(249 days)
No
The device description and performance studies focus on the mechanical and physical properties of the catheter for delivery assistance, with no mention of AI or ML capabilities.
No
The device is intended to assist in the delivery of other interventional devices and does not directly provide therapy.
No
Explanation: The device, the AXS Offset Delivery Assist Catheter, is described as intended to assist in the delivery of interventional devices, facilitating the insertion and delivery of catheters into a selected blood vessel. Its function is to provide a smooth transition and reduce the gap between devices, not to diagnose a condition or disease.
No
The device description clearly describes a physical catheter with specific dimensions, materials (hydrophilic coating, radiopaque marker), and a luer hub. The performance studies also focus on physical properties and bench testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the delivery of interventional devices... in the neurovasculature." This describes a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a catheter designed for insertion into blood vessels to guide other devices. This is consistent with an interventional medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on the physical properties and functionality of the catheter within a simulated neurovascular environment (bench testing), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural, assisting in the delivery of other devices within the body.
N/A
Intended Use / Indications for Use
The AXS Offset Delivery Assist Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
Product codes
DQY
Device Description
The AXS Offset Delivery Assist Catheter ("AXS Offset") is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and delivery of appropriately sized interventional devices, such as distal access catheters (DAC), into a selected blood vessel in the neurovascular system.
The AXS Offset catheter, when used in conjunction with an appropriately sized steerable guidewire and DAC, provides a smooth interventional device system profile. The distal outer diameter (OD) of the AXS Offset catheter gradually increases from 0.036in at the RO Marker to 0.050in, 2 cm proximal to the RO marker. The bulb section with a 0.050in OD is maintained for 28 cm. then gradually decreases towards the proximal section. The overall distal profile of the AXS Offset catheter acts as a smooth transition and reduces the gap between the outer diameter of a steerable guidewire and inner diameter of a DAC while allowing for continuous saline flush through the DAC.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular system
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)
The following tests were performed on the subject device:
- Dimensional Verification: Meets acceptance criteria for catheter effective length, uncoated length, distal tip outer diameter, and inner diameter. Substantial Equivalence: XT-27 and AXS Offset meet the same dimensional effective length, uncoated length, and distal tip outer diameter acceptance criteria. For inner diameter, XT-27 and AXS Offset meet their respective dimensional inner diameter acceptance criteria. The inner lumens of both devices are compatible with standard neurovascular guide wires.
- Dimensional: Maximum Outer Diameter: Meets acceptance criteria for maximum outer diameter. Substantial Equivalence: XT-27 and AXS Offset meet their respective dimensional (maximum outer diameter) acceptance criteria. The differences in the max OD between the XT27 and AXS Offset are related to the differences in the indications for use of both devices.
- Friction Force: Meets acceptance criteria. Substantial Equivalence: XT-27 and AXS Offset meet the same friction force acceptance criteria.
- Catheter Distal Tip Buckling: Meets acceptance criteria. Substantial Equivalence: XT-27 and AXS Offset meet the same distal tip buckling acceptance criteria.
- Catheter Tensile Strength: Meets acceptance criteria. Substantial Equivalence: XT-27 and AXS Offset meet the same catheter tensile strength acceptance criteria.
- Catheter Hub Tensile Strength: Meets acceptance criteria. Substantial Equivalence: XT-27, Transform, and AXS Offset meet the same catheter hub tensile strength acceptance criteria.
- Liquid-Leakage: Meets acceptance criteria. Substantial Equivalence: XT-27, Transform, and AXS Offset meet the same liquid-leakage acceptance criteria.
- Air Aspiration Leakage: Meets acceptance criteria. Substantial Equivalence: XT-27, Transform, and AXS Offset meet the same air aspiration leakage acceptance criteria.
- Particle Analysis for Catheters: Particle analysis characterization testing completed and is for reference only. Particulate count results for the AXS Offset in all particulate size ranges are similar or lower than the predicate device XT-27.
- Coating Integrity: Neither the Baseline test articles nor the Post-tracking test articles exhibited any delamination at coating edges (either proximal or distal). The Baseline test articles did not exhibit any coating defects (voids or scratches). The post tracking devices exhibited no anomolies along the 80cm coating length. When considered in conjunction with coating lubricity and durability results and the particulate generation results, the coating functions as intended and has exhibited appropriate integrity (via visual assessment) post simulated use.
- Track and Advance Force: AXS Offset catheter advance and retraction force in simulated use testing has been demonstrated to be equivalent or lower than the predicate XT-27.
- Flow Rate: Testing has demonstrated a continuous positive displacement of saline fluid through the lumen of the DAC with the AXS Offset catheter positioned in the DAC lumen. Testing was conducted in a simulated neurovascular tortuosity model.
- Catheter Kink Radius: Meets acceptance criteria. Substantial Equivalence: XT-27 and AXS Offset meet the same kink radius acceptance criteria.
- Catheter Torsional Resistance: Meets acceptance criteria. Substantial Equivalence: XT-27 and AXS Offset meet the same torsional resistance acceptance criteria.
- Visual Standards: Visual standards meet acceptance criteria for catheter length being free from extraneous matter and process defects and for catheter distal tip being smooth and rounded. Substantial Equivalence: XT-27 and AXS Offset meet the same visual standards acceptance criteria.
- Visual and Dimensional Integrity – Chemical Compatibility: Meets acceptance criteria. Substantial Equivalence: XT-27 and AXS Offset meet the same visual and dimensional integrity - chemical compatibility acceptance criteria.
- Device Trackability: Meets acceptance criteria. Substantial equivalence: XT-27 and AXS Offset meet the same device trackability acceptance criteria. After advancing the Test article with the intermediate catheters in the model, the physicians confirmed that all of the test articles were able to advance to the M1 using standard access methods similar to XT-27.
- Device - Durability and Integrity: Meets acceptance criteria. The evaluating physicians confirmed that the all test articles maintained their integrity throughout procedure. Substantial Equivalence: XT-27 and AXS Offset meet the device durability and integrity acceptance criteria.
- Guidewire Compatibility: Meets acceptance criteria. The evaluating physicians confirmed that all test articles allowed smooth advancement and withdrawal of standard guidewires up to 0.018in OD. Substantial Equivalence: XT-27 and AXS Offset meet the same guidewire compatibility acceptance criteria.
- Labelling requirements: Meets acceptance criteