AXS Vecta Aspiration Catheter

K190833 · Stryker Neurovascular · DQY · Dec 15, 2019 · Cardiovascular

Device Facts

• Record ID: K190833
• Device Name: AXS Vecta Aspiration Catheter
• Applicant: Stryker Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Device Story

Single lumen, flexible stiffness catheter; radiopaque marker band at distal end; Luer hub at proximal end; hydrophilic coating on distal shaft to reduce friction. Advanced into neurovasculature by trained physician under fluoroscopic guidance; used with compatible sheath or guide catheter, microcatheter, guidewire, and/or Scout Introducer. Provided with peel-away introducer sheaths to facilitate insertion. Acts as conduit for interventional or retrieval devices. Benefits include facilitating access to distal anatomy for endovascular procedures.

Clinical Evidence

No clinical study conducted. Bench testing only. Simulated use testing in an in vitro model replicating human ICA and MCA arteries confirmed device performance for delivery of retrieval devices. Particulate characterization testing confirmed acceptable levels.

Technological Characteristics

Materials: Polymeric outer jacket, stainless steel/nitinol reinforcement, PTFE inner layer, nylon hub, platinum/iridium marker band, cyanoacrylate adhesive. Hydrophilic coating. EO sterilization. Single-use. Dimensions: 115-132 cm length; 0.071-0.074 in ID. No software or electronic components.

Indications for Use

Indicated for facilitating insertion and guidance of interventional devices into peripheral and neurovascular blood vessels and as a conduit for retrieval devices in patients requiring such procedures.

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 Catalyst 7 Distal Access Catheter (K183463)

Reference Devices

• AXS Vecta Aspiration System (K172167 & K181354)

Submission Summary (Full Text)

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December 15, 2019

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

Re: K190833

Device Name: AXS Vecta Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 15, 2019 Received: November 18, 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,

Xiaolin Zheng, Ph.D. 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) K190833

Device Name AXS Vecta Intermediate Catheter

#### Indications for Use (Describe)

The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

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

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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<br>Senior Staff Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 29, 2019 |
| Device Name and Classification: | |
| Trade/Proprietary Name: | AXS Vecta® Intermediate Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | DQY |

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| Legally Marketed<br>Predicate<br>Devices: | Predicate Devices | Reference Device |
|-------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| | AXS Catalyst 7 Distal<br>Access Catheter (K183463) | AXS Vecta Aspiration System<br>(K172167 & K181354) |

## Device Description

The AXS Vecta Intermediate Catheter is a single lumen, flexible stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal end (distal 25cm) to reduce friction during use. It is packaged with one Scout Introducer, one hemostasis valve, and two peel-away introducers.

The Scout Introducer may be used in conjunction with the AXS Vecta Intermediate Catheter to facilitate in the introduction of the AXS Vecta Intermediate Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Intermediate Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible wires and microcatheters of an outer diameter of less than 0.044in.

## Indications for Use

The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

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## Technological Characteristics and Product Feature Comparison

Stryker Neurovascular has demonstrated the AXS Vecta® Intermediate Catheter (AXS Vecta® 71 & 74 Intermediate Catheters) is substantially equivalent to the Predicate device, AXS Catalyst Distal Access Catheter (K183463) and Reference Device (K172167 & K181354) 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 1: Product Feature Comparison of Subject Device to Predicate Device below.

