AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)

K183464 · Stryker · NRY · Mar 13, 2019 · Cardiovascular

Device Facts

• Record ID: K183464
• Device Name: AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
• Applicant: Stryker
• Product Code: NRY · Cardiovascular
• Decision Date: Mar 13, 2019
• 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 7 Distal Access Catheter is a sterile, single-lumen, variable-stiffness catheter for neurovascular thrombus removal via continuous aspiration. Input: vacuum pressure from external Medela Dominant Flex Pump (-68 kPa). Operation: physician advances catheter through vasculature under fluoroscopic guidance over a guidewire to the occlusion site; aspiration is applied via the catheter lumen to remove the clot. Output: thrombus removal. Used in clinical settings by interventionalists. Benefits: restores blood flow in acute ischemic stroke patients. Device includes RHV, Tuohy Borst valve, and peel-away introducer sheaths.

Clinical Evidence

No clinical study conducted. Evidence consists of bench testing (dimensional, tip configuration, surface integrity, buckling, lubricity, particulate, tensile, leak resistance, torsional bond, flexural fatigue, kink radius, aspiration flow rate) and animal testing (in-vivo safety/navigation/aspiration). Published clinical literature on predicate devices was reviewed to support the line extension.

Technological Characteristics

Materials: Pebax, Nylon, Tecoflex, Nitinol wire, polymer fiber, PTFE, Platinum/Iridium marker, Cyanoacrylate adhesive. Dimensions: 6.2F distal OD, 6.3F proximal OD, 0.068 in ID. Energy: External vacuum pump (-68 kPa). Sterilization: 100% Ethylene Oxide. Connectivity: None (mechanical).

Indications for Use

Indicated for revascularization of 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 patients ineligible for or 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

• AXS Catalyst Distal Access Catheter (K173841)
• Penumbra System ACE 68 Reperfusion Catheter (K161640)

Submission Summary (Full Text)

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March 13, 2019

Stryker Neurovascular Germaine Fu. PhD Associate Project Manager, Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538

Re: K183464

Trade/Device Name: AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 13, 2018 Received: December 14, 2018

Dear Germaine Fu, PhD:

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.htm); 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
Date: 2019.03.13
18:49:44 -04'00'
Lin Zheng-s

Carlos L. Peña. PhD, MS for 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) K183464

#### Device Name

AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter)

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)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary K183464

#### 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: | Germaine Fu<br>Associate Project Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 13, 2018 |
| Device Name and Classification: | |
| Trade/Proprietary Name: | AXS Universal Aspiration System (AXS Catalyst 7 Distal Access<br>Catheter) |
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | NRY |

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| Legally Marketed<br>Predicate<br>Device(s): | Primary Predicate Device | Additional Predicate Device |
|---------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------|
| | AXS Catalyst Distal Access<br>Catheter<br>(K173841) | Penumbra System ACE 68<br>Reperfusion Catheter<br>(K161640) |

#### Device Description

The AXS Catalyst 7 Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in the removal of thrombus from the neuro vasculature using continuous aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel-away introducer sheaths. The RHV 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.

When used as part of the aspiration system, the AXS Catalyst Distal Access Catheter requires a minimum vacuum pressure of -68 kPa [-20.08 in Hg] from an external device (Medela Dominant Flex Pump). Bench and Animal testing utilizing the Medela Dominant Flex Pump and Suction Jar, AXS Universal Aspiration Tubing, and AXS Universal Liner Set were conducted to successfully demonstrate aspiration.

## 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 7 Distal Access Catheter when used as part of the aspiration system is substantially equivalent to the Primary Predicate device (K173841) and Additional Predicate device (K161640) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate devices is summarized in Table 1 below.

