Predicate Devices

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

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and hydraulic properties of the aspiration system components, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for revascularization in patients with acute ischemic stroke, which is a medical treatment aimed at restoring blood flow and thus falls under the definition of a therapeutic device.

Diagnostic

No

The device is a treatment device, specifically designed for revascularization in patients with acute ischemic stroke by restoring blood flow. It facilitates clot removal through aspiration and does not provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a catheter, tubing, pump, and liner set. The device is a physical system used for aspiration, not a software-only solution.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to revascularize patients with acute ischemic stroke by removing intracranial large vessel occlusions. This is a therapeutic intervention performed in vivo (within the living body).
Device Description: The device components are designed for mechanical aspiration of blood clots from blood vessels. This is a physical process, not a diagnostic test performed on a sample in vitro (outside the living body).
Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, tissue, etc.) to provide diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically remove an obstruction from a blood vessel, which is a treatment, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

NRY

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).

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician trained in interventional endovascular procedures.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Data - Bench Testing:

In-vitro Simulated Use (Direct Aspiration): Evaluated the performance of the Subject Device to Primary Predicate when aspirating clot in tortuous anatomical model. All test samples met acceptance criteria.
In-vitro Usability Study: Multiple User evaluation of the clot retrieval, durability and kink resistance of the Subject and Primary Predicate Devices in a tortuous anatomical model. All test samples met acceptance criteria.
Aspiration Flow Rate: Determined the aspiration flow rate and lumen integrity of the system when no occlusion is present. All test samples met acceptance criteria.
Tip Buckling: Determined the maximum force a catheter tip could withstand before buckling. All test samples met acceptance criteria.
Track Force: Determined the maximum force a test catheter exerts on the tortuous vessel model as it tracks to the M2 for both advancing and retracting. All test samples met acceptance criteria.
Catheter Tip and Lumen Patency (Direct Aspiration): Tested resistance to tip and lumen collapse during direct aspiration and test tip integrity to tears and missing material. All test samples met acceptance criteria.

Performance Data - Bench Testing Previously Cleared (from K151667):

Dimensional Verification: Met acceptance criteria.
Tip Configuration: Met acceptance criteria.
Surface Integrity: Met acceptance criteria.
Tip Buckling: Met acceptance criteria.
Catheter lubricity and durability: Met acceptance criteria.
Trackability: Met acceptance criteria.
Tensile Strength: Met acceptance criteria.
Liquid Leak Resistance: Of catheter met acceptance criteria.
Air Leak Resistance: Of catheter met acceptance criteria.
Catheter Torsional Bond Strength: Met acceptance criteria.
Flexural Fatigue: Met acceptance criteria.
Catheter Kink Radius: Met acceptance criteria.
Chemical Compatibility: Met acceptance criteria.
Hub Gauging: Met acceptance criteria.

Performance Data - Animal Study:

In-vivo Efficacy and Safety Evaluation (Arm 1): Assessed vessel revascularization and adverse events associated with mechanical thrombectomy procedure via direct aspiration comparing Subject Device to Primary Predicate Device. Conclusion: Subject Device is equivalent to the Primary Predicate in efficacy and safety.
In-vivo Efficacy and Safety Evaluation (Arm 2): Assessed the vascular safety profile of treatment by aspiration and navigation of the Subject Device compared to the Primary Predicate Device. Conclusion: Subject Device is equivalent to the Primary Predicate in safety.
In-vivo Vascular Response (Direct Aspiration): Assessed the vascular response of direct aspiration through the Subject Device compared to Primary Predicate device. Conclusion: Subject Device is equivalent to the Primary Predicate in safety.

