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.

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 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
- 0 IEC 60601-1 Compliant

Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Imperative Care Zoom System, based on the provided text:

Acceptance Criteria and Device Performance

The study refers to "performance goals" but does not explicitly define each as an "acceptance criterion" with a specific threshold prior to reporting results. Based on the way the results are presented against these goals, they are treated as acceptance criteria. Performance goals were met for effectiveness and a specific safety endpoint.

Acceptance Criteria (Performance Goal as stated in the text)	Reported Device Performance
Effectiveness: Lower bound of the two-sided 95% CI > 69% for mTICI ≥ 2b in three or fewer passes of Zoom System without using other devices.	84% (177/211; 95% CI: 78% to 89%)
Safety: Observed rate < 6.0% for ECASS III defined symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure.	0.9% (2/211; 95% CI: 0.1% to 3.4%)

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 211 evaluable subjects for the primary effectiveness and safety analyses. The overall study enrolled 260 evaluable subjects.
- Data Provenance: Prospective, multi-center, open-label, single-arm pivotal clinical investigation. All 26 clinical sites were located in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text mentions "independent core lab adjudicated reperfusion success" for effectiveness and "adjudicated by an independent core lab and Independent Safety Board (ISB)" for sICH.
- Number of Experts: Not explicitly stated how many radiologists, neurologists, or other specialists were part of the "independent core lab" or "ISB."
- Qualifications of Experts: Not explicitly stated, but implied to be qualified medical professionals experienced in neurovascular imaging and stroke outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The text simply states "independent core lab adjudicated" and "adjudicated by an independent core lab and Independent Safety Board (ISB)." The specific method (e.g., how many reviewers, how disagreements were resolved) is not detailed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader, multi-case comparative effectiveness study involving AI assistance for human readers was not done. This was a clinical trial assessing the device's direct performance in revascularization procedures.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This study evaluated a medical device (Zoom System catheters, tubing, and pump) used by human operators in a clinical setting. It is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Effectiveness Ground Truth: Independent core lab adjudicated reperfusion success, defined by mTICI score (a grading scale for reperfusion) based on imaging.
- Safety Ground Truth: Independent core lab and ISB adjudicated symptomatic intracranial hemorrhage (sICH) based on imaging (ECASS III criteria). Other secondary safety endpoints also relied on core lab and ISB adjudication, and 90-day all-cause mortality is an outcomes data point.
The sample size for the training set:
- This was a pivotal clinical trial for device approval, not an AI algorithm development study. Therefore, there is no "training set" in the context of machine learning. The device itself was refined through engineering and non-clinical testing.
How the ground truth for the training set was established:
- As this is not an AI algorithm study, the concept of a "training set" and its associated ground truth does not apply. The device's design and engineering would have been informed by preclinical studies (bench and animal testing) and previous clinical experience with similar devices.

Summary of the study:

The Imperative Trial was a prospective, multi-center, open-label, single-arm pivotal clinical investigation that assessed the safety and effectiveness of the Zoom System for acute ischemic stroke patients with large vessel occlusions. The study enrolled 260 evaluable subjects across 26 clinical sites in the United States. The primary effectiveness endpoint was reperfusion success (mTICI ≥ 2b in three or fewer passes without other devices), which was 84% (95% CI: 78%-89%), meeting the performance goal of a lower bound > 69%. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH), observed in 0.9% (95% CI: 0.1%-3.4%), meeting the performance goal of < 6.0%. Secondary safety endpoints included all-cause mortality, all intracranial hemorrhage, device-related SAEs, and procedure-related vessel injury. The ground truth for effectiveness and sICH was established through independent core lab and/or Independent Safety Board adjudication based on post-procedure imaging. The study concluded that the Zoom System is safe and effective for this indication.

Summary

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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.

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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

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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

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Indications for Use

510(k) Number (if known) K242672

Device Name Zoom System

Indications for Use (Describe)

Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to 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)

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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

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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 ●

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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".

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

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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.

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.

