AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm

K173841 · Stryker · NRY · Mar 18, 2018 · Cardiovascular

Device Facts

• Record ID: K173841
• Device Name: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
• Applicant: Stryker
• Product Code: NRY · Cardiovascular
• Decision Date: Mar 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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 are candidates for treatment.

Device Story

AXS Catalyst Distal Access Catheter is a sterile, single-lumen, variable-stiffness catheter used for mechanical thrombectomy. It functions as part of the AXS Universal Aspiration System, which includes aspiration tubing, a Medela Dominant Flex Pump, and a liner set. The catheter is advanced into the neurovasculature by an interventional physician under fluoroscopic guidance over a guidewire. Once positioned proximal to the thrombus, the system applies vacuum pressure (minimum -68 kPa) generated by the external pump to aspirate the clot. The device is used in clinical settings (e.g., neuro-interventional suites). The physician monitors the procedure via angiography. Successful aspiration restores blood flow, potentially improving patient outcomes in acute ischemic stroke. The catheter features a hydrophilic coating for navigation and a radiopaque marker for visualization.

Clinical Evidence

No clinical study was conducted. Substantial equivalence is supported by bench testing (simulated use, usability, flow rate, tip buckling, track force, patency) and animal studies (porcine model) comparing the subject device to the primary predicate. A literature review of clinical outcomes for the predicate device was used to support the indication.

Technological Characteristics

Sterile, single-lumen, variable-stiffness catheter. Materials: Pebax/Nylon outer jacket, PTFE inner layer, stainless steel/nitinol/polymer fiber reinforcement, platinum/iridium marker band, cyanoacrylate adhesive. Hydrophilic coating. Dimensions: 5.3F-5.4F distal OD, 5.6F-6.0F proximal OD. Aspiration via external Medela Dominant Flex Pump (-68 kPa). EO sterilization. Single-use.

Indications for Use

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

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

• Penumbra Reperfusion Catheter (K090752)
• Penumbra Max Pump (K160449)
• Penumbra Hi-Flo Aspiration Tubing (K160449)
• Penumbra MAX Canister (K160449)

Reference Devices

• AXS Catalyst Distal Access Catheter (K151667)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 18, 2018

Stryker Neurovascular Angelica Beckmann Director, Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538

Re: K173841

Trade/Device Name: AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II

Product Code: NRY Dated: December 14, 2017 Received: December 18, 2017

Dear Angelica Beckmann:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Carlos L. Pena -S

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) K173841

#### Device Name

AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System

Indications for Use (Describe)

The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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 are candidates for treatment.

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

| <span style="font-size:10pt"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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#### 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### 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: | Angelica Beckmann<br>Director, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 12, 2018 |
| Device Name and Classification: | |
| Trade/Proprietary Name: | AXS Catalyst ^™ Distal Access Catheter as part of the AXS Universal<br>Aspiration System |
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | NRY |

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| Legally<br>Marketed<br>Predicate<br>Device(s): | | Primary Predicate | Reference Predicate |
|------------------------------------------------|------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Catheter | Penumbra Reperfusion<br>Catheter<br>(K090752) | AXS Catalyst Distal Access<br>Catheter<br>(K151667) |
| | Aspiration<br>System<br>Components | Penumbra Max Pump<br>Penumbra Hi-Flo Aspiration<br>Tubing<br>Penumbra MAX Canister<br>(K160449) | N/A |

#### Device Description

The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The AXS Universal Aspiration System is designed for use within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries. The AXS Universal Aspiration System is composed of the following components:

- AXS Catalyst™ Distal Access Catheter ●
- AXS Universal Aspiration Tubing
- . Medela Dominant Flex Pump
- AXS Universal Liner Set

The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter. The catheter shaft has a hydrophilic coating to reduce friction during use, includes a radiopaque marker on the distal end for angiographic visualization, and includes a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostastic Valve (RHV), Tuohy Borst Valve with Sideport, and Peel Away Introducer. The Rotating Hemostastic Valve and Tuohy Borst valve with sideport are used for flushing, insertion of catheters, and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst. The AXS Catalyst Distal Access Catheter is the only component of the AXS Universal Aspiration System that is used intravascularly.

The AXS Universal Aspiration Tubing serves as a conduit to supply vacuum from the Medela Dominant Flex Pump to the distal tip of the AXS Catalyst Distal Access Catheter. The AXS Universal Aspiration Tubing provides a connection between the sterile and nonsterile environments. The proximal end of the AXS Universal Aspiration Tubing is connected to the AXS Universal Liner Set (outside of the sterile environment) while the distal end of the AXS Universal Aspiration Tubing is connected to the AXS Catalyst Distal Access Catheter (inside the sterile environment). The AXS Universal Liner Set is connected to the Medela Dominant Flex Pump (also outside of the sterile environment).