Performance Data - Clinical:
No clinical study was conducted. A review of published clinical study articles featuring the Primary Predicate Device demonstrated that equivalent devices had clinical outcomes supporting the proposed indication for use and product code.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K151667 (AXS Catalyst Distal Access Catheter)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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);

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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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
47900 Bayside Parkway
Fremont, CA 94538-6515
(FDA Registration Number: 3008853977) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angelica Beckmann
Director, Regulatory Affairs
Phone: 510-413-2900
Fax: 510-413-2588
Email: angelica.beckmann@stryker.com |
| Date Prepared: | March 12, 2018 |
| Device Name and Classification: | |
| Trade/Proprietary Name: | AXS Catalyst ™ Distal Access Catheter as part of the AXS Universal
Aspiration System |
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | NRY |

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| Legally
Marketed
Predicate

Device(s):		Primary Predicate
	Catheter	Penumbra Reperfusion
Catheter
(K090752)	AXS Catalyst Distal Access
Catheter
(K151667)
	Aspiration
System
Components	Penumbra Max Pump
Penumbra Hi-Flo Aspiration
Tubing
Penumbra MAX Canister
(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
Subject Device
AXS Catalyst Distal Access
Catheter	Primary
Predicate Device
Penumbra Reperfusion
Catheter
Manufacturer	Stryker Neurovascular	Penumbra, Inc.
510(k) Number	K173841	K090752
Device Trade Name	AXS Catalyst TM Distal Access
Catheter	Penumbra Reperfusion
Catheter (aka 5MAX ACE or
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
Subject Device
AXS Catalyst Distal Access
Catheter	Primary
Predicate Device
Penumbra Reperfusion
Catheter
Regulation Name	Percutaneous Catheter	Same as Subject Device
Regulatory Class	II	Same as Subject Device
Product Code	NRY	NRY
Intended Use/
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.	The Penumbra System is
intended 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.
Device Description	The AXS Catalyst Distal Access
Catheter when used 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:	Per the associated
DFU: The Penumbra System
consists of three devices that
work as a system to remove
thrombus including the
Penumbra Reperfusion
Catheter, Penumbra Separator
and Aspiration Tubing. The
Penumbra System is used with
the Penumbra Aspiration
Pump.
(Note: The use of the
separator may not be needed
for catheters of inner diameter
of .054" or greater).
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	Submission
Subject Device	Primary
Predicate Device
	AXS Catalyst Distal Access
Catheter	Penumbra Reperfusion
Catheter
	AXS Catalyst™ Distal Access Catheter AXS Universal Aspiration Tubing AXS Universal Liner Set Medela Dominant Flex Pump
Accessory Devices
Provided (not in
direct contact with
patient)	Rotating Hemostatic Valve,
Tuohy Borst Valve with
sideport (2) Peel Away Sheaths	Peelable Sheath, Rotating
Hemostasis Valve, Shaping
Mandrel
Outer Jacket	Pebax with Nylon	Not available
Reinforcement	Stainless Steel with Nitinol wire
and polymer fiber	Stainless Steel Flat wire
(0.002x0.007")
Strain Relief	Thermoplastic rubber	Stainless Steel, 304
Inner Layer	PTFE	Not available
Catheter Hub	Nylon	Proximal Hub Grilamid (TR55-
LX)
Marker Band	Platinum/Iridium	Same as Subject Device
Adhesive	Cyanoacrylate	Not available
Outer Jacket
Coating	Hydrophilic Coating	SRDX Harmony (proprietary)
coating
Labeled Shaft Outer
Diameter	Distal OD:
5.3F, 5.4F	Distal OD:
5MAX 5F
5MAX ACE 5.4F
	Proximal OD:
5.6F, 6.0 F	Proximal OD:
5MAX 6F
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
and Configuration	Polyethylene Tube and HDPE
Packaging Card	Polyester / Polyethylene /
Tyvek and Polyethylene
Packaging Card
Sterilization	EO Sterilization	Same as Subject Device
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	Submission
Subject Device
AXS Catalyst Distal Access
Catheter	Primary
Predicate Device
Penumbra Reperfusion
Catheter
Method
Non-Reusable
Device	Single Use device	Same as Subject Device
Principles of
Operation	The AXS Catalyst Distal Access
Catheter is advanced into the
neuro vasculature by a
physician trained in
interventional endovascular
procedures using a compatible
sheath or guide catheter, and
over an appropriately sized
guide wire. A peel away sheath
is provided in the package to
provide support and facilitate
the introduction of the AXS
Catalyst Catheter tip into the
sheath/guide catheter valve.
Once the catheter is inserted,
the peel away sheath can be
removed. Under fluoroscopic
guidance, the catheter can be
advanced through the
vasculature to the desired
location. The catheter is
designed to remove thrombus
from the vasculature using
aspiration provided by an
external source device, the
Medela Dominant Flex Pump.
The aspiration system is
attached to the catheter via the
RHV (or Tuohy Borst), and the
vacuum is turned on. The
aspiration tubing clamp is
opened to apply aspiration.
Upon completion of the
procedure, the AXS Catalyst
Distal Access Catheter, the AXS	Confirm vessel diameter and
select an appropriate size
Penumbra Reperfusion
Catheter. The catheter tip may
be shaped using the steam
shaping mandrel provided.
Attach the rotating hemostatis
valve provided to the catheter.
Insert the catheter into the
rotating hemostasis valve
connected to the proximal hub
of a guide catheter. If a guide
catheter is not used, insert the
catheter through the valve of
the long femoral sheath using
the peelable sheath. After
inserting the catheter, remove
the peelable sheath from the
vascular sheath, and peel from
the catheter shaft. Using
conventional catheterization
techniques under fluoroscopic
guidance, advance the catheter
into the target vessel over an
appropriate neurovascular
guidewire. Position the
catheter proximal to the
thrombus. Remove the
guidewire from the catheter.
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	Submission
Subject Device
AXS Catalyst Distal Access
Catheter	Primary
Predicate Device
Penumbra Reperfusion
Catheter
	Universal Aspiration Tubing,
and the AXS Universal Liner Set
are disposed of per the
institution's procedures. The
Medela Dominant Flex Pump is
cleaned per the instructions
provided with the pump.
How Supplied	Sterile/Single Use	Same as Subject Device
Aspiration Pump	Medela AG Dominant Flex
Pump
K170329
• Adjustable vacuum pressure
dial
• Three selectable air flow
rates:
40,50,60 L/min
• Non-Sterile
• Reusable
• Cleanable
• Minimum Vacuum Pressure
for aspiration:
-68 kPa [-20.08 inHg]	Penumbra MAX Pump
K160449
• Adjustable vacuum pressure
dial
• Non-adjustable air flow rate
• Non-Sterile
• Reusable
• Cleanable
• Minimum Vacuum Pressure
for aspiration:
-68 kPa [-20.08 inHg]
Aspiration Tubing	Medela AG AXS Universal
Aspiration Tubing
• Class II Exempt
• EO Sterilized
• Non-reusable
• ID: 0.218"
• Length: 300cm
• Flow clamp	Penumbra Hi-Flo Aspiration
Tubing
• K160449
• EO Sterilized
• Non-reusable
• ID: 0.110"
• Length: 284.5cm
• Flow switch
Aspiration Canister	Medela AG Dominant Flex
Pump utilizes a reusable
polycarbonate suction jar and a
non-reusable liner. The AXS
Universal Liner Set consists of 3
individually packaged poly-bags
containing one canister liner.	Penumbra MAX Canister is a
non-reusable polycarbonate
jar.
• Class I Exempt
• Non-Sterile
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	Submission	Primary
	Subject Device	Predicate Device
	AXS Catalyst Distal Access	Penumbra Reperfusion
	Catheter	Catheter
	and one ClotFinder specimen
	cup. The AXS Universal Liner
	Set if offered with and without
	a desiccant.
	• Class I Exempt
	• Non-Sterile

