The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Device Description

The AXS Vecta Intermediate Catheter is a single lumen, flexible stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal end (distal 25cm) to reduce friction during use. It is packaged with one Scout Introducer, one hemostasis valve, and two peel-away introducers.

The Scout Introducer may be used in conjunction with the AXS Vecta Intermediate Catheter to facilitate in the introduction of the AXS Vecta Intermediate Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Intermediate Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible wires and microcatheters of an outer diameter of less than 0.044in.

AI/ML Overview

The AXS Vecta Intermediate Catheter's acceptance criteria and the studies proving it meets them are described below. The device is not an AI/ML device, so certain categories will be marked as "Not Applicable".

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Design Verification Testing
Particulate Characterization	Particulate generated during simulated use must be acceptable.	Particulate generation was acceptable.
Design Validation Testing
Simulated Use (Torque, ID, Product Compatibility)	Test catheters must meet applicable user needs: introduction of interventional devices into the peripheral and neuro vasculature.	All test samples met the applicable user needs and design specifications.
Shelf Life Testing	Must meet established acceptance criteria (specific criteria not detailed in the provided text).	Results met the established acceptance criteria.
Sterilization Testing	Must meet established acceptance criteria (specific criteria not detailed in the provided text) and achieve a sterility assurance level (SAL) of 10-6.	Results met the established acceptance criteria. A SAL of 10-6 has been demonstrated.
Biocompatibility	Must be in accordance with EN ISO 10993-1 for an externally communicating medical device with circulating blood contact for less than 24 hours.	Testing for the identical catheter component in the Reference device (K172167 and K181354) supports the biocompatibility of the subject device.

2. Sample Size Used for the Test Set and Data Provenance:

The document primarily refers to "test samples" for bench testing and does not explicitly state the numerical sample size for each bench test. For the "Simulated Use" test, it mentions "All test samples," implying N > 1, but the exact number isn't provided.

Particulate Characterization: Not explicitly stated.
Simulated Use: Not explicitly stated.
Shelf Life Testing: Not explicitly stated.
Sterilization Testing: Not explicitly stated.
Biocompatibility: Not explicitly stated for specific tests, but based on the Reference device.

Data Provenance: The studies were conducted by Stryker Neurovascular ("Stryker Neurovascular has demonstrated...") and are retrospective for most tests as they leverage previous device submissions (K172167 and K181354). The animal study, for instance, was also performed to support previously cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a physical medical catheter, and the evaluation involves engineering and performance testing, not analysis of medical images or data requiring expert interpretation for ground truth.

4. Adjudication Method:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a physical medical device (catheter), not an AI/ML system that would involve human readers.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is defined by compliance with established engineering design specifications, international standards (e.g., EN ISO 10993-1), and acceptable performance in simulated use models. For example:

Particulate Characterization: Acceptable levels of particulates.
Simulated Use: Meeting applicable user needs and design specifications in an in vitro neurovascular model.
Shelf Life/Sterilization: Meeting established acceptance criteria for shelf life and achieving a specific sterility assurance level.
Biocompatibility: Compliance with EN ISO 10993-1.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 15, 2019

Stryker Neurovascular Shazia Hakim Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K190833

Device Name: AXS Vecta Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 15, 2019 Received: November 18, 2019

Dear Shazia Hakim:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190833

Device Name AXS Vecta Intermediate 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

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:	Shazia HakimSenior Staff Regulatory Affairs SpecialistPhone: 510-413-2636Fax: 510-413-2588Email: shazia.hakim@stryker.com
Date Prepared:	March 29, 2019
Device Name and Classification:
Trade/Proprietary Name:	AXS Vecta® Intermediate Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Product Code:	DQY

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Legally MarketedPredicateDevices:	Predicate Devices	Reference Device
	AXS Catalyst 7 DistalAccess Catheter (K183463)	AXS Vecta Aspiration System(K172167 & K181354)

Device Description

Indications for Use

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Technological Characteristics and Product Feature Comparison

Stryker Neurovascular has demonstrated the AXS Vecta® Intermediate Catheter (AXS Vecta® 71 & 74 Intermediate Catheters) is substantially equivalent to the Predicate device, AXS Catalyst Distal Access Catheter (K183463) and Reference Device (K172167 & K181354) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device is summarized in Table 1: Product Feature Comparison of Subject Device to Predicate Device below.