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DeviceAttribute	Predicate Device	Subject Device	Reference Device
FDA ProductClassification	Class IIProduct Code: NRY21 CFR 870.1250	Same as Predicate	Class IIProduct Code: QJP, DQY21 CFR 870.1250
Product Name	ZOOM 71 Reperfusion CatheterZOOM 55 Reperfusion CatheterZOOM 45 Reperfusion CatheterZOOM 35 Reperfusion Catheter	Zoom 71 CatheterZoom 55 CatheterZoom 45 CatheterZoom 35 CatheterTracStar LDPZoom 88 LDPZoom 88 LDP Support	TracStar LDPZoom 88 LDPZoom 88 LDP Support
510(k) Number	K211476, K210996	K242672	K240948
Manufacturer	Imperative Care, Inc.	Same	Same
Indications forUse	The ZOOM Reperfusion Catheters,with the ZOOM Aspiration Tubingand ZOOM Aspiration Pump (orequivalent vacuum pump), areindicated for use in therevascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset.Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PA therapy are candidates fortreatment.	The Zoom System, when used with theZoom Aspiration Pump (or equivalentvacuum pump), is indicated for use in therevascularization of patients with acuteischemic stroke secondary to intracraniallarge vessel occlusive disease (within theinternal carotid, middle cerebral - M1 andM2 segments, basilar, and vertebral arteries)within 8 hours of last known well.Patients who are ineligible for intravenousthrombolytic drug therapy or who have notresponded to thrombolytic drug therapy arecandidates for treatment.	The TracStar LDP Large Distal Platform isindicated for the introduction ofinterventional devices into the peripheral,coronary, and neuro vasculature.The Zoom 88 Large Distal Platform andZoom 88 Large Distal Platform Support areindicated for the introduction ofinterventional devices into the peripheral,coronary, and neuro vasculature.
DeviceAttribute	Predicate Device	Subject Device	Reference Device
ConditionSupplied	Sterile, Single Use Only	Same	Same
SterilizationMethod	Ethylene Oxide (EO), SAL 10-6One (1) EO Cycle	Same	SameUp to Two (2) EO Cycles
Inner Diameter(Distal)	0.035"-0.071"	Same as Predicate and Reference Devices	0.088"
Outer Diameter(Distal)	0.051"-0.083"	Same as Predicate and Reference Devices	0.106"
Inner Diameter(Proximal)	0.047"-0.071"	Same as Predicate and Reference Devices	0.088"
Outer Diameter(Proximal)	0.061"-0.083"	Same as Predicate and Reference Devices	0.110"
EffectiveWorking Length	137 cm – 160 cm	Same as Predicate and Reference Devices	80 cm – 110 cm
Tip Design	Beveled distal edge, soft, flexible,atraumatic tip	Same	Same
Materials	Commonly used medical gradeplastics and metals with hydrophiliccoating	Same	Same
PackagedAccessories	RHV	Same	Same
PackagingConfiguration	The catheter is placed in a protectivepolyethylene tube and then mounted,along with the RHV accessory, onto apolyethylene packaging card.The packaging card is inserted into aTyvek® pouch which is then sealed.The sealed pouch and Instructions forUse (IFU) are placed in a shelf carton	Same	Same
DeviceAttribute	Predicate Device	Subject Device	Reference Device
AspirationPump	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

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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 TubingZoom POD Aspiration Tubing
Indications for Use	The ZOOM Aspiration Tubing is intended to connect theZOOM Reperfusion Catheter to the ZOOM Canister of theZOOM Aspiration Pump and to allow the user to controlthe fluid flow.	The Zoom Aspiration Tubing and the Zoom POD AspirationTubing are intended to connect the Zoom (71, 55, 45, 35) Catheterand the TracStar LDP Large Distal Platform, the Zoom 88 LargeDistal Platform, or the Zoom 88 Large Distal Platform Support tothe Zoom Canister of the Zoom Aspiration Pump (or equivalentvacuum 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(ID)	0.110"	Same
Working Length	104''	Zoom Aspiration Tubing: 104"Zoom POD Aspiration Tubing: 117"
Flow ControlMechanism	External Pinch Clamp	Same
Clot Filter	N/A – does not have a clot filter	Zoom Aspiration Tubing: N/AZoom POD Aspiration Tubing: in-line clot filter
PackagingConfiguration	The Zoom Aspiration Tubing is coiled and placed inside alabeled pouch and sealed. The sealed pouch and IFU areplaced in a labeled shelf carton box.	Same
Shelf Life	43 Months	Same

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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.