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7

8

9

10

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

Risk Assessment

Risk assessment of the AXS Catalyst Distal Access Catheter when used as part of the AXS Universal Aspiration System has been conducted in accordance with EN ISO 14971. A warning has been added to the instructions for use to instruct users as to appropriate use of aspiration. Results of testing are appropriate for determining that the AXS Catalyst Distal Access Catheter when used as part of the AXS Universal Aspiration System is substantially equivalent to the legally marketed predicate devices.

Testing Summary

Performance Data - Bench Testing

The results of design verification and design validation testing conducted on the AXS Catalyst Distal Access Catheter when used as part of the AXS Universal Aspiration System demonstrate that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Primary Predicate device. The following design validation tests outlined below in Table 2 were performed on the subject device in support of the indication for use:

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Table 2: Overview of Design Validation Testing Results – Clot Aspiration
Test	Test Method Summary	Conclusions
In-vitro Simulated Use
(Direct Aspiration)	Purpose: To evaluate the performance
of the Subject Device to Primary
Predicate when aspirating clot in
tortuous anatomical model.

Method: Simulated use testing uses a
physiological neurovascular model
where clot is aspirated following the
written protocol. | All test samples met
acceptance criteria. |
| In-vitro Usability Study | Purpose: Multiple User evaluation of
the clot retrieval, durability and kink
resistance of the Subject and Primary
Predicate Devices in a tortuous
anatomical model.

Method: Users performed a direct
aspiration of a clot procedure, tracked
the devices to the site of the occlusion
using a neurovascular model that
replicated the tortuosity, diameter and
location of the arteries in the
neurovasculature. | All test samples met
acceptance criteria. |

Design Verification testing was performed comparing the flow rates of the subject aspiration system to the primary predicate aspiration system. Tip buckling and track forces (insertion and retraction) for the subject device catheters were also compared to the predicate device catheters. Design Verification testing was also performed to assess catheter tip and lumen patency under direct and adjunctive aspiration using the Medela Dominant Flex Pump.

The design verification bench testing is summarized in Table 3 below.

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Table 3: Performance Data - Bench Testing
Test	Test Method Summary	Conclusions
Aspiration Flow Rate	Purpose: To determine the aspiration
flow rate and lumen integrity of the
system when no occlusion is present.

Method: The volume of water an
aspiration system (catheter + associated
pump and accessories) could aspirate in
20s was measured. This volume in mL
was divided by 20 to give the flow rate in
mL/s. | All test samples met
acceptance criteria. |
| Tip Buckling | Purpose: To determine the maximum
force a catheter tip could withstand
before buckling.

Method: The test catheter was soaked in
37°C water prior to testing. A mandrel
was then inserted into the distal end of
the catheter and the catheter with
mandrel was placed into the test fixture
on a tensile test machine. The test
catheter was compressed against a load
cell until the distal tip buckled. The
compression force was recorded. | All test samples met
acceptance criteria. |
| Track Force | Purpose: To determine the maximum
force a test catheter exerts on the
tortuous vessel model as it tracks to the
M2 for both advancing and retracting.

Method: The test catheter was soaked in
37°C water prior to testing. The catheter
was tracked to the M2 through the
smallest ID compatible guide in the
neurovascular challenge path model and
the force was recorded. The catheter
was then retracted through the same
model path and the force was recorded. | All test samples met
acceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Catheter Tip and Lumen
Patency
(Direct Aspiration) | Purpose: To test resistance to tip and
lumen collapse during direct aspiration
and test tip integrity to tears and missing
material.

Method: Prepare test sample and
simulated use model. Insert plug in
catheter tip. Place test sample in the
model to a specified location following
procedural instructions outlined in the
Instructions for Use. Aspirate test
sample using 60cc syringe and aspiration
pump. Visually inspect test sample to
verify indication of no tip or lumen
collapse. | All test samples met
acceptance criteria. |

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The following bench tests were submitted and cleared as part of K151667 for the AXS Catalyst Distal Access Catheter and remain in effect. The results are provided below in Table 4 for reference purposes.

Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Dimensional Verification	Purpose: To describe the procedure and
technique of making dimensional
measurements using various
measurement equipment.
Method: Verify dimensions using
specified measurement tool. Record
measurements.	Dimensional verification
met acceptance criteria
and was cleared as part
of K151667.
Tip Configuration	Purpose: To verify that the catheter tip is
smooth, rounded, tapered or similarly
finished in order to minimize trauma to
vessels during use per EN ISO 10555-1.
Method: Visually inspect distal tip at 10X
magnification to verify distal tip end is
smooth, rounded, tapered or similarly
finished. Record results.	Tip configuration met
acceptance criteria and
was cleared as part of
K151667.
Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Surface Integrity	Purpose: To determine if external
surface of the catheter is free from
extraneous matter, process and surface
defects, and does not have drops of
lubricant fluids.
Method: Visually inspect external
surface of catheter for extraneous
matter, process and surface defects, and
drops of lubricant fluids. Record results.	Surface integrity met
acceptance criteria and
was cleared as part of
K151667.
Tip Buckling	Purpose: To measure the maximum
force required to cause a test sample to
buckle.
Method: Prepare sample for test. Use
buckling tester to measure the maximum
force required to cause a test sample to
buckle. Record results.	Tip buckling met
acceptance criteria and
was cleared as part of
K151667.
Catheter lubricity and
durability	Purpose: To determine the lubricity and
durability of the coating on the catheter
outer shaft.
Method: Prepare sample for test. Use
friction tester to measure the frictional
force of the device sample when pulled
between two clamped pads. Record the
peak frictional force after 5 cycles.	Coating lubricity and
durability met
acceptance criteria and
was cleared as part of
K151667.
Trackability	Purpose: To measure track advance
force of catheter over microcatheter.
Method: A neurovascular model is
placed in a re-circulating water bath at
37°C to simulate human arterial
circulation. The sample is inserted
through model over a microcatheter and
attached to a tensile tester. Advance
catheter through model and determine
peak tracking force. Record results.	Track advance force met
acceptance criteria and
was cleared as part of
K151667.
Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Tensile Strength	Purpose: To determine tensile force
tensile force required to induce failure of
fused joints, shaft junctions, and marker
band for non-hydratable catheters based
on EN ISO 10555-1.	Tensile strength met
acceptance criteria and
was cleared as part of
K151667.
	Method: Identify joint and prepare
sample for test. Use tensile tester to
determine applied peak tensile force.
Record results.
Liquid Leak Resistance	Purpose:

To determine whether catheter
meets the freedom from leakage-liquid
leak requirement 4.7.1 of EN ISO 10555-

To determine if catheter hub meets
the liquid leakage requirement 4.2.1 of
EN 1707. | Liquid leak resistance of
catheter met
acceptance criteria and
was cleared as part of
K151667. | |
| | Method: Connect test hub sample to
fixture and flush with water to expel air.
Occlude distal tip. Apply pressure of
300kPa minimum and maintain pressure
for 30s. Visually inspect catheter/hub
joint and catheter shaft for leaks.
Record results. | | |

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15

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Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Air Leak Resistance	Purpose:

To determine whether catheter meets
the freedom from leakage-air aspiration
requirement of 4.7.2 of EN ISO 10555-1.
To determine if catheter hub meets
the air leakage requirement 4.2.2 of EN

Method: Connect test hub sample to a
partially filled syringe. With the nozzle of
the syringe pointing down towards the
ground, withdraw the plunger to the
10cc mark. Hold for 15 seconds and
examine the water in the syringe for the
formation of air bubbles. Record results. | Air leak resistance of
catheter met
acceptance criteria and
was cleared as part of
K151667. |
| Catheter Torsional Bond
Strength | Purpose: To measure the strength of a
catheter shaft when torque is applied.
Torque strength is defined as number of
rotations before failure occurs.

Method: Prepare test sample and insert
into torsional bond strength test fixture
with tortuous path model. Apply torque
to catheter shaft and observe number of
360-degree rotations before failure
occurs. Record results. | Catheter torsional bond
strength met
acceptance criteria and
was cleared as part of
K151667. |

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Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Flexural Fatigue	Purpose: To determine the flexural
fatigue on the catheter shaft.
Method: Prepare test sample. Advance
entire assembly of guide wire,
microcatheter, and test sample into test
model and track it through test model.
While holding the guide wire,
microcatheter, and test sample, pull the
whole assembly pack proximally until it
exits the models. Repeat for nine more
runs. After run number ten, remove
guide wire and microcatheter out of test
sample and inspect for kink or damage.
Record results.	Flexural fatigue met
acceptance criteria and
was cleared as part of
K151667.
Catheter Kink Radius	Purpose: To measure the kink radius of a
catheter at its distal and specific mid-
shaft joint section.
Method: Prepare test sample. Thread
test sample through fixture loop and lock
down test sample. Pull both ends of test
sample until test sample kinks. Calculate
kink radius using measurement of 2nd to
final loop OD and sample OD. Record
results.	Catheter kink radius met
acceptance criteria and
was cleared as part of
K151667.

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Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Chemical Compatibility	Purpose: To determine visual and
dimensional integrity of catheter
following exposure to saline, non-ionic
and ionic contrast liquids.