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Detail	Submission Subject Device	Predicate Device	Reference Device
Manufacturer	Stryker NeurovascularK190833	Stryker NeurovascularK183463	Stryker NeurovascularK172167 & K181354
Device TradeName	AXS Vecta®Intermediate Catheters(AXS Vecta® 71 & 74IntermediateCatheters)	AXS Catalyst DistalAccess Catheter(AXS Catalyst 7Distal AccessCatheter)	AXS Vecta AspirationSystem
RegulationNumber	21 CFR 870.1250	Same	Same
RegulationName	Percutaneous Catheter	Same	Same
Classification	II	Same	Same
Product Code	DQY	Same	NRY
IntendedUse/Indicationfor Use	The AXS VectaIntermediate Catheteris indicated for use infacilitating theinsertion and guidanceof appropriately sizedinterventional devicesinto a selected bloodvessel in the peripheraland neurovascularsystems. The AXSVecta IntermediateCatheter is alsoindicated for use as aconduit for retrievaldevices.	The AXS CatalystDistal AccessCatheter is indicatedfor use infacilitating theinsertion andguidance ofappropriately sizedinterventionaldevices into aselected bloodvessel in theperipheral andneurovascularsystems. The AXSCatalyst DistalAccess Catheter isalso indicated foruse as a conduit forretrieval devices.	The AXS VectaAspiration Catheter,as part of the AXSVecta AspirationSystem is indicatedin therevascularization ofpatients with acuteischemic strokesecondary tointracranial largevessel occlusivedisease (within theinternal carotid,middle cerebral – M1and M2 segments,basilar, and vertebralarteries) within 8hours of symptomonset. Patients whoare ineligible forintravenous tissueplasminogenactivator (IV t-PA) orwho failed IV t-PAtherapy are
Detail	Submission SubjectDevice	Predicate Device	Reference Device
DeviceDescription	The AXS VectaIntermediate Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascular proceduresusing a compatiblesheath or guide catheter,and over anappropriately sizedmicrocatheter, guidewire, and/or the ScoutIntroducer. Two peel-away introducer sheathsare provided in thepackage to providesupport and facilitate theintroduction of the AXSVecta IntermediateCatheter tip into thesheath/guide cathetervalve. Once theassembly is inserted, thepeel-away introducersheath can be removed.Under fluoroscopicguidance, the assemblycan be advanced throughthe vasculature to thedesired location.	The AXS CatalystDistal Access Catheteris a sterile, singlelumen, variablestiffness catheterdesigned for use infacilitating theinsertion and guidanceof appropriately sizedinterventional devicesinto a selected bloodvessel in theperipheral andneurovascularsystems. The cathetershaft has a hydrophiliccoating to reducefriction during use.The catheter includesa radiopaque markeron the distal end forangiographicvisualization and aluer hub on theproximal end allowingattachments forflushing andaspiration.	treatment.The AXS VectaAspiration Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, and overan appropriately sizedmicrocatheter, guidewire, and/or the ScoutIntroducer. Two peel-away introducersheaths are provided inthe package to providesupport and facilitatethe introduction of theAXS Vecta AspirationCatheter tip into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer sheath canbe removed. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to theintended vascular site,with the distal end ofthe AXS VectaAspiration Catheterpositioned proximal tothe clot. The proximalend of the AspirationTubing Set is attachedto the "to patient"connection of thecanister installed to theVC-701 Cliq AspiratorPump, and the VC-701Cliq Aspirator Pump is
Detail	Submission SubjectDevice	Predicate Device	Reference Device
