Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 14, 2026 Maduro Medical, Inc. Janice Kemp Director RA/QA 983 University Avenue Building A Los Gatos, California 95032 Re: K261089 Trade/Device Name: Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 5, 2026 Received: August 11, 2026 Dear Janice Kemp: 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} K261089 - Janice Kemp 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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} K261089 - Janice Kemp 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261089 | ? | | Please provide the device trade name(s). | | ? | | Radical 064 Reperfusion Catheter;Radical 076 Reperfusion Catheter;Radical Aspiration Tubing Kit | | | | Please provide your Indications for Use below. | | ? | | Radical 064 Reperfusion CatheterThe Radical 064 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.Radical 076 Reperfusion CatheterThe Radical 076 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.Radical Aspiration Tubing KitThe Radical Aspiration Tubing Kit is intended to connect the Radical Reperfusion Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} MADURO # 510(k) SUMMARY # K261089 Manufacturer/Sponsor: Maduro Medical, Inc. 983 University Avenue Building A Los Gatos, California 95032 Phone: (408) 600-2235 Contact: Janice Kemp QA/RA Director (408) 600-2235 janice@maduromed.com Date Prepared: August 05, 2026 Device Trade Name: Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit Common/Usual Name: Catheter, Thrombus Retriever Classification: 21 CFR 870.1250, Percutaneous Catheter Class: II Product Code: NRY Predicate Device: AXS Vecta Aspiration System (K191768) Reference Device: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K152541) Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601) Penumbra System (Modified 110 Aspiration Tubing) (K182522) Penumbra System (Reperfusion Catheter RED 62) (K203440) Zoom System (K242672) Riptide Aspiration System (React 71 Catheter) (K182101) # Indications for Use Radical 064 Reperfusion Catheter The Radical 064 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. 1 {5} MADURO Radical 076 Reperfusion Catheter The Radical 076 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. Radical Aspiration Tubing Kit The Radical Aspiration Tubing Kit is intended to connect the Radical Reperfusion Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. # Device Description The Radical 064 and 076 Reperfusion Catheters are sterile, single-use intravascular catheters intended to remove thrombus from a patient's neurovasculature with the aid of a vacuum pump and the Radical Aspiration Tubing Kit (ATK). The Radical 064 Reperfusion Catheter has a usable length between 125 cm and 140 cm, and an inner diameter (ID) size designation of 0.064". The Radical 076 Reperfusion Catheter has a usable length between 125 cm and 140 cm, and an ID size designation of 0.076". The catheters have polymer ribbon and coil technologies to maintain stability and vary stiffness while eliminating discrete transitions throughout the device length. The proximal end of the catheter is bonded to a luer connector hub. The distal end includes a hydrophilic coating, radiopaque marker, and atraumatic tip. The Radical Aspiration Tubing Kit is a sterile, single-use accessory device that helps the Radical 064 and 076 Reperfusion Catheters remove thrombus from a patient's neurovasculature with the aid of a vacuum pump system with a collection canister. The Radical Aspiration Tubing Kit is a 112" long extension tubing assembly with an on/off flow switch that connects the hub of the Radical 064 or 076 Reperfusion Catheter to the canister of a commercially available vacuum pump system. # Comparison of Technological Characteristics with the Predicate Device The predicate device, AXS Vecta Aspiration System, cleared under K191768 and the subject devices, Radical Reperfusion Catheters and ATK, share the same intended use and basic technological characteristics. A comparison of the technological characteristics of the subject, predicate and reference devices is shown in Table 1. 2 {6} MADURO Table 1: Comparison of Subject, Predicate, and Reference Devices | Device Attribute | Subject Device | Predicate Device | Reference Device | | --- | --- | --- | --- | | Product Name | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | AXS Vecta Aspiration System | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | | 510(k) Number | K261089 | K191768 | K243601 | | Indications for Use | The Radical 064 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Radical 076 Reperfusion Catheter, with a compatible aspiration pump and the Radical Aspiration Tubing Kit, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. | The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t- PA) or who failed IV t-PA therapy are candidates for treatment. | The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. | 3 {7} MADURO | Device Attribute | Subject Device | Predicate Device | Reference Device | | --- | --- | --- | --- | | Product Name | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | AXS Vecta Aspiration System | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | | | Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Radical Aspiration Tubing Kit is intended to connect the Radical Reperfusion Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. | | | | Product Code | NRY | NRY | NRY | | Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | | Classification | Class II | Class II | Class II | | Components Supplied | Catheter, Rotating Hemostasis Valve (RHV), ATK | Catheter, Scout Introducer, x2 Peel-Away Introducers, RHV, AXS Universal Aspiration Tubing, AXS Universal Liner Set | Catheter, Delivery Catheter, Base Camp Sheath, Aspiration Tubing Set, Dilator, Navigating Catheter, RHV | | Catheter Shaft Material | Polyurethane, Pebax, Nylon | Vestamid, Pebax | Polymers and metals commonly used in the manufacture of medical devices. | | Inner Liner | PTFE | Same | Polymers commonly used in the manufacture of medical devices. | | Hub Material | Polypropylene Copolymer | Nylon | Polymers commonly used in the manufacture of medical devices. | | Strain Relief | Polyolefin | Same | Polymers commonly used in the manufacture of medical devices. | | Catheter Shaft Reinforcement | Braid: 304V Stainless Steel | Stainless Steel/Nitinol | Metals commonly used in the | 4 {8} MADURO | Device Attribute | Subject Device | Predicate Device | Reference Device | | --- | --- | --- | --- | | Product Name | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | AXS Vecta Aspiration System | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | | | Coil: 304V Stainless Steel | | manufacture of medical devices. | | Lubricious Coating | Hydrophilic Coating | Same | Polymers commonly used in the manufacture of medical devices. | | Radiopaque Marker Band | Platinum/Iridium | Same | Metals commonly used in the manufacture of medical devices. | | RHV | Polycarbonate, Silicone | Same | Polymers commonly used in the manufacture of medical devices. | | Working Length | 125, 130, 135, 140 cm | 115, 125, 132 cm | 88 Aspiration Catheter: 143 cm 70 Aspiration Catheter: 142 cm | | Inner Diameter | Radical 064: 0.064" Radical 076: 0.076" | Vecta 71: 0.071" Vecta 74: 0.074" | 88 Aspiration Catheter: 0.088" 70 Aspiration Catheter: 0.070" | | Outer Diameter | Radical 064: 0.076" distal 0.078" proximal Radical 076: 0.089" distal 0.091" proximal | Vecta 71: 0.082" distal 0.085" proximal Vecta 74: 0.083" distal 0.087" proximal | 88 Aspiration Catheter: 0.101" distal 0.105" proximal 70 Aspiration Catheter: 0.082" distal 0.087" proximal | | Packaging | Tyvek/Nylon/Polyethylene (PE) pouch, PE tube, polypropylene clip, packaging card, SBS carton | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | Unknown | | Sterilization | Ethylene Oxide (EO) SAL 10^{-6} | Same | Same | | Pyrogenicity | Nonpyrogenic | Same | Same | | Number of Uses | Single use | Same | Same | | ATK Materials | Polyurethane, Nylon, PVC, Silicone, Acetal, ABS | Unknown | Polyurethane, Nylon, Polycarbonate and PVC | 5 {9} MADURO | Device Attribute | Subject Device | Predicate Device | Reference Device | | --- | --- | --- | --- | | Product Name | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | AXS Vecta Aspiration System | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | | ATK Inner Diameter | 0.110” | 0.218” | 0.110” | | ATK Total Length | 112” | 300 cm | 112” | 6 {10} MADURO ## Nonclinical Performance Testing The following nonclinical performance testing was conducted to demonstrate substantial equivalence. ### Bench Testing Table 2 and Table 3 list the bench testing performed to demonstrate substantial equivalence of the Radical 064 and 076 Reperfusion Catheters and the Radical Aspiration Tubing Kit to the predicate device. Table 2: Radical Reperfusion Catheter Bench Testing Summary | Radical Reperfusion Catheters | | | | --- | --- | --- | | Test | Test Method/Applicable Standard | Result | | Visual Inspection | Visual inspection completed for surface defects. | **Pass** All samples met the pre-determined acceptance criteria | | Dimensional Inspection | Critical dimensions were verified. | **Pass** All