K Number
K190833
Device Name
AXS Vecta Aspiration Catheter
Date Cleared
2019-12-15

(258 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter and introducer, with no mention of AI or ML capabilities.

No
The device is indicated for facilitating the insertion and guidance of other interventional devices and for retrieval devices, rather than directly treating a disease or condition itself.

No

Explanation: The AXS Vecta Intermediate Catheter is indicated for facilitating the insertion and guidance of interventional devices and for use as a conduit for retrieval devices. Its described function is interventional, not diagnostic.

No

The device description clearly describes a physical catheter with a shaft, marker band, Luer hub, and hydrophilic coating, along with accompanying physical accessories like an introducer and valves. This indicates a hardware medical device, not a software-only one.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for facilitating the insertion and guidance of interventional devices into blood vessels and as a conduit for retrieval devices. This is a therapeutic or interventional use, not a diagnostic one.
  • Device Description: The description details a catheter designed for physical manipulation within the vascular system. This aligns with interventional procedures, not in vitro testing of samples.
  • Input Imaging Modality: Fluoroscopic guidance is used for real-time visualization during the procedure, which is typical for interventional procedures, not IVD testing.
  • Anatomical Site: The device is used within the peripheral and neurovascular systems, which are internal anatomical locations, not external samples for laboratory analysis.
  • Performance Studies: The performance studies described (bench testing for particulate and simulated use, animal study) focus on the physical performance and safety of the device during simulated procedures, not on the accuracy or reliability of diagnostic measurements from biological samples.

IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform such tests.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DQY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and neurovascular systems

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician trained in interventional endovascular procedures

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design Verification Testing - Particulate characterization

  • Study Type: Bench Testing
  • Test Method Summary: To characterize acute phase particulate generated as a result of product specific simulated use steps. Use light obscuration particle counting to measure the total number of particulates generated during simulated use in each of three size ranges: 10-25μm, 25-50μm, 50-100μm. If >100μm are observed, complete particle count analysis of size ranges >=200μm, >=500μm and >=1000μm.
  • Key Results: Particulate generation was acceptable.

Design Validation Testing - Simulated Use (Torque. ID, Product Compatibility)

  • Study Type: Bench Testing
  • Test Method Summary: To provide objective evidence that test catheters meet applicable user needs: the introduction of interventional devices into the peripheral and neuro vasculature. Perform a simulated procedure with delivery of retrieval devices. Track the devices to the target site for endovascular device delivery using a neurovascular in vitro model that replicates the vascular characteristics of human ICA and MCA arteries.
  • Key Results: All test samples met the applicable user needs and design specifications.

Animal Study

  • Study Type: Animal Study
  • Key Results: 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.

Shelf Life Testing

  • Study Type: Shelf Life Testing
  • Key Results: 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

  • Study Type: Sterilization Testing
  • Key Results: 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.

Biocompatibility

  • Study Type: Biocompatibility Testing
  • Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

AXS Catalyst 7 Distal Access Catheter (K183463)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

AXS Vecta Aspiration System (K172167 & K181354)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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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

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/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

2

Indications for Use

510(k) Number (if known) K190833

Device Name AXS Vecta Intermediate Catheter

Indications for Use (Describe)

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.

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 Neurovascular
47900 Bayside Parkway
Fremont, CA 94538-6515
(FDA Registration Number: 3008853977) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shazia Hakim
Senior Staff Regulatory Affairs Specialist
Phone: 510-413-2636
Fax: 510-413-2588
Email: 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 Marketed
Predicate

Devices:Predicate DevicesReference Device
AXS Catalyst 7 Distal
Access Catheter (K183463)AXS Vecta Aspiration System
(K172167 & K181354)

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.