			turned ON. All devicesinside of the AXSVecta AspirationCatheter are removed.The distal end of theAspiration Tubing Setis attached to theproximal end of theAXS Vecta AspirationCatheter. To startaspiration, the switchon the AspirationTubing Set is turnedON, and the clot isengaged with the AXSVecta AspirationCatheter.
AccessoryDevicesProvided (notin directcontact withpatient)	Hemostasis Valve, 2Peel-Away IntroducersScout Introducer	Rotating HemostasisValve, Tuohy BorstValve with Sideport,(2) Peel-AwayIntroducer Sheaths	Same
Outer Jacket	Polymeric catheter	Same	Same
Reinforcement	Stainless Steel/Nitinol	Nitinol wire andpolymer fiber	Same
Strain Relief	Polyolefin	Same	Same
Inner Layer	PTFE	PTFE/Tecoflex	Same
Catheter Hub	Nylon	Same	Same
Marker Band	Platinum/Iridium	Same	Same
Adhesive	Cyanoacrylate	Same	Same
Outer JacketCoating	Hydrophilic Coating	Same	Same
Labeled Shaft	Distal OD:	Distal OD:	Distal OD:
Outer	Vecta 71: 0.082 in.	6.2F (0.082 in.)	Same
Diameter	Vecta 74: 0.083 in.Proximal OD:Vecta 71: 0.085 in.Vecta 74: 0.087 in.	Proximal OD:6.3F (0.0825 in.)	Proximal OD:Same
EffectiveLengths	115, 125, 132 cm	Same	Same
Distal ID	0.071 in.0.074 in.	0.068 in.	Same
Proximal ID	0.071 in.	0.068 in.	Same
Detail	Submission Subject Device	Predicate Device	Reference Device
	0.074 in.
PackagingMaterialsandConfiguration	Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton	Polyethylene Tubeand HDPE PackagingCard	Same
SterilizationMethod	EO Sterilization	Same	Same
How Supplied	Single Use/Sterile	Same	Same
Principles ofOperation	The AXS VectaIntermediate Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascular proceduresusing a compatiblesheath or guide catheter,and over anappropriately sizedmicrocatheter, guidewire, and/or the ScoutIntroducer. Two peel-away introducer sheathsare provided in thepackage to providesupport and facilitate theintroduction of the AXSVecta IntermediateCatheter tip and theScout Introducer into thesheath/guide cathetervalve. Once theassembly is inserted, thepeel-away introducer canbe removed. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to the desiredlocation.	The AXS CatalystDistal Access Catheteris advanced into theneuro vasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, andover an appropriatelysized guide wire. Apeel away sheath isprovided in thepackage to providesupport and facilitatethe introduction of theAXS Catalyst Cathetertip into thesheath/guide cathetervalve. Once thecatheter is inserted,the peel away sheathcan be removed.Under fluoroscopicguidance, the cathetercan be advancedthrough thevasculature to thedesired location. Oncethe catheter is at thedesired location,appropriately sizedinterventional devicesmay be inserted intothe selected bloodvessel.	The AXS VectaAspiration Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, and overan appropriately sizedmicrocatheter, guidewire, and/or the ScoutIntroducer. Two peel-away introducersheaths are provided inthe package to providesupport and facilitatethe introduction of theAXS Vecta AspirationCatheter tip into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer sheath canbe removed. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to theintended vascular site,with the distal end ofthe AXS VectaAspiration Catheterpositioned proximal tothe clot. The proximalend of the Aspiration
Detail	Submission SubjectDevice	Predicate Device	Reference Device
			Tubing Set is attachedto the "to patient"connection of thecanister installed to theVC-701 Cliq AspiratorPump, and the VC-701Cliq Aspirator Pump isturned ON. All devicesinside of the AXSVecta AspirationCatheter are removed.The distal end of theAspiration Tubing Setis attached to theproximal end of theAXS Vecta AspirationCatheter. To startaspiration, the switchon the AspirationTubing Set is turnedON, and the clot isengaged with the AXSVecta AspirationCatheter.

