Zoom System

K242672 · Imperative Care, Inc. · NRY · Jan 14, 2025 · Cardiovascular

Device Facts

Record IDK242672
Device NameZoom System
ApplicantImperative Care, Inc.
Product CodeNRY · Cardiovascular
Decision DateJan 14, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1250
Device ClassClass 2
AttributesTherapeutic

Intended Use

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 (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

Device Story

Zoom System is a mechanical neurothrombectomy device for acute ischemic stroke. Components include Zoom reperfusion catheters (71, 55, 45, 35), Large Distal Platform (LDP) catheters (Zoom 88 LDP, Zoom 88 LDP Support, TracStar LDP), aspiration tubing (with or without POD clot filter), and aspiration pump. System uses vacuum aspiration to remove thrombus from intracranial arteries. Operated by physicians in clinical/hospital settings. Catheters are single-lumen, braid/coil-reinforced, variable stiffness with hydrophilic coating. Physician navigates catheters to occlusion site via guidewire; applies vacuum via pump to aspirate clot. Output is restored blood flow (reperfusion). Benefits include rapid revascularization, improved clinical outcomes, and reduced stroke-related disability.

Clinical Evidence

Prospective, multi-center, single-arm pivotal trial (Imperative Trial, NCT04129125) of 260 subjects. Primary effectiveness: mTICI ≥ 2b in ≤ 3 passes achieved in 84% (177/211) of analyzed cohort (p<0.001 vs PG). Primary safety: sICH rate 0.9% (2/211), meeting PG ≤ 6.0%. Secondary endpoints: 90-day all-cause mortality 12.3%, device-related SAE 1.4%, procedure-related vessel injury 0.5%.

Technological Characteristics

Catheters: single-lumen, braid/coil-reinforced, variable stiffness, radiopaque markers, hydrophilic coating. Materials: medical-grade plastics/metals. Sterilization: Ethylene Oxide (EO), SAL 10^-6. Connectivity: manual luer connections to aspiration pump. Aspiration tubing: hollow polymer tube with external pinch clamp; Zoom POD includes in-line clot filter. Compliant with ISO 10555-1 (catheter performance) and ISO 11135 (sterilization).