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 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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DetailSubmission Subject DevicePredicate DeviceReference Device
ManufacturerStryker Neurovascular
K190833Stryker Neurovascular
K183463Stryker Neurovascular
K172167 & K181354
Device Trade
NameAXS Vecta®
Intermediate Catheters
(AXS Vecta® 71 & 74
Intermediate
Catheters)AXS Catalyst Distal
Access Catheter
(AXS Catalyst 7
Distal Access
Catheter)AXS Vecta Aspiration
System
Regulation
Number21 CFR 870.1250SameSame
Regulation
NamePercutaneous CatheterSameSame
ClassificationIISameSame
Product CodeDQYSameNRY
Intended
Use/Indication
for UseThe 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.The AXS Catalyst
Distal Access
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
Catalyst Distal
Access Catheter is
also indicated for
use as a conduit for
retrieval devices.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
DetailSubmission Subject
DevicePredicate DeviceReference Device
Device
DescriptionThe AXS Vecta
Intermediate Catheter is
advanced into the
neurovasculature by a
physician trained in
interventional
endovascular procedures
using a compatible
sheath or guide catheter,
and over an
appropriately sized
microcatheter, guide
wire, and/or the Scout
Introducer. Two peel-
away introducer sheaths
are provided in the
package to provide
support and facilitate the
introduction of the AXS
Vecta Intermediate
Catheter tip into the
sheath/guide catheter
valve. Once the
assembly is inserted, the
peel-away introducer
sheath can be removed.
Under fluoroscopic
guidance, the assembly
can be advanced through
the vasculature to the
desired location.The AXS Catalyst
Distal Access Catheter
is a sterile, single
lumen, variable
stiffness catheter
designed 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 catheter
shaft has a hydrophilic
coating to reduce
friction during use.
The catheter includes
a radiopaque marker
on the distal end for
angiographic
visualization and a
luer hub on the
proximal end allowing
attachments for
flushing and
aspiration.treatment.
The AXS Vecta
Aspiration Catheter is
advanced into the
neurovasculature by a
physician trained in
interventional
endovascular
procedures using a
compatible sheath or
guide catheter, and over
an appropriately sized
microcatheter, guide
wire, and/or the Scout
Introducer. Two peel-
away introducer
sheaths are provided in
the package to provide
support and facilitate
the introduction of the
AXS Vecta Aspiration
Catheter tip into the
sheath/guide catheter
valve. Once the
assembly is inserted,
the peel-away
introducer sheath can
be removed. Under
fluoroscopic guidance,
the assembly can be
advanced through the
vasculature to the
intended vascular site,
with the distal end of
the AXS Vecta
Aspiration Catheter
positioned proximal to
the clot. The proximal
end of the Aspiration
Tubing Set is attached
to the "to patient"
connection of the
canister installed to the
VC-701 Cliq Aspirator
Pump, and the VC-701
Cliq Aspirator Pump is
DetailSubmission Subject
DevicePredicate DeviceReference Device
turned ON. All devices
inside of the AXS
Vecta Aspiration
Catheter are removed.
The distal end of the
Aspiration Tubing Set
is attached to the
proximal end of the
AXS Vecta Aspiration
Catheter. To start
aspiration, the switch
on the Aspiration
Tubing Set is turned
ON, and the clot is
engaged with the AXS
Vecta Aspiration
Catheter.
Accessory
Devices
Provided (not
in direct
contact with
patient)Hemostasis Valve, 2
Peel-Away Introducers
Scout IntroducerRotating Hemostasis
Valve, Tuohy Borst
Valve with Sideport,
(2) Peel-Away
Introducer SheathsSame
Outer JacketPolymeric catheterSameSame
ReinforcementStainless Steel/NitinolNitinol wire and
polymer fiberSame
Strain ReliefPolyolefinSameSame
Inner LayerPTFEPTFE/TecoflexSame
Catheter HubNylonSameSame
Marker BandPlatinum/IridiumSameSame
AdhesiveCyanoacrylateSameSame
Outer Jacket
CoatingHydrophilic CoatingSameSame
Labeled ShaftDistal OD:Distal OD:Distal OD:
OuterVecta 71: 0.082 in.6.2F (0.082 in.)Same
DiameterVecta 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
Effective
Lengths115, 125, 132 cmSameSame
Distal ID0.071 in.
0.074 in.0.068 in.Same
Proximal ID0.071 in.0.068 in.Same
DetailSubmission Subject DevicePredicate DeviceReference Device
0.074 in.
Packaging
