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 neurovascular system. The AXS Vecta Internediate Catheter is also indicated for use as a conduit for retrieval devices.

Device Description

The AXS Vecta 46 Intermediate Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 46 Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal 25cm) to reduce friction during use. It is packaged with one hemostasis valve, and one peel-away introducer.

AI/ML Overview

The provided text does NOT describe an AI/ML powered medical device, therefore, a detailed response regarding acceptance criteria for such a device, including sample size, expert ground truth, MRMC study, and training set information, cannot be extracted.

The document discusses the substantial equivalence of the AXS Vecta 46 Intermediate Catheter to existing predicate devices. This is a physical medical device (a catheter) and its clearance is based on bench testing (simulated use, burst testing, particulate testing), animal studies, and shelf-life testing, not on AI/ML performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets acceptance criteria based on this input. The information requested (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) is specific to AI/ML device evaluations and is not relevant or present in this document about a physical catheter.

Summary

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August 27, 2021

Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker Neurovascular Shivani Patel Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K202752

Trade/Device Name: AXS Vecta 46 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP Dated: July 23, 2021 Received: July 26, 2021

Dear Shivani Patel:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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 -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202752

Device Name AXS Vecta 46 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 K202752

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:	Shivani PatelSenior Staff Regulatory Affairs SpecialistPhone: 341-465-2199Email: shivani.patel2@stryker.com
Date Prepared:	August 24, 2021
Device Name and Classification:	Trade/Proprietary Name: AXS Vecta® 46 Intermediate Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Product Code:	QJP

