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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding the AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System. This type of document is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

The document does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance. Instead, it details bench testing and animal studies to demonstrate the substantial equivalence of the mechanical device (catheter and aspiration system) to existing predicate devices.

Therefore, many of the requested information points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this document. The document focuses on the physical and functional characteristics of a medical device intended for mechanical thrombectomy in stroke patients.

Nonetheless, I will extract and present the information that is available in the document, framed within the context of the device's mechanical performance and substantial equivalence.

Device Acceptance Criteria and Performance (Based on Mechanical/Physical Testing)

The acceptance criteria for this device are demonstrated through various bench tests and animal studies, showing that the AXS Catalyst Distal Access Catheter, when used as part of the AXS Universal Aspiration System, performs similarly to its predicate devices concerning its physical properties, functionality, and safety. There is no AI component in this device.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for a mechanical device, formal "acceptance criteria" are not listed in terms of numerical thresholds for clinical outcomes in the same way they would be for an AI device. Instead, the "acceptance criteria" are implicit in the conclusion that "All test samples met acceptance criteria" or "met established criteria," demonstrating parity or superiority to predicate devices in specific bench and animal tests. The device's performance is reported as meeting these (unspecified) criteria.

Test Category	Test Name	Test Method Summary	Reported Device Performance/Conclusion
Design Validation (Bench)	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 (Bench)	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.
	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.
Previously Cleared Bench Tests	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.
	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.
	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 met acceptance criteria and was cleared as part of K151667.
	Liquid Leak Resistance	Purpose: 1) To determine whether catheter meets the freedom from leakage-liquid leak requirement 4.7.1 of EN ISO 10555-1. 2) 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 met acceptance criteria and was cleared as part of K151667.
	Air Leak Resistance	Purpose: 1) To determine whether catheter meets the freedom from leakage-air aspiration requirement of 4.7.2 of EN ISO 10555-1. 2) To determine if catheter hub meets the air leakage requirement 4.2.2 of EN 1707. 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.
	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.
	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.
Animal Study	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. 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.	Subject Device is equivalent to the Primary Predicate in efficacy and safety.
	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. 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.	Subject Device is equivalent to the Primary Predicate in safety.
	In-vivo Vascular Response (Direct Aspiration)	Purpose: To assess the vascular response of direct aspiration through the Subject Device compared to Primary Predicate device. 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.	Subject Device is equivalent to the Primary Predicate in safety.
Biocompatibility	MEM Elution Cytotoxicity	No biological activity (Grade 0) was observed in the L929 mammalian cells at 48 hours post exposure to the test article extract. 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)
	Guinea Pig Maximization Sensitization	The USP 0.9% Sodium Chloride for Injection (NaCl) and Cottonseed Oil (CSO) extracts of the test article elicited no reaction at the challenge (0% sensitization), following an induction phase.	PASS (No evidence of sensitization)
	Intracutaneous Reactivity	The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. The difference of the overall mean score between the test article and the control article was 0.0.	PASS (Non-irritant)
	Acute Systemic Injection	The 0.9% Sodium Chloride for Injection (NaCl) and Cottonseed Oil (CSO) extracts of the test article did not induce a significantly greater biological reaction than the control extracts, when tested in Swiss Albino mice.	PASS (No mortality or evidence of systemic toxicity)
	Rabbit Pyrogen	No rabbit injected with the test article extract showed an individual rise in temperature of 0.5℃ or more.	PASS (Non-pyrogenic)
	Hemolysis Extract/Direct Contact Method	The test article exhibited 0.17% hemolysis above the level of hemolysis exhibited by the negative control via the direct method and 0.12% hemolysis above the level of hemolysis exhibited by the negative control via the indirect method.	PASS (Non-hemolytic)
	In Vitro Hemocompatibility	Results comparable to the Negative Control. The test article results for WBC, RBC, platelets, hematocrit and hemoglobin were: Group 1 89% - 98% Group 2 97% - 103% Group 3 100% - 105% Group 4 98% - 105%	PASS
	Complement Activation (SC5b-9)	Concentration of SC5b-9 in the test articles was not statistically higher than the negative control. The test articles are not considered to be potential activators of the complement system.	PASS
	Complement Activation (C3a)	Concentration of C3a in the test articles was not statistically higher than the negative control. The test articles are not considered to be a potential activator of the complement system.	PASS
	Partial Thromboplastin (PTT)	The test sample and the predicate sample demonstrated a shortened clotting time when compared to the negative control. However, the test sample demonstrated a similar clotting time when compared to the predicate sample.	PASS (Results were comparable to the Negative Control; minimal activators)

