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 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.

AI/ML Overview

The provided document is a 510(k) summary for the AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter). It details the device's characteristics, comparison to predicate devices, and a summary of performance data (bench, animal, and clinical) to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document presents its "acceptance criteria" implicitly through the "Conclusions" column in Table 2 (Performance Data - Bench Testing), Table 3 (Performance Data - Animal Testing), and Table 4 (Biocompatibility Studies). The acceptance criteria are "meets acceptance criteria," "acceptable," "equivalent," or "PASS."

Test Type	Acceptance Criteria (Implicit from "Conclusions")	Reported Device Performance ("Conclusions" column)
Design Verification Bench Testing
Dimensional Verification	Meets acceptance criteria	Dimensional verification meets acceptance criteria.
Tip Configuration	Meets acceptance criteria	Tip configuration meets acceptance criteria.
Surface Integrity	Meets acceptance criteria	Surface integrity meets acceptance criteria.
Tip Buckling	Meets acceptance criteria	Tip buckling meets acceptance criteria.
Catheter lubricity and durability	Meets acceptance criteria	Coating lubricity and durability meets acceptance criteria.
Particulate characterization	Acceptable	Particulate generation was acceptable.
Coating integrity	Acceptable	Coating integrity was acceptable.
Trackability	Meets acceptance criteria	Track advance force meets acceptance criteria.
Tensile Strength	Meets acceptance criteria	Tensile strength meets acceptance criteria.
Liquid Leak Resistance	Meets acceptance criteria	Liquid leak resistance of catheter meets acceptance criteria.
Air Leak Resistance	Meets acceptance criteria	Air leak resistance of catheter meets acceptance criteria.
Catheter Torsional Bond Strength	Meets acceptance criteria	Catheter torsional bond strength meets acceptance criteria.
Flexural Fatigue	Meets acceptance criteria	Flexural fatigue meets acceptance criteria.
Catheter Kink Radius	Meets acceptance criteria	Catheter kink radius meets acceptance criteria.
Catheter Tip and Lumen Integrity (Direct Aspiration)	Meets acceptance criteria	Catheter tip and lumen integrity during direct aspiration meets acceptance criteria.
Chemical Compatibility	Meets acceptance criteria	Chemical compatibility meets acceptance criteria.
Hub Gauging	Meets acceptance criteria	Hub gauging meets acceptance criteria.
Aspiration Flow Rate Bench Testing
Aspiration Flow Rate	Meets acceptance criteria	All test samples meet acceptance criteria.
Design Validation Bench Testing
In-vitro Usability Study	Meets acceptance criteria	All test samples meet acceptance criteria.
Animal Study	Equivalent to predicate in safety	Subject Device is equivalent to the Additional Predicate Device in safety.
Biocompatibility Studies	PASS	MEM Elution Cytotoxicity: PASS (No cytotoxicity or cell lysis)
		Hemolysis Extract/Direct Contact Method: PASS (Non-hemolytic)
		USP Physiochemical <661>: PASS
		Chemistry (Heptane) Analysis: PASS (Below level of detection)
		FTIR (ISO 10993-18): PASS
		Natural Rubber Latex ELISA Inhibition Assay for Antigenic Protein ASTM D6499-12: PASS (Below level of detection)

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the numerical sample sizes (e.g., number of catheters tested) for each bench test. It mentions qualitative assessments like "Visually inspect" or "Prepare sample for test." For the animal study, it mentions "porcine test subjects" but does not give the exact number.

Provenance: The studies were conducted by Stryker Neurovascular ("Submitter Name, Address, and Content" section) and likely took place at their facilities or certified labs. The animal study was conducted "in compliance with applicable requirements in the GLP regulation (21 CFR Part 58)," which specifies good laboratory practices, but not geographic provenance. The clinical data was not from a study conducted by the submitter but rather a "review was conducted considering published clinical study articles that featured the Predicate devices." This implies that the clinical data is retrospective from existing literature, and its origin would vary based on those publications.

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

This information is not provided in the document. The studies described are primarily bench and animal tests, along with a review of published clinical articles. There's no mention of expert consensus or human readers being used to establish ground truth for a test set in the context of device performance, as one might find for an AI/imaging device. The "In-vitro Usability Study" mentions "multiple physician users" but doesn't specify their number or qualifications, nor is it described as establishing "ground truth" for the device's technical performance, but rather "evaluat[ing] aspiration integrity, ability to restore flow and the durability and kink resistance."

