AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter

• K Number: K200206
• Device Name: AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
• Manufacturer: Stryker Neurovascular
• Date Cleared: 2020-02-27 ( 30 days)
• Product Code: QJP DQY
• Regulation Number: 870.1250

Intended Use

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.

Predicate Devices

K190833

Reference Devices

K191768

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and intended use of a catheter and introducer, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

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

Diagnostic

No

Explanation: The device is described as an intermediate catheter intended for the insertion and guidance of interventional devices and for use as a conduit for retrieval devices. Its purpose is to facilitate therapeutic procedures, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with a lumen, radiopaque marker, Luer hub, and hydrophilic coating. It also includes physical accessories like an introducer and valves. This is a hardware medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly describes a device used within the body for the insertion and guidance of other interventional devices into blood vessels. This is an in vivo procedure.
• Device Description: The description details a catheter designed for physical manipulation within the vascular system.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples. This device is used inside the body for interventional procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

QJP, 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 with guide 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

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.

Key Metrics

Not Found

Predicate Device(s)

K190833

Reference Device(s)

K191768

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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 ([e-mail]) or phone [phone] 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 Neurovascular
47900 Bayside Parkway
Fremont, CA 94538-6515
(FDA Registration Number: 3008853977) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shazia Hakim
Sr. Staff Regulatory Affairs Specialist
Phone: [phone]
Fax: [phone]
Email: [e-mail] |
| 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 of
Manufacturer | 510(k)
Number |
|------------------------------------|--------------------------|------------------|
| AXS Vecta Intermediate
Catheter | Stryker
Neurovascular | K190833 |

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.

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®
Intermediate
Catheters (AXS
Vecta® 71 & 74
Intermediate
Catheters)	AXS Vecta®
Intermediate
Catheters (AXS
Vecta® 71 & 74
Intermediate
Catheters)	AXS Vecta®
Aspiration
System (AXS Vecta®
71 & 74
Aspiration 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 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	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	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
Feature	Submission Subject
Device	Predicate Device	Reference Device
	Catheter is also
indicated for use as a
conduit for retrieval
devices.	Catheter is also
indicated for use as a
conduit for retrieval
devices.	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.
Device
Description	The AXS Vecta
Intermediate Catheter is
advanced into the
neurovasculature by a
physician trained
interventional
endovascular
procedures using a
compatible sheath or
guide catheter, and over
the 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	The AXS Vecta
Intermediate Catheter
is advanced into the
neurovasculature by a
physician trained
interventional
endovascular
procedures using a
compatible sheath or
guide catheter, and
over the 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	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
Feature	Submission Subject
Device	Predicate Device	Reference Device
	the assembly can be
advanced through the
vasculature to the
desired location.	the assembly can be
advanced through the
vasculature to the
desired location.	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 AXS Universal
Aspiration Tubing is
connected to the AXS
Universal Liner Set.
The AXS Universal
Liner Set is connected
to the Medela
Dominant Flex Pump,
and the Medela
Dominant Flex Pump is
turned ON. All devices
inside of the AXS
Vecta Aspiration
Catheter are removed.
The distal end of the
AXS Universal
Aspiration Tubing is
attached to the
proximal end of the
AXS Vecta Aspiration
Catheter. To
start aspiration, the
aspiration tubing clamp
on the AXS Universal
Aspiration Tubing is
opened, 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 Introducer	Same	Same
Feature	Submission Subject
Device	Predicate Device	Reference Device
Outer Jacket	Polymeric catheter	Same	Same
Proximal Shaft	Vestamid/Pebax	Vestamid	Same as Subject
device
Reinforcement	Stainless
Steel/Nitinol	Same materials, but
different wind
pattern)	Same as Subject
device
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 Subject
device
Outer Jacket
Coating	Hydrophilic Coating	Same	Same
Labeled Shaft
Outer 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:
Same

Proximal OD:
Same | Distal OD:
Same

Proximal OD:
Same |
| Effective
Lengths | 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 |
| Packaging
Materials
and
Configuration | Tyvek/Nylon Pouch,
polyethylene support
tube, packaging card,
SBS carton | Same | Same |
| Sterilization
Method | EO Sterilization | Same | Same |
| How Supplied | Single Use/Sterile | Same | Same |
| Principles of
Operation | The AXS Vecta
Intermediate Catheter is
advanced into the
neurovasculature by a
physician trained in
interventional
endovascular
procedures using a
compatible sheath or | The AXS Vecta
Intermediate Catheter
is advanced into the
neurovasculature by a
physician trained in
interventional
endovascular
procedures using a
compatible sheath or | The AXS Vecta
Aspiration Catheter is
advanced into the
neurovasculature by a
physician trained in
interventional
endovascular
procedures using a
compatible sheath or |
| Feature | Submission Subject | Predicate Device | Reference Device |
| | Device | | |
| | 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. | 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. | 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 peelaway
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
AXS Universal
Aspiration Tubing is
connected to the AXS
Universal Liner Set.
The AXS Universal
Liner Set is connected
to the Medela
Dominant Flex Pump,
and the Medela
Dominant Flex Pump is
turned ON. All devices
inside of the AXS |
| Feature | Submission Subject
Device | Predicate Device | Reference Device |
| | | | Vecta Aspiration
Catheter are removed.
The distal end of the
AXS Universal
Aspiration Tubing is
attached to the
proximal end of the
AXS Vecta Aspiration
Catheter. To
start aspiration, the
aspiration tubing clamp
on the AXS Universal
Aspiration Tubing is
opened, and the clot is
engaged with the AXS
Vecta Aspiration
Catheter. |
| Patient
Contacting
Components | AXS Vecta
Intermediate Catheter
and 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 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 Reistance	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.

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).