(258 days)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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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3
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 |
4
| Legally Marketed
Predicate
Devices: | Predicate Devices | Reference 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.
5
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.
6
Detail | Submission Subject Device | Predicate Device | Reference Device |
---|---|---|---|
Manufacturer | Stryker Neurovascular | ||
K190833 | Stryker Neurovascular | ||
K183463 | Stryker Neurovascular | ||
K172167 & K181354 | |||
Device Trade | |||
Name | AXS 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 | |||
Number | 21 CFR 870.1250 | Same | Same |
Regulation | |||
Name | Percutaneous Catheter | Same | Same |
Classification | II | Same | Same |
Product Code | DQY | Same | 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 | |||
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 | |||
Detail | Submission Subject | ||
Device | Predicate Device | Reference Device | |
Device | |||
Description | The 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 | |||
Detail | Submission Subject | ||
Device | Predicate Device | Reference 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 Introducer | Rotating Hemostasis | ||
Valve, Tuohy Borst | |||
Valve with Sideport, | |||
(2) Peel-Away | |||
Introducer Sheaths | Same | ||
Outer Jacket | Polymeric catheter | Same | Same |
Reinforcement | Stainless Steel/Nitinol | Nitinol wire and | |
polymer fiber | Same | ||
Strain Relief | Polyolefin | Same | Same |
Inner Layer | PTFE | PTFE/Tecoflex | Same |
Catheter Hub | Nylon | Same | Same |
Marker Band | Platinum/Iridium | Same | Same |
Adhesive | Cyanoacrylate | Same | Same |
Outer Jacket | |||
Coating | Hydrophilic Coating | Same | Same |
Labeled Shaft | Distal OD: | Distal OD: | Distal OD: |
Outer | Vecta 71: 0.082 in. | 6.2F (0.082 in.) | Same |
Diameter | Vecta 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 | |||
Lengths | 115, 125, 132 cm | Same | Same |
Distal ID | 0.071 in. | ||
0.074 in. | 0.068 in. | Same | |
Proximal ID | 0.071 in. | 0.068 in. | Same |
Detail | Submission Subject Device | Predicate Device | Reference Device |
0.074 in. | |||
Packaging | |||
Materials | |||
and | |||
Configuration | Tyvek/Nylon Pouch, | ||
polyethylene support | |||
tube, packaging card, | |||
SBS carton | Polyethylene Tube | ||
and HDPE Packaging | |||
Card | 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 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 | |||
Detail | Submission Subject | ||
Device | Predicate Device | Reference 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
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The differences between the devices are not critical as demonstrated above and through the testing referenced below.
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Testing Summary
The purpose of this notification is to add functionality to the catheters by adding a new indication for use. All design verification testing which utilized the catheters were reviewed to assess the impact due to the 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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Test | Test Method Summary | Conclusions |
---|---|---|
Design Verification Testing | ||
Particulate | ||
characterization | Purpose: 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.