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

This information is not applicable/not provided. Adjudication methods are typically used in studies involving human readers or expert panels evaluating diagnostic outputs (like images), especially in the context of establishing ground truth where there might be disagreement. The studies described here are primarily engineering (bench) and animal model tests, where outcomes are determined by physical measurements or biological responses, not human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a "Percutaneous Catheter" (specifically, a distal access catheter for stroke treatment), not an AI-based diagnostic or assistive software. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance would not be relevant to this device's submission.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench and animal tests, the "ground truth" is established through physical measurements, established engineering test methods (e.g., EN ISO 10555-1, EN 1707, EN ISO 14971), and biological evaluations (histopathology in the animal study). For the biocompatibility tests, it's based on established ISO standards (EN ISO 10993-1 and sub-parts) and analytical chemistry results. There is no mention of expert consensus or pathology reports serving as "ground truth" in the way it might for a diagnostic imaging AI. The "clinical performance" relies on a review of published clinical outcomes of predicate devices, leveraging their established safety and efficacy rather than generating new outcomes data for the subject device.

8. The sample size for the training set

This is not applicable/not provided. The device is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This is not applicable. As there is no training set for a physical device, there's no ground truth established for one.

Summary

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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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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Indications for Use

510(k) Number (if known) K183464

Device Name

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

Indications for Use (Describe)

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 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 Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977)
Contact:	Germaine FuAssociate Project Manager, Regulatory AffairsPhone: 510-413-2862Fax: 510-413-2588Email: germaine.fu@stryker.com
Date Prepared:	December 13, 2018
Device Name and Classification:
Trade/Proprietary Name:	AXS Universal Aspiration System (AXS Catalyst 7 Distal AccessCatheter)
Common Name:	Catheter, Thrombus Retriever
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Product Code:	NRY

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Legally MarketedPredicateDevice(s):	Primary Predicate Device	Additional Predicate Device
	AXS Catalyst Distal AccessCatheter(K173841)	Penumbra System ACE 68Reperfusion Catheter(K161640)