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (ICA, MCA M1/M2, basilar, vertebral arteries) within 8 hours of last known well. Candidates include patients ineligible for or non-responsive to IV thrombolytic therapy.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. January 14, 2025 Imperative Care, Inc. Teri Nguven Lead Regulatory Affairs Specialist 1359 Dell Avenue Campbell, California 95008 Re: K242672 Trade/Device Name: Zoom System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 16, 2024 Received: December 16, 2024 Dear Teri Nguyen: 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. {1}------------------------------------------------ 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 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. 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory {2}------------------------------------------------ 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, Ph.D. 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 510(k) Number (if known) K242672 Device Name Zoom System ### Indications for Use (Describe) 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 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 (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## 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}------------------------------------------------ ## 510(k) Summary Imperative Care, Inc. 1359 Dell Avenue Campbell, CA 95008 Teri Nguyen 408-833-4415 January 13, 2025 #### I. SUBMITTER Submitter's Name: Address: Contact Person: Telephone: Email: Date of Preparation: #### II. DEVICE Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Product Code: Regulation Zoom™ System Catheter, Thrombus Retriever Percutaneous Catheter II NRY 21 CFR 870.1250 vtnguyen@imperativecare.com ### III. PREDICATE DEVICE Proprietary Name: Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k) #: Proprietary Name: Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k) #: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing Catheter, Thrombus Retriever Percutaneous Catheter NRY 21 CFR 870.1250 Imperative Care, Inc. K211476 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Catheter, Thrombus Retriever Percutaneous Catheter NRY 21 CFR 870.1250 Imperative Care, Inc. K210996 {5}------------------------------------------------ #### IV. REFERENCE DEVICE Proprietary Names: Common/Usual Name: Classification Name: Product Codes: Regulation: Manufacturer: 510(k) #: TracStar™ LDP Large Distal Platform™; Zoom™ 88 Large Distal Platform™: Zoom™ 88 Large Distal Platform™ Support Catheter, Percutaneous, Neurovasculature Percutaneous Catheter OJP, DOY 21 CFR 870.1250 Imperative Care, Inc. K240948 ### V. DEVICE DESCRIPTION The Imperative Care Zoom System consists of the following devices: - Zoom Catheters . - o Zoom™ (71, 55, 45, 35) Catheters - Large Distal Platform Catheters (LDP Catheters) ● - Zoom™ 88 Large Distal Platform™ (Zoom 88 LDP) o - Zoom™ 88 Large Distal Platform™ Support (Zoom 88 LDP Support) O - TracStar™ LDP Large Distal Platform™ (TracStar LDP) O - Zoom Aspiration Tubing and Zoom POD Aspiration Tubing - Zoom Aspiration Pump ● The Zoom Catheters and the LDP Catheters are intended to be used as a system in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and the Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus in patients with acute ischemic stroke. The Zoom Catheters and LDP Catheters are single lumen, braid and coil reinforced, variable stiffness catheters with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The catheters have a luer hub on the proximal end. Dimensions for each catheter are included on the individual device label. The Zoom Catheters are compatible with 0.014" - 0.018" guidewires. The LDP Catheters are compatible with 0.038" or smaller guidewires. An additional support catheter may be used {6}------------------------------------------------ to assist in accessing the target vasculature. The Zoom 45, 55, and 71 Catheters are compatible with 6F guide sheaths with a minimum inner diameter of 0.088". The Zoom 35 Catheter is compatible with 5F guide sheaths with a minimum inner diameter of 0.068". The LDP Catheters are compatible with 8F or greater introducer sheaths with a minimum inner diameter of 0.115". The Zoom 71 Catheter is compatible with 5F microcatheters or intermediate catheters with a maximum outer diameter of 0.065". The Zoom 45 and 55 Catheters are compatible with 2.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.031". The Zoom 35 Catheter is compatible with 1.