Method: Prepare sample for test. Flush
sample with appropriate chemical.
Measure ID and OD using RAM optical
measurement system. Insert mandrel
through sample to verify inner lumen
integrity. Repeat with second mandrel
and record results. Visually inspect distal
end of sample for any chemical effects
on the shaft, inner lumen and cross-
sectional areas. Record results. | Chemical compatibility
met acceptance criteria
and was cleared as part
of K151667. |
| Hub Gauging | Purpose: To determine if catheter hub
meets gauging requirement 4.1 of EN
1707.

Method: Using the appropriate gauge,
the gauge was applied to the conical
fitting with a total axial force of 5N
without the use of torque. The axial load
was then removed and the sample
inspected. | Hub gauging met
acceptance criteria and
was cleared as part of
K151667. |

Performance Data – Animal Study

Animal studies were conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate performance design attributes of the AXS Catalyst™ Distal Access Catheter when used as part of the AXS Universal Aspiration System through user evaluation in an animal model as outlined below in Table 5.

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Table 5: Performance Data – Animal Study
Test	Test Method Summary	Conclusions
In-vivo Efficacy and
Safety Evaluation
(Arm 1)	Purpose: To assess vessel revascularization
and adverse events, if any, associated with a
mechanical thrombectomy procedure
performed via direct aspiration using the
Subject Device compared to the Primary
Predicate Device.	Subject Device is
equivalent to the
Primary Predicate in
efficacy and safety.
	Method: Porcine test subjects were exposed
to aspiration treatment using the AXS
Universal Aspiration System and the
predicate Penumbra System after a vascular
occlusion was artificially induced. Vascular
response was assessed by contrast
angiography and histopathology.
In-vivo Efficacy and
Safety Evaluation
(Arm 2)	Purpose: To assess the vascular safety
profile of treatment by aspiration and
navigation of the Subject Device compared
to the Primary Predicate Device.	Subject Device is
equivalent to the
Primary Predicate in
safety.
	Method: Porcine test subjects were exposed
to aspiration treatment using the AXS
Universal Aspiration System and the
predicate Penumbra System under worst-
case aspiration force and treatment
duration conditions. Vascular response was
assessed by contrast angiography and
histopathology.
In-vivo Vascular
Response
(Direct Aspiration)	Purpose: To assess the vascular response of
direct aspiration through the Subject Device
compared to Primary Predicate device.	Subject Device is
equivalent to the
Primary Predicate in
safety.
	Method: A porcine model was used to
evaluate acute and chronic vessel damage
after direct aspiration in vessels sized
appropriately to simulate the human M2.
Vascular response was assessed by contrast
angiography and histopathology.

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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 Primary Predicate Device. The review demonstrated that equivalent devices published clinical outcomes that supported the proposed indication for use, and the corresponding product code. Given the equivalency of the Subject Device and Primary Predicate Device, the Subject Device is therefore suitable for the proposed indication for use and the associated NRY Product Code.

Shelf Life Testing

The labeled shelf life for the AXS Catalyst Distal Access Catheter is two years. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing were performed on the subject device and the results met established criteria. The Shelf Life testing protocol was cleared as part of the reference predicate under K151667 and is ongoing.

The shelf life for the AXS Universal Aspiration Tubing, AXS Universal Liner Set, and Medela Dominant Flex Pump are established by Medela.

Sterilization

The AXS Catalyst Distal Access Catheter and all system components (including the Rotating Hemostatic Valve, the Tuohy Borst Valve and the Peel Away Introducer Sheath) are sterilized with 100% Ethylene Oxide. The AXS Catalyst Distal Access Catheter and the accessories packaged with the Catheter (RHV, TBV, and the Peel Away Introducer Sheath) are provided sterile to a sterility assurance level (SAL) of 10th, and are for single use only.

Ethylene oxide (EO) residuals on a sample representative of the AXS Catalyst Distal Access Catheter are less than the maximum allowed for EO residuals per EN ISO 10993-7 for a limited contact delivery system -externally communicating.

As reported in the reference predicate clearance as part of K151667, results are:

. Ethylene Oxide Results: 2.29 mg/device extracted residuals (EN ISO 10993-7 requirement is average daily dose