AXS Vecta Aspiration System

K191768 · Stryker Neurovascular · NRY · Jul 30, 2019 · Cardiovascular

Device Facts

• Record ID: K191768
• Device Name: AXS Vecta Aspiration System
• Applicant: Stryker Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Jul 30, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Device Story

AXS Vecta Aspiration System is a percutaneous catheter system used for clot aspiration in acute ischemic stroke. Physician advances catheter through neurovasculature under fluoroscopic guidance using compatible sheath/guide catheter, microcatheter, and guidewire. Distal end positioned proximal to clot; proximal end connected to Medela Dominant Flex Pump via aspiration tubing. Pump provides vacuum pressure (up to 28 in Hg) to engage and remove clot. Used in clinical settings by interventionalists. System includes aspiration catheter, Scout/peel-away introducers, hemostasis valve, aspiration tubing, and liner set. Benefits include revascularization of occluded vessels to restore blood flow.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including tensile strength, torque, burst, leak, dimensional, kink resistance, lumen patency, vacuum drop, tip flexibility, and friction force. Biocompatibility confirmed via confirmatory testing (cytotoxicity, sensitization, irritation) per ISO 10993-1.

Technological Characteristics

Percutaneous catheter; materials: PTFE (inner), stainless steel/nitinol (reinforcement), Vestamid ML21 (outer jacket), Nylon (hub), Platinum/Iridium (marker band), Cyanoacrylate (adhesive). Hydrophilic coating. EO sterilization per ISO 11135:2014. Vacuum-based aspiration via external pump. Dimensions: 115-132 cm length; 0.071-0.074 in ID.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or failed IV t-PA 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

• AXS Vecta Aspiration System (K190212)

Reference Devices

• K172167
• K181354

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 30, 2019

Stryker Neurovascular Shazia Hakim Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K191768

Device Name: AXS Vecta Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 28, 2019 Received: July 1, 2019

Dear Shazia Hakim:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Xiaolin Zheng, 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

#### K191768

Device Name

AXS Vecta Aspiration System

#### Indications for Use (Describe)

The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

## Introduction:

According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence.

# Submitter Name, Address, and Content:

| Submitter: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515<br>(FDA Registration Number: 3008853977) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shazia Hakim |
| | Senior Staff Regulatory Affairs Specialist |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | June 28, 2019 |
| Trade/Proprietary Name: | AXS Vecta® Aspiration System (formerly known as the InNeuroCo<br>Zenith Flex System and InNeuroCo 071 & 074 Zenith Flex Catheters) |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | NRY |

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# Legally Marketed Predicate Devices

| Name of Predicate Device | Name of<br>Manufacturer | 510(k)<br>Number |
|--------------------------------|--------------------------|------------------|
| AXS Vecta Aspiration<br>System | Stryker<br>Neurovascular | K190212 |

## Device Description

The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.

## Indications for Use

The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

# Technological Characteristics and Product Feature Comparison

Stryker Neurovascular has demonstrated the AXS Vecta® Aspiration Catheter (AXS Vecta® 71 & 74 Aspiration Catheters) is substantially equivalent to the Predicate device, AXS Vecta Aspiration System (K190212) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device is summarized in table below.