2. Sample size used for the test set and the data provenance:

Bench Testing: The document states that "All test samples met acceptance criteria" for various bench tests, but the specific numerical sample sizes for each test (e.g., number of catheters tested for aspiration flow rate, tip buckling, etc.) are not explicitly provided in this summary. The tests were likely conducted in a controlled laboratory environment.
Animal Study: "Porcine test subjects" were used. The exact number of animals is not specified in this summary. The studies were conducted in compliance with GLP regulation (21 CFR Part 58), typically implying rigorous, controlled experimental settings. Data provenance would be from these controlled in-vivo studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is mechanical and its evaluation does not involve image interpretation or AI-driven diagnostic tasks requiring expert ground truth for a test set in the traditional sense. The "ground truth" for mechanical properties is established by physical measurement, and for biological response by expert pathological/angiographic assessment. The "usability study" mentions "Multiple User evaluation," but does not detail their qualifications or roles in "ground truth" establishment beyond performing the procedure.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are relevant for subjective assessments, typically in AI or interpretive diagnostic studies. The testing here is largely objective mechanical/biological evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is typically performed for diagnostic imaging devices or AI systems where human readers interpret cases. This submission is for a mechanical medical device (catheter and aspiration system).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is not an algorithm-based device. "Standalone" performance would refer to the mechanical operation of the device in a bench or animal model without direct human intervention in the data results (e.g., measuring flow rate via automated systems), which is implied in the bench testing.

7. The type of ground truth used:

Bench Testing: Physical measurements, engineered models (e.g., tortuous anatomical models, neurovascular challenge path model), and established laboratory testing standards.
Animal Study: Vascular response assessed by contrast angiography and histopathology. These are considered objective, often expert-interpreted, assessments of the biological effects of the device.

8. The sample size for the training set:

Not applicable. This document describes the testing and validation of a mechanical medical device, not an AI/machine learning model. Therefore, there is no "training set" in the context of data for model development.

9. How the ground truth for the training set was established:

Not applicable. As there is no AI/ML training set, this question is irrelevant to the provided document.

Summary

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March 18, 2018

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

Re: K173841

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

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

Dear Angelica Beckmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (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)

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 Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977)
Contact:	Angelica BeckmannDirector, Regulatory AffairsPhone: 510-413-2900Fax: 510-413-2588Email: 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 UniversalAspiration System
Common Name:	Catheter, Thrombus Retriever
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Product Code:	NRY

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LegallyMarketedPredicateDevice(s):		Primary Predicate	Reference Predicate
	Catheter	Penumbra ReperfusionCatheter(K090752)	AXS Catalyst Distal AccessCatheter(K151667)
	AspirationSystemComponents	Penumbra Max PumpPenumbra Hi-Flo AspirationTubingPenumbra MAX Canister(K160449)	N/A