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.018". The LDP Catheters are compatible with 6F microcatheters or intermediate catheters with a maximum outer diameter of 0.083". All catheters are packaged with an accessory rotating hemostasis valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom Catheter and the LDP Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD Aspiration Tubing are made of common medical grade polymers. In addition to the accessories discussed above, the adjunctive devices and supplies listed below could be used with the Zoom System. - Guidewires . - Support/Diagnostic Catheters ● - Introducer Sheaths . - Aspiration Pump* . - Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg) - 0 Airflow rating of 0 23 LPM {7}------------------------------------------------ ## 0 IEC 60601-1 Compliant * Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria. ### INDICATIONS FOR USE VI. 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 (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. PREDICATE AND REFERENCE DEVICES The predicate devices are the Imperative Care ZOOM (71, 55, 45, 35) Reperfusion Catheters (ZOOM Reperfusion Catheters) and ZOOM Aspiration Tubing cleared under K211476 and K210996. The predicate and subject devices share the same intended use and basic technological characteristics, and equivalent performance characteristics, demonstrated through bench, and clinical testing. Table 1 provides a comparison of the subject Zoom System Catheters and the predicate ZOOM Reperfusion Catheters. Table 2 provides a comparison of the subject Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing and the predicate ZOOM Aspiration Tubing. {8}------------------------------------------------ | Device<br>Attribute | Predicate Device | Subject Device | Reference Device | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Product<br>Classification | Class II<br>Product Code: NRY<br>21 CFR 870.1250 | Same as Predicate | Class II<br>Product Code: QJP, DQY<br>21 CFR 870.1250 | | Product Name | ZOOM 71 Reperfusion Catheter<br>ZOOM 55 Reperfusion Catheter<br>ZOOM 45 Reperfusion Catheter<br>ZOOM 35 Reperfusion Catheter | Zoom 71 Catheter<br>Zoom 55 Catheter<br>Zoom 45 Catheter<br>Zoom 35 Catheter<br>TracStar LDP<br>Zoom 88 LDP<br>Zoom 88 LDP Support | TracStar LDP<br>Zoom 88 LDP<br>Zoom 88 LDP Support | | 510(k) Number | K211476, K210996 | K242672 | K240948 | | Manufacturer | Imperative Care, Inc. | Same | Same | | Indications for<br>Use | The ZOOM Reperfusion Catheters,<br>with the ZOOM Aspiration Tubing<br>and ZOOM Aspiration Pump (or<br>equivalent vacuum pump), are<br>indicated for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral – M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset.<br>Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-<br>PA therapy are candidates for<br>treatment. | The Zoom System, when used with the<br>Zoom Aspiration Pump (or equivalent<br>vacuum pump), is indicated for use in the<br>revascularization of patients with acute<br>ischemic stroke secondary to intracranial<br>large vessel occlusive disease (within the<br>internal carotid, middle cerebral - M1 and<br>M2 segments, basilar, and vertebral arteries)<br>within 8 hours of last known well.<br>Patients who are ineligible for intravenous<br>thrombolytic drug therapy or who have not<br>responded to thrombolytic drug therapy are<br>candidates for treatment. | The TracStar LDP Large Distal Platform is<br>indicated for the introduction of<br>interventional devices into the peripheral,<br>coronary, and neuro vasculature.<br>The Zoom 88 Large Distal Platform and<br>Zoom 88 Large Distal Platform Support are<br>indicated for the introduction of<br>interventional devices into the peripheral,<br>coronary, and neuro vasculature. | | Device<br>Attribute | Predicate Device | Subject Device | Reference Device | | Condition<br>Supplied | Sterile, Single Use Only | Same | Same | | Sterilization<br>Method | Ethylene Oxide (EO), SAL 10-6<br>One (1) EO Cycle | Same | Same<br>Up to Two (2) EO Cycles | | Inner Diameter<br>(Distal) | 0.035"-0.071" | Same as Predicate and Reference Devices | 0.088" | | Outer Diameter<br>(Distal) | 0.051"-0.083" | Same as Predicate and Reference Devices | 0.106" | | Inner Diameter<br>(Proximal) | 0.047"-0.071" | Same as Predicate and Reference Devices | 0.088" | | Outer Diameter<br>(Proximal) | 0.061"-0.083" | Same as Predicate and Reference Devices | 0.110" | | Effective<br>Working Length | 137 cm – 160 cm | Same as Predicate and Reference Devices | 80 cm – 110 cm | | Tip Design | Beveled distal edge, soft, flexible,<br>atraumatic tip | Same | Same | | Materials | Commonly used medical grade<br>plastics and metals with hydrophilic<br>coating | Same | Same | | Packaged<br>Accessories | RHV | Same | Same | | Packaging<br>Configuration | The catheter is placed in a protective<br>polyethylene tube and then mounted,<br>along with the RHV accessory, onto a<br>polyethylene packaging card.<br><br>The packaging card is inserted into a<br>Tyvek® pouch which is then sealed.