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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,and Retraction(Trackability)	The catheter shall be able to be delivered,deployed, and retracted per the IFU within asimulated neurovascular model withoutincurring any damage to the catheter.	Pass
Tip Flexibility	The catheter distal tip flexibility shall becomparable to the predicate.	Pass
Visual Inspection	The catheter shall meet visual inspectioncriteria.The printing on the strain relief must be legible.	Pass
Dimensional (Distal ID,Proximal ID, Distal OuterDiameter (OD), ProximalOD)	All defined catheter dimensions are within thespecified tolerances.	Pass
Catheter Bond Strength	The catheter shall have sufficient bond strengthto remain intact throughout a procedure.	Pass
Freedom from Leakage -Positive Pressure	The catheter must remain leak free underspecified test conditions.	Pass
Freedom from Leakage -Negative Pressure	The catheter must remain leak free underspecified test conditions.	Pass
Dynamic Burst	The catheter must withstand pressures underdynamic flow conditions.	Pass
Static Burst	The catheter shall meet criteria for static burstpressure testing.	Pass
Test Attribute	Specification	Results
Catheter Torque Strength	With the catheter tip constrained frommovement, the proximal end was rotated untilfailure. The catheter shall not be damaged whenrotated at least two (2) full rotations (720degrees).	Pass
Kink Resistance	There shall be no kinking of the catheter shaftaround respective clinically relevant minimumbend radii in distal tip, medial, and proximallocations.	Pass
Flexibility	The catheters need to have acceptable flexurevalues for tracking in the vasculature.	Pass
Proximal Shaft Stiffness	The stiffness of the proximal shaft wasevaluated to ensure comparable stiffness to thepredicate.	Pass
Delivery Force	The catheters shall not be too stiff or requireexcessive force to safely navigate and track tothe target neurovasculature.	Pass
Compatibility with otherDevices (External)	The catheters shall be able to be deliveredthrough the minimum introducer sheath or guidecatheter size indicated in the product labeling.	Pass
Guidewire Compatibility	The catheters shall be able to be delivered overthe maximum size guidewire indicated in theproduct labeling.	Pass
Microcatheter/IntermediateCatheter Compatibility	The catheters shall be able to accommodate amicrocatheter/intermediate catheter up to themaximum size indicated in the product labeling.	Pass
Luer Compatibility	Devices and RHV accessory shall be compatiblewith standard syringe luer fittings per ISO80369-7.	Pass
Accessory Compatibility	Devices shall be compatible with an RHV.	Pass
Coating - Particulate	The amount of particulate matter generatedduring simulated use testing shall be determinedand compared to competitive products andtechniques.	Pass
Coating - Lubricity,Durability and Integrity	Coating must be lubricious with a specifiedaverage pull force. There were no coatinganomalies or significant wear observed postsimulated use.	Pass
Clot Retrieval	The catheters will be able to be delivered in aclinically relevant vascular model andeffectively aspirate clots when used with theaspiration pump and aspiration tubing set whenplaced at appropriate locations based on the sizeof the catheter.	Pass
Test Attribute	Specification	Results
Lumen Integrity	The catheter lumen shall not collapse undervacuum.	Pass
Vacuum Force at CatheterTip	The vacuum force at the tip of the cathetershould be comparable to the vacuum force at thetip of the predicate devices.	Pass
Flowrate - Positive(forward) Pressure	The catheter lumen shall allow for a minimumflowrate comparable to comparator products.	Pass
Flowrate - Negative(Vacuum) Pressure	The minimum flowrate under a vacuum shallbe similar to or greater than comparatordevices.	Pass

Table 3: Tests and Performance Specifications for Zoom System Catheters

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Table 4: Tests and Performance Specifications for Zoom System Aspiration Tubing