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Legally MarketedPredicateDevices:	Predicate Devices	Reference Device
	AXS Vecta IntermediateCatheter (K190833)	Zenith Flex AspirationSystem (046 Zenith FlexCatheter) (K190338)
Detail	Submission SubjectDevice	Predicate Device	Reference Device
Manufacturer	Stryker Neurovascular	Stryker Neurovascular	Stryker Neurovascular
510(k) Number	K202752	K190833	K190338
Device TradeName	AXS Vecta 46Intermediate Catheter	AXS Vecta IntermediateCatheter	Zenith Flex AspirationSystem (046 Zenith FlexCatheter)
RegulationNumber	21 CFR 870.1250	Same	Same
RegulationName	Percutaneous Catheter	Same	Same
Classification	II	Same	Same
Product Code	QJP	DQY	NRY
IntendedUse/Indicationfor Use	The AXS VectaIntermediateCatheter is indicatedfor use infacilitating theinsertion andguidance ofappropriately sizedinterventionaldevices into aselected bloodvessel in theneurovascularsystem. The AXSVecta IntermediateCatheter is alsoindicated for use asa conduit forretrieval devices.	The AXS VectaIntermediate Catheteris indicated for use infacilitating theinsertion andguidance ofappropriately sizedinterventional devicesinto a selected bloodvessel in theperipheral andneurovascularsystems. The AXSVecta IntermediateCatheter is alsoindicated for use as aconduit for retrievaldevices.	The Zenith FlexAspiration System,including the 046 ZenithFlex Aspiration Catheter,Aspiration Tubing Set,and VC-701 CliqAspirator Pump, isindicated in therevascularization ofpatients with acuteischemic strokesecondary to intracraniallarge vessel occlusivedisease (within theinternal carotid, middlecerebral – M1 and M2segments, basilar, andvertebral arteries) within8 hours of symptomonset. Patients who areineligible for intravenoustissue plasminogenactivator (IV t-PA) orwho failed IV t-PAtherapy are candidatesfor treatment.
DeviceDescription	The AXS Vecta 46Intermediate Catheteris advanced into the	The AXS VectaIntermediate Catheter isadvanced into the	The InNeuroCo 046Zenith Flex Catheter is avariable stiffness catheter
	neurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, andover an appropriatelysized microcatheter orguide wire. One peel-away introduce sheathis provided in thepackage to providesupport and facilitatethe introduction of theAXS Vecta 46Intermediate Cathetertip into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer sheath canbe removed. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to thedesired location.	neurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, and overan appropriately sizedmicrocatheter, guidewire, and/or the ScoutIntroducer. Two peel-away introducer sheathsare provided in thepackage to providesupport and facilitatethe introduction of theAXS Vecta IntermediateCatheter tip into thesheath/guide cathetervalve. Once theassembly is inserted, thepeel-away introducersheath can be removed.Under fluoroscopicguidance, the assemblycan be advancedthrough the vasculatureto the desired location.	that has a catheter shaftreinforced with Nitinol toprovide support. Theproximal section has anembedded nitinol flatwire cross coil thattransitions to a nitinolround wire single coil inthe distal end. It has aradiopaquePlatinum/Iridium markerband on the distal end.The 046 Zenith FlexCatheter is available withan internal diameter of0.046 inches. The outerdiameter is 0.058 inchesalong the proximal shaftand 0.056 inches at thedistal tip. The 046 ZenithFlex Catheter is availablein two working lengths:153 cm, and 160 cm. The046 Zenith Flex Catheterhas a PTFE-lined lumento reduce friction as ittravels over a guidewire.Accessories includedwith the device are aTuohy-Borst HemostasisValve and peel-awayintroducer.
AccessoryDevicesProvided (not indirect contactwith patient)	Hemostasis Valve,1 Peel-AwayIntroducer	Hemostasis Valve,2 Peel-AwayIntroducers,Scout Introducer	Same as Subject device
Outer Jacket	Polymeric catheter	Same	Same
Reinforcement	Nitinol	Stainless Steel/Nitinol	Same as Subjectdevice
Strain Relief	Polyolefin	Same	Same
Inner Layer	PTFE	Same	Same
Catheter Hub	Polycarbonate	Same	Same
Marker Band	Platinum/Iridium	Same	Same
Adhesive	Cyanoacrylate	Same	Same
Outer JacketCoating	Hydrophilic Coating	Same	Same
Labeled ShaftOuter Diameter	Distal OD: 0.056 inProximal OD: 0.058in	Distal OD:Vecta 71: 0.082 in.Vecta 74: 0.083 in.Proximal OD:Vecta 71: 0.085 in.Vecta 74: 0.087 in.	Same as Subject device
EffectiveLengths	125, 146, 153, 160 cm	115, 125, 132 cm	153, 160 cm
Distal ID	0.046 in.	Vecta 71: 0.071 in.Vecta 74: 0.074 in.	Same as Subject device
Proximal ID	0.046 in.	Vecta 71: 0.071 in.Vecta 74: 0.074 in.	Same as Subject device
PackagingMaterials &Configuration	Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton	Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton	Same as Subject device
SterilizationMethod	EO Sterilization	Same	Same
How Supplied	Single Use/Sterile	Same	Same
Principles ofOperation	The AXS Vecta 46Intermediate Catheteris advanced into theneurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, andover an appropriatelysized microcatheter, orguide wire. One peel-away introducersheath is provided inthe package to providesupport and facilitatethe introduction of theAXS Vecta 46Intermediate Cathetertip into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-away	The AXS VectaIntermediate 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 introducer sheathsare provided in thepackage to providesupport and facilitatethe introduction of theAXS Vecta IntermediateCatheter tip and theScout Introducer intothe sheath/guidecatheter valve. Once theassembly is inserted the	The 046 Zenith FlexAspiration Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascular proceduresusing a compatiblesheath or guide catheter,and over an appropriatelysized microcatheter orguide wire. One peel-away introducer sheath isprovided in the packageto provide support andfacilitate the introductionof the The 046 ZenithFlex Aspiration Cathetertip into the sheath/guidecatheter valve. Once theassembly is inserted, thepeel-away introducersheath can be removed.Under fluoroscopicguidance, the assembly
introducer can be	peel-away introducer	can be advanced through
removed. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to thedesired location.	can be removed. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to thedesired location.	the vasculature to theintended vascular site,with the distal end of theAXS Vecta AspirationCatheter positionedproximal to the clot. Theproximal end of theAspiration Tubing Set isattached to the “topatient” connection ofthe canister installed tothe VC-701 CliqAspirator Pump, and theVC-701 Cliq AspiratorPump is turned ON. Alldevices inside of theAXS Vecta AspirationCatheter are removed.The distal end of theAspiration Tubing Set isattached to the proximalend of the AXS VectaAspiration Catheter. Tostart aspiration, theswitch on the AspirationTubing Set is turned ON,and the clot is engagedwith the 046 Zenith FlexAspiration Catheter

Device Description

Indications for Use

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 neurovascular system. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Technological Characteristics and Product Feature Comparison

Stryker Neurovascular has demonstrated the AXS Vecta® 46 Intermediate Catheter is substantially equivalent to the Predicate device, AXS Vecta Intermediate Catheters (K190833) and Reference Device (K190338) based on the same or similar materials, same or similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device and Reference device is summarized in Table 1: Product Feature Comparison of Subject Device to Predicate Device below.