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The Medela Dominant Flex Pump is designed to generate vacuum for the AXS Universal Aspiration System. When used as part of the AXS Universal Aspiration System, the AXS Catalyst Distal Access Catheter requires a minimum vacuum pressure of -68 kPa [-20.08 in Hg] from the Medela Dominant Flex Pump. The Medela Dominant Flex Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The AXS Universal Liner Set is provided non-sterile and consists of an individually packaged canister liner and a ClotFinder specimen cup. The AXS Universal Liner Set is offered with and without a desiccant. The AXS Universal Liner Set is single-use and the repository for aspirated material.

#### Indications for Use

The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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 are candidates for treatment.

## Technological Characteristics and Product Feature Comparison

Stryker Neurovascular has demonstrated the AXS Catalyst Distal Access Catheters when used as part of the AXS Universal Aspiration System are substantially equivalent to the primary predicate device (K090752 and K160449) and reference predicate device (K151667) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the subject device with the primary predicate and reference predicate device is summarized in Table 1 below.

| Table 1: Product Feature Comparison of Subject Device to Predicate Device | | |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detail | Submission<br>Subject Device<br>AXS Catalyst Distal Access<br>Catheter | Primary<br>Predicate Device<br>Penumbra Reperfusion<br>Catheter |
| Manufacturer | Stryker Neurovascular | Penumbra, Inc. |
| 510(k) Number | K173841 | K090752 |
| Device Trade Name | AXS Catalyst TM Distal Access<br>Catheter | Penumbra Reperfusion<br>Catheter (aka 5MAX ACE or<br>5MAX or ACE60) |
| Regulation Number | 21 CFR 870.1250 | Same as Subject Device |
| Table 1: Product Feature Comparison of Subject Device to Predicate Device | | |
| Detail | Submission<br>Subject Device<br>AXS Catalyst Distal Access<br>Catheter | Primary<br>Predicate Device<br>Penumbra Reperfusion<br>Catheter |
| Regulation Name | Percutaneous Catheter | Same as Subject Device |
| Regulatory Class | II | Same as Subject Device |
| Product Code | NRY | NRY |
| Intended Use/<br>Indications for Use | The AXS Catalyst Distal Access<br>Catheter as part of the AXS<br>Universal Aspiration System is<br>indicated for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (in the<br>internal carotid, middle<br>cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who failed<br>IV t-PA are candidates for<br>treatment. | The Penumbra System is<br>intended for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (in the<br>internal carotid, middle<br>cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset. |
| Device Description | The AXS Catalyst Distal Access<br>Catheter when used as part of<br>the AXS Universal Aspiration<br>System is designed to restore<br>blood flow in patients with<br>acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease. The<br>AXS Universal Aspiration<br>System is designed for use<br>within the internal carotid,<br>middle cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries. The AXS<br>Universal Aspiration System is<br>composed of the following<br>components: | Per the associated<br>DFU: The Penumbra System<br>consists of three devices that<br>work as a system to remove<br>thrombus including the<br>Penumbra Reperfusion<br>Catheter, Penumbra Separator<br>and Aspiration Tubing. The<br>Penumbra System is used with<br>the Penumbra Aspiration<br>Pump.<br>(Note: The use of the<br>separator may not be needed<br>for catheters of inner diameter<br>of .054" or greater). |
| Table 1: Product Feature Comparison of Subject Device to Predicate Device | | |
| Detail | Submission<br>Subject Device | Primary<br>Predicate Device |
| | AXS Catalyst Distal Access<br>Catheter | Penumbra Reperfusion<br>Catheter |
| | AXS Catalyst™ Distal Access Catheter AXS Universal Aspiration Tubing AXS Universal Liner Set Medela Dominant Flex Pump | |
| Accessory Devices<br>Provided (not in<br>direct contact with<br>patient) | Rotating Hemostatic Valve,<br>Tuohy Borst Valve with<br>sideport (2) Peel Away Sheaths | Peelable Sheath, Rotating<br>Hemostasis Valve, Shaping<br>Mandrel |
| Outer Jacket | Pebax with Nylon | Not available |
| Reinforcement | Stainless Steel with Nitinol wire<br>and polymer fiber | Stainless Steel Flat wire<br>(0.002x0.007") |
| Strain Relief | Thermoplastic rubber | Stainless Steel, 304 |
| Inner Layer | PTFE | Not available |
| Catheter Hub | Nylon | Proximal Hub Grilamid (TR55-<br>LX) |
| Marker Band | Platinum/Iridium | Same as Subject Device |
| Adhesive | Cyanoacrylate | Not available |
| Outer Jacket<br>Coating | Hydrophilic Coating | SRDX Harmony (proprietary)<br>coating |
| Labeled Shaft Outer<br>Diameter | Distal OD:<br>5.3F, 5.4F | Distal OD:<br>5MAX 5F<br>5MAX ACE 5.4F |
| | Proximal OD:<br>5.6F, 6.0 F | Proximal OD:<br>5MAX 6F<br>5MAX ACE 6F |
| Effective Lengths | 115 cm, 132 cm | 125 cm, 127 cm, 132 cm |
| Distal ID (") | 0.058, 0.060 | 0.054, 0.060 |
| Proximal ID (") | 0.058, 0.060 | 0.064, 0.068 |
| Packaging Materials<br>and Configuration | Polyethylene Tube and HDPE<br>Packaging Card…