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| Detail | Submission Subject Device | Predicate Device |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Manufacturer | Stryker Neurovascular | Stryker Neurovascular |
| 510(k) Number | K191768 | K190212 |
| Device Trade Name | AXS Vecta® Aspiration<br>System (AXS Vecta® 71 & 74<br>Aspiration Catheters) | AXS Vecta® Aspiration<br>System (AXS Vecta® 71 & 74<br>Aspiration Catheters) |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | II | Same |
| Product Code | NRY | Same |
| Intended<br>Use/Indication for<br>Use | The AXS Vecta Aspiration<br>Catheter, as part of the AXS<br>Vecta Aspiration System is<br>indicated in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial<br>large vessel occlusive disease<br>(within the internal carotid,<br>middle cerebral – M1 and<br>M2 segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>Patients who are ineligible<br>for intravenous tissue<br>plasminogen activator (IV t-<br>PA) or who failed IV t-PA<br>therapy are candidates for<br>treatment. | Same |
| Device Description | The AXS Vecta Aspiration<br>Catheter is advanced into the<br>neurovasculature by a<br>physician trained in<br>interventional endovascular<br>procedures using a compatible<br>sheath or guide catheter, and<br>over an appropriately sized<br>microcatheter, guide wire,<br>and/or the Scout Introducer.<br>Two peel-away introducer<br>sheaths are provided in the<br>package to provide support and<br>facilitate the introduction of the | Same |
| | | |
| | AXS Vecta Aspiration Catheter<br>tip into the sheath/guide<br>catheter valve. Once the<br>assembly is inserted, the peel-<br>away introducer sheath can be<br>removed. Under fluoroscopic<br>guidance, the assembly can be<br>advanced through the<br>vasculature to the intended<br>vascular site, with the distal<br>end of the AXS Vecta<br>Aspiration Catheter positioned<br>proximal to the clot. The<br>proximal end of the AXS<br>Universal Aspiration Tubing is<br>connected to the AXS<br>Universal Liner Set. The AXS<br>Universal Liner Set is<br>connected to the Medela<br>Dominant Flex Pump, and the<br>Medela Dominant Flex Pump is<br>turned ON. All devices inside<br>of the AXS Vecta Aspiration<br>Catheter are removed. The<br>distal end of the AXS Universal<br>Aspiration Tubing is attached<br>to the proximal end of the AXS<br>Vecta Aspiration Catheter. To<br>start aspiration, the aspiration<br>tubing clamp on the AXS<br>Universal Aspiration Tubing is<br>opened, and the clot is engaged<br>with the AXS Vecta Aspiration<br>Catheter. | |
| Accessory Devices<br>Provided (not in<br>direct contact with<br>patient) | Hemostasis Valve, 2 Peel-<br>Away Introducers<br>Scout Introducer | Same |
| Outer Jacket | Polymeric catheter | Same |
| Reinforcement | Stainless Steel/Nitinol | Same |
| Strain Relief | Polyolefin | Same |
| Inner Layer | PTFE | Same |
| Catheter Hub | Nylon | Same |
| Marker Band | Platinum/Iridium | Same |
| Adhesive | Cyanoacrylate | Same |
| Outer Jacket Coating | Hydrophilic Coating | Same |
| Labeled Shaft Outer<br>Diameter | Distal OD: | Distal OD: |
| | Vecta 71: 0.082 in.<br>Vecta 74: 0.083 in. | Same |
| | Proximal OD:<br>Vecta 71: 0.085 in.<br>Vecta 74: 0.087 in. | Proximal OD:<br>Same |
| Effective Lengths | 115, 125, 132 cm | Same |
| Distal ID | 0.071 in.<br>0.074 in. | Same |
| Proximal ID | 0.071 in.<br>0.074 in. | Same |
| Packaging Materials<br>and Configuration | Tyvek/Nylon Pouch,<br>polyethylene support tube,<br>packaging card, SBS carton | Same |
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Principles of<br>Operation | The AXS Vecta Aspiration<br>Catheter is advanced into the<br>neurovasculature by a<br>physician trained in<br>interventional endovascular<br>procedures using a compatible<br>sheath or guide catheter, and<br>over an appropriately sized<br>microcatheter, guide wire,<br>and/or the Scout Introducer.<br>Two peel-away introducer<br>sheaths are provided in the<br>package to provide support and<br>facilitate the introduction of the<br>AXS Vecta Aspiration Catheter<br>tip into the sheath/guide<br>catheter valve. Once the<br>assembly is inserted, the peel-<br>away introducer sheath can be<br>removed. Under fluoroscopic<br>guidance, the assembly can be<br>advanced through the<br>vasculature to the intended<br>vascular site, with the distal<br>end of the AXS Vecta<br>Aspiration Catheter positioned<br>proximal to the clot. The<br>proximal end of the AXS<br>Universal Aspiration Tubing is | Same |

# Table 1. Product Feature Comparison of Subject Device to Predicate Device

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| Patient Contacting<br>Components | AXS Vecta Aspiration Catheter<br>and its Accessories | Same | | |
|----------------------------------|----------------------------------------------------------------|----------------------------|-------------|----------------------------|
| Pump | Medela Dominant Flex Pump | Same | | |
| Aspiration Tubing | AXS Universal Aspiration<br>Tubing | Same | | |
| Replacement<br>Components | AXS Universal Liner Set | Same | | |
| Aspiration Method | Pump | Same | | |
| Single Use<br>Components | Catheter and its accessories,<br>Aspiration Tubing, Liner Sets | Same | | |
| Reusable<br>Components | Pump | Same | | |
| Maximum Aspiration<br>Pressure | 28 in Hg | Same | | |
| Calculated Force at<br>Tip | Catheter ID | Calculated<br>Force at Tip | Catheter ID | Calculated<br>Force at Tip |
| | 0.071 in | 0.024 kgf | Same | Same |
| | 0.074 in | 0.026 kgf | | |
| Pressure Regulator<br>Method | Adjustable vacuum pressure<br>dial | | Same | |
| Flow Rate | Non-adjustable flow rate | | Same | |

The differences between the devices are not critical as demonstrated above and through the testing referenced below.

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# Summary of Non-Clinical Data

Testing was only conducted for specifications that were impacted by the changes to the catheter proximal shaft material (coextrusion), mixed coil winding pattern (cross coil to single) and pitch (.026 to .012) of the stainless steel wire on the proximal section of the catheter shaft of the AXS Vecta 71 and 74 catheters, modification (tightening) of the tip length specification, as well as updating the AXS Vecta 71 marker band tacking to use the same UV adhesive and adhesive curing process as the AXS Vecta 74 cleared in K181354. Although an evaluation of the packaging was not required as part of simulated use bench testing, an assessment was included as part of the design validation to confirm that the packaging configuration does not result in any damage to the catheter when opened with the typical sense of urgency; refer to Table 2 below.

## Animal Testing

Animal testing previously conducted for the AXS Vecta Aspiration System was leveraged to support the changes to AXS Vecta 71 and 74 Aspiration Catheters. Prior to design changes, Simulated Use-Animal testing was performed to support the previously cleared AXS Vecta Aspiration Catheters as part of the system and can be found in K190212, K172167 and K181354 (cleared as Zenith Flex System). Additional testing was not performed because the current design changes do not impact the overall efficacy and safety of the device. The UV adhesive tacking adhesive change does not impact safety or efficacy because the tip design is not changing. The mixed coil and coextrusion changes do not change the distal tip, does not change the outer patient interacting material (Vestamid ML21), and the inner coextrusion material (Pebax 72D) is currently used in the catheter design. The new tip length specification is still within the original tip length specification window and is not anticipated to impact the safety or efficacy.

# AXS Vecta Performance Data – Bench Testing

To demonstrate substantial equivalence between the Subject device, AXS Vecta Aspiration System with proposed design changes and the currently cleared AXS Vecta Aspiration System (Predicate device), performance testing was conducted. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed. Therefore, this test data supports the argument that the AXS Vecta Aspiration System has similar performance

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characteristics as the predicate device. All the testing conducted to demonstrate substantial equivalence are presented in the following table.

| Test | Conclusion |
|--------------------------------------------------|------------------------------------------------------------------------------------------------|
| Visual Inspection (Packaging: Pouch Visual) | All units met the acceptance criteria and passed Packaging Visual Inspection. |
| Visual Inspection (Packaging: Undamaged Product) | All units met the acceptance criteria and passed Packaging Visual Inspection. |
| Tensile Strength | All units met the acceptance criteria and passed Tensile Strength testing. |
| PTFE Delamination | All units met the acceptance criteria and passed PTFE Delamination testing. |
| Torque Strength | All samples met acceptance criteria and passed Torque Strength testing. |
| Catheter Burst | All samples met acceptance criteria and passed Catheter Burst testing. |
| Leak (Liquid)<br>Leak (Air) | All samples met acceptance criteria and passed the Air and Liquid Leakage testing. |
| Dimensional (ID, OD, & Working Length) | All samples met acceptance criteria and passed Dimensional testing. |
| Kink Resistance | All samples met acceptance criteria and passed Kink Resistance testing. |
| Visual Inspection (Transition & Tip) | All samples met acceptance criteria and passed both the transition and tip visual inspections. |
| Lumen Patency | All samples met acceptance criteria and passed Lumen Patency testing. |
| Vacuum Drop | All samples met acceptance criteria and passed Vacuum Drop testing. |
| Tip Flexibility | All samples met acceptance criteria and passed Tip Flexibility testing. |
| Friction Force | All samples met acceptance criteria and passed Friction Force testing |

Table 2. Performance Testing Summary

# Performance Data – Clinical

No clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.

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### Shelf Life Testing

Shelf life testing previously conducted for the AXS Vecta Aspiration System was leveraged to support the changes to AXS Vecta 71 and 74 Aspiration Catheters and can be found in K172167 and K181354. Shelf life testing was not performed since it was determined that there is no impact on material degradation and the design changes do not impact the overall efficacy and safety of the device.

### Sterilization

The subject device is sterilized by 100% EtO and has been adopted into a validated sterilization process in accordance with the principles of AAMI TIR 28:2016 Product Adoption & Process Equivalence for Ethylene Oxide Sterilization and per the requirements of ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

# Biocompatibility

Biocompatibility testing previously conducted for the AXS Vecta Aspiration System was leveraged to support the changes to AXS Vecta 71 and 74 Aspiration Catheters and can be found in K172167 and K181354. Additionally, though no biological risks were identified, confirmatory tests (cytotoxicity, sensitization and irritation) were conducted to confirm that there is no impact on existing biocompatibility study. Based on the testing results, the AXS Vecta 71 and 74 Aspiration Catheters with the design change is free from biological hazard per ISO 10993-1.

# Summary of Substantial Equivalence

The performance characteristics and the test results demonstrate that the AXS Vecta Aspiration System meets the acceptance criteria to determine that the AXS Vecta Aspiration System is substantially equivalent to the predicate device. Furthermore, the intended use, the operating principles, and the design are all equivalent and support the conclusion that all devices are technologically similar. Additionally, the testing results summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.

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Stryker Neurovascular has demonstrated that the AXS Vecta Aspiration Catheters are as safe, as effective, and perform as well as the legally marketed Predicate device.