Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and physical properties of the catheter and aspiration system, with no mention of AI or ML for image analysis, decision support, or any other function.

Therapeutic

Yes
The device is indicated for revascularization and thrombus removal in patients with acute ischemic stroke, which are therapeutic interventions.

Diagnostic

No

This device is a therapeutic revascularization catheter used to remove thrombus (blood clots) in stroke patients, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with various components (shaft, coating, marker, hub, valves, sheaths) and requires an external hardware pump for operation. It is not solely software.

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 for the revascularization of patients with acute ischemic stroke by removing thrombus from the neuro vasculature. This is a therapeutic procedure performed directly on the patient's body.
Device Description: The device is a catheter designed for insertion into blood vessels for aspiration. This is an invasive medical device used for treatment.
Lack of In Vitro Testing: The description of performance studies includes bench testing and animal studies, but there is no mention of testing performed on biological samples outside of the body (in vitro).
Anatomical Site: The device is used within the intracranial blood vessels, which is an in-vivo application.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used for direct intervention and treatment within the body.

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

NRY

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.

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

Revascularization of patients by a 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)

Bench Testing:
The results of design verification and design validation testing conducted on the AXS Catalyst 7 Distal Access Catheter when used as part of the aspiration system demonstrates that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate devices. Testing was conducted in accordance with EN ISO 10555-1 and EN 1707.

Summary of tests performed and their conclusions:

Dimensional Verification: Dimensional verification meets acceptance criteria.
Tip Configuration: Tip configuration meets acceptance criteria.
Surface Integrity: Surface integrity meets acceptance criteria.
Tip Buckling: Tip buckling meets acceptance criteria.
Catheter lubricity and durability: Coating lubricity and durability meets acceptance criteria.
Particulate characterization: Particulate generation was acceptable.
Coating integrity: Coating integrity was acceptable.
Trackability: Track advance force meets acceptance criteria.
Tensile Strength: Tensile strength meets acceptance criteria.
Liquid Leak Resistance: Liquid leak resistance of catheter meets acceptance criteria.
Air Leak Resistance: Air leak resistance of catheter meets acceptance criteria.
Catheter Torsional Bond Strength: Catheter torsional bond strength meets acceptance criteria.
Flexural Fatigue: Flexural fatigue meets acceptance criteria.
Catheter Kink Radius: Catheter kink radius meets acceptance criteria.
Catheter Tip and Lumen Integrity (Direct Aspiration): Catheter tip and lumen integrity during direct aspiration meets acceptance criteria.
Chemical Compatibility: Chemical compatibility meets acceptance criteria.
Hub Gauging: Hub gauging meets acceptance criteria.
Aspiration Flow Rate Bench Testing: All test samples meet acceptance criteria.
In-vitro Usability Study: All test samples meet acceptance criteria.

Animal Study:

Test: In-vivo Safety Evaluation
Method: "Expose porcine test subjects to aspiration treatment using the Subject AXS Catalyst 7 with AXS Universal Aspiration System and the Additional Predicate Penumbra System under worst-case aspiration force and treatment duration conditions. Assess vascular response by contrast angiography and histopathology at both a subacute (~3 days) and chronic time points (~30 days)."
Conclusions: "Subject Device is equivalent to the Additional Predicate Device in safety."

Clinical Data:
"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 Predicate devices. The review demonstrated that equivalent devices published clinical outcomes that supports the proposed line extension to the AXS Catalyst Distal Access Catheter product family. Given the equivalency of the Subject device and Predicate devices, the Subject device is therefore suitable for the proposed indication for use under the associated NRY 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.

K173841, K161640

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.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

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)

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

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3

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
47900 Bayside Parkway
Fremont, CA 94538-6515
(FDA Registration Number: 3008853977) |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Germaine Fu
Associate Project Manager, Regulatory Affairs
Phone: 510-413-2862
Fax: 510-413-2588
Email: germaine.fu@stryker.com |
| Date Prepared: | December 13, 2018 |
| Device Name and Classification: | |
| Trade/Proprietary Name: | AXS Universal Aspiration System (AXS Catalyst 7 Distal Access
Catheter) |
| 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 Device	Additional Predicate Device
	AXS Catalyst Distal Access
Catheter
(K173841)	Penumbra System ACE 68
Reperfusion Catheter
(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:
• AXS Catalyst Distal Access Catheter
• AXS Universal Aspiration Tubing
• AXS Universal Liner Set
• Medela Dominant Flex Pump

