The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI 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 therapy are candidates for treatment.

Device Description

The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.

AI/ML Overview

The acceptance criteria and study proving the device meets them are described in the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Method Summary	Acceptance Criteria	Conclusions (Reported Device Performance)
Simulated Use - Bench (AXS Vecta Aspiration System)	AXS Vecta Aspiration System underwent simulated use testing by a physician in a benchtop model.	Test samples must meet predetermined user needs.	AXS Vecta Aspiration System test samples met the acceptance criteria for Simulated Use - Bench to demonstrate that the AXS Vecta System is substantially equivalent to the predicate device.
Simulated Use Testing – Usability (AXS Vecta Aspiration System)	AXS Vecta Aspiration System underwent simulated use testing by a physician in a benchtop model.	Test samples must meet predetermined user needs.	AXS Vecta Aspiration System test samples met the acceptance criteria for Simulated Use - Usability to demonstrate that the AXS Vecta Aspiration System is substantially equivalent to the predicate device.
Vacuum Drop / Suction Connector Secure Attachment (Aspiration Tubing Set)	Vacuum pressure measured at source and tip to evaluate pressure difference.	Test sample results must meet or exceed existing pressure specifications.	AXS Vecta Aspiration System test samples met the acceptance criteria for Vacuum Drop to demonstrate that the AXS Vecta Aspiration System is substantially equivalent to the predicate device.
Lumen Patency (Aspiration Tubing Set)	Samples were evaluated for lumen collapse during aspiration.	Test sample results must meet or exceed existing lumen patency specifications.	AXS Vecta Aspiration System test samples met the acceptance criteria for Lumen Patency to demonstrate that the AXS Vecta Aspiration System is substantially equivalent to the predicate device.
Note: For Calculated Force at Tip (shown in a previous table within the document), the reported values for the Subject Device (AXS Vecta Aspiration System) are 0.025 kgf for 0.071 in ID and 0.027 kgf for 0.074 in ID. The original document does not explicitly state the acceptance criteria for force at tip, but compares it to values for the predicate and reference devices, implying that similar characteristics are acceptable.	Note: For Calculated Force at Tip (shown in a previous table within the document), the measurement method is not explicitly detailed but involves measuring Catheter Inner Diameter (ID) to calculate force.	Note: For Calculated Force at Tip, the document doesn't explicitly state numerical acceptance criteria. However, the comparison table implicitly suggests that the calculated forces for the subject device (0.025 kgf for 0.071 in ID and 0.027 kgf for 0.074 in ID) are considered acceptable because they are similar to or slightly higher than the predicate device (0.024 kgf for 0.071 in ID, 0.026 kgf for 0.074 in ID) which was already cleared. The text states: "a calculation of the force at the tip demonstrated that the pressure differences and forces exhibited on the product with the different pumps are minimal."	The calculated forces at the tip for the AXS Vecta Aspiration System (0.025 kgf for 0.071 in ID and 0.027 kgf for 0.074 in ID) are shown to be comparable to the predicate device, supporting substantial equivalence.

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

Sample Size: The document repeatedly refers to "test samples" for each test. However, the exact number of samples used for "Simulated Use - Bench," "Simulated Use – Usability," "Vacuum Drop / Suction Connector Secure Attachment," and "Lumen Patency" tests is not explicitly stated.
Data Provenance: The tests are described as "benchtop model" tests and "Animal testing previously conducted for the Zenith Flex System was used to support this change." This indicates:
- Bench Tests: Performed in a laboratory setting.
- Animal Testing: The previous animal testing for the predicate device (Zenith Flex System) was retrospectively leveraged. The original context of this animal testing (country of origin, etc.) is not detailed in this document.

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

For "Simulated Use - Bench" and "Simulated Use – Usability," the testing was conducted "by a physician." The document specifies "a physician" (singular).
Qualifications of the physician: Not explicitly stated beyond "physician."

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "Simulated Use" tests were conducted "by a physician," and the "test samples must meet predetermined user needs." It implies a direct assessment by the physician against predefined criteria rather than an adjudication process involving multiple reviewers of outcomes.

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

No MRMC study was done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a medical aspiration system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.

