(147 days)
No
The description focuses on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.
No
The device is described as a catheter used to facilitate the insertion and guidance of other interventional devices and for use as a conduit for retrieval devices. It does not provide therapy itself, but rather assists in procedures where other devices might deliver therapy or retrieve substances.
No
Explanation: The device is described as facilitating the insertion and guidance of interventional devices and acting as a conduit for retrieval devices. It does not perform any diagnostic functions like disease detection or measurement of physiological parameters.
No
The device description clearly describes a physical catheter with a lumen, coating, radiopaque marker, and luer hub. It also mentions packaging with physical components like a RHV and Tuohy Borst valve. 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AXS Catalyst™ Distal Access Catheter is a medical device used within the body to facilitate the insertion and guidance of other interventional devices and for retrieval. It is a tool for accessing and navigating blood vessels.
- Intended Use: The intended use clearly describes a procedural function within the vascular system, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical characteristics of a catheter designed for insertion into the body.
- Performance Studies: The performance studies focus on the physical and functional performance of the catheter itself (trackability, tensile strength, leak resistance, etc.) and its use in an animal model, not on the accuracy or reliability of a diagnostic test.
Therefore, the AXS Catalyst™ Distal Access Catheter is an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
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 the peripheral and neuro vascular system. 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. It is packaged with a Rotating Hemostastic Valve (RHV) and Tuohy Borst valve with sideport for flushing, insertion of catheters and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovascular systems / peripheral and neuro vascular systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Data – Bench: The results of design verification testing conducted on the AXS Catalyst Distal Access Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device. Testing was conducted in accordance with EN ISO 10555-1 and EN 1707. The following tests were performed: Dimensional Verification, Tip Configuration, Surface Integrity, Tip Buckling, Catheter lubricity and durability, Trackability, Tensile Strength, Liquid Leak Resistance, Air Leak Resistance, Catheter Torsional Bond Strength, Flexural Fatigue, Catheter Kink Radius, Catheter Tip and Lumen Patency (Adjunctive Aspiration), Catheter Tip and Lumen Patency (with retrieval device), Chemical Compatibility, Hub Gauging, Simulated Use. All tests met acceptance criteria.
Performance Data – Animal: An animal study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate performance design attributes of the AXS Catalyst™ Distal Access Catheter through user evaluation in an acute animal model.
Performance Data - Clinical: No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes.
Shelf Life Testing: The labeled shelf life for the AXS Catalyst Distal Access Catheter is 6 months. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing were performed on the subject device and the results met established criteria.
Sterilization: The AXS Catalyst Distal Access Catheter and all system components are sterilized with 100% Ethylene Oxide. The AXS Catalyst Distal Access Catheter is provided sterile to a sterility assurance level (SAL) of 10°, and is for single use only. EO residuals and Epichlorydrin residuals were within limits per EN ISO 10993-7.
Biocompatibility: The AXS Catalyst™ Distal Access Catheter was assessed for biocompatibility in accordance with EN ISO 10993-1. The subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The device passed all required biocompatibility testing: MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Rabbit Pyrogen, Hemolysis Extract/Direct Contact Method, In Vitro Hemocompatibility, Complement Activation (SC5b-9), Complement Activation (C3a), Partial Thromboplastin (PTT).
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Stryker Neurovascular Ms. Rhoda M. Santos Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K151667
Trade/Device Name: AXS Catalyst™ Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 9, 2015 Received: October 13, 2015
Dear Ms. Santos:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151667
Device Name
AXS Catalyst™ Distal Access Catheter
Indications for Use (Describe)
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.
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 | ||
|---|---|---|
| Date Prepared: | July 27, 2015 | |
| Trade Name: | AXS Catalyst™ Distal Access Catheter | |
| Common Name: | Percutaneous Catheter | |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | |
| Product Code: | DQY | |
| Submitter: | Stryker Neurovascular | |
| 47900 Bayside Parkway | ||
| Fremont, CA 94538-6515 | ||
| (FDA Registration Number: 3008853977) | ||
| Contact: | Rhoda M. Santos | |
| Principal Regulatory Affairs Specialist | ||
| Phone: 510-413-2269 | ||
| Fax: 510-413-2588 | ||
| Email: rhoda.santos@stryker.com | ||
| Legally Marketed | ||
| Predicate Device(s): | Reference | |
| (Clearance Date) | Device | |
| K090335 (May 6, 2009) | Concentric HD Guide Catheter | |
| K110483 (April 4, 2011) | Modified HD Guide Catheter | |
| K133177 (February 25, 2014) | Modified HD Guide Catheter |
Device Description
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 the peripheral and neuro vascular system. 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. It is packaged with a Rotating Hemostastic Valve (RHV) and Tuohy Borst valve with sideport for flushing, insertion of catheters and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.
