The AXS Vecta® Intermediate Catheter is indicating 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 with guide wires and microcatheters of an outer diameter of less than 0.044in.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the AXS Vecta® Intermediate Catheter to demonstrate substantial equivalence to a predicate device, rather than a device proving novel acceptance criteria for AI/ML. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type for test set, training set details) are not applicable to this submission.

However, I can extract information related to the device's performance testing against pre-determined acceptance criteria from the provided document.

Here's the relevant information based on the provided text:

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

The document states that "performance testing was conducted. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed." It then provides a summary of the performance testing.

Test Method Summary	Acceptance Criteria and Reported Device Performance
Visual Inspection (Packaging: Pouch Visual)	All units met the acceptance criteria and passed Packaging Visual Inspection
Visual Inspection (Packaging: Undamaged Product)	All units met the acceptance criteria and passed Packaging Visual Inspection
Tensile Strength	All units met the acceptance criteria and passed Tensile Strength testing.
PTFE Delamination	All units met the acceptance criteria and passed PTFE Delamination testing
Torque Strength	All samples met acceptance criteria and passed Torque Strength testing.
Catheter Burst	All samples met acceptance criteria and passed Catheter Burst testing
Leak (Liquid)	All samples met acceptance criteria and passed the Air and Liquid Leakage testing.
Leak	All samples met acceptance criteria and passed the Air and Liquid Leakage testing.
Dimensional (ID, OD, & Working Length)	All samples met acceptance criteria and passed Dimensional testing.
Kink Resistance	All samples met acceptance criteria and passed Kink Resistance testing.
Visual Inspection (Transition & Tip)	All samples met acceptance criteria and passed both the transition and tip visual inspections.
Tip Flexibility	All samples met acceptance criteria and passed Tip Flexibility testing.
Friction Force	All samples met acceptance criteria and passed Friction Force testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each test listed in Table 2. It generally states that "All units" or "All samples" met the criteria.
Data provenance is not explicitly mentioned as this is a bench testing and simulated-use study for a medical device's physical performance, not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving human expert interpretation for ground truth. The "ground truth" for these tests would be the established engineering specifications and performance standards for medical catheters.

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

Not applicable. This is not a study involving human adjudication of results.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm or AI. The performance studies are for the device itself.

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

The ground truth used for the performance testing is based on pre-determined acceptance criteria derived from standard test methods and engineering specifications relevant to percutaneous catheters. This is a form of engineering/technical specification ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

February 27, 2020

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

Re: K200206

Trade/Device Name: AXS Vecta® Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: January 27, 2020 Received: January 28, 2020

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., M.S. 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) K200206

Device Name AXS Vecta Intermediate Catheter

Indications for Use (Describe)

The AXS Vecta Intermediate Catheter is indicating 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.

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 HakimSr. Staff Regulatory Affairs SpecialistPhone: 510-413-2636Fax: 510-413-2588Email: shazia.hakim@stryker.com
Date Prepared:	January 27, 2020
Trade/Proprietary Name:	AXS Vecta® Intermediate Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Product Code:	OJP and DOY

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Legally Marketed Predicate Devices

Name of Predicate Device	Name ofManufacturer	510(k)Number
AXS Vecta IntermediateCatheter	StrykerNeurovascular	K190833

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

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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 Vecta Intermediate Catheter (K190833) and Reference device (K191768) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate and Reference device is summarized in Table 1: Product Feature Comparison of Subject Device to Predicate and Reference Device below.