AXS Catalyst 7 Distal
Access Catheter | Primary Predicate
Device

AXS Catalyst 5 and 6
Distal Access Catheter | Additional Predicate
Device

Penumbra System
ACE 68 Reperfusion
Catheter |
| | 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, 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 Universal
Aspiration Tubing,
and the AXS
Universal Liner Set
are disposed of per
the institution's
procedures. The
Medela Dominant
Flex Pump is cleaned | | 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 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 |
| | per the instructions
provided with the
pump. | | |
| Aspiration System Components | | | |
| 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] | Same | Penumbra MAX
Pump K161640 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 | Same | Penumbra
Aspiration Tubing K161640 EO Sterilized Non-reusable ID: 0.110" Length: 284.5cm Flow switch |
| Aspiration
Canister | Medela AG Dominant
Flex Pump utilizes a
reusable
polycarbonate suction | Same | Penumbra MAX
Canister is a non- |
| 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 |
| | jar and a non-reusable
liner. The AXS
Universal Liner Set
consists of 3
individually packaged
poly-bags containing
one canister liner and
one ClotFinder
specimen cup. The
AXS Universal Liner
Set is offered with and
without a desiccant.
• Class I Exempt
• Non-Sterile | | reusable
polycarbonate jar.
• Class I Exempt
• Non-Sterile |

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7

8

9

10

11

12

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 7 Distal Access Catheter when used as part of the aspiration system has been conducted in accordance with EN ISO 14971. A warning is included in the instructions for use to instruct users as to appropriate use of aspiration. Results of testing are appropriate for determining that the AXS Catalyst 7 Distal Access Catheter when used as part of the aspiration system is substantially equivalent to the legally marketed Predicate devices.

Testing Summary

Performance Data – Bench Testing

13

The results of design verification and design validation testing conducted on the AXS Catalyst 7 Distal Access Catheter when used as part of the aspiration system demonstrates that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate devices. Testing was conducted in accordance with EN ISO 10555-1 and EN 1707. The design verification and design validation bench testing are summarized in Table 2 below.

Table 2: Performance Data - Bench Testing
Test	Test Method Summary	Conclusions
Design Verification Testing
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
meets acceptance
criteria.
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 meets
acceptance criteria.
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 meets
acceptance criteria.
Table 2: Performance Data - Bench Testing
Test	Test Method Summary	Conclusions
Tip Buckling	Purpose: To measure the maximum
force required to cause a test sample to
buckle.	Tip buckling meets
acceptance criteria.
	Method: Prepare sample for test. Use
buckling tester to measure the maximum
force required to cause a test sample to
buckle. Record results.
Catheter lubricity and
durability	Purpose: To determine the lubricity and
durability of the coating on the catheter
outer shaft.	Coating lubricity and
durability meets
acceptance criteria.
	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 over 5 cycles.
Particulate
characterization	Purpose: To evaluate particulates per the
FDA Guidance Document: Class II Special
Controls for Certain Percutaneous
Transluminal Coronary Angioplasty
(PTCA) Catheters.
Method: Use light obscuration particle
counting to measure the total number of	Particulate generation
was acceptable.
	particulates generated during simulated
use in each of three size ranges: ≥ 10
µm, ≥ 25 µm, and ≥ 50 µm.
Coating integrity	Purpose: To evaluate coating consistency
pre and post simulated use.	Coating integrity was
acceptable.
	Method: Visually inspect for coating
anomalies, defects or artifacts pre and
post simulated use using a simulated in
vitro test model.
Table 2: Performance Data - Bench Testing
Test	Test Method Summary	Conclusions
Trackability	Purpose: To measure track advance
force of catheter over microcatheter.
Method: Place neurovascular model in a
re-circulating water bath at 37°C to
simulate human arterial circulation.
Insert sample, attached to a motor drive
assembly, through model over a
microcatheter. Advance catheter
through model and determine peak
tracking force. Record results.	Track advance force
meets acceptance
criteria.
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.
Method: Identify joint and prepare
sample for test. Use tensile tester to
determine applied peak tensile force.
Record results.	Tensile strength meets
acceptance criteria.
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.
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. | Liquid leak resistance of
catheter meets
acceptance criteria. | |
| Table 2: Performance Data - Bench Testing | | | |
| 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 meets
acceptance criteria. | |
| 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 meets
acceptance criteria. | |

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15

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Table 2: Performance Data - Bench Testing
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 back 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 sample for kink or
damage. Record results. | Flexural fatigue meets
acceptance criteria. |
| 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
meets acceptance
criteria. |
| Table 2: Performance Data - Bench Testing | | |
| Test | Test Method Summary | Conclusions |
| Catheter Tip and Lumen Integrity
(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 aspiration pump. Visually inspect test sample to verify absence of tip or lumen collapse. Record results. | Catheter tip and lumen integrity during direct aspiration meets acceptance criteria. |
| Chemical Compatibility | Purpose: To determine visual and dimensional integrity of catheter following exposure to saline and non-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 meets acceptance criteria. |
| Hub Gauging | Purpose: To determine if catheter hub meets gauging requirement 4.1 of EN 1707.