4
Indications for Use
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.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular believes the AXS Catalyst Distal Access Catheters are substantially equivalent to the predicate devices (K133177, K110483, K090335) based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same fundamental operating principles. A comparison of the subject device with the predicate device is summarized in the table below.
| Feature | Reference
Predicate Device
HD Guide Catheter
(DAC®) (K090335) | Reference
Predicate Device
Modified HD Guide
Catheter (DAC®)
(K110483) | Primary Predicate
Device
Modified HD Guide
Catheter (DAC®)
(K133177) | Subject Device
AXS Catalyst Distal
Access Catheter | Rationale for
difference (if
applicable) |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | Indicated for use in
facilitating the
insertion and
guidance of an
occlusion catheter,
infusion catheter or
other appropriate
microcatheter into
a selected blood
vessel in the
peripheral,
coronary or neuro
vascular systems. It
may also be used as
a diagnostic
angiographic
catheter. | Same | The Modified HD
Guide Catheter is
indicated for use
in facilitating the
insertion and
guidance of an
occlusion catheter,
infusion catheter
or other
appropriate
microcatheter into
a selected blood
vessel in the
peripheral,
coronary and
neuro vascular
systems. It may
also be used as a
diagnostic
angiographic
catheter and 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. | Intended Use /
Indications for Use
reflect user
preferences. AXS
Catalyst Catheter is
not intended to be
marketed for use in
coronary systems
nor is it intended to
be used as a
diagnostic catheter.
Bench testing and
animal testing has
demonstrated that
the proposed
intended use /
indications for use
do not affect the
safety and
effectiveness of the
device. |
| Device
Description | The HD Guide
Catheter is a single-
lumen, braided
shaft, variable | Same | The Modified HD
Guide Catheter is a
single-lumen,
braided shaft, | The AXS Catalyst™
Distal Access
Catheter is a single
lumen, variable | Additional
accessories
included for ease of
use |
| Feature | Reference
Predicate Device
HD Guide Catheter
(DAC®) (K090335) | Reference
Predicate Device
Modified HD Guide
Catheter (DAC®)
(K110483) | Primary Predicate
Device
Modified HD Guide
Catheter (DAC®)
(K133177) | Subject Device
AXS Catalyst Distal
Access Catheter | Rationale for
difference (if
applicable) |
| | stiffness catheter
with a radiopaque
marker on the distal
end and a luer hub
on the proximal
end. The catheter
shaft has a
hydrophilic coating
to reduce friction
during use. A
rotation hemostatic
side arm adapter is
provided with each
catheter. | | variable stiffness
catheter with
radiopaque marker
on the distal end
and a luer hub on
the proximal end.
The catheter shaft
has a hydrophilic
coating to reduce
friction during use.
Device dimensions
and configuration
are shown on the
product label. A
rotating hemostasis
valve with side-arm
adapter is provided
with each catheter.
The rotating
hemostasis valve is
typically "y" shaped
with a female luer
lock and a manual
hemostasis valve.
The female port
allows for
aspiration and
contrast injections
while the
hemostasis valve
allows direct
arterial access
when using other
devices such as
guidewires and/or
interventional
devices. | stiffness catheter
designed for use in
facilitating the
insertion and
guidance of
appropriately sized
interventional
devices into the
peripheral and
neuro vascular
system. 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. It is
packaged with a
Rotating
Hemostastic Valve
(RHV) and Tuohy
Borst valve with
sideport for
flushing, insertion
of catheters and
aspiration. The peel
away introducer
sheaths are
designed to protect
the distal tip of the
catheter during
insertion into the
RHV or Tuohy Borst. | Bench testing and
animal testing has
demonstrated that
the proposed
intended use /
indications for use
do not affect the
|
| Feature | Reference
Predicate Device
HD Guide Catheter
(DAC®) (K090335) | Reference
Predicate Device
Modified HD Guide
Catheter (DAC®)
(K110483) | Primary Predicate
Device
Modified HD Guide
Catheter (DAC®)
(K133177) | Subject Device
AXS Catalyst Distal
Access Catheter | Rationale for
difference (if
applicable) |
| Accessory
Devices
Provided
(not in direct
contact with
patient) | RHV | Same | Same | RHV
Tuohy Borst Valve
with Sideport
(2) Peel Away
Sheaths | Additional
accessories
included for ease of
use.
