AXS Vecta Aspiration System

K190212 · Stryker Neurovascular · NRY · Apr 24, 2019 · Cardiovascular

Device Facts

• Record ID: K190212
• Device Name: AXS Vecta Aspiration System
• Applicant: Stryker Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Apr 24, 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 - 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.

Device Story

AXS Vecta Aspiration System is a neurovascular intervention tool for acute ischemic stroke. System components include an aspiration catheter, Scout/Peel-Away introducers, hemostasis valve, universal aspiration tubing, Medela Dominant Flex pump, and universal liner set. Operated by physicians in clinical settings, the device uses vacuum aspiration to remove thrombi from intracranial vessels. The pump provides adjustable vacuum pressure to the catheter tip, facilitating clot retrieval. The system is designed for revascularization within 8 hours of symptom onset. Clinical benefit includes restoring blood flow in large vessel occlusions. The device is a modification of the predicate system, specifically integrating the Medela Dominant Flex pump and associated tubing. Performance is verified through benchtop simulated use and usability testing, confirming that the system maintains required vacuum pressure and lumen patency during operation.

Clinical Evidence

No clinical study was conducted. Substantial equivalence is supported by bench testing (simulated use, usability, vacuum drop, lumen patency) and a literature review of clinical outcomes for technologically similar devices used for direct aspiration.

Technological Characteristics

System includes aspiration catheter, introducers, hemostasis valve, aspiration tubing, and Medela Dominant Flex pump. Operates via vacuum aspiration with adjustable vacuum pressure (max 28 in Hg). Components are single-use (catheter, tubing, liners) or reusable (pump). Connectivity is mechanical/pneumatic. Sterilization method not specified.

Indications for Use

Indicated for revascularization in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset. Applicable to patients 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

• Zenith Flex Aspiration System (K181354)

Reference Devices

• Stryker AXS Universal Aspiration System (K173841)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring an abstract symbol. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 24, 2019

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

Re: K190212

Trade/Device Name: AXS Vecta Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 22, 2019 Received: March 25, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Xiaolin Zheng him in the many of the subject of the subject of the station of the subject of the subject of the station of the station of the subject of the subjection of the subjection o -5 J Date: 2019.04.24 14:13:14 -04'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190212

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)

| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(k) SUMMARY

## Submitter's Name and Address

Stryker Neurovascular 47900 Bayside Parkway Fremont, California 94538 Telephone: [phone] Facsimile: 1-510-413-2588

## Contact Information

Shazia Hakim Staff Regulatory Affairs Specialist Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 510-413-2636 (phone) 510-413-2588 (fax) [e-mail]

#### Secondary Contact

Angelica Beckmann Director of Regulatory Affairs Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 650-224-9823 (phone) [e-mail]

#### Date Prepared

January 31, 2019

## Device Trade or Proprietary Name

AXS Vecta Aspiration System

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### Device Common or Classification Name:

Catheter, Percutaneous, 21 CFR 870.1250, Class II

## Product Code:

NRY (Catheter)

ldentification of the Legally Marketed Devices to which Equivalence is Being Claimed

| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|-------------------------------|----------------------|---------------|
| Zenith Flex Aspiration System | InNeuroCo, Inc | K181354 |
| Name of Reference Device | Name of Manufacturer | 510(k) Number |

### 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.

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# Comparison to Predicate Device

| | Predicate Device<br>Stryker AXS Vecta<br>Aspiration System<br>(formerly<br>InNeuroCo Zenith<br>Flex System) | Reference Device<br>Stryker AXS<br>Universal<br>Aspiration System | Subject Device<br>AXS Vecta<br>Aspiration System<br>(with the Medela<br>Dominant Flex<br>Pump) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Number | K181354 | K173841 | K190212 |
| Classification | Class II | Class II | Same |
| Product Code | NRY | NRY | Same |
| Review Panel | Neurology | Neurology | Same |
| Indications For<br>Use | The Zenith Flex<br>System, including the<br>Zenith Flex Catheter,<br>Aspiration Tubing<br>Set, and VC-701 Cliq<br>Aspirator Pump, is<br>indicated in the<br>revascularization of<br>patients with acute<br>ischemic stroke<br>secondary to<br>intracranial large<br>vessel occlusive<br>disease (within the<br>internal carotid,<br>middle cerebral – M1<br>and M2 segments,<br>basilar, and vertebral<br>arteries) within 8<br>hours of symptom<br>onset. Patients who<br>are ineligible for<br>intravenous tissue<br>plasminogen<br>activator (IV t-PA) or<br>who failed IV t-PA<br>therapy are<br>candidates for<br>treatment. | The AXS Catalyst<br>Distal Access<br>Catheter as part of<br>the AXS Universal<br>Aspiration System is<br>indicated for use in<br>the<br>revascularization of<br>patients with acute<br>ischemic stroke<br>secondary to<br>intracranial large<br>vessel occlusive<br>disease (in the<br>internal carotid,<br>middle cerebral - M1<br>and M2 segments,<br>basilar, and vertebral<br>arteries) within 8<br>hours of symptom<br>onset.<br>Patients who are<br>ineligible for<br>intravenous tissue<br>plasminogen<br>activator (IV t-PA) or<br>who failed IV t-PA<br>are candidates<br>for treatment. | Same |