Device Description

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

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	SubmissionSubject DeviceAXS Catalyst Distal AccessCatheter	PrimaryPredicate DevicePenumbra ReperfusionCatheter
Manufacturer	Stryker Neurovascular	Penumbra, Inc.
510(k) Number	K173841	K090752
Device Trade Name	AXS Catalyst TM Distal AccessCatheter	Penumbra ReperfusionCatheter (aka 5MAX ACE or5MAX or ACE60)
Regulation Number	21 CFR 870.1250	Same as Subject Device
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	SubmissionSubject DeviceAXS Catalyst Distal AccessCatheter	PrimaryPredicate DevicePenumbra ReperfusionCatheter
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 AccessCatheter as part of the AXSUniversal Aspiration System isindicated for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (in theinternal carotid, middlecerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who failedIV t-PA are candidates fortreatment.	The Penumbra System isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (in theinternal carotid, middlecerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.
Device Description	The AXS Catalyst Distal AccessCatheter when used as part ofthe AXS Universal AspirationSystem is designed to restoreblood flow in patients withacute ischemic strokesecondary to intracranial largevessel occlusive disease. TheAXS Universal AspirationSystem is designed for usewithin the internal carotid,middle cerebral - M1 and M2segments, basilar, andvertebral arteries. The AXSUniversal Aspiration System iscomposed of the followingcomponents:	Per the associatedDFU: The Penumbra Systemconsists of three devices thatwork as a system to removethrombus including thePenumbra ReperfusionCatheter, Penumbra Separatorand Aspiration Tubing. ThePenumbra System is used withthe Penumbra AspirationPump.(Note: The use of theseparator may not be neededfor catheters of inner diameterof .054" or greater).
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	SubmissionSubject Device	PrimaryPredicate Device
	AXS Catalyst Distal AccessCatheter	Penumbra ReperfusionCatheter
	AXS Catalyst™ Distal Access Catheter AXS Universal Aspiration Tubing AXS Universal Liner Set Medela Dominant Flex Pump
Accessory DevicesProvided (not indirect contact withpatient)	Rotating Hemostatic Valve,Tuohy Borst Valve withsideport (2) Peel Away Sheaths	Peelable Sheath, RotatingHemostasis Valve, ShapingMandrel
Outer Jacket	Pebax with Nylon	Not available
Reinforcement	Stainless Steel with Nitinol wireand 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 JacketCoating	Hydrophilic Coating	SRDX Harmony (proprietary)coating
Labeled Shaft OuterDiameter	Distal OD:5.3F, 5.4F	Distal OD:5MAX 5F5MAX ACE 5.4F
	Proximal OD:5.6F, 6.0 F	Proximal OD:5MAX 6F5MAX 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 Materialsand Configuration	Polyethylene Tube and HDPEPackaging Card	Polyester / Polyethylene /Tyvek and PolyethylenePackaging Card
Sterilization	EO Sterilization	Same as Subject Device
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	SubmissionSubject DeviceAXS Catalyst Distal AccessCatheter	PrimaryPredicate DevicePenumbra ReperfusionCatheter
Method
Non-ReusableDevice	Single Use device	Same as Subject Device
Principles ofOperation	The AXS Catalyst Distal AccessCatheter is advanced into theneuro vasculature by aphysician trained ininterventional endovascularprocedures using a compatiblesheath or guide catheter, andover an appropriately sizedguide wire. A peel away sheathis provided in the package toprovide support and facilitatethe introduction of the AXSCatalyst Catheter tip into thesheath/guide catheter valve.Once the catheter is inserted,the peel away sheath can beremoved. Under fluoroscopicguidance, the catheter can beadvanced through thevasculature to the desiredlocation. The catheter isdesigned to remove thrombusfrom the vasculature usingaspiration provided by anexternal source device, theMedela Dominant Flex Pump.The aspiration system isattached to the catheter via theRHV (or Tuohy Borst), and thevacuum is turned on. Theaspiration tubing clamp isopened to apply aspiration.Upon completion of