Bench testing and
animal testing has
demonstrated that
the additional
accessories do not
affect the safety
and effectiveness of
the device. |
| Regulation
Number | 21CFR 870.1250 | Same | Same | Same | NA |
| Regulation
Name | Percutaneous
Catheter | Same | Same | Same | NA |
| Regulatory
Class | II | Same | Same | Same | NA |
| Product Code | DQY, DQO | Same | Same | DQY | Product code
reflects intended
use / indications for
use |
| Materials | | | | | |
| Outer Jacket | Pebax | Same | Same | Same with Nylon | Nylon material
added to meet
performance needs
of user.
Bench testing and
animal testing has
demonstrated that
the additional nylon
material does not
affect the safety
and effectiveness of
the device. |
| Feature | Reference
Predicate Device
HD Guide Catheter
(DAC®) (K090335) | Reference
Predicate Device
Modified HD Guide
Catheter (DAC®)
(K110483) | Primary Predicate
Device
Modified HD Guide
Catheter (DAC®)
(K133177) | Subject Device
AXS Catalyst Distal
Access Catheter | Rationale for
difference (if
applicable) |
| Reinforcement | Stainless Steel | Same | Same | Same with Nitinol
and Polymer fiber | Nitinol wire and
polymer fiber
added to meet
performance needs
of user.
Bench testing and
animal testing has
demonstrated that
the additional
nitinol and polymer
fiber materials do
not affect the safety
and effectiveness of
the device. |
| Strain Relief | Polyolefin | Same | Same | Thermoplastic
rubber | Use of
thermoplastic
rubber material is
consistent with
other commercially
available Stryker
Neurovascular
products.
Bench testing has
demonstrated that
the thermoplastic
rubber material
does not affect the
safety and
effectiveness of the
device. |
| Inner layer | PTFE | Same | Same | Same | NA |
| Catheter Hub | Pebax | Same | Same | Nylon | Use of nylon
material is
consistent with
other commercially
available Stryker
Neurovascular
products.
Bench testing has
demonstrated that
the nylon material
does not affect the
safety and
effectiveness of the
device. |
| Feature | Reference
Predicate Device
HD Guide Catheter
(DAC®) (K090335) | Reference
Predicate Device
Modified HD Guide
Catheter (DAC®)
(K110483) | Primary Predicate
Device
Modified HD Guide
Catheter (DAC®)
(K133177) | Subject Device
AXS Catalyst Distal
Access Catheter | Rationale for
difference (if
applicable) |
| Marker Band | Platinum/Iridium | Same | Same | Same | NA |
| Adhesive | Acrylic (Acrylated
Urethane) | Same | Same | Cyanoacrylate | Use of
cyanoacrylate
adhesive is
consistent with
other commercially
available Stryker
Neurovascular
products.
Bench testing has
demonstrated that
the cyanoacrylate
adhesive does not
affect the safety
and effectiveness of
the device. |
| Outer jacket
coating | hydrophilic coating | Same | Same | Same | NA |
| Labeled Shaft
Outer
Diameter | OD of effective
length:
3.9F, 5.2F | OD of effective
length:
6.3F | Same as predicate
devices, K090335
and K114083 | Distal OD: 5.3F, 5.4F
Proximal OD: 5.6F,
6.0F | NA |
| Effective
Lengths | 115 cm, 125 cm,
136 cm | 105 cm, 120 cm | Same as predicate
devices, K090335
and K114083 | 115 cm, 132 cm | NA |
| Packaging
Materials and
Configuration | Polyethylene Tube
and HDPE
Packaging Card | Same | Same | Same | NA |
| Sterilization
Method | EO Sterilization | Same | Same | Same | NA |
| How Supplied | Pebax | Same | Same | Same | NA |
Product Feature Comparison of Subject Device to Primary Predicate Device and Reference Predicate Devices
5
6
7
8
Risk Assessment
Risk assessment of the AXS Catalyst Distal Access Catheter has been conducted in accordance with EN ISO 14971. Stryker Neurovascular has determined that the AXS Catalyst Distal Access Catheter raises no new questions of safety or effectiveness. Results of verification and validation testing are appropriate for use in determining that the AXS Catalyst™ Distal Access Catheter is substantially equivalent to the legally marketed predicate devices.