<br><br>The sealed pouch and Instructions for<br>Use (IFU) are placed in a shelf carton | Same | Same | | Device<br>Attribute | Predicate Device | Subject Device | Reference Device | | Aspiration<br>Pump | Zoom Aspiration Pump | Same as Predicate Device | N/A - Not indicated for reperfusion | | Shelf Life | 12 Months (1 Year) | Same as Reference Device | 3 Years | # Table 1: Comparison of Technological Characteristics with Predicate and Reference Devices – Zoom System Catheters {9}------------------------------------------------ {10}------------------------------------------------ # Table 2: Comparison of Technological Characteristics with Predicate Device – Zoom and Zoom POD Aspiration Tubing | Device Attribute | Predicate Device | Subject Device | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | ZOOM Aspiration Tubing | Zoom Aspiration Tubing<br>Zoom POD Aspiration Tubing | | Indications for Use | The ZOOM Aspiration Tubing is intended to connect the<br>ZOOM Reperfusion Catheter to the ZOOM Canister of the<br>ZOOM Aspiration Pump and to allow the user to control<br>the fluid flow. | The Zoom Aspiration Tubing and the Zoom POD Aspiration<br>Tubing are intended to connect the Zoom (71, 55, 45, 35) Catheter<br>and the TracStar LDP Large Distal Platform, the Zoom 88 Large<br>Distal Platform, or the Zoom 88 Large Distal Platform Support to<br>the Zoom Canister of the Zoom Aspiration Pump (or equivalent<br>vacuum pump) and to allow the user to control the fluid flow. | | Condition Supplied | Sterile and Single Use | Same | | Sterilization Method | EO, SAL 10-6 | Same | | Tubing Inner Diameter<br>(ID) | 0.110" | Same | | Working Length | 104'' | Zoom Aspiration Tubing: 104"<br>Zoom POD Aspiration Tubing: 117" | | Flow Control<br>Mechanism | External Pinch Clamp | Same | | Clot Filter | N/A – does not have a clot filter | Zoom Aspiration Tubing: N/A<br>Zoom POD Aspiration Tubing: in-line clot filter | | Packaging<br>Configuration | The Zoom Aspiration Tubing is coiled and placed inside a<br>labeled pouch and sealed. The sealed pouch and IFU are<br>placed in a labeled shelf carton box. | Same | | Shelf Life | 43 Months | Same | {11}------------------------------------------------ #### VIII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility Testing The tissue contacting materials, including raw materials, manufacturing processes and manufacturing aids, of the subject Zoom Catheters are similar to the predicate ZOOM Reperfusion Catheters (K211476 and K210996). Original testing on the predicate devices apply to the subject Zoom Catheters and additional biocompatibility testing was not required. The subject LDP Catheters are identical to the reference LDP Catheters (K240948). There are no changes to the patient contacting materials, including raw materials, manufacturing processes, and manufacturing aids, of the subject LDP Catheters. Therefore, the original testing on the reference devices apply to the subject LDP Catheters and additional biocompatibility testing was not required. The changes made to the Zoom Aspiration Tubing to create the Zoom POD Aspiration Tubing (Zoom POD) were evaluated for the Zoom POD in accordance with the FDA guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"," and International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process." Supporting biocompatibility testing (cytotoxicity, sensitization, and irritation / intracutaneous reactivity) was completed to confirm that the addition of the in-line clot filter component (collection pod) did not result in any significant changes to the biocompatibility of the Zoom POD Aspiration Tubing. {12}------------------------------------------------ # Non-clinical Bench Testing A summary of the evaluated design and performance specifications is presented in Table 3 and Table 4. 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 the differences between the subject devices and predicate or reference devices do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject devices. | Test Attribute | Specification | Results | |----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Delivery, Compatibility,<br>and Retraction<br>(Trackability) | The catheter shall be able to be delivered,<br>deployed, and retracted per the IFU within a<br>simulated neurovascular model without<br>incurring any damage to the catheter. | Pass | | Tip Flexibility | The catheter distal tip flexibility shall be<br>comparable to the predicate. | Pass | | Visual Inspection | The catheter shall meet visual inspection<br>criteria.