theprocedure, the AXS CatalystDistal Access Catheter, the AXS	Confirm vessel diameter andselect an appropriate sizePenumbra ReperfusionCatheter. The catheter tip maybe shaped using the steamshaping mandrel provided.Attach the rotating hemostatisvalve provided to the catheter.Insert the catheter into therotating hemostasis valveconnected to the proximal hubof a guide catheter. If a guidecatheter is not used, insert thecatheter through the valve ofthe long femoral sheath usingthe peelable sheath. Afterinserting the catheter, removethe peelable sheath from thevascular sheath, and peel fromthe catheter shaft. Usingconventional catheterizationtechniques under fluoroscopicguidance, advance the catheterinto the target vessel over anappropriate neurovascularguidewire. Position thecatheter proximal to thethrombus. Remove theguidewire from the catheter.
Table 1: Product Feature Comparison of Subject Device to Predicate Device
Detail	SubmissionSubject DeviceAXS Catalyst Distal AccessCatheter	PrimaryPredicate DevicePenumbra ReperfusionCatheter
	Universal Aspiration Tubing,and the AXS Universal Liner Setare disposed of per theinstitution's procedures. TheMedela Dominant Flex Pump iscleaned per the instructionsprovided with the pump.
How Supplied	Sterile/Single Use	Same as Subject Device
Aspiration Pump	Medela AG Dominant FlexPumpK170329• Adjustable vacuum pressuredial• Three selectable air flowrates:40,50,60 L/min• Non-Sterile• Reusable• Cleanable• Minimum Vacuum Pressurefor aspiration:-68 kPa [-20.08 inHg]	Penumbra MAX PumpK160449• Adjustable vacuum pressuredial• Non-adjustable air flow rate• Non-Sterile• Reusable• Cleanable• Minimum Vacuum Pressurefor aspiration:-68 kPa [-20.08 inHg]
Aspiration Tubing	Medela AG AXS UniversalAspiration Tubing• Class II Exempt• EO Sterilized• Non-reusable• ID: 0.218"• Length: 300cm• Flow clamp	Penumbra Hi-Flo AspirationTubing• K160449• EO Sterilized• Non-reusable• ID: 0.110"• Length: 284.5cm• Flow switch
Aspiration Canister	Medela AG Dominant FlexPump utilizes a reusablepolycarbonate suction jar and anon-reusable liner. The AXSUniversal Liner Set consists of 3individually packaged poly-bagscontaining one canister liner.	Penumbra MAX Canister is anon-reusable polycarbonatejar.• 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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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 performanceof the Subject Device to PrimaryPredicate when aspirating clot intortuous anatomical model.Method: Simulated use testing uses aphysiological neurovascular modelwhere clot is aspirated following thewritten protocol.	All test samples metacceptance criteria.
In-vitro Usability Study	Purpose: Multiple User evaluation ofthe clot retrieval, durability and kinkresistance of the Subject and PrimaryPredicate Devices in a tortuousanatomical model.Method: Users performed a directaspiration of a clot procedure, trackedthe devices to the site of the occlusionusing a neurovascular model thatreplicated the tortuosity, diameter andlocation of the arteries in theneurovasculature.	All test samples metacceptance 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 aspirationflow rate and lumen integrity of thesystem when no occlusion is present.Method: The volume of water anaspiration system (catheter + associatedpump and accessories) could aspirate in20s was measured. This volume in mLwas divided by 20 to give the flow rate inmL/s.	All test samples metacceptance criteria.
Tip Buckling	Purpose: To determine the maximumforce a catheter tip could withstandbefore buckling.Method: The test catheter was soaked in37°C water prior to testing. A mandrelwas then inserted into the distal end ofthe catheter and the catheter withmandrel was placed into the test fixtureon a tensile test machine. The testcatheter was compressed against a loadcell until the distal tip buckled. Thecompression force was recorded.	All test samples metacceptance criteria.