Table 1: Product Feature Comparison of Subject Device to Predicate and Reference Device

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

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Testing Summary

The purpose of this notification is to add functionality to the catheters by adding a new indication for use. All design verification testing which utilized the catheters were reviewed to assess the impact due to the DQY indication addition. The design of the AXS Vecta Catheters and accessories, including device configurations, materials, or dimensions are not changing and therefore had no impact on Design Verification. Therefore, design verification from previous AXS Vecta Catheter submissions in K172167 and K181354 was used to support the subject device with the exception of particulate testing. The impact assessment of the AXS Vecta Catheter Verification and Validation activities, including impact to risk management, yielded the following additional verification testing and Validation study summarized in the section below.

Performance Data – Bench Testing

The results of design verification and design validation testing conducted on the AXS Vecta Catheter demonstrates that it performs as designed, is suitable for the additional indication for use, and is substantially equivalent to the legally marketed Predicate devices. The design verification and design validation bench testing is summarized in Table 2 below.

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Test	Test Method Summary	Conclusions
Design Verification Testing
Particulatecharacterization	Purpose: To characterize acute phaseparticulate generated as a result of productspecific simulated use steps.	Particulate generationwas acceptable.
	Method: Use light obscuration particlecounting to measure the total number ofparticulates generated during simulated use ineach of three size ranges: 10-25μm, 25-50μm,50-100μm.If >100μm are observed, complete particlecount analysis of size ranges ≥200μm,≥500μm and ≥1000μm.
Design Validation Testing
Simulated Use(Torque. ID, ProductCompatibility)	Purpose: to provide objective evidence thattest catheters meet applicable user needs: theintroduction of interventional devices into theperipheral and neuro vasculature.Method: Perform a simulated procedure withdelivery of retrieval devices. Track the devicesto the target site for endovascular devicedelivery using a neurovascular in vitro modelthat replicates the vascular characteristics ofhuman ICA and MCA arteries.	All test samples met theapplicable user needsand designspecifications.

Table 2: Performance Data - Bench Testing

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Performance Data – Animal Study

The Simulated Use-Animal testing is focused on the safety and efficacy of the device and was performed to support the previously cleared AXS Vecta Aspiration Catheters as part of the system and can be found in K172167 and K181354 (cleared as Zenith Flex System). Because the subject AXS Vecta Intermediate Catheter is identical to the catheter component cleared in K172167 and K181354, additional animal testing was not performed for the delivery catheter indication under product code DQY.

Performance Data – Clinical

No clinical study was conducted as bench testing was determined sufficient for validation purposes.

Shelf Life Testing

The labeled shelf life for the AXS Vecta® Intermediate Catheters is three years. Shelf life testing was performed on the Reference device and the results met the established acceptance criteria. Testing results were reviewed and cleared in K172167 and K181354.

Sterilization

Sterilization testing was performed on the Reference device and the results met the established acceptance criteria. Testing results were reviewed and cleared in K172167 and K181354.

The AXS Vecta Intermediate Catheters are currently sterilized with 100% Ethylene Oxide and provided sterile. A sterility assurance level (SAL) of 10 6 has been demonstrated. The AXS Vecta Intermediate Catheters meets EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The AXS Vecta Intermediate Catheters are for single use only.

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Biocompatibility

The AXS Vecta Intermediate Catheters are identical to the catheter component in the AXS Vecta Aspiration System cleared under K172167 and K181354. No catheter materials are changing; therefore, biocompatibility is not impacted by the addition of the indications for use under the DOY Product Code and the completed biocompatibility testing was used to support the biocompatibility of the subject device.

The AXS Vecta Intermediate Catheters were 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.

Conclusion

Stryker Neurovascular has demonstrated the AXS Vecta Intermediate Catheters are substantially equivalent to the Predicate device, AXS Catalyst Distal Access Catheter (AXS Catalyst 7 Distal Access Catheter) K183463, based on the same intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from risk assessments and the bench testing conducted using the Subject device demonstrate that the subject device is suitable for the indication for use with the associated DQY Product Code. Additionally, the 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 the device Instructions for Use.

Stryker Neurovascular has demonstrated that the AXS Vecta Intermediate Catheters are as safe, as effective, and perform as well as the legally marketed predicate device.

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).