9
Testing Summary
Performance Data – Bench
The results of design verification testing conducted on the AXS Catalyst Distal Access Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device. Testing was conducted in accordance with EN ISO 10555-1 and EN 1707. Specifically, the following tests were performed on the subject device:
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Dimensional Verification | Purpose: To describe the procedure and | |
| technique of making dimensional | ||
| measurements using various measurement | ||
| equipment. | ||
| Method: Verify dimensions using specified | ||
| measurement tool. Record measurements. | Dimensional verification | |
| meets acceptance criteria. | ||
| Tip Configuration | Purpose: To verify that the catheter tip is | |
| smooth, rounded, tapered or similarly | ||
| finished in order to minimize trauma to | ||
| vessels during use per EN ISO 10555-1. | ||
| Method: Visually inspect distal tip at 10X | ||
| magnification to verify distal tip end is | ||
| smooth, rounded, tapered or similarly | ||
| finished. Record results. | Tip configuration meets | |
| acceptance criteria. | ||
| Surface Integrity | Purpose: To determine if external surface of | |
| the catheter is free from extraneous matter, | ||
| process and surface defects, and does not | ||
| have drops of lubricant fluids. | ||
| Method: Visually inspect external surface of | ||
| catheter for extraneous matter, process and | ||
| surface defects, and drops of lubricant | ||
| fluids. Record results. | Surface integrity meets | |
| acceptance criteria. | ||
| Tip Buckling | Purpose: To measure the maximum force | |
| required to cause a test sample to buckle. | ||
| Method: Prepare sample for test. Use | ||
| buckling tester to measure the maximum | ||
| force required to cause a test sample to | ||
| buckle. Record results. | Tip buckling meets | |
| acceptance criteria. | ||
| Test | Test Method Summary | Conclusions |
| Catheter lubricity and | ||
| durability | Purpose: To determine the lubricity and | |
| durability of the coating on the catheter | ||
| outer shaft. |
Method: Prepare sample for test. Use
friction tester to measure the frictional force
of the device sample when pulled between
two clamped pads. Record the peak
frictional force after 5 cycles. | Coating lubricity and
durability meets
acceptance criteria. |
| Trackability | Purpose: To measure track advance force of
catheter over microcatheter.
Method: A neurovascular model is placed in
a re-circulating water bath at 37°C to
simulate human arterial circulation. The
sample is inserted through model over a
microcatheter and attached to a tensile
tester. Advance catheter through model and
determine peak tracking force. Record
results. | Track advance force meets
acceptance criteria. |
| Tensile Strength | Purpose: To determine tensile force tensile
force required to induce failure of fused
joints, shaft junctions, and marker band for
non-hydratable catheters based on EN ISO
10555-1.
Method: Identify joint and prepare sample
for test. Use tensile tester to determine
applied peak tensile force. Record results. | Tensile strength meets
acceptance criteria. |
| Liquid Leak Resistance | Purpose:
- To determine whether catheter meets
the freedom from leakage-liquid leak
requirement 4.7.1 of EN ISO 10555-1. - To determine if catheter hub meets the
liquid leakage requirement 4.2.1 of EN 1707.
Method: Connect test hub sample to fixture
and flush with water to expel air. Occlude
distal tip. Apply pressure of 300kPa
minimum and maintain pressure for 30s.
Visually inspect catheter/hub joint and
catheter shaft for leaks. Record results. | Liquid leak resistance of
catheter meets
acceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Air Leak Resistance | Purpose:
- To determine whether catheter meets the
freedom from leakage-air aspiration
requirement of 4.7.2 of EN ISO 10555-1. - To determine if catheter hub meets the
air leakage requirement 4.2.2 of EN 1707.
Method: Connect test hub sample to a
partially filled syringe. With the nozzle of the
syringe pointing down towards the ground,
withdraw the plunger to the 10cc mark. Hold
for 15 seconds and examine the water in the
syringe for the formation of air bubbles.
Record results. | Air leak resistance of
catheter meets
acceptance criteria. |
| Catheter Torsional Bond
Strength | Purpose: To measure the strength of a
catheter shaft when torque is applied.
Torque strength is defined as number of
rotations before failure occurs.
Method: Prepare test sample and insert into
torsional bond strength test fixture with
tortuous path model. Apply torque to
catheter shaft and observe number of 360-
degree rotations before failure occurs.