Track Force	Purpose: To determine the maximumforce a test catheter exerts on thetortuous vessel model as it tracks to theM2 for both advancing and retracting.Method: The test catheter was soaked in37°C water prior to testing. The catheterwas tracked to the M2 through thesmallest ID compatible guide in theneurovascular challenge path model andthe force was recorded. The catheterwas then retracted through the samemodel path and the force was recorded.	All test samples metacceptance criteria.
Test	Test Method Summary	Conclusions
Catheter Tip and LumenPatency(Direct Aspiration)	Purpose: To test resistance to tip andlumen collapse during direct aspirationand test tip integrity to tears and missingmaterial.Method: Prepare test sample andsimulated use model. Insert plug incatheter tip. Place test sample in themodel to a specified location followingprocedural instructions outlined in theInstructions for Use. Aspirate testsample using 60cc syringe and aspirationpump. Visually inspect test sample toverify indication of no tip or lumencollapse.	All test samples metacceptance 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 andtechnique of making dimensionalmeasurements using variousmeasurement equipment.Method: Verify dimensions usingspecified measurement tool. Recordmeasurements.	Dimensional verificationmet acceptance criteriaand was cleared as partof K151667.
Tip Configuration	Purpose: To verify that the catheter tip issmooth, rounded, tapered or similarlyfinished in order to minimize trauma tovessels during use per EN ISO 10555-1.Method: Visually inspect distal tip at 10Xmagnification to verify distal tip end issmooth, rounded, tapered or similarlyfinished. Record results.	Tip configuration metacceptance criteria andwas cleared as part ofK151667.
Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Surface Integrity	Purpose: To determine if externalsurface of the catheter is free fromextraneous matter, process and surfacedefects, and does not have drops oflubricant fluids.Method: Visually inspect externalsurface of catheter for extraneousmatter, process and surface defects, anddrops of lubricant fluids. Record results.	Surface integrity metacceptance criteria andwas cleared as part ofK151667.
Tip Buckling	Purpose: To measure the maximumforce required to cause a test sample tobuckle.Method: Prepare sample for test. Usebuckling tester to measure the maximumforce required to cause a test sample tobuckle. Record results.	Tip buckling metacceptance criteria andwas cleared as part ofK151667.
Catheter lubricity anddurability	Purpose: To determine the lubricity anddurability of the coating on the catheterouter shaft.Method: Prepare sample for test. Usefriction tester to measure the frictionalforce of the device sample when pulledbetween two clamped pads. Record thepeak frictional force after 5 cycles.	Coating lubricity anddurability metacceptance criteria andwas cleared as part ofK151667.
Trackability	Purpose: To measure track advanceforce of catheter over microcatheter.Method: A neurovascular model isplaced in a re-circulating water bath at37°C to simulate human arterialcirculation. The sample is insertedthrough model over a microcatheter andattached to a tensile tester. Advancecatheter through model and determinepeak tracking force. Record results.	Track advance force metacceptance criteria andwas cleared as part ofK151667.
Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Tensile Strength	Purpose: To determine tensile forcetensile force required to induce failure offused joints, shaft junctions, and markerband for non-hydratable catheters basedon EN ISO 10555-1.	Tensile strength metacceptance criteria andwas cleared as part ofK151667.
	Method: Identify joint and preparesample for test. Use tensile tester todetermine applied peak tensile force.Record results.
Liquid Leak Resistance	Purpose:1) To determine whether cathetermeets the freedom from leakage-liquidleak requirement 4.7.1 of EN ISO 10555-1.2) To determine if catheter hub meetsthe liquid leakage requirement 4.2.1 ofEN 1707.	Liquid leak resistance ofcatheter metacceptance criteria andwas cleared as part ofK151667.
	Method: Connect test hub sample tofixture and flush with water to expel air.Occlude distal tip. Apply pressure of300kPa minimum and maintain pressurefor 30s. Visually inspect catheter/hubjoint and catheter shaft for leaks.Record results.