Feature	Submission Subject Device	Predicate Device	Reference Device
Manufacturer	Stryker Neurovascular	Stryker Neurovascular	Stryker Neurovascular
510(k) Number	K200206	K190833	K191768
Device Trade Name	AXS Vecta®IntermediateCatheters (AXSVecta® 71 & 74IntermediateCatheters)	AXS Vecta®IntermediateCatheters (AXSVecta® 71 & 74IntermediateCatheters)	AXS Vecta®AspirationSystem (AXS Vecta®71 & 74Aspiration Catheters)
Regulation Number	21 CFR 870.1250	Same	Same
Regulation Name	Percutaneous Catheter	Same	Same
Classification	II	Same	Same
Product Code	QJP and DQY	DQY	NRY
Intended Use/Indication for Use	The AXS VectaIntermediate Catheter isindicated for use infacilitating the insertionand guidance ofappropriately sizedinterventional devicesinto a selected bloodvessel in the peripheraland neurovascularsystems. The AXSVecta Intermediate	The AXS VectaIntermediate Catheteris indicated for use infacilitating the insertionand guidance ofappropriately sizedinterventional devicesinto a selected bloodvessel in the peripheraland neurovascularsystems. The AXSVecta Intermediate	The AXS VectaAspiration Catheter, aspart of the AXS VectaAspiration System isindicated in therevascularization ofpatients with acuteischemic strokesecondary tointracraniallarge vessel occlusivedisease (within the
Feature	Submission SubjectDevice	Predicate Device	Reference Device
	Catheter is alsoindicated for use as aconduit for retrievaldevices.	Catheter is alsoindicated for use as aconduit for retrievaldevices.	internal carotid, middlecerebral – M1 and M2segments, basilar, andvertebral arteries)within 8 hours ofsymptom onset.Patients who areineligible forintravenous tissueplasminogen activator(IV t - PA) or whofailed IV t - PAtherapy are candidatesfor treatment.
DeviceDescription	The AXS VectaIntermediate Catheter isadvanced into theneurovasculature by aphysician trainedinterventionalendovascularprocedures using acompatible sheath orguide catheter, and overthe appropriately sizedmicrocatheter, guidewire, and/or the ScoutIntroducer. Two peelaway introducersheaths are provided inthe package to providesupport and facilitatethe introduction of theAXS VectaIntermediate Cathetertip into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer sheath canbe removed. Under	The AXS VectaIntermediate Catheteris advanced into theneurovasculature by aphysician trainedinterventionalendovascularprocedures using acompatible sheath orguide catheter, andover the appropriatelysized microcatheter,guide wire, and/or theScout Introducer. Twopeel away introducersheaths are provided inthe package to providesupport and facilitatethe introduction of theAXS VectaIntermediate Cathetertip into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer sheath canbe removed. Under	The AXS VectaAspiration Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath orguide catheter, andover an appropriatelysizedmicrocatheter, 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. Under
Feature	Submission SubjectDevice	Predicate Device	Reference Device
	the assembly can beadvanced through thevasculature to thedesired location.	the assembly can beadvanced through thevasculature to thedesired location.	guidance, the assemblycan be advancedthrough the vasculatureto the intended vascularsite, with the distal endof the AXS VectaAspiration Catheterpositionedproximal to the clot.The proximal end ofthe AXS UniversalAspiration Tubing isconnected to the AXSUniversal Liner Set.The AXS UniversalLiner Set is connectedto the MedelaDominant Flex Pump,and the MedelaDominant Flex Pump isturned ON. All devicesinside of the AXSVecta AspirationCatheter are removed.The distal end of theAXS UniversalAspiration Tubing isattached to theproximal end of theAXS Vecta AspirationCatheter. Tostart aspiration, theaspiration tubing clampon the AXS UniversalAspiration Tubing isopened, and the clot isengaged with the AXSVecta AspirationCatheter.
AccessoryDevicesProvided (not indirect contactwith patient)	Hemostasis Valve, 2Peel-AwayIntroducersScout Introducer	Same	Same
Feature	Submission SubjectDevice	Predicate Device	Reference Device
Outer Jacket	Polymeric catheter	Same	Same
Proximal Shaft	Vestamid/Pebax	Vestamid	Same as Subjectdevice
Reinforcement	StainlessSteel/Nitinol	Same materials, butdifferent windpattern)	Same as Subjectdevice
Strain Relief	Polyolefin	Same	Same
Inner Layer	PTFE	Same	Same
Catheter Hub	Nylon	Same	Same
Marker Band	Platinum/Iridium	Same	Same
Adhesive	Dymax	Cyanoacrylate	Same as Subjectdevice
Outer JacketCoating	Hydrophilic Coating	Same	Same
Labeled ShaftOuter Diameter	Distal OD:Vecta 71: 0.082 in.Vecta 74: 0.083 in.Proximal OD:Vecta 71: 0.085 in.Vecta 74: 0.087 in.	Distal OD:SameProximal OD:Same	Distal OD:SameProximal OD:Same
EffectiveLengths	115, 125, 132 cm	Same	Same
Distal ID	0.071 in.0.074 in.	Same	Same
Proximal ID	0.071 in.0.074 in.	Same	Same
PackagingMaterialsandConfiguration	Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton	Same	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 ininterventionalendovascularprocedures using acompatible sheath or	The AXS VectaIntermediate Catheteris advanced into theneurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath or	The AXS VectaAspiration Catheter isadvanced into theneurovasculature by aphysician trained ininterventionalendovascularprocedures using acompatible sheath or
Feature	Submission Subject	Predicate Device	Reference Device
	Device
	guide 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 VectaIntermediate Cathetertip and the ScoutIntroducer into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer can beremoved. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to thedesired location.	guide catheter, andover an appropriatelysized microcatheter,guide wire, and/or theScout Introducer. Twopeel-away introducersheaths are provided inthe package to providesupport and facilitatethe introduction of theAXS VectaIntermediate Cathetertip and the ScoutIntroducer into thesheath/guide cathetervalve. Once theassembly is inserted,the peel-awayintroducer can beremoved. Underfluoroscopic guidance,the assembly can beadvanced through thevasculature to thedesired location.	guide catheter, andover an appropriatelysizedmicrocatheter, 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 peelawayintroducer sheath canbe removed. Underfluoroscopicguidance, the assemblycan be advancedthrough the vasculatureto the intended vascularsite, with the distal endof the AXS VectaAspiration Catheterpositionedproximal to the clot.Theproximal end of theAXS UniversalAspiration Tubing isconnected to the AXSUniversal Liner Set.The AXS UniversalLiner Set is connectedto the MedelaDominant Flex Pump,and the MedelaDominant Flex Pump isturned ON. All devicesinside of the AXS
Feature	Submission SubjectDevice	Predicate Device	Reference Device
			Vecta AspirationCatheter are removed.The distal end of theAXS UniversalAspiration Tubing isattached to theproximal end of theAXS Vecta AspirationCatheter. Tostart aspiration, theaspiration tubing clampon the AXS UniversalAspiration Tubing isopened, and the clot isengaged with the AXSVecta AspirationCatheter.
PatientContactingComponents	AXS VectaIntermediate Catheterand its Accessories	Same	Same