Test Attribute	Specification	Results
Vacuum Force at CatheterTip	The vacuum force delivered by the aspirationtubing to the tip of the catheter should becomparable to the vacuum force delivered bythe predicate aspiration tubing.	Pass
Connector Compatibility	The aspiration tubing connectors shall securelyconnect to the pump canister lid and standardluer fittings.	Pass
Lumen Collapse Test	The tubing lumen shall not collapse undervacuum.	Pass
Flow ControlFunctionality	The flow control mechanism shall allow users tostart and stop flow multiple times when theconnected pump is running at maximumvacuum.	Pass
Freedom From Leakage	The vacuum pressure delivered at the tip of theaspiration tubing shall be consistent with thepressure generated by the pump.	Pass
Tensile Strength	The bonds between the tubing and connectorsshall be sufficiently strong to ensure the tubingremains intact during use.	Pass
Clot Filter Functionality(Zoom POD only)	The clot filter should be able to be opened andclosed without causing leak.	Pass
Aspiration Flowrate	Minimum aspiration catheter flowrate shall beachieved with the Zoom Aspiration Tubing andZoom POD Aspiration Tubing.	Pass

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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:

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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/Treatment(Day 0)	24-HourAssessment(Day 1)	Discharge/Day7 Assessment(Day 3-7)	90-DayFollow UpAssessment(Day 90)	Total Withdrawal,LTF, and Deaths
EvaluableSubjects	260	260	259	253
Withdrawal	0	0	1	4	5
Lost toFollow-up(LTF)	N/A	0	0	5	5
Death	0	1*	5	27	33
SubjectsCompletingEach 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.

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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 primary effectiveness endpoint analysis. The subject received standard hospital/medical care after mechanical neurothrombectomy.

From the 260 subjects, the analyzed cohort includes 211 subjects of which 210 underwent concomitant aspiration mechanical neurothrombectomy with combined use of an LDP Catheter (Zoom 88 LDP, Zoom 88 LDP Support, or TracStar LDP) and a Zoom (71, 55, 45, or 35) Catheter and one underwent concomitant aspiration mechanical neurothrombectomy with two Zoom (55 + 35) Catheters. Subjects with single catheter aspiration mechanical neurothrombectomy were excluded from the analysis (n=49), including 28 subjects with direct clot aspiration applied only through the LDP Catheter (Zoom 88 LDP, Zoom 88 LDP Support, or TracStar LDP) for at least one pass and 21 subjects with direct clot aspiration applied only through the Zoom (71, 55, 45, or 35) Catheters for at least one pass. The limited sample size of 28 subjects with direct clot aspiration applied only through the LDP Catheter for at least one pass was not sufficient to establish the safety and effectiveness of the LDP Catheters for use in direct aspiration alone.

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Key Inclusion Criteria

1. Age 18 and older.
1. National Institutes of health Stroke Scale (NIHSS) score ≥ 6.
The operator feels that the stroke can be treated with endovascular thrombectomy 3. approaches and the interventionalist estimates that groin puncture can be achieved within 8 hours from time last seen well.
Pre-event modified Rankin Scale (mRS) score 0-1. 4.
1. Large vessel occlusion of the intracranial internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 and M2 segments, basilar, and vertebral arteries as evidenced by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
For strokes in anterior circulation, Alberta Stroke Program Early CT Score 6. (ASPECTS) > 6; for strokes in posterior circulation, pc-ASPECTS ≥8.
1. Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated at treating stroke center or outside medical facility within two hours of treatment initiation.
If indicated per American Heart Association (AHA) clinical guidelines, thrombolytic 8. therapy should be administered as soon as possible.
1. Consenting requirements met according to local institutional review board (IRB) or ethics committee.

Kev Exclusion Criteria

1. Female known to be pregnant at time of admission.
1. Patient has suffered a stroke in the past 3 months.
1. Presence of an existing or pre-existing large territory infarction.
1. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor.
1. Known history of severe contrast allergy or absolute contraindication to iodinated contrast.
1. Clinical history, past imaging, or clinical judgement suggest that the intracranial occlusion is chronic.

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1. Life expectancy of less than 6 months prior to stroke onset.
1. Clinical symptoms suggestive of bilateral stroke in multiple territories.
1. Subject participating in another clinical trial involving an investigational device or drug.
1. Known cancer with metastases.
1. Evidence of active systemic infection.
1. Any known hemorrhagic or coagulation deficiency.