7. Type of Ground Truth Used

Expert Assessment/Predicate Device Performance:
- For the "Simulated Use" tests, the ground truth was effectively whether the "test samples met predetermined user needs" as assessed by a physician.
- For the engineering tests (Vacuum Drop, Lumen Patency, Calculated Force at Tip), the ground truth was based on meeting "existing pressure specifications" or "existing lumen patency specifications," which are predefined technical performance standards, and comparison to the performance of the predicate device.
- For the animal testing (leveraged from the predicate), the ground truth would have been safety and efficacy outcomes observed in the animal model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. As above, there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring an abstract symbol. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 24, 2019

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

Re: K190212

Trade/Device Name: AXS Vecta Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 22, 2019 Received: March 25, 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

{1}------------------------------------------------

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.html; 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 him in the many of the subject of the subject of the station of the subject of the subject of the station of the station of the subject of the subjection of the subjection o -5 J Date: 2019.04.24 14:13:14 -04'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190212

Device Name AXS Vecta Aspiration System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

Submitter's Name and Address

Stryker Neurovascular 47900 Bayside Parkway Fremont, California 94538 Telephone: 1-510-413-2636 Facsimile: 1-510-413-2588

Contact Information

Shazia Hakim Staff Regulatory Affairs Specialist Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 510-413-2636 (phone) 510-413-2588 (fax) Shazia.Hakim@stryker.com

Secondary Contact

Angelica Beckmann Director of Regulatory Affairs Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 650-224-9823 (phone) angelica.beckmann@stryker.com

Date Prepared

January 31, 2019

Device Trade or Proprietary Name

AXS Vecta Aspiration System

{4}------------------------------------------------

Device Common or Classification Name:

Catheter, Percutaneous, 21 CFR 870.1250, Class II

Product Code:

NRY (Catheter)

ldentification of the Legally Marketed Devices to which Equivalence is Being Claimed

Name of Predicate Device	Name of Manufacturer	510(k) Number
Zenith Flex Aspiration System	InNeuroCo, Inc	K181354
Name of Reference Device	Name of Manufacturer	510(k) Number

Device Description

Indications for Use

The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated 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, 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 therapy are candidates for treatment.

{5}------------------------------------------------

Comparison to Predicate Device

	Predicate DeviceStryker AXS VectaAspiration System(formerlyInNeuroCo ZenithFlex System)	Reference DeviceStryker AXSUniversalAspiration System	Subject DeviceAXS VectaAspiration System(with the MedelaDominant FlexPump)
510(k) Number	K181354	K173841	K190212
Classification	Class II	Class II	Same
Product Code	NRY	NRY	Same
Review Panel	Neurology	Neurology	Same
Indications ForUse	The Zenith FlexSystem, including theZenith Flex Catheter,Aspiration TubingSet, and VC-701 CliqAspirator Pump, isindicated in 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 arecandidates fortreatment.	The AXS CatalystDistal AccessCatheter as part ofthe AXS UniversalAspiration System isindicated for use intherevascularization ofpatients with acuteischemic strokesecondary tointracranial largevessel occlusivedisease (in theinternal carotid,middle cerebral - M1and M2 segments,basilar, and vertebralarteries) within 8hours of symptomonset.Patients who areineligible forintravenous tissueplasminogenactivator (IV t-PA) orwho failed IV t-PAare candidatesfor treatment.	Same

{6}------------------------------------------------

	Predicate DeviceStryker AXS VectaAspiration System(formerlyInNeuroCo ZenithFlex System)	Reference DeviceStryker AXSUniversalAspiration System	Subject DeviceAXS VectaAspiration System(with the MedelaDominant FlexPump)
Patient ContactingComponents	AXS Vecta AspirationCatheter and itsAccessories	AXS Catalyst DistalAccess Catheter	Same as AXS VectaAspiration System
Pump	Cliq VC-701Aspirator	Medela DominantFlex Pump	Same as AXSUniversal AspirationSystem
Aspiration Tubing	Aspiration Tubing Set	AXS UniversalAspiration Tubing	Same as AXSUniversal AspirationSystem
ReplacementComponents	Canister Set	AXS Universal LinerSet	Same as AXSUniversal AspirationSystem
Aspiration Method	Pump	Pump	Same
Single UseComponents	Catheter and itsaccessories,Aspiration Tubing,Canister Sets	Catheter and itsaccessories, AspirationTubing, Liner Set	Same as AXSUniversal AspirationSystem
ReusableComponents	Pump	Pump	Same
MaximumAspirationPressure	27 in Hg	28 in Hg	Same as AXSUniversal AspirationSystem
Calculated Forceat Tip	Catheter ID	CalculatedForce at tip	Catheter ID	CalculatedForce at tip	Catheter ID	CalculatedForce at tip
	0.071 in	0.024 kgf	0.060 in	0.018 kgf	0.071 in	0.025 kgf
	0.074 in	0.026 kgf			0.074 in	0.027 kgf
PressureRegulator Method	Adjustable vacuumpressure dial	Same		Same
Flow Rate	Non-adjustable FlowRate	Three Selectable AirFlow Rates: 40, 50,60 mL		Same as AXSUniversal AspirationSystem