Record results. | Catheter torsional bond
strength meets
acceptance criteria. |
| Flexural Fatigue | Purpose: To determine the flexural fatigue
on the catheter shaft.
Method: Prepare test sample. Advance
entire assembly of guide wire,
microcatheter, and test sample into test
model and track it through test model.
While holding the guide wire, microcatheter,
and test sample, pull the whole assembly
pack proximally until it exits the models.
Repeat for nine more runs. After run
number ten, remove guide wire and
microcatheter out of test sample and inspect | Flexural fatigue meets
acceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Catheter Kink Radius | Purpose: To measure the kink radius of a
catheter at its distal and specific mid-shaft
joint section. | Catheter kink radius meets
acceptance criteria. |
| | Method: Prepare test sample. Thread test
sample through fixture loop and lock down
test sample. Pull both ends of test sample
until test sample kinks. Calculate kink radius
using measurement of 2nd to final loop OD
and sample OD. Record results. | |
| Catheter Tip and Lumen
Patency
(Adjunctive Aspiration) | Purpose: To test resistance to tip and lumen
collapse during adjunctive aspiration and
test tip integrity to tears and missing
material. | Catheter tip and lumen
patency during adjunctive
aspiration meets
acceptance criteria. |
| | Method: Prepare test sample and simulated
use model. Place test sample in the model to
a specified location following procedural
instructions outlined in the Instructions for
Use. Aspirate test sample using 60cc syringe.
Visually inspect test sample to verify
indication of no tip or lumen collapsed.
Record results. | |
| Catheter Tip and Lumen
Patency
(with retrieval device) | Purpose: To determine ability of catheter to
deliver and withdraw retrieval device 3
times when located in a simulated use
tortuous path without functional impact and
integrity to the tip. | Catheter tip and lumen
patency meets acceptance
criteria. |
| | Method: Prepare test sample and simulated
use model. Place test sample in the model to
a specified location following procedural
instructions outlined in the Instructions for
Use. Aspirate test sample using 60cc syringe.
Visually inspect test sample to verify
indication of no tip or lumen collapsed.
Record results. | |
| Test | Test Method Summary | Conclusions |
| Chemical Compatibility | Purpose: To determine visual and
dimensional integrity of catheter following
exposure to saline, non-ionic and ionic
contrast liquids. | Chemical compatibility
meets acceptance criteria. |
| | Method: Prepare sample for test. Flush
sample with appropriate chemical. Measure
ID and OD using RAM optical measurement
system. Insert mandrel through sample to
verify inner lumen integrity. Repeat with
second mandrel and record results. Visually
inspect distal end of sample for any chemical
effects on the shaft, inner lumen and cross-
sectional areas. Record results. | |
| Hub Gauging | Purpose: To determine if catheter hub
meets gauging requirement 4.1 of EN 1707.
Method: Using the appropriate gauge, the
gauge was applied to the conical fitting with
a total axial force of 5N without the use of
torque. The axial load was then removed
and the sample inspected. | Hub gauging meets
acceptance criteria. |
| Simulated Use | Purpose: To evaluate performance design
attributes through user evaluation in an in
vitro flow model.
Method: Simulated use testing uses a
neurovascular model that replicates the
tortuosity, diameter and location of the
arteries in the neurovasculature. The model
incorporates a re-circulating water bath at
approximately 37ºC to simulate the human
arterial circulation and interior core body
temperature. All testing follows the
procedural instructions outlined in the
Instructions for Use. | Simulated use meets
acceptance criteria. |
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Performance Data – Animal
An animal study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate performance design attributes of the AXS Catalyst™ Distal Access Catheter through user evaluation in an acute animal model.
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Performance Data - Clinical
No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes.
Shelf Life Testing
The labeled shelf life for the AXS Catalyst Distal Access Catheter is 6 months. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing were performed on the subject device and the results met established criteria.
Sterilization
The AXS Catalyst Distal Access Catheter and all system components are sterilized with 100% Ethylene Oxide. The AXS Catalyst Distal Access Catheter is provided sterile to a sterility assurance level (SAL) of 10°, and is for single use only.
Ethylene oxide (EO) residuals on a sample representative of the AXS Catalyst Distal Access Catheter are less than the maximum allowed for EO residuals per EN ISO 10993-7 for a limited contact delivery system -externally communicating.
Results are:
- Ethylene Oxide Results: 2.29 mg/device extracted residuals (EN ISO 10993-7 requirement is average daily dose