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| Detail | Submission Subject Device | Predicate Device | Reference Device |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Stryker Neurovascular<br>K190833 | Stryker Neurovascular<br>K183463 | Stryker Neurovascular<br>K172167 & K181354 |
| Device Trade<br>Name | AXS Vecta®<br>Intermediate Catheters<br>(AXS Vecta® 71 & 74<br>Intermediate<br>Catheters) | AXS Catalyst Distal<br>Access Catheter<br>(AXS Catalyst 7<br>Distal Access<br>Catheter) | AXS Vecta Aspiration<br>System |
| Regulation<br>Number | 21 CFR 870.1250 | Same | Same |
| Regulation<br>Name | Percutaneous Catheter | Same | Same |
| Classification | II | Same | Same |
| Product Code | DQY | Same | NRY |
| Intended<br>Use/Indication<br>for Use | The AXS Vecta<br>Intermediate Catheter<br>is indicated for use in<br>facilitating the<br>insertion and guidance<br>of appropriately sized<br>interventional devices<br>into a selected blood<br>vessel in the peripheral<br>and neurovascular<br>systems. The AXS<br>Vecta Intermediate<br>Catheter is also<br>indicated for use as a<br>conduit for retrieval<br>devices. | The AXS Catalyst<br>Distal Access<br>Catheter is indicated<br>for use in<br>facilitating the<br>insertion and<br>guidance of<br>appropriately sized<br>interventional<br>devices into a<br>selected blood<br>vessel in the<br>peripheral and<br>neurovascular<br>systems. The AXS<br>Catalyst Distal<br>Access Catheter is<br>also indicated for<br>use as a conduit for<br>retrieval devices. | The AXS Vecta<br>Aspiration Catheter,<br>as part of the AXS<br>Vecta Aspiration<br>System is indicated<br>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 |
| Detail | Submission Subject<br>Device | Predicate Device | Reference Device |
| Device<br>Description | The AXS Vecta<br>Intermediate Catheter is<br>advanced into the<br>neurovasculature by a<br>physician trained in<br>interventional<br>endovascular procedures<br>using a compatible<br>sheath or guide catheter,<br>and over an<br>appropriately sized<br>microcatheter, guide<br>wire, and/or the Scout<br>Introducer. Two peel-<br>away introducer sheaths<br>are provided in the<br>package to provide<br>support and facilitate the<br>introduction of the AXS<br>Vecta Intermediate<br>Catheter tip into the<br>sheath/guide catheter<br>valve. Once the<br>assembly is inserted, the<br>peel-away introducer<br>sheath can be removed.<br>Under fluoroscopic<br>guidance, the assembly<br>can be advanced through<br>the vasculature to the<br>desired location. | The AXS Catalyst<br>Distal Access Catheter<br>is a sterile, single<br>lumen, variable<br>stiffness catheter<br>designed for use in<br>facilitating the<br>insertion and guidance<br>of appropriately sized<br>interventional devices<br>into a selected blood<br>vessel in the<br>peripheral and<br>neurovascular<br>systems. The catheter<br>shaft has a hydrophilic<br>coating to reduce<br>friction during use.<br>The catheter includes<br>a radiopaque marker<br>on the distal end for<br>angiographic<br>visualization and a<br>luer hub on the<br>proximal end allowing<br>attachments for<br>flushing and<br>aspiration. | treatment.<br>The AXS Vecta<br>Aspiration Catheter is<br>advanced into the<br>neurovasculature by a<br>physician trained in<br>interventional<br>endovascular<br>procedures using a<br>compatible sheath or<br>guide catheter, and over<br>an appropriately sized<br>microcatheter, guide<br>wire, and/or the Scout<br>Introducer. Two peel-<br>away introducer<br>sheaths are provided in<br>the package to provide<br>support and facilitate<br>the introduction of the<br>AXS Vecta Aspiration<br>Catheter tip into the<br>sheath/guide catheter<br>valve. Once the<br>assembly is inserted,<br>the peel-away<br>introducer sheath can<br>be removed. Under<br>fluoroscopic guidance,<br>the assembly can be<br>advanced through the<br>vasculature to the<br>intended vascular site,<br>with the distal end of<br>the AXS Vecta<br>Aspiration Catheter<br>positioned proximal to<br>the clot. The proximal<br>end of the Aspiration<br>Tubing Set is attached<br>to the "to patient"<br>connection of the<br>canister installed to the<br>VC-701 Cliq Aspirator<br>Pump, and the VC-701<br>Cliq Aspirator Pump is |
| Detail | Submission Subject<br>Device | Predicate Device | Reference Device |
| | | | turned ON. All devices<br>inside of the AXS<br>Vecta Aspiration<br>Catheter are removed.<br>The distal end of the<br>Aspiration Tubing Set<br>is attached to the<br>proximal end of the<br>AXS Vecta Aspiration<br>Catheter. To start<br>aspiration, the switch<br>on the Aspiration<br>Tubing Set is turned<br>ON, and the clot is<br>engaged with the AXS<br>Vecta Aspiration<br>Catheter. |
| Accessory<br>Devices<br>Provided (not<br>in direct<br>contact with<br>patient) | Hemostasis Valve, 2<br>Peel-Away Introducers<br>Scout Introducer | Rotating Hemostasis<br>Valve, Tuohy Borst<br>Valve with Sideport,<br>(2) Peel-Away<br>Introducer Sheaths | Same |
| Outer Jacket | Polymeric catheter | Same | Same |
| Reinforcement | Stainless Steel/Nitinol | Nitinol wire and<br>polymer fiber | Same |
| Strain Relief | Polyolefin | Same | Same |
| Inner Layer | PTFE | PTFE/Tecoflex | Same |
| Catheter Hub | Nylon | Same | Same |
| Marker Band | Platinum/Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Outer Jacket<br>Coating | Hydrophilic Coating | Same | Same |
| Labeled Shaft | Distal OD: | Distal OD: | Distal OD: |
| Outer | Vecta 71: 0.082 in. | 6.2F (0.082 in.) | Same |
| Diameter | Vecta 74: 0.083 in.<br>Proximal OD:<br>Vecta 71: 0.085 in.<br>Vecta 74: 0.087 in. | Proximal OD:<br>6.3F (0.0825 in.) | Proximal OD:<br>Same |
| Effective<br>Lengths…