{7}------------------------------------------------

Summary of Non-Clinical Data

The subject device has the same materials, packaging, manufacturing process, and sterilization process as the predicate device. Therefore, testing was only conducted for specifications that were affected by changing the pump and the tubing.

Animal Testing

Animal testing previously conducted for the Zenith Flex System was used to support this change. The GLP animal testing performed with the System included a safety evaluation and an efficacy evaluation at a maximum pressure rating of -27 inHq. However, a calculation of the force at the tip demonstrated that the pressure differences and forces exhibited on the product with the different pumps are minimal. Therefore, this is a modification of an interchangeable component. Since both components have already received clearance for this indication and because the bench top data supports that the catheter still works within the pressure ranges previously established as safe, the animal testing previously conducted can be used to support this change as well.

AXS Vecta Performance Testing

To demonstrate substantial equivalence between the subject AXS Vecta Aspiration System and the predicate Zenith Flex System and the reference Stryker AXS Universal Aspiration System, 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 Aspiration System has similar performance characteristics as the predicate device and the reference device. All the testing conducted to demonstrate substantial equivalence are presented in the following table.

Test	Test MethodSummary	Acceptance Criteria	Conclusions
Simulated Use - Bench(AXS Vecta AspirationSystem)	AXS Vecta AspirationSystem underwentsimulated use testing bya physician in abenchtop model	Test samples must meetpredetermined user needs	AXS Vecta Aspiration Systemtest samples met theacceptance criteria forSimulated Use- Bench to demonstrate thatthe AXS Vecta System issubstantially equivalent to thepredicate device.

{8}------------------------------------------------

Test	Test MethodSummary	Acceptance Criteria	Conclusions
Simulated Use Testing– Usability(AXS Vecta AspirationSystem)	AXS Vecta AspirationSystem underwentsimulated use testing by aphysician in a benchtopmodel	Test samples must meetpredetermined user needs	AXS Vecta Aspiration Systemtest samples met theacceptance criteria forSimulated Use- Usability to demonstrate thatthe AXS Vecta AspirationSystem is substantiallyequivalent to the predicatedevice.
Vacuum Drop / SuctionConnector SecureAttachment(Aspiration Tubing Set)	Vacuum pressuremeasured at source andtip to evaluate pressuredifference	Test sample results mustmeet or exceed existingpressure specifications.	AXS Vecta Aspiration Systemtest samples met theacceptance criteria forVacuum Drop to demonstratethat the AXS Vecta AspirationSystem is substantiallyequivalent to the predicatedevice.
Lumen Patency(Aspiration Tubing Set)	Samples were evaluatedfor lumen collapse duringaspiration	Test sample results mustmeet or exceed existinglumen patencyspecifications.	AXS Vecta Aspiration Systemtest samples met theacceptance criteria for LumenPatency to demonstrate thatthe AXS Vecta AspirationSystem is substantiallyequivalent to the predicatedevice.

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 Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by using clinical outcomes from devices that are considered technologically similar. This documentation was reviewed within the scope of this change and determined to be applicable.

Summary of Substantial Equivalence

The performance characteristics and the test results demonstrate that the AXS Vecta Aspiration System meets the acceptance criteria to determine that the AXS Vecta Aspiration System is substantially equivalent to the predicate device. Furthermore, the intended use, the operating principles, and the design are all equivalent and support the conclusion that all devices are technologically similar.

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).