Device Description

Indications for Use

Technological Characteristics and Product Feature Comparison

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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 PumpThe AXS Universal Aspiration System is designed to remove thrombus from the neurovasculature using continuous aspiration.	Same	The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only.
Detail	Submission SubjectDevice	Primary PredicateDevice	Additional PredicateDevice
	AXS Catalyst 7 DistalAccess Catheter	AXS Catalyst 5 and 6Distal Access Catheter	Penumbra SystemACE 68 ReperfusionCatheter
AccessoryDevicesProvided (notin directcontact withpatient)	The AXS CatalystDistal Access Catheterdelivers aspirationfrom the MedelaDominant Flex Pumpdirectly to the site ofthe occlusion toremove the clot. TheAXS Catalyst DistalAccess Catheter is asterile, single lumen,variable stiffnesscatheter.	Same	Peelable sheath,rotating hemostasisvalve, shapingmandrel
Materials
Outer Jacket	Pebax with Nylon,Tecoflex	Same	Vestamid, Pebax,Tecoflex, Pellethane
Reinforcement	Nitinol wire andpolymer fiber	Stainless Steel,Nitinol wire, andpolymer fiber	Stainless steel andNitinol wire
Strain Relief	Thermoplastic rubber(Polyolefin)	Thermoplastic rubber(Santoprene)	Stainless steel, 304
Inner Layer	PTFE	Same	Same
Catheter Hub	Nylon	Same	Proximal HubGrilamid(TR55-LX)
Table 1: Product Feature Comparison of Subject Device to Predicate Devices
Detail	Submission SubjectDevice	Primary PredicateDevice	Additional PredicateDevice
	AXS Catalyst 7 DistalAccess Catheter	AXS Catalyst 5 and 6Distal Access Catheter	Penumbra SystemACE 68 Reperfusion
			Catheter
Marker Band	Platinum/Iridium	Same	Same
Adhesive	Cyanoacrylate	Same	Not available
Outer JacketCoating	Hydrophilic Coating	Same	SRDX Harmony(proprietary) coating
Features
Labeled Shaft	Distal OD:	Distal OD:	Distal OD:
OuterDiameter	6.2F (0.082 in.)	5.3F (0.0696 in.)	0.084 in.
	Proximal OD:	5.4F (0.0709 in.)	Proximal OD:
	6.3F (0.0825 in.)		0.084 in.
		Proximal OD:
		5.6F (0.0735 in.)
		6.0F (0.0787 in.)
Effective	115cm	CAT 5:115cm, 132cm	115cm
Lengths	125cm132cm		120cm
		CAT 6: 132cm	125cm
			127cm
			132cm
Distal ID	0.068 in.	CAT 5: 0.058 in.CAT 6: 0.060 in.	0.068 in.
Proximal ID	0.068 in.	CAT 5: 0.058 in.CAT 6: 0.060 in.	0.068 in.
PackagingMaterials	Polyethylene Tubeand HDPEPackaging Card	Same	Polyester/Polyethylene/Tyvek and
Table 1: Product Feature Comparison of Subject Device to Predicate Devices
Detail	Submission Subject Device	Primary Predicate Device	Additional Predicate Device
andConfiguration			Polyethylene Packaging Card
Sterilization Method	EO Sterilization	Same	Same
How Supplied	Single Use/Sterile	Same	Same
Principles of Operation	The AXS Catalyst Distal AccessCatheter is advancedinto the neurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, andover anappropriately sizedguide wire. A peelaway sheath isprovided in thepackage to providesupport and facilitatethe introduction ofthe AXS CatalystCatheter tip into thesheath/guidecatheter valve. Oncethe catheter isinserted, the peelaway sheath can beremoved. Underfluoroscopic	Same	Confirm vesseldiameter andselect anappropriate sizePenumbraReperfusionCatheter. Thecatheter tip maybe shaped usingthe steam shapingmandrel provided.Attach therotatinghemostasis valveprovided to thecatheter. Insertthe catheter intothe rotatinghemostasis valveconnected to theproximal hub of aguide catheter. If aguide catheter isnot used, insertthe catheterthrough the valveof the longfemoral sheath
	AXS Catalyst 7 DistalAccess Catheter	AXS Catalyst 5 and 6Distal Access Catheter	Penumbra SystemACE 68 ReperfusionCatheter
Table 1: Product Feature Comparison of Subject Device to Predicate Devices
Detail	Submission SubjectDeviceAXS Catalyst 7 DistalAccess Catheter	Primary PredicateDeviceAXS Catalyst 5 and 6Distal Access Catheter	Additional PredicateDevicePenumbra SystemACE 68 ReperfusionCatheter
	catheter can beadvanced throughthe vasculature tothe desired location.The catheter isdesigned to removethrombus from thevasculature usingaspiration providedby an externalsource, the MedelaDominant FlexPump. The aspirationsystem is attached tothe catheter via theRHV (or TuohyBorst), and thevacuum is turned on.The aspiration tubingclamp is opened toapply aspiration.Upon completion ofthe procedure, theAXS Catalyst DistalAccess Catheter, theAXS UniversalAspiration Tubing,and the AXSUniversal Liner Setare disposed of perthe institution'sprocedures. TheMedela DominantFlex Pump is cleaned		sheath. Afterinserting thecatheter, removethe peelablesheath from thevascular sheath,and peel from thecatheter shaft.Usingconventionalcatheterizationtechniques underfluoroscopicguidance, advancethe catheter intothe target vesselover anappropriateneurovascularguidewire.Position thecatheter proximalto the thrombus.Remove theguidewire fromthe 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 DistalAccess Catheter	AXS Catalyst 5 and 6Distal Access Catheter	Penumbra SystemACE 68 ReperfusionCatheter
	per the instructionsprovided with thepump.
Aspiration System Components
AspirationPump	Medela AG DominantFlex PumpK170329 Adjustable vacuumpressure dial Three selectable airflow rates:40,50,60 L/min Non-Sterile Reusable Cleanable Minimum VacuumPressure foraspiration:-68 kPa [-20.08inHg]	Same	Penumbra MAXPump K161640 Adjustable vacuumpressure dial Non-adjustable airflow rate Non-Sterile Reusable Cleanable Minimum VacuumPressure foraspiration:-68 kPa [-20.08inHg]
AspirationTubing	Medela AG AXSUniversal AspirationTubing Class II Exempt EO Sterilized Non-reusable ID: 0.218" Length: 300cm Flow clamp	Same	PenumbraAspiration Tubing K161640 EO Sterilized Non-reusable ID: 0.110" Length: 284.5cm Flow switch
AspirationCanister	Medela AG DominantFlex Pump utilizes areusablepolycarbonate suction	Same	Penumbra MAXCanister is a non-
Table 1: Product Feature Comparison of Subject Device to Predicate Devices
Detail	Submission SubjectDevice	Primary PredicateDevice	Additional PredicateDevice
	AXS Catalyst 7 DistalAccess Catheter	AXS Catalyst 5 and 6Distal Access Catheter	Penumbra SystemACE 68 ReperfusionCatheter
	jar and a non-reusableliner. The AXSUniversal Liner Setconsists of 3individually packagedpoly-bags containingone canister liner andone ClotFinderspecimen cup. TheAXS Universal LinerSet is offered with andwithout a desiccant.• Class I Exempt• Non-Sterile		reusablepolycarbonate jar.• 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 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