Key Baseline Demographics

Characteristics	Summary
Female, % (n/N)	49% (103/211)
Age, Median (IQR)	69 years (59-79 years)
Admission NIHSS, Median (IQR)	14 (10-20)
mRS before Stroke§
0	172/210 (82%)
1	38/210 (18%)
Baseline ASPECTS per Core Lab, Mean ± SD	8.8 ± 1.7
Baseline pc-ASPECTS per Core Lab, Mean ± SD	9.7 ± 0.5
Baseline Core Infarct Volume per Core Lab,Mean ± SD	13 ± 25 mL
Initial Occlusion Location On CTA†
ICA	10% (20/201)
MCA - M1	60% (120/201)
MCA - M2	25% (50/201)
Vertebral	0.0% (0/201)
Basilar	3.3% (7/201)
Multiple Territories‡	2.0% (4/201)

& The baseline mRS for one subject was not reported.

The baseline CTA form was not completed or did not indicate the initial occlusion for 10 subjects resulting in a sample size of N=201 for this characteristic. The treated occlusion for these 10 subjects were: ICA (N=1), MCA-M1 (N=6), and MCA-M2 (N=3).

In the cases with occlusions in multiple territories the following locations were treated:

. Unilateral, right MCA-M1 and right ACA
Unilateral, right MCA-M1 and right ACA
Bilateral, right MCA-M1 and left ICA ●
Unilateral, right MCA-M1 and right ACA ●

Catheters Used for Concomitant Aspiration

In all but one subject, which used a combination of the Zoom 55 and Zoom 35 Catheters,

concomitant aspiration within the Imperative Trial was performed using a combination of

an LDP Catheter (Zoom 88 LDP, Zoom 88 LDP Support, TracStar LDP) and a smaller

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diameter Zoom (71, 55, 45, or 35) Catheter. The Zoom Catheters most commonly used with the LDP Catheters on the first procedural pass were: Zoom 71 (81%, 170/211), Zoom 55 (15%, 31/211), Zoom 45 (2.4%, 5/211), and Zoom 35 (1.9%, 4/211).

Results

The primary effectiveness endpoint was independent core lab adjudicated reperfusion success, defined as achieving a mTICI score of ≥ 2b in three or fewer passes with the Zoom System (primary modality), without using additional mechanical neurothrombectomy devices or rescue therapy (e.g., intra-arterial lytics).

Core lab adjudicated reperfusion success within three or fewer passes was achieved in 84% (177/211; 95% confidence interval (CI) of 78% to 89%) of subjects, with a p-value <0.001 compared to the performance goal (PG). The performance goal of a lower bound of the two-sided 95% CI >69% was met.

Endpoint	Rate, % (n/N)	95% ConfidenceInterval	PG, %	P-Value
Primary AnalysismTICI ≥ 2b in three orfewer passes of ZoomSystem without usingother devices	84%(177/211)	[78% - 89%]	> 69% forlower boundtwo-sided 95%CI	< 0.001
Additional AnalysismTICI ≥ 2b in three orfewer passes of ZoomSystem, use of any non-study devices afterachieving mTICI ≥ 2bwith Zoom Systemimputed as a failure	82%(173/211)	[76% - 87%]	> 69% forlower boundtwo-sided 95%CI	< 0.001

Primary Effectiveness Analysis Results

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Endpoint	Rate, % (n/N)	95% Confidence Interval
mTICI ≥ 2b after all passes with Zoom System	87% (183/211)	[81% – 91%]
mTICI ≥ 2b at end of procedure	91% (192/211)	[86% – 94%]

The primary safety endpoint was the rate of ECASS III defined symptomatic intracranial hemorrhage (sICH), confirmed by imaging 24 hours post-procedure and adjudicated by an independent core lab and Independent Safety Board (ISB). sICH was observed in 0.9% (2/211; 95% CI of 0.1% to 3.4%) of subjects, which meets the pre-specified performance goal of ≤ 6.0% for the observed rate.

The secondary safety endpoints included an all-cause mortality rate of 12.3% (26/211; 95% CI of 8.1% to 17.2%), a rate of all intracranial hemorrhage (ICH) within 24 hours postprocedure as adjudicated by the independent core lab of 20.0% (42/210; 95% CI of 14.8% to 26.1%), a rate of device-related serious adverse events (SAE) as adjudicated by the ISB of 1.4% (3/211; 95% CI of 0.3% to 4.1%) at 90-day follow-up, a rate of procedure-related serious vessel injury (dissections and perforations) of 0.5% (1/211; 95% CI of < 0.1% to 2.6%) and a rate of embolization in new territory (ENT) of 1.0% (2/200; 95% CI of 0.1% to 3.6%).