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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 QJP product code. The design of the AXS Vecta 46 Intermediate Catheters and accessories, including device configurations, materials, or dimensions are not changing and therefore had no impact on Design Verification. Therefore, design verification was leveraged from previous AXS Vecta 46 Intermediate Catheter submissions in K190338. The impact assessment of the AXS Vecta 46 Intermediate Catheter Verification and Validation activities, including impact to risk management, yielded the following additional Validation study summarized in the section below.

Performance Data - Bench Testing

The results of design validation testing (TP-13700/TR-13700), particulate testing and 3-year aging analysis, (NV00045476 and NV00045788, respectively) conducted on the AXS Vecta 46 Intermediate Catheter demonstrates that it performs as designed, is suitable for the addition of the QJP product code, indication for use, and is substantially equivalent to the legally marketed Predicate devices. Testing was conducted in accordance with ISO 10555-1. The design validation/supplemental confirmatory bench testing is summarized in Table 2 below.

Test	Test Method Summary	Conclusions
Design Validation Testing
Simulated Use(Torque, ID, ProductCompatibility)	Purpose: to provide objective evidence thattest catheter meets applicable user needs: theintroduction of interventional devices into theneuro vasculature.Method: Perform a simulated thrombectomyprocedure. Track the devices to the target sitefor endovascular device delivery using aneurovascular in vitro model that replicates thevascular characteristics of human ICA andMCA arteries.	All test samples met theapplicable user needsand designspecifications.

Table 2. Performance Data - Bench Testing

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Test	Test Method Summary	Conclusions
Design Verification Testing
Burst Testing	Purpose: to measure the maximum static burstpressure of AXS Vecta 46 IntermediateCatheter and to ensure the device canwithstand the pressures that may be generatedwith manual delivery of contrast media aftersimulated delivery of the most clinicallychallenging interventional device.Method: Testing was conducted onconditioned AXS Vecta 46 units. The catheterwas connected via its hub or proximal end to apressure generating device. Fluid was appliedat a constant rate until product leak or burstwhile device pressure was monitored.	All test samples met theapplicable user needsand acceptance criteria.
Supplemental Confirmatory Particulate Testing
Particulate Testing	Purpose: The purpose of this test was todocument and assess the particulate mattergenerated from the delivery of neuro-interventional devices through the inner lumenof the AXS Vecta 46 Intermediate Catheter.Method: Particulate testing was conductedwith AXS Vecta 46 in a simulated usecondition based on the device IFU and aclinically relevant tortuous model.	All test samples met theapplicable user needsand acceptance criteria.

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 46 Intermediate Catheter as part of the system and can be found in K190338 (cleared as 046 Zenith Flex). Although the addition of the QJP product code will expand the use of the device, the "worst case" use of the device in terms of safety and efficacy is as a Thrombectomy System; therefore, Simulated Use-Animal testing is leveraged to support the QJP product code.

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510(k) Summary K202752

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® 46 Intermediate Catheter 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 K190338 Zenith Flex Aspiration System (046 Zenith Flex Catheter). Additionally, particulate testing and subsequent analysis between the Predicate and Subject devices confirmed that shelf-life was not impacted by the addition of the QJP product code.

Sterilization

Sterilization testing was performed on the Reference device and the results met the established acceptance criteria. Testing results leveraged from the Reference device were reviewed and cleared in K190338, Zenith Flex Aspiration System (046 Zenith Flex Catheter).

The AXS Vecta 46 Intermediate Catheter and all system components are currently sterilized with 100% Ethylene Oxide and provided sterile. A sterility assurance level (SAL) of 10° has been demonstrated. The AXS Vecta 46 Intermediate Catheter and all system components are for single use only.

Biocompatibility

The AXS Vecta 46 Intermediate Catheter is identical to the catheter component in the Reference device cleared under K190338, Zenith Flex Aspiration System (046 Zenith Flex Catheter). No catheter materials are changing; therefore, biocompatibility is not impacted by the addition of the OJP product code. The completed biocompatibility testing was used to support the biocompatibility of the Subject device.

The AXS Vecta 46 Intermediate Catheter was assessed for biocompatibility in accordance with ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within

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510(k) Summary K202752

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 46 Intermediate Catheter is substantially equivalent to the Predicate device, AXS Vecta Intermediate Catheter K190833 based on 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 QJP Product Code. Additionally, the comparison of the technological characteristics and the intended use of the Subject device and the Predicate device does not raise new questions of safety and effectiveness.

Stryker Neurovascular has demonstrated that the AXS Vecta 46 Intermediate Catheter is substantially equivalent to 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).