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.

Design Verification – Bench Testing

To demonstrate substantial equivalence between the Subject device, AXS Vecta Intermediate Catheter with proposed design changes and the currently cleared AXS Vecta Intermediate Catheter (Predicate device), performance testing was conducted. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed. Therefore, this test data supports the argument that the AXS Vecta Intermediate Catheter has similar performance characteristics as the predicate device. All the testing conducted to demonstrate substantial equivalence are presented in Table 2: Performance Testing Summary below.

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Test Method Summary	Conclusion
Visual Inspection (Packaging: Pouch Visual)	All units met the acceptance criteria and passed PackagingVisual Inspection
Visual Inspection (Packaging: Undamaged Product)	All units met the acceptance criteria and passed PackagingVisual Inspection
Tensile Strength	All units met the acceptance criteria and passed TensileStrength testing.
PTFE Delamination	All units met the acceptance criteria and passed PTFEDelamination testing
Torque Strength	All samples met acceptance criteria and passed TorqueStrength testing.
Catheter Burst	All samples met acceptance criteria and passed Catheter Bursttesting
Leak (Liquid)	All samples met acceptance criteria and passed the Air andLiquid Leakage testing.
Leak	All samples met acceptance criteria and passed the Air andLiquid Leakage testing.
Dimensional (ID, OD, & Working Length)	All samples met acceptance criteria and passed Dimensionaltesting.
Kink Reistance	All samples met acceptance criteria and passed KinkResistance testing.
Visual Inspection (Transition & Tip)	All samples met acceptance criteria and passed both thetransition and tip visual inspections.
Tip Flexibility	All samples met acceptance criteria and passed Tip Flexibilitytesting.
Friction Force	All samples met acceptance criteria and passed Friction Forcetesting.

Table 2. Performance Testing Summary
--------------------------------------	--	--

Design Validation – Simulated-Use Testing

The modified AXS Vecta Intermediate Catheter (Subject device) was evaluated through simulated use testing using standard bench top models which included tortuosity of worst-case pathways in which the AXS Vecta Intermediate Catheter would traverse. The modified AXS Vecta Intermediate Catheter met all relevant user needs.

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Performance Data – Animal, Clinical

No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.

Shelf Life Testing

Shelf life testing previously conducted for the AXS Vecta Aspiration System was used to support the changes to AXS Vecta Intermediate Catheters and can be found in K172167 and K181354. Shelf life testing was not performed since it was determined that there is no impact on material degradation and the design changes do not impact the overall efficacy and safety of the device.

Sterilization

The subject device is sterilized by 100% EtO and has been adopted into a validated sterilization process in accordance with the principles of AAMI TIR 28:2016 Product Adoption & Process Equivalence for Ethylene Oxide Sterilization and per the requirements of ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

Biocompatibility

Biocompatibility testing previously conducted for the AXS Vecta Aspiration System was used to support the changes to AXS Vecta Intermediate Catheters and can be found in K172167 and K181354. Additionally, though no biological risks were identified, confirmatory tests (cytotoxicity, sensitization and irritation) were conducted to confirm that there is no impact on existing biocompatibility study. Based on the testing results, the AXS Vecta Intermediate Catheters with the design change is free from biological hazard per ISO 10993-1.

Summary of Substantial Equivalence

Based on the conclusions drawn from risk assessment and the bench testing results summarized above, the Subject device demonstrates substantial equivalence to the legally marketed Predicate device (K190833).

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).