The median time from puncture to achieve mTICI ≥ 2b flow was 19 minutes.

Primary Safety Analysis Results
---------------------------------

Endpoint	Rate, % (n/N)	95% ConfidenceInterval	PG, %
ECASS III sICH	0.9%(2/211)	[0.1% - 3.4%]	Observed rate < 6.0%

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Endpoint	Rate, % (n/N)	95% ConfidenceInterval
90 Day All-Cause Mortality	12.3% (26/211)	[8.1% – 17.2%]
Core Lab Adjudicated ICH	20.0% (42/210‡)	[14.8% – 26.1%]
Embolism in New Territory(ENT)	1.0% (2/200§)	[0.1% – 3.6%]

Secondary Safety Endpoint Results

*Imaging for one case was inadequate for the core lab to determine if there was a hemorrhage. The site reported no hemorrhage and no neurological deterioration for this subject. SENT assessment forms were not completed for 11 subjects.

In total, 147/211 (69.7%) subjects had at least one adverse event, with 74/211 (35.1%) subjects having at least one serious adverse event.

	Rate, % (n/N)	95% ConfidenceInterval
Non-Serious Adverse Event (AE)	62% (131/211)	[55% - 69%]
Serious Adverse Event (SAE)	35% (74/211)	[29% - 42%]
Device Related SAE, Adjudicatedby ISB	1.4% (3/211)	[0.3% - 4.1%]
Procedure Related Serious VesselInjury (Dissections andPerforations)	0.5% (1/211)	[<0.1% - 2.6%]

Adverse Event Data

Common Serious Adverse Events

System Organ Class	Preferred Term	Rate, % (n/N)
Cardiac disorders	Cardiac arrest	1.9% (4/211)
	Cardiac failure	1.4% (3/211)
Gastrointestinal disorders	Dysphagia	1.9% (4/211)
	Gastrointestinal haemorrhage	1.9% (4/211)
Infections and infestations	Pneumonia	2.4% (5/211)
	Urinary tract infection	1.9% (4/211)
Injury, poisoning andprocedural complications	Vascular pseudoaneurysm§§	1.4% (3/211)
	Vessel perforation	0.5% (1/211)
Nervous system disorders	Brain oedema	1.9% (4/211)
	Cerebral artery occlusion	1.4% (3/211)
	Cerebral artery restenosis	1.9% (4/211)
	Cerebral haemorrhage	0.9% (2/211)
	Cerebrovascular accident	1.9% (4/211)
	Haemorrhagic transformation stroke	1.9% (4/211)
	Seizure	1.9% (4/211)

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System Organ Class	Preferred Term	Rate, % (n/N)
Respiratory, thoracic andmediastinal disorders	Acute respiratory failure	2.8% (6/211)
	Pneumonia aspiration	3.3% (7/211)
	Respiratory failure	3.3% (7/211)

§§ All groin pseudoaneurysms

Direct aspiration using the LDP Catheters (Zoom 88 LDP, Zoom 88 LDP Support, TracStar LDP) alone is not supported by the Imperative Trial due to insufficient data. Aspiration through the LDP Catheter (Zoom 88 LDP, Zoom 88 LDP Support, or TracStar LDP) must be performed in conjunction with a Zoom (71, 55, 45, or 35) Catheter.

Imperative Trial Conclusions

Stroke mechanical neurothrombectomy with the Zoom System is safe and effective in subjects with large vessel occlusions within eight hours of last known well. All prespecified performance goals were met.

CONCLUSIONS IX.

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 concerns. As appropriate, bench and laboratory testing were evaluated for applicability and either the rationale for no impact was documented or verification and validation was repeated as required. The non-clinical bench and animal data support the safety of the device and demonstrate that the subject Zoom System performs as intended in the specified use conditions. The clinical performance data from the Imperative Trial demonstrates that the Zoom System meets the safety and effectiveness performance goals.

Based on the non-clinical and clinical performance data presented above, the subject and predicate devices are substantially equivalent and there are no new safety or effectiveness concerns. The subject Zoom System and predicate devices share the same intended use, basic technological characteristics, and performance characteristics.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).