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| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device |
| | AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | Penumbra System ACE 68 Reperfusion Catheter |
| Manufacturer | Stryker Neurovascular | Stryker Neurovascular | Penumbra, Inc. |
| 510(k) Number | K183464 | K173841 | K161640 |
| Device Trade Name | AXS Catalyst® 7 Distal Access Catheter | AXS Catalyst® 5 and 6 Distal Access Catheter | Penumbra System ACE 68 Reperfusion Catheter |
| Regulation Number | 21 CFR 870.1250 | Same | Same |
| Regulation Name | Percutaneous Catheter | Same | Same |
| Classification | II | Same | Same |
| Product Code | NRY | Same | Same |
| Intended Use/ Indication 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 | Same | As part of the Penumbra System, the Reperfusion Catheters and Separators are 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, |
| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | |
| Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device |
| | AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | Penumbra System ACE 68 Reperfusion Catheter |
| | 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. | | and vertebral arteries) within 8 hours of symptom onset. |
| Device Description | The AXS Universal Aspiration System is composed of the following components:<br>• AXS Catalyst Distal Access Catheter<br>• AXS Universal Aspiration Tubing<br>• AXS Universal Liner Set<br>• Medela Dominant Flex Pump<br><br>The AXS Universal Aspiration System is designed to remove thrombus from the neurovasculature using continuous aspiration. | Same | The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only. |
| Detail | Submission Subject<br>Device | Primary Predicate<br>Device | Additional Predicate<br>Device |
| | AXS Catalyst 7 Distal<br>Access Catheter | AXS Catalyst 5 and 6<br>Distal Access Catheter | Penumbra System<br>ACE 68 Reperfusion<br>Catheter |
| Accessory<br>Devices<br>Provided (not<br>in direct<br>contact with<br>patient) | The AXS Catalyst<br>Distal Access Catheter<br>delivers aspiration<br>from the Medela<br>Dominant Flex Pump<br>directly to the site of<br>the occlusion to<br>remove the clot. The<br>AXS Catalyst Distal<br>Access Catheter is a<br>sterile, single lumen,<br>variable stiffness<br>catheter. | Same | Peelable sheath,<br>rotating hemostasis<br>valve, shaping<br>mandrel |
| Materials | | | |
| Outer Jacket | Pebax with Nylon,<br>Tecoflex | Same | Vestamid, Pebax,<br>Tecoflex, Pellethane |
| Reinforcement | Nitinol wire and<br>polymer fiber | Stainless Steel,<br>Nitinol wire, and<br>polymer fiber | Stainless steel and<br>Nitinol wire |
| Strain Relief | Thermoplastic rubber<br>(Polyolefin) | Thermoplastic rubber<br>(Santoprene) | Stainless steel, 304 |
| Inner Layer | PTFE | Same | Same |
| Catheter Hub | Nylon | Same | Proximal Hub<br>Grilamid<br>(TR55-LX) |
| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | |
| Detail | Submission Subject<br>Device | Primary Predicate<br>Device | Additional Predicate<br>Device |
| | AXS Catalyst 7 Distal<br>Access Catheter | AXS Catalyst 5 and 6<br>Distal Access Catheter | Penumbra System<br>ACE 68 Reperfusion |
| | | | Catheter |
| Marker Band | Platinum/Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Not available |
| Outer Jacket<br>Coating | Hydrophilic Coating | Same | SRDX Harmony<br>(proprietary) coating |
| Features | | | |
| Labeled Shaft | Distal OD: | Distal OD: | Distal OD: |
| Outer<br>Diameter | 6.2F (0.082 in.) | 5.3F (0.0696 in.) | 0.084 in. |
| | Proximal OD: | 5.4F (0.0709 in.) | Proximal OD: |
| | 6.3F (0.0825 in.) | | 0.084 in. |
| | | Proximal OD: | |
| | | 5.6F (0.0735 in.) | |
| | | 6.0F (0.0787 in.) | |
| Effective | 115cm | CAT 5:<br>115cm, 132cm | 115cm |
| Lengths | 125cm<br>132cm | | 120cm |
| | | CAT 6: 132cm | 125cm |
| | | | 127cm |
| | | | 132cm |
| Distal ID | 0.068 in. | CAT 5: 0.058 in.<br>CAT 6: 0.060 in. | 0.068 in. |
| Proximal ID | 0.068 in. | CAT 5: 0.058 in.<br>CAT 6: 0.060 in. | 0.068 in. |
| Packaging<br>Materials | Polyethylene Tube<br>and HDPE<br>Packaging Card | Same | Polyester/<br>Polyethylene/Tyvek and…