<br>The printing on the strain relief must be legible. | Pass | | Dimensional (Distal ID,<br>Proximal ID, Distal Outer<br>Diameter (OD), Proximal<br>OD) | All defined catheter dimensions are within the<br>specified tolerances. | Pass | | Catheter Bond Strength | The catheter shall have sufficient bond strength<br>to remain intact throughout a procedure. | Pass | | Freedom from Leakage -<br>Positive Pressure | The catheter must remain leak free under<br>specified test conditions. | Pass | | Freedom from Leakage -<br>Negative Pressure | The catheter must remain leak free under<br>specified test conditions. | Pass | | Dynamic Burst | The catheter must withstand pressures under<br>dynamic flow conditions. | Pass | | Static Burst | The catheter shall meet criteria for static burst<br>pressure testing. | Pass | | Test Attribute | Specification | Results | | Catheter Torque Strength | With the catheter tip constrained from<br>movement, the proximal end was rotated until<br>failure. The catheter shall not be damaged when<br>rotated at least two (2) full rotations (720<br>degrees). | Pass | | Kink Resistance | There shall be no kinking of the catheter shaft<br>around respective clinically relevant minimum<br>bend radii in distal tip, medial, and proximal<br>locations. | Pass | | Flexibility | The catheters need to have acceptable flexure<br>values for tracking in the vasculature. | Pass | | Proximal Shaft Stiffness | The stiffness of the proximal shaft was<br>evaluated to ensure comparable stiffness to the<br>predicate. | Pass | | Delivery Force | The catheters shall not be too stiff or require<br>excessive force to safely navigate and track to<br>the target neurovasculature. | Pass | | Compatibility with other<br>Devices (External) | The catheters shall be able to be delivered<br>through the minimum introducer sheath or guide<br>catheter size indicated in the product labeling. | Pass | | Guidewire Compatibility | The catheters shall be able to be delivered over<br>the maximum size guidewire indicated in the<br>product labeling. | Pass | | Microcatheter/Intermediate<br>Catheter Compatibility | The catheters shall be able to accommodate a<br>microcatheter/intermediate catheter up to the<br>maximum size indicated in the product labeling. | Pass | | Luer Compatibility | Devices and RHV accessory shall be compatible<br>with standard syringe luer fittings per ISO<br>80369-7. | Pass | | Accessory Compatibility | Devices shall be compatible with an RHV. | Pass | | Coating - Particulate | The amount of particulate matter generated<br>during simulated use testing shall be determined<br>and compared to competitive products and<br>techniques. | Pass | | Coating - Lubricity,<br>Durability and Integrity | Coating must be lubricious with a specified<br>average pull force. There were no coating<br>anomalies or significant wear observed post<br>simulated use. | Pass | | Clot Retrieval | The catheters will be able to be delivered in a<br>clinically relevant vascular model and<br>effectively aspirate clots when used with the<br>aspiration pump and aspiration tubing set when<br>placed at appropriate locations based on the size<br>of the catheter. | Pass | | Test Attribute | Specification | Results | | Lumen Integrity | The catheter lumen shall not collapse under<br>vacuum. | Pass | | Vacuum Force at Catheter<br>Tip | The vacuum force at the tip of the catheter<br>should be comparable to the vacuum force at the<br>tip of the predicate devices. | Pass | | Flowrate - Positive<br>(forward) Pressure | The catheter lumen shall allow for a minimum<br>flowrate comparable to comparator products. | Pass | | Flowrate - Negative<br>(Vacuum) Pressure | The minimum flowrate under a vacuum shall<br>be similar to or greater than comparator<br>devices. | Pass | Table 3: Tests and Performance Specifications for Zoom System Catheters {13}------------------------------------------------ {14}------------------------------------------------ # Table 4: Tests and Performance Specifications for Zoom System Aspiration Tubing | Test Attribute | Specification | Results | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Vacuum Force at Catheter<br>Tip | The vacuum force delivered by the aspiration<br>tubing to the tip of the catheter should be<br>comparable to the vacuum force delivered by<br>the predicate aspiration tubing. | Pass | | Connector Compatibility | The aspiration tubing connectors shall securely<br>connect to the pump canister lid and standard<br>luer fittings. | Pass | | Lumen Collapse Test | The tubing lumen shall not collapse under<br>vacuum. | Pass | | Flow Control<br>Functionality | The flow control mechanism shall allow users to<br>start and stop flow multiple times when the<br>connected pump is running at maximum<br>vacuum. | Pass | | Freedom From Leakage | The vacuum pressure delivered at the tip of the<br>aspiration tubing shall be consistent with the<br>pressure generated by the pump. | Pass | | Tensile Strength | The bonds between the tubing and connectors<br>shall be sufficiently strong to ensure the tubing<br>remains intact during use. | Pass | | Clot Filter Functionality<br>(Zoom POD only) | The clot filter should be able to be opened and<br>closed without causing leak. | Pass | | Aspiration Flowrate | Minimum aspiration catheter flowrate shall be<br>achieved with the Zoom Aspiration Tubing and<br>Zoom POD Aspiration Tubing. | Pass | {15}------------------------------------------------ ## Sterilization The Zoom System devices (Zoom Catheters, LDP Catheters, Zoom Aspiration Tubing, Zoom POD Aspiration Tubing) are sterilized using validated EO processes with a sterility assurance level (SAL) of 106. The sterilization processes were 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 Accelerated aging testing based on ASTM F1980 was previously conducted to verify packaged device performance of the subject LDP Catheters and Zoom Aspiration Tubing. Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance of the subject Zoom Catheters and Zoom POD Aspiration Tubing. A minimum shelf life was established based on these testing and is indicated by the expiration date provided on the product labeling. Verification testing of the subject devices followed the same test methods as the predicate devices. Packaging and sterile barrier integrity following a transportation challenge has been verified for the packaging configurations used for the Zoom Catheters, LDP Catheters, and Zoom Aspiration Tubing within the Zoom System. Aging testing has also been performed that supports the sterile barrier integrity following aging. ### Animal Studies A series of subacute and chronic animal studies were conducted to evaluate the safe and effective use of the Zoom Catheters and LDP Catheters with the Imperative Care Zoom Aspiration Pump and Zoom Aspiration Tubing in a porcine model. Testing included worst case positioning of the catheter in a "wedged" position, retrieval of various types of clots, and evaluation of various aspiration pressures. The Penumbra System was used as a control device in all completed studies. The studies concluded that: {16}------------------------------------------------ - All vessels treated with the Zoom Catheters and the LDP Catheters were patent, . with no perforation, dissection or thrombosis following completion of the procedure. - The subacute and chronic vascular response was histologically comparable between . the Zoom Catheters/LDP Catheters and control Penumbra System Reperfusion Catheter. - The subacute and chronic pathological findings were comparable between the . Zoom Catheters/LDP Catheters and control Penumbra System Reperfusion Catheter. ## Clinical Study The Imperative Care Zoom Catheters and the LDP Catheters were studied in the Imperative Trial, a prospective, multi-center, open-label, single-arm pivotal clinical investigation designed to assess the safety and effectiveness of the Zoom System in subjects diagnosed with acute ischemic stroke secondary to large vessel occlusions and undergoing a stroke mechanical neurothrombectomy procedure within 8 hours of last known well. A total of 260 evaluable subjects were enrolled across 26 clinical sites in the United States. Further details on this study can be accessed at ClinicalTrials.gov using the identifier NCT04129125. | | Intervention/<br>Treatment<br>(Day 0) | 24-Hour<br>Assessment<br>(Day 1) | Discharge/Day<br>7 Assessment<br>(Day 3-7) | 90-Day<br>Follow Up<br>Assessment<br>(Day 90) | Total Withdrawal,<br>LTF, and Deaths | |--------------------------------------|---------------------------------------|----------------------------------|--------------------------------------------|-----------------------------------------------|--------------------------------------| | Evaluable<br>Subjects | 260 | 260 | 259 | 253 | | | Withdrawal | 0 | 0 | 1 | 4 | 5 | | Lost to<br>Follow-up<br>(LTF) | N/A | 0 | 0 | 5 | 5 | | Death | 0 | 1* | 5 | 27 | 33 | | Subjects<br>Completing<br>Each Visit | 260 | 259 | 253 | 217 | | Reconciliation of Evaluable Subjects One subject death occurred 2 days post-procedure, but declining status prevented the 24-hour visit from being completed. {17}------------------------------------------------ ### Imperative Trial Mechanical Neurothrombectomy Procedure Mechanical neurothrombectomy was performed using the Zoom System under general anesthesia or conscious sedation, at the discretion of the investigator. The Zoom Catheters and the LDP Catheters were the primary device. An LDP Catheter was employed to access the vasculature in all cases, while its use to aspirate was according to the treating physicians' preference. Aspiration was applied through an LDP Catheter alone or in conjunction with a Zoom (71, 55, 45, or 35) Catheter either proximal to the clot or at the clot in 92% (238/260) of subjects and in 52% (124/238) of these subjects, aspiration was applied through an LDP Catheter alone or in conjunction with a Zoom (71, 55, 45, or 35) Catheter at the clot. If multiple revascularization attempts were required, the Zoom System was recommended to be used for at least the first three attempts before considering switching to any non-Zoom System device. If the modified thrombolysis in cerebral infarction (mTICI) score ≥ 2b revascularization was not achieved after three attempts with the study device, the procedure was considered a treatment failure for the…
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