Materials
and
ConfigurationTyvek/Nylon Pouch,
polyethylene support
tube, packaging card,
SBS cartonPolyethylene Tube
and HDPE Packaging
CardSame
Sterilization
MethodEO SterilizationSameSame
How SuppliedSingle Use/SterileSameSame
Principles of
OperationThe AXS Vecta
Intermediate Catheter is
advanced into the
neurovasculature by a
physician trained in
interventional
endovascular procedures
using a compatible
sheath or guide catheter,
and over an
appropriately sized
microcatheter, guide
wire, and/or the Scout
Introducer. Two peel-
away introducer sheaths
are provided in the
package to provide
support and facilitate the
introduction of the AXS
Vecta Intermediate
Catheter tip and the
Scout Introducer into the
sheath/guide catheter
valve. Once the
assembly is inserted, the
peel-away introducer can
be removed. Under
fluoroscopic guidance,
the assembly can be
advanced through the
vasculature to the desired
location.The AXS Catalyst
Distal Access Catheter
is advanced into the
neuro vasculature by a
physician trained in
interventional
endovascular
procedures using a
compatible sheath or
guide catheter, and
over an appropriately
sized guide wire. A
peel away sheath is
provided in the
package to provide
support and facilitate
the introduction of the
AXS Catalyst Catheter
tip into the
sheath/guide catheter
valve. Once the
catheter is inserted,
the peel away sheath
can be removed.
Under fluoroscopic
guidance, the catheter
can be advanced
through the
vasculature to the
desired location. Once
the catheter is at the
desired location,
appropriately sized
interventional devices
may be inserted into
the selected blood
vessel.The AXS Vecta
Aspiration Catheter is
advanced into the
neurovasculature by a
physician trained in
interventional
endovascular
procedures using a
compatible sheath or
guide catheter, and over
an appropriately sized
microcatheter, guide
wire, and/or the Scout
Introducer. Two peel-
away introducer
sheaths are provided in
the package to provide
support and facilitate
the introduction of the
AXS Vecta Aspiration
Catheter tip into the
sheath/guide catheter
valve. Once the
assembly is inserted,
the peel-away
introducer sheath can
be removed. Under
fluoroscopic guidance,
the assembly can be
advanced through the
vasculature to the
intended vascular site,
with the distal end of
the AXS Vecta
Aspiration Catheter
positioned proximal to
the clot. The proximal
end of the Aspiration
DetailSubmission Subject
DevicePredicate DeviceReference Device
Tubing Set is attached
to the "to patient"
connection of the
canister installed to the
VC-701 Cliq Aspirator
Pump, and the VC-701
Cliq Aspirator Pump is
turned ON. All devices
inside of the AXS
Vecta Aspiration
Catheter are removed.
The distal end of the
Aspiration Tubing Set
is attached to the
proximal end of the
AXS Vecta Aspiration
Catheter. To start
aspiration, the switch
on the Aspiration
Tubing Set is turned
ON, and the clot is
engaged with the AXS
Vecta Aspiration
Catheter.

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

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8

9

10

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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TestTest Method SummaryConclusions
Design Verification Testing
Particulate
characterizationPurpose: To characterize acute phase
particulate generated as a result of product
specific simulated use steps.Particulate generation
was acceptable.
Method: Use light obscuration particle
counting to measure the total number of
particulates generated during simulated use in
each of three size ranges: 10-25μm, 25-50μm,
50-100μm.

If >100μm are observed, complete particle
count analysis of size ranges ≥200μm,
≥500μm and ≥1000μm. | |
| Design Validation Testing | | |
| Simulated Use
(Torque. ID, Product
Compatibility) | Purpose: to provide objective evidence that
test catheters meet applicable user needs: the
introduction of interventional devices into the
peripheral and neuro vasculature.

Method: Perform a simulated procedure with
delivery of retrieval devices. Track the devices
to the target site for endovascular device
delivery using a neurovascular in vitro model
that replicates the vascular characteristics of
human ICA and MCA arteries. | All test samples met the
applicable user needs
and design
specifications. |

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.