Zoom 4S Catheter

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 28, 2026 Imperative Care, Inc. Peter Taylor Principal Regulatory Affairs Specialist 1359 Dell Avenue Campbell, California 95008 Re: K261176 Trade/Device Name: Zoom 4S Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: July 24, 2026 Received: July 27, 2026 Dear Peter Taylor: 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} K261176 - Peter Taylor 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} K261176 - Peter Taylor 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. | K261176 | ? | | Please provide the device trade name(s). | | ? | | Zoom 4S Catheter | | | | Please provide your Indications for Use below. | | ? | | The Zoom 4S Catheter is indicated for the introduction of interventional devices into the neuro vasculature. | | | | 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} # **510(k) Summary** 510(k) #: K261176 # **I. SUBMITTER** Submitter's Name: Imperative Care, Inc. Address: 1359 Dell Avenue Campbell, CA 95008 Contact Person: Peter Taylor Telephone: 831-227-4810 Email: ptaylor@imperativecare.com Date of Preparation: July 24, 2026 # **II. DEVICE** Proprietary Names: Zoom™ 4S Catheter Common/Usual Name: Percutaneous Catheter Classification Name: Percutaneous Catheter Regulatory Class: II Product Code: QJP Regulation: 21 CFR 870.1250 # **III. PREDICATE DEVICE** Proprietary Name: AXS Vecta 46 Intermediate Catheter Common/Usual Name: Percutaneous Catheter Classification Name: Percutaneous Catheter Product Code: QJP Regulation: 21 CFR 870.1250 Manufacturer: Stryker Neurovascular 510(k) #: K202752 # **IV. REFERENCE DEVICE** Proprietary Names: Zoom System (Zoom™ 4S Catheter) Common/Usual Name: Catheter, Thrombus Retriever Classification Name: Percutaneous Catheter Product Code: NRY Regulation: 21 CFR 870.1250 Manufacturer: Imperative Care, Inc. 510(k) #: K252046 Page 1 of 8 {5} # V. DEVICE DESCRIPTION The Zoom™ 4S Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The Zoom™ 4S Catheter has a luer hub on the proximal end. The Zoom™ 4S Catheter is compatible with guide catheters that have a minimum inner diameter of 0.071” and 0.014”-0.035” guidewires. A microcatheter with a maximum outer diameter of 0.040” may be used with the Zoom™ 4S Catheter to assist in accessing the target vasculature. The Zoom™ 4S Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the Zoom™ 4S Catheter and used to control hemostasis during use with other devices. # VI. INDICATIONS FOR USE The Zoom™ 4S Catheter is indicated for the introduction of interventional devices into the neuro vasculature. # VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE AND REFERENCE DEVICES The subject, predicate, and reference devices have similar technological characteristics, and equivalent performance characteristics, as demonstrated through bench testing. Table 1 provides a comparison of the subject Zoom 4S Catheter, predicate AXS Vecta 46 Intermediate Catheter (K202752), and reference Zoom 4S Catheter (K252046). Page 2 of 8 {6} **Table 1: Comparison of Technological Characteristics with Predicate and Reference Devices** | Description | Predicate Device | Subject Device | Reference Device | | --- | --- | --- | --- | | FDA Product Classification | Class II Product Code: QJP 21 CFR 870.1250 | Class II Product Code: QJP 21 CFR 870.1250 | Class II Product Code: NRY 21 CFR 870.1250 | | Product Name | AXS Vecta 46 Intermediate Catheter | Zoom 4S Catheter | Zoom System (Zoom 4S Catheter) | | 510(k) Number | K202752 | K261176 | K252046 | | Manufacturer | Stryker Neurovascular | Imperative Care, Inc. | Imperative Care, Inc. | | Indications for Use | The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The Zoom 4S Catheter is indicated for the introduction of interventional devices into the neuro vasculature. | The Zoom System, when used with the Zoom Aspiration Pump (or equivalent 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, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 4S, 45, 35) Catheter and the Zoom 88 Large Distal Platform, the Zoom 88 Large Distal Platform Support, or the TracStar LDP Large Distal Platform to the Zoom Canister or Zoom DuoPort Canister of the Zoom Aspiration Pump | Page 3 of 8 {7} | Description | Predicate Device | Subject Device | Reference Device | | --- | --- | --- | --- | | | | | (or equivalent vacuum pump) and to allow the user to control the fluid flow. | | Condition Supplied | Sterile, Single Use Only | Same | Same | | Sterilization Method | Ethylene Oxide (EO), SAL 10^{-6} | Same | Same | | Inner Diameter (Distal) | 0.046” | 0.045” | Same as Subject Device | | Outer Diameter (Distal) | 0.056” | 0.060” max | Same as Subject Device | | Inner Diameter (Proximal) | 0.046” | 0.045” | Same as Subject Device | | Outer Diameter (Proximal) | 0.058” | 0.062” max | Same as Subject Device | | Effective Working Length | 125cm 146cm 153cm 160cm | 125cm 144cm 160cm | Same as Subject Device | | Tip Design | Square edge, soft, flexible, and atraumatic | Angled edge, flexible, and atraumatic | Same as Subject Device | | Materials | Commonly used medical grade plastics & metals with hydrophilic coating | Same | Same | | Packaged Accessories | Peel-away Introducer, Rotating Hemostasis Valve | Rotating Hemostasis Valve (RHV) | Same as Subject Device | | Packaging Configuration | Pouch Backing Card Shelf Carton Shipper Box | Same | Same | | Shelf Life | 3 years | 1 year | Same as Subject Device | Page 4 of 8 {8} ## VIII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility Testing The device design, materials and manufacturing of the subject Zoom 4S Catheter and the reference Zoom 4S Catheter are identical, and the patient contact type and duration per International Standard ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process” is the same. Therefore, biocompatibility is unchanged from K252046. ### Non-clinical Bench Testing As the subject and reference devices are technologically identical, applicable performance testing previously completed on the reference device has been leveraged to support the substantial equivalence determination. A summary of the evaluated applicable performance specifications is presented in **Table 2**. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1. The test results were reviewed and found to demonstrate that there are no differences between the subject device and predicate device that would adversely affect the safety or effectiveness of the subject device, and to support a determination of substantial equivalence to the legally marketed predicate device. **Table 2: Tests and Performance Specifications for the Zoom 4S Catheter** | Test Attribute | Specification | Results | | --- | --- | --- | | Delivery (Trackability), Compatibility, and Retraction | The catheter shall be able to be delivered, deployed, and retracted per the IFU within a simulated neurological model without incurring any damage to the catheter. | Pass | | Distal Tip Flexibility | The flexibility of the catheter tip shall be comparable to competitive products. | Pass | | Visual Inspection | The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. | Pass | Page 5 of 8 {9} | Test Attribute | Specification | Results | | --- | --- | --- | | Dimensional (Distal ID, Proximal ID, Distal OD, Proximal OD) | All defined catheter dimensions are within the specified tolerances. | Pass | | Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass | | Freedom from Leakage – Positive Pressure | The catheter must remain leak free under specified test conditions. | Pass | | Freedom from Leakage – Negative Pressure | The catheter must remain leak free under specified test conditions. | Pass | | Dynamic Burst | The catheter must withstand pressure testing under dynamic flow conditions. | Pass | | Static Burst | The catheter shall meet criteria for static burst pressure testing. | Pass | | Catheter Torque Strength | With the catheter tip constrained from movement, the proximal end was rotated until failure. The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees). | Pass | | Kink Resistance | There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. | Pass | | Flexibility | The catheter needs to have acceptable flexure values for tracking in the vasculature. | Pass | | Compatibility with other Devices (External) | The catheter shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass | | Guidewire Compatibility | The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass | | Microcatheter / Intermediate Catheter Compatibility | The catheter shall be able to accommodate a microcatheter/intermediate catheter up to the maximum size indicated in the product labeling. | Pass | | Luer Compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass | | Accessory Compatibility | Devices shall be compatible with an RHV. | Pass | Page 6 of 8 {10} | Test Attribute | Specification | Results | | --- | --- | --- | | Coating - Particulate | The amount of particulate matter generated during simulated use testing shall be determined and compared to a competitive product. | Pass | | Coating – Lubricity, Durability and Integrity | Coating must be lubricious with a specified average pull force. No coating anomalies or significant wear shall be observed post simulated use. | Pass | | Flowrate – Positive (forward) Pressure | The catheter lumen shall allow for a minimum flowrate comparable to comparator products. | Pass | ### Sterilization The Zoom 4S Catheter is sterilized using validated EO processes with a minimum sterility assurance level (SAL) of 10⁻⁶. The sterilization process was validated per the overkill method in accordance with ISO 11135, “Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.” ### Shelf Life and Packaging The device design (including packaging) and shelf life of the subject Zoom 4S Catheter and the reference Zoom 4S Catheter are identical and are therefore unchanged from K252046. ### Animal Study Substantial equivalence was established based on non-clinical testing presented above. ### Clinical Study Substantial equivalence was established based on non-clinical testing presented above. ### IX. CONCLUSIONS Where differences were identified between the subject and predicate devices, a risk assessment was completed to determine if the differences would result in new safety or effectiveness issues. As appropriate, bench and laboratory testing were evaluated for applicability and either the rationale for no impact was documented or verification and Page 7 of 8 {11} validation was repeated as required. The non-clinical bench data supports the safety of the device and demonstrates that the subject Zoom 4S Catheter performs as intended in the specified use conditions. Based on the non-clinical data presented above, the subject and predicate devices are substantially equivalent and there are no new questions of safety or effectiveness. The subject device and predicate device share the same intended use, basic technological characteristics, and performance characteristics. Therefore, the subject Zoom 4S catheter is substantially equivalent to the predicate device. Page 8 of 8