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Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Air Leak Resistance	Purpose:1) To determine whether catheter meetsthe freedom from leakage-air aspirationrequirement of 4.7.2 of EN ISO 10555-1.2) To determine if catheter hub meetsthe air leakage requirement 4.2.2 of EN1707.Method: Connect test hub sample to apartially filled syringe. With the nozzle ofthe syringe pointing down towards theground, withdraw the plunger to the10cc mark. Hold for 15 seconds andexamine the water in the syringe for theformation of air bubbles. Record results.	Air leak resistance ofcatheter metacceptance criteria andwas cleared as part ofK151667.
Catheter Torsional BondStrength	Purpose: To measure the strength of acatheter shaft when torque is applied.Torque strength is defined as number ofrotations before failure occurs.Method: Prepare test sample and insertinto torsional bond strength test fixturewith tortuous path model. Apply torqueto catheter shaft and observe number of360-degree rotations before failureoccurs. Record results.	Catheter torsional bondstrength metacceptance criteria andwas cleared as part ofK151667.

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Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Flexural Fatigue	Purpose: To determine the flexuralfatigue on the catheter shaft.Method: Prepare test sample. Advanceentire assembly of guide wire,microcatheter, and test sample into testmodel and track it through test model.While holding the guide wire,microcatheter, and test sample, pull thewhole assembly pack proximally until itexits the models. Repeat for nine moreruns. After run number ten, removeguide wire and microcatheter out of testsample and inspect for kink or damage.Record results.	Flexural fatigue metacceptance criteria andwas cleared as part ofK151667.
Catheter Kink Radius	Purpose: To measure the kink radius of acatheter at its distal and specific mid-shaft joint section.Method: Prepare test sample. Threadtest sample through fixture loop and lockdown test sample. Pull both ends of testsample until test sample kinks. Calculatekink radius using measurement of 2nd tofinal loop OD and sample OD. Recordresults.	Catheter kink radius metacceptance criteria andwas cleared as part ofK151667.

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Table 4: Performance Data - Bench Testing Previously Cleared
Test	Test Method Summary	Conclusions
Chemical Compatibility	Purpose: To determine visual anddimensional integrity of catheterfollowing exposure to saline, non-ionicand ionic contrast liquids.Method: Prepare sample for test. Flushsample with appropriate chemical.Measure ID and OD using RAM opticalmeasurement system. Insert mandrelthrough sample to verify inner lumenintegrity. Repeat with second mandreland record results. Visually inspect distalend of sample for any chemical effectson the shaft, inner lumen and cross-sectional areas. Record results.	Chemical compatibilitymet acceptance criteriaand was cleared as partof K151667.
Hub Gauging	Purpose: To determine if catheter hubmeets gauging requirement 4.1 of EN1707.Method: Using the appropriate gauge,the gauge was applied to the conicalfitting with a total axial force of 5Nwithout the use of torque. The axial loadwas then removed and the sampleinspected.	Hub gauging metacceptance criteria andwas cleared as part ofK151667.

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 andSafety Evaluation(Arm 1)	Purpose: To assess vessel revascularizationand adverse events, if any, associated with amechanical thrombectomy procedureperformed via direct aspiration using theSubject Device compared to the PrimaryPredicate Device.	Subject Device isequivalent to thePrimary Predicate inefficacy and safety.
	Method: Porcine test subjects were exposedto aspiration treatment using the AXSUniversal Aspiration System and thepredicate Penumbra System after a vascularocclusion was artificially induced. Vascularresponse was assessed by contrastangiography and histopathology.
In-vivo Efficacy andSafety Evaluation(Arm 2)	Purpose: To assess the vascular safetyprofile of treatment by aspiration andnavigation of the Subject Device comparedto the Primary Predicate Device.	Subject Device isequivalent to thePrimary Predicate insafety.
	Method: Porcine test subjects were exposedto aspiration treatment using the AXSUniversal Aspiration System and thepredicate Penumbra System under worst-case aspiration force and treatmentduration conditions. Vascular response wasassessed by contrast angiography andhistopathology.
In-vivo VascularResponse(Direct Aspiration)	Purpose: To assess the vascular response ofdirect aspiration through the Subject Devicecompared to Primary Predicate device.	Subject Device isequivalent to thePrimary Predicate insafety.
	Method: A porcine model was used toevaluate acute and chronic vessel damageafter direct aspiration in vessels sizedappropriately to simulate the human M2.Vascular response was assessed by contrastangiography 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 < 4 mg)
. Ethylene Chlorohydrin Results: 0.07 mg/device extracted residuals (EN ISO 10993-7 requirement is average daily dose < 9 mg)

The AXS Universal Aspiration Tubing sterilization is provided by Medela.

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Biocompatibility

The AXS Catalyst™ 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.

Based on this classification, tests relevant to the device were selected and conducted in accordance with EN ISO 10993-1 and its applicable sub-parts. The AXS Catalyst Distal Access Catheter, including its packaging, passed all required biocompatibility testing.