samples met the pre-determined acceptance criteria | | Simulated Use Test | Functionality of devices in a clinically relevant benchtop model was evaluated. | **Pass** All samples met the pre-determined acceptance criteria | | PTFE Delamination | Assessed for PTFE delamination following simulated use. | **Pass** All samples met the pre-determined acceptance criteria | | Tensile Testing | Tensile strength measured along entire catheter length. | **Pass** All samples met the pre-determined acceptance criteria | | Kink Resistance | Resistance to kink tested at various locations. | **Pass** All samples met the pre-determined acceptance criteria | | Catheter Burst | Catheter burst tested per ISO 10555-1. | **Pass** All samples met the pre-determined acceptance criteria | | Liquid Leak Test | Liquid leak tested per ISO 10555-1. | **Pass** All samples met the pre-determined acceptance criteria | | Air Leak Test | Air leak tested per ISO 10555-1. | **Pass** All samples met the pre-determined acceptance criteria | | Corrosion Resistance | Corrosion resistance tested per ISO 10555-1. | **Pass** All samples met the pre-determined acceptance criteria | | Hub Compatibility Testing | Tested per ISO 80369-7. | **Pass** All samples met the pre-determined acceptance criteria | 7 {11} MADURO | Radical Reperfusion Catheters | | | | --- | --- | --- | | Test | Test Method/Applicable Standard | Result | | Particulate | The size and quantity of particulates generated during simulated use were evaluated. | **Pass** All samples met the pre-determined acceptance criteria | | Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after simulated use. | **Pass** All samples met the pre-determined acceptance criteria | | Positive Flowrate | Positive pressure flowrate tested per ISO 10555-1. | **Pass** All samples met the pre-determined acceptance criteria | | Vacuum Flowrate | Flowrate measured at specified vacuum pressures. | **Pass** All samples met the pre-determined acceptance criteria | | Vacuum Force | Force at the tip of the catheter when under vacuum was assessed. | **Pass** All samples met the pre-determined acceptance criteria | | Dynamic Burst | Mechanical integrity was assessed under pressure. | **Pass** All samples met the pre-determined acceptance criteria | | Tip Stiffness | Test specimens were tested for tip flexibility. | **Pass** All samples met the pre-determined acceptance criteria | | Torque Strength | The test specimens were rotated to evaluate integrity after rotation. | **Pass** All samples met the pre-determined acceptance criteria | Table 3: Radical Aspiration Tubing Kit Bench Testing Summary | Radical Aspiration Tubing Kit | | | | --- | --- | --- | | Test | Test Method/Applicable Standard | Result | | Visual Inspection | Visual inspection completed for surface defects. | **Pass** All samples met the pre-determined acceptance criteria | | Dimensional Inspection | Critical dimensions were verified. | **Pass** All samples met the pre-determined acceptance criteria | | Simulated Use Test | Functionality of units was evaluated. | **Pass** All samples met the pre-determined acceptance criteria | | Flow Switch Functionality | Ability to cycle fluid flow on and off under vacuum was tested. | **Pass** All samples met the pre-determined acceptance criteria | | Vacuum Leakage | Leakage under vacuum was tested. | **Pass** All samples met the pre-determined acceptance criteria | 8 {12} [Non-Text] MADURO | Radical Aspiration Tubing Kit | | | | --- | --- | --- | | Test | Test Method/Applicable Standard | Result | | Tubing Collapse | Test specimens were tested for lumen patency under vacuum. | PassAll samples met the pre-determined acceptance criteria | | Kink/Pinch Resistance | Resistance to kink and pinch was tested. | PassAll samples met the pre-determined acceptance criteria | | Tensile Testing | Tensile strength measured along entire device length. | PassAll samples met the pre-determined acceptance criteria | | Vacuum Flowrate | Flowrate measured at specified vacuum pressures. | PassAll samples met the pre-determined acceptance criteria | ### Biocompatibility In accordance with ISO 10993-1 and FDA guidance, “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”,” the Radical 064 and 076 Reperfusion Catheters are categorized as limited exposure ( \( \leq \) 24 hours), externally communicating devices with circulating blood contact and the Radical Aspiration Tubing Kit is categorized as limited exposure ( \( \leq \) 24 hours), surface-contacting with intact skin surfaces only. These subject devices are constructed using materials that are commonly used in the medical device industry. Therefore, based on risk analysis, the following tests were performed to confirm biocompatibility of the subject devices (Table 4 and Table 5). Table 4: Radical Reperfusion Catheters Biocompatibility Tests and Results | Radical Reperfusion Catheters | | | | --- | --- | --- | | Tests | Results | Conclusion | | Cytotoxicity Assay (ISO MEM Elution) | Grade=0 (Reactivity None) | Pass | | Maximum Sensitization | All test group grades were 0. | Pass | | Irritation: Intracutaneous Reactivity | The difference between the average scores for the extract of the test article and the control is ≤ 1.0. | Pass | | Acute Systemic Toxicity (ISO) | No mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | Pass | | Material-Mediated Pyrogenicity | No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. Test article met the requirements for the absence of pyrogens. | Pass | 9 {13} [Non-Text] MADURO | Radical Reperfusion Catheters | | | | --- | --- | --- | | Tests | Results | Conclusion | | Hemolysis (ASTM Direct and Indirect) | Non-hemolytic. The measured hemolytic index values met the predefined acceptance criteria, and no hemolytic response was observed. | Pass | | Complement Activation | Test device was a non-activator of the complement system. | Pass | | Thrombogenicity in Canine Model | An in vivo canine test to evaluate the thrombogenic potential of the subject device compared to a comparator device. | Pass | Table 5: Radical Aspiration Tubing Kit Biocompatibility Tests and Results | Radical Aspiration Tubing Kit | | | | --- | --- | --- | | Tests | Results | Conclusion | | Cytotoxicity Assay (ISO MEM Elution) | Grade=0 (Reactivity None) | Pass | | Maximum Sensitization | All test group grades were 0. | Pass | | Irritation: Intracutaneous Reactivity | The difference between the average scores for the extract of the test article and the control is ≤ 1.0. | Pass | ### Animal Testing The Radical 064 and 076 Reperfusion Catheters were each evaluated in a separate Good Laboratory Practice (GLP) animal study for the purpose of demonstrating usability, performance, and safety in a porcine model in comparison to a cleared control aspiration catheter system. The Radical 064 Reperfusion Catheter and Radical Aspiration Tubing Kit were evaluated against the Penumbra ACE064 Aspiration Catheter and Penumbra Indigo Aspiration Tubing and the Radical 076 Reperfusion Catheter was evaluated against the predicate, the Stryker AXS Vecta 74 Intermediate Aspiration Catheter. Assessments included soft and firm experimental clot aspiration, worst-case wedge aspiration without clot, stent retriever pass-through compatibility (Radical 064 only), device usability, and thrombogenicity. Animals were survived to subacute (2–4 days) and chronic (27–29 days) timepoints. At termination, comprehensive necropsies were performed, and treated vessels and downstream organs were evaluated via gross pathology and histopathology. Both subject catheters met all predefined safety, performance, usability, and thrombogenicity acceptance criteria. Vascular responses were within acceptable limits for this preclinical model and were comparable between the subject and control devices at both timepoints. ### Sterilization The Radical Reperfusion Catheters and Radical Aspiration Tubing Kit are sterilized using a validated ethylene oxide (EO) process with a sterility assurance level (SAL) of \( 10^{-6} \) . 10 {14} MADURO ### **Shelf Life and Packaging** Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance. Accelerated aging equivalent to 1-year of real time shelf life was used to support a 1-year shelf-life claim for the Radical 064 and Radical 076 Reperfusion Catheters. Accelerated aging and real time aging equivalent to 3-years of shelf life was used to support a 3-year shelf-life claim for the Radical Aspiration Tubing Kit. Device performance was verified by functional testing. ### **Clinical Testing** The non-clinical testing was determined to be sufficient to support the substantial equivalence of the subject device. ### **Conclusion** The subject Radical 064 and 076 Reperfusion Catheters and Radical Aspiration Tubing Kit have similar intended use, indications for use, principles of operation, and technological characteristics as the predicate device. The technological differences identified do not raise new questions of safety or effectiveness between the subject and predicate devices. Performance testing demonstrates that the Radical 064 and 076 Reperfusion Catheters and Radical Aspiration Tubing Kit perform as intended and are substantially equivalent to the predicate device. 11