Method: Using the appropriate gauge, apply gauge to the conical fitting with a total axial force of 5N without use of torque. Remove axial load and inspect sample. | Hub gauging meets acceptance criteria. |
| Aspiration Flow Rate Bench Testing | | |
| Table 2: 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: Measure the volume of water an aspiration system (catheter + associated pump and accessories) can aspirate in 20s. Divide this volume in mL by 20 to give the flow rate in mL/s. | All test samples meet acceptance criteria. |
| Design Validation Testing | | |
| In-vitro Usability Study | Purpose: To evaluate aspiration integrity, ability to restore flow and the durability and kink resistance of the Subject and Predicate devices in a tortuous anatomical model with multiple physician users.
Method: Track the devices to the target site to perform simulated neurothrombectomy procedure in the neurovascular model that replicates the tortuosity, diameter and location of the arteries in the neurovasculature. | All test samples meet acceptance criteria. |

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Performance Data – Animal Study

An animal study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate navigation and aspiration safety of the AXS Catalyst 7 Distal Access Catheter when used as part of the aspiration system as outlined below in Table 3. Additionally, safety and performance with simulated clot retrieval from a GLP study conducted on the AXS Catalyst 5 and 6 Primary Predicate devices, which are considered to be worst-case test articles for thrombus retrieval, have been leveraged for AXS Catalyst 7 Subject device safety and performance.

Table 3: Performance Data - Animal Testing
Test	Test Method Summary	Conclusions
In-vivo Safety Evaluation	Purpose: To assess the vascular safety
profile of treatment by aspiration and
navigation of the Subject Device
compared to the Additional Predicate
Device.
Method: Expose porcine test subjects to
aspiration treatment using the Subject
AXS Catalyst 7 with AXS Universal
Aspiration System and the Additional
Predicate Penumbra System under
worst-case aspiration force and
treatment duration conditions. Assess
vascular response by contrast
angiography and histopathology at both
a subacute (~3 days) and chronic time
points (~30 days).	Subject Device is
equivalent to the
Additional Predicate
Device in safety.

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 Predicate devices. The review demonstrated that equivalent devices published clinical outcomes that supports the proposed line extension to the AXS Catalyst Distal Access Catheter product family. Given the equivalency of the Subject device and Predicate devices, the Subject device is therefore suitable for the proposed indication for use under the associated NRY Product Code.

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Shelf Life Testing

The labeled shelf life for the AXS Catalyst 7 Distal Access Catheter is one year. 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 for the AXS Universal Aspiration Tubing, AXS Universal Liner Set, and Medela Dominant Flex Pump are established by Medela.

Sterilization

The AXS Catalyst 7 Distal Access Catheter and all system components (including the Rotating Hemostasis Valve, the Tuohy Borst Valve and the Peel-Away Introducer Sheath) are sterilized with 100% Ethylene Oxide. The AXS Catalyst 7 Distal Access Catheter and the accessories packaged with the Catheter (RHV, Tuohy Borst Valve, and the Peel-Away Introducer Sheath) are provided sterile. A sterility assurance level (SAL) of 10-6 has been demonstrated. The AXS Catalyst 7 Distal Access Catheter and all system components meets EO residuals per EN ISO 10993-7 for a limited contact delivery system – externally communicating. The AXS Catalyst 7 Distal Access Catheter and all system components are for single use only.

The AXS Universal Aspiration Tubing sterilization is provided by Medela.

Biocompatibility

The AXS Catalyst™ 7 Distal Access Catheter was assessed for biocompatibility in accordance with EN ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process". The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours.

Biocompatibility testing previously conducted for AXS Catalyst 5 & 6 Distal Access Catheter product is representative of the AXS Catalyst 7 Distal Access Catheter product due to similarity of materials, manufacturing processes and design. While there are minor differences, the biocompatibility assessment determined that these differences are low risk and do not impact product biocompatibility. Therefore, the AXS Catalyst 7 Distal Access Catheter will have the same or similar toxicological profile as the AXS Catalyst 5 and 6 Distal Access Catheter. This conclusion was confirmed by conducting selected tests in accordance with EN ISO 10993-1 and its applicable sub-parts. The AXS Catalyst 7 Distal Access Catheter, passed all required biocompatibility testing.

The results of the biocompatibility testing are summarized in Table 4 below.

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Table 4: Overview of Biocompatibility Studies Performed on the Subject Device
Test Performed /
Applicable ISO 10993
Part No.	Results	Conclusion
MEM Elution
Cytotoxicity/Part 5	No biological activity (Grade 0) was observed
in the L929 mammalian cells at 48 hours post
exposure to the test article extract. The test
article met the requirements of the test since
the grade was less than grade 2.
The observed cellular response obtained from
the positive control article extract (Grade 4)
and negative control article extract (Grade 0)
confirmed the suitability of the test system.	PASS
No cytotoxicity
or cell lysis
Hemolysis Extract/Direct
Contact Method
/Part 4	The test article exhibited 0.0% hemolysis
above the level of hemolysis exhibited by the
negative control via the direct method and
0.0% hemolysis above the level of hemolysis
exhibited by the negative control via the
indirect method.	PASS
Non-hemolytic
USP Physiochemical
/ Part 18	Non-volatile residue: 7 mg
Residue on ignition: