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

• K Number: K173841
• Device Name: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
• Manufacturer: Stryker
• Date Cleared: 2018-03-18 ( 90 days)
• Product Code: NRY
• Regulation Number: 870.1250
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K151667

Intended Use

The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA are candidates for treatment.

Device 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.

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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.

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).