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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 andtechnique of making dimensionalmeasurements using variousmeasurement equipment.Method: Verify dimensions usingspecified measurement tool. Recordmeasurements.	Dimensional verificationmeets acceptancecriteria.
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 meetsacceptance criteria.
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 meetsacceptance criteria.
Table 2: Performance Data - Bench Testing
Test	Test Method Summary	Conclusions
Tip Buckling	Purpose: To measure the maximumforce required to cause a test sample tobuckle.	Tip buckling meetsacceptance criteria.
	Method: Prepare sample for test. Usebuckling tester to measure the maximumforce required to cause a test sample tobuckle. Record results.
Catheter lubricity anddurability	Purpose: To determine the lubricity anddurability of the coating on the catheterouter shaft.	Coating lubricity anddurability meetsacceptance criteria.
	Method: Prepare sample for test. Usefriction tester to measure the frictionalforce of the device sample when pulledbetween two clamped pads. Record thepeak frictional force over 5 cycles.
Particulatecharacterization	Purpose: To evaluate particulates per theFDA Guidance Document: Class II SpecialControls for Certain PercutaneousTransluminal Coronary Angioplasty(PTCA) Catheters.Method: Use light obscuration particlecounting to measure the total number of	Particulate generationwas acceptable.
	particulates generated during simulateduse in each of three size ranges: ≥ 10µm, ≥ 25 µm, and ≥ 50 µm.
Coating integrity	Purpose: To evaluate coating consistencypre and post simulated use.	Coating integrity wasacceptable.
	Method: Visually inspect for coatinganomalies, defects or artifacts pre andpost simulated use using a simulated invitro test model.
Table 2: Performance Data - Bench Testing
Test	Test Method Summary	Conclusions
Trackability	Purpose: To measure track advanceforce of catheter over microcatheter.Method: Place neurovascular model in are-circulating water bath at 37°C tosimulate human arterial circulation.Insert sample, attached to a motor driveassembly, through model over amicrocatheter. Advance catheterthrough model and determine peaktracking force. Record results.	Track advance forcemeets acceptancecriteria.
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.Method: Identify joint and preparesample for test. Use tensile tester todetermine applied peak tensile force.Record results.	Tensile strength meetsacceptance criteria.
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.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.	Liquid leak resistance ofcatheter meetsacceptance criteria.
Table 2: Performance Data - Bench Testing
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 meetsacceptance criteria.
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 meetsacceptance criteria.

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Table 2: Performance Data - Bench Testing
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 back proximally until itexits the models. Repeat for nine moreruns. After run number ten, removeguide wire and microcatheter out of testsample and inspect sample for kink ordamage. Record results.	Flexural fatigue meetsacceptance criteria.
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 radiusmeets acceptancecriteria.
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 safetyprofile of treatment by aspiration andnavigation of the Subject Devicecompared to the Additional PredicateDevice.Method: Expose porcine test subjects toaspiration treatment using the SubjectAXS Catalyst 7 with AXS UniversalAspiration System and the AdditionalPredicate Penumbra System underworst-case aspiration force andtreatment duration conditions. Assessvascular response by contrastangiography and histopathology at botha subacute (~3 days) and chronic timepoints (~30 days).	Subject Device isequivalent to theAdditional PredicateDevice 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 10993Part No.	Results	Conclusion
MEM ElutionCytotoxicity/Part 5	No biological activity (Grade 0) was observedin the L929 mammalian cells at 48 hours postexposure to the test article extract. The testarticle met the requirements of the test sincethe grade was less than grade 2.The observed cellular response obtained fromthe positive control article extract (Grade 4)and negative control article extract (Grade 0)confirmed the suitability of the test system.	PASSNo cytotoxicityor cell lysis
Hemolysis Extract/DirectContact Method/Part 4	The test article exhibited 0.0% hemolysisabove the level of hemolysis exhibited by thenegative control via the direct method and0.0% hemolysis above the level of hemolysisexhibited by the negative control via theindirect method.	PASSNon-hemolytic
USP Physiochemical<661> / Part 18	Non-volatile residue: 7 mgResidue on ignition: < 1 mgHeavy metal: < 1 ppmBuffering capacity: < 1.0 ml	PASS
Chemistry (Heptane)Analysis	Below level of detection	PASS
FTIR (ISO 10993-18)	Scan was conducted to establish baseline forthe AXS Catalyst 7 Distal Access Catheterdevice.	PASS
Natural Rubber LatexELISA Inhibition Assay	Below level of detection	PASS
Table 4: Overview of Biocompatibility Studies Performed on the Subject Device
Test Performed /Applicable ISO 10993Part No.	Results	Conclusion
for Antigenic ProteinASTM D6499-12

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Conclusion

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 the Additional Predicate device (K161640) 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 and testing conducted using the Subject device compared to the Predicate devices, and a review of available real-world 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 summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.

Stryker Neurovascular has demonstrated that the AXS Catalyst 7 Distal Access Catheter when used as part of the aspiration system is as safe, as effective, and performs as well as the legally marketed Predicate devices.

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).