, blister, Tyvek pouch, and Carton box | Placed into a Dispenser hoop, blister Tyvek pouch, and Carton box | # Non-Clinical Performance Data In order to demonstrate safety and effectiveness of the subject device and to show substantial equivalence to the predicate device, Rapid Medical Ltd. completed a number of non-clinical tests. # Bench Tests The device passed all performance bench testing in accordance with internal requirements, national standards and international standards as shown in the table below to support substantial equivalence of the device. | Performance Bench Testing | | | | --- | --- | --- | | Test | Test Method Summary | Results | | Simulated Use | Simulated use testing of the Tigertriever 17 Ultra Revascularization Device was performed in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the device at retrieval of firm and soft clots. | The subject device retrieved clots and restored flow in the test model. | | Radial Force | The radial force of the subject device was measured within a range of lumen diameters applicable to the intended vasculature and compared with the radial forces measured for the predicate device. | The radial force of the subject device when tested in applicable lumen sizes is comparable to the predicate device. | | Durability Testing | Damage was evaluated after delivery and withdrawal of the device beyond the number of passes and resheathings recommended in the instructions for use. | Devices tested demonstrated no damage after delivery and withdrawal testing. | {8} Rapid Medical | Delivery, Deployment and Retrieval forces | The forces required to deliver, deploy, and retrieve the device were evaluated in an in vitro neurovascular model. | The subject device demonstrated acceptable performance with respect to delivery, deployment and retrieval. | | --- | --- | --- | | Torque Strength Testing | The ability of the device to endure turns without failure was evaluated. | All devices passed acceptance criteria. | | Dimensions Test | Test samples were examined to verify that the dimensions of the Tigertriever 17 Ultra devices are in compliance with specifications. | All devices passed acceptance criteria. | | Tip Flexibility | The tip deflection maximum force of the device was evaluated. | All devices passed acceptance criteria and were comparable to the predicate device. | | Kink Resistance Testing | Kink resistance is tested along the device. | All devices passed acceptance criteria. | | Tensile Strength | The tensile strength was tested for all joints. | All devices passed acceptance criteria. | | Particulates Evaluation | The number and size of particulates following simulated use of the device in a neurovascular model were evaluated. | The particulate generated by the subject device was similar to the particulate generated by the predicate device. | | Austenite Finish (Af) Temperature Evaluation | Data from predicate submission is used because of similarities in device design. | All devices passed acceptance criteria. | | Corrosion Resistance | Data from predicate submission is used because of similarities in device design. | All devices passed acceptance criteria. | # Biocompatibility Biocompatibility testing conducted supports the biocompatibility of the Tigertriever 17 Ultra Revascularization Device in accordance with ISO 10993 and consisted of the following tests conducted on various models of the Tigertriever devices, which were considered worst-case in terms of overall design and included the same materials and manufacturing processes as the Tigertriever 17 Ultra Revascularization Device: {9} Rapid Medical | Test | Test Description | Result Summary | Conclusion | | --- | --- | --- | --- | | Cytotoxicity | Cytotoxicity Study using MEM Elution | The test article extract showed no evidence of causing cell lysis or toxicity. The test article showed no cytotoxic potential. | Pass | | Irritation (Intracutaneous Reactivity) | ISO Intracutaneous Irritation Study using extracts | Test article met the requirements of the test with no differences between each test article extract overall mean score and corresponding control extract mean score. | Pass | | Sensitization | ISO Guinea Pig Maximization Sensitization Test | Test articles showed no evidence of causing delayed dermal contact sensitization. Test article is not considered a sensitizer. | Pass | | Hemocompatibility – Hemolysis | ASTM Hemolysis Study – Extract and Direct Contact | The test articles in direct and indirect contact with blood were non-hemolytic. | Pass | | Hemocompatibility – Complement Activation | SC5b-9 Complement Activation Assay | The test article was not considered to be a potential activator of the complement system. | Pass | | Hemocompatibility – Thrombogenicity | Acute Pre-Clinical Evaluation of the Safety of Tigertriever device in a Swine Model Thrombogenicity | Data from predicate submission is used. | Pass | 6 {10} Rapid Medical | Pyrogenicity | USP Rabbit Pyrogen Study, Material Mediated | The total rise of rabbit temperatures during the observation period was within acceptable USP limits. The test article was judged as nonpyrogenic. | Pass | | --- | --- | --- | --- | | Acute Systemic Toxicity | ISO Acute Systemic Toxicity in Mice | No mortality or evidence of systemic toxicity from extracts injected into mice. | Pass | All tests confirmed that the Tigertriever 17 Ultra Revascularization Device met biological safety requirements per the ISO 10993 standard. ## Pre-Clinical Animal Testing Data No animal studies were conducted, as substantial equivalence of the Tigertriever 17 Ultra Revascularization Device to the predicate device is established through the results of non-clinical performance testing. ## Sterilization and Shelf Life The subject device and its accessories are sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of $1 \times 10^{-6}$ in accordance with ISO 11135: 2014/AC: 2014 (“Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices”). The subject device and package shelf-life studies established that the subject device and packaging remain functional for the labeled expiration date. ## Clinical Performance Data No clinical studies were conducted, as substantial equivalence of the Tigertriever 17 Ultra Revascularization Device to the predicate device is established through the results of non-clinical performance testing. ## Statement of Substantial Equivalence The Tigertriever 17 Ultra Revascularization Device has the same intended use, indications for use, and similar technological characteristics as the predicate Tigertriever 17 Revascularization Device. The technological differences do not raise new questions regarding the safety or effectiveness. Performance data demonstrate that the subject Tigertriever 17 Ultra Revascularization Device is substantially equivalent to the predicate device.