The results of the biocompatibility testing were previously provided in K151667and are summarized in Table 6 below.

Table 6: Overview of Biocompatibility Studies Performed on the Subject Device andCleared as Part of K151667
Test Performed /Applicable ISO 10993Part No.	Results	Conclusion
MEM ElutionCytotoxicity/Part 5	No biological activity (Grade 0) wasobserved in the L929 mammalian cellsat 48 hours post exposure to the testarticle extract. The observed cellularresponse obtained from the positivecontrol article extract (Grade 4) andnegative control article extract (Grade0) confirmed the suitability of the testsystem.	PASSNo cytotoxicity or celllysis
Guinea PigMaximizationSensitization/Part 10	The USP 0.9% Sodium Chloride forInjection (NaCl) and Cottonseed Oil(CSO) extracts of the test article elicitedno reaction at the challenge (0%sensitization), following an inductionphase.	PASSNo evidence ofsensitization
IntracutaneousReactivity/Part 10	The test article sites did not show asignificantly greater biological reactionthan the sites injected with the controlarticle. The difference of the overallmean score between the test articleand the control article was 0.0.	PASSNon-irritant

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Table 6: Overview of Biocompatibility Studies Performed on the Subject Device and Cleared as Part of K151667

Test Performed /Applicable ISO 10993Part No.	Results	Conclusion
Acute SystemicInjection/Part 11	The 0.9% Sodium Chloride for Injection(NaCl) and Cottonseed Oil (CSO)extracts of the test article did notinduce a significantly greater biologicalreaction than the control extracts,when tested in Swiss Albino mice.	PASSNo mortality orevidence of systemictoxicity
Rabbit Pyrogen / Part 11	No rabbit injected with the test articleextract showed an individual rise intemperature of 0.5℃ or more.	PASSNon-pyrogenic
Hemolysis Extract/DirectContact Method/Part 4	The test article exhibited 0.17%hemolysis above the level of hemolysisexhibited by the negative control viathe direct method and 0.12% hemolysisabove the level of hemolysis exhibitedby the negative control via the indirectmethod.	PASSNon-hemolytic
In VitroHemocompatibility/Part 4	Results comparable to the NegativeControl.The test article results for WBC, RBC,platelets, hematocrit and hemoglobinwere:Group 1 89% - 98%Group 2 97% - 103%Group 3 100% - 105%Group 4 98% - 105%	PASS
Complement Activation(SC5b-9) /Part 4	Concentration of SC5b-9 in the testarticles was not statistically higher thanthe negative control. The test articlesare not considered to be potentialactivators of the complement system.	PASS
Complement Activation(C3a) /Part 4	Concentration of C3a in the test articles	PASS
Table 6: Overview of Biocompatibility Studies Performed on the Subject Device andCleared as Part of K151667
Test Performed /Applicable ISO 10993Part No.	Results	Conclusion
	was not statistically higher than thenegative control. The test articles arenot considered to be a potentialactivator of the complement system.
Partial Thromboplastin(PTT) /Part 4	The test sample and the predicatesample demonstrated a shortenedclotting time when compared to thenegative control. However, the testsample demonstrated a similar clottingtime when compared to the predicatesample.	PASSResults werecomparable to theNegative Control. Testarticles are consideredminimal activatorswith clotting timebeing 90.0%(catheter) and 92.1%(tubing) of theNegative Control andtherefore met therequirements of thetest.

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The AXS Universal Aspiration Tubing biocompatibility information is provided by Medela.

Conclusion

Stryker Neurovascular has demonstrated the AXS Catalyst Distal Access Catheter when used as part of the AXS Universal Aspiration System is substantially equivalent to the Primary Predicate device (K090752 and K160449) and the Reference Predicate (K151667) based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same fundamental operating principles. The conclusions drawn from risk assessments, the bench testing conducted using the Subject Device compared to the Primary Predicate Device, and a review of available scientific evidence from published clinical articles demonstrate that the subject device is suitable for the indication for use with the associated NRY Product Code. Additionally, testing results risk assessment also demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.

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).