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| | Predicate Device<br>Stryker AXS Vecta<br>Aspiration System<br>(formerly<br>InNeuroCo Zenith<br>Flex System) | Reference Device<br>Stryker AXS<br>Universal<br>Aspiration System | Subject Device<br>AXS Vecta<br>Aspiration System<br>(with the Medela<br>Dominant Flex<br>Pump) | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------|----------------------------|
| Patient Contacting<br>Components | AXS Vecta Aspiration<br>Catheter and its<br>Accessories | AXS Catalyst Distal<br>Access Catheter | Same as AXS Vecta<br>Aspiration System | | | |
| Pump | Cliq VC-701<br>Aspirator | Medela Dominant<br>Flex Pump | Same as AXS<br>Universal Aspiration<br>System | | | |
| Aspiration Tubing | Aspiration Tubing Set | AXS Universal<br>Aspiration Tubing | Same as AXS<br>Universal Aspiration<br>System | | | |
| Replacement<br>Components | Canister Set | AXS Universal Liner<br>Set | Same as AXS<br>Universal Aspiration<br>System | | | |
| Aspiration Method | Pump | Pump | Same | | | |
| Single Use<br>Components | Catheter and its<br>accessories,<br>Aspiration Tubing,<br>Canister Sets | Catheter and its<br>accessories, Aspiration<br>Tubing, Liner Set | Same as AXS<br>Universal Aspiration<br>System | | | |
| Reusable<br>Components | Pump | Pump | Same | | | |
| Maximum<br>Aspiration<br>Pressure | 27 in Hg | 28 in Hg | Same as AXS<br>Universal Aspiration<br>System | | | |
| Calculated Force<br>at Tip | Catheter ID | Calculated<br>Force at tip | Catheter ID | Calculated<br>Force at tip | Catheter ID | Calculated<br>Force at tip |
| | 0.071 in | 0.024 kgf | 0.060 in | 0.018 kgf | 0.071 in | 0.025 kgf |
| | 0.074 in | 0.026 kgf | | | 0.074 in | 0.027 kgf |
| Pressure<br>Regulator Method | Adjustable vacuum<br>pressure dial | Same | | Same | | |
| Flow Rate | Non-adjustable Flow<br>Rate | Three Selectable Air<br>Flow Rates: 40, 50,<br>60 mL | | Same as AXS<br>Universal Aspiration<br>System | | |

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### Summary of Non-Clinical Data

The subject device has the same materials, packaging, manufacturing process, and sterilization process as the predicate device. Therefore, testing was only conducted for specifications that were affected by changing the pump and the tubing.

#### Animal Testing

Animal testing previously conducted for the Zenith Flex System was used to support this change. The GLP animal testing performed with the System included a safety evaluation and an efficacy evaluation at a maximum pressure rating of -27 inHq. However, a calculation of the force at the tip demonstrated that the pressure differences and forces exhibited on the product with the different pumps are minimal. Therefore, this is a modification of an interchangeable component. Since both components have already received clearance for this indication and because the bench top data supports that the catheter still works within the pressure ranges previously established as safe, the animal testing previously conducted can be used to support this change as well.

### AXS Vecta Performance Testing

To demonstrate substantial equivalence between the subject AXS Vecta Aspiration System and the predicate Zenith Flex System and the reference Stryker AXS Universal Aspiration System, 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 characteristics as the predicate device and the reference device. All the testing conducted to demonstrate substantial equivalence are presented in the following table.

| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use - Bench<br>(AXS Vecta Aspiration<br>System) | AXS Vecta Aspiration<br>System underwent<br>simulated use testing by<br>a physician in a<br>benchtop model | Test samples must meet<br>predetermined user needs | AXS Vecta Aspiration System<br>test samples met the<br>acceptance criteria for<br>Simulated Use<br>- Bench to demonstrate that<br>the AXS Vecta System is<br>substantially equivalent to the<br>predicate device. |

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| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use Testing<br>– Usability<br>(AXS Vecta Aspiration<br>System) | AXS Vecta Aspiration<br>System underwent<br>simulated use testing by a<br>physician in a benchtop<br>model | Test samples must meet<br>predetermined user needs | AXS Vecta Aspiration System<br>test samples met the<br>acceptance criteria for<br>Simulated Use<br>- Usability to demonstrate that<br>the AXS Vecta Aspiration<br>System is substantially<br>equivalent to the predicate<br>device. |
| Vacuum Drop / Suction<br>Connector Secure<br>Attachment<br>(Aspiration Tubing Set) | Vacuum pressure<br>measured at source and<br>tip to evaluate pressure<br>difference | Test sample results must<br>meet or exceed existing<br>pressure specifications. | AXS Vecta Aspiration System<br>test samples met the<br>acceptance criteria for<br>Vacuum Drop to demonstrate<br>that the AXS Vecta Aspiration<br>System is substantially<br>equivalent to the predicate<br>device. |
| Lumen Patency<br>(Aspiration Tubing Set) | Samples were evaluated<br>for lumen collapse during<br>aspiration | Test sample results must<br>meet or exceed existing<br>lumen patency<br>specifications. | AXS Vecta Aspiration System<br>test samples met the<br>acceptance criteria for Lumen<br>Patency to demonstrate that<br>the AXS Vecta Aspiration<br>System is substantially<br>equivalent to the predicate<br>device. |

## Performance Data - Clinical

No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by using clinical outcomes from devices that are considered technologically similar. This documentation was reviewed within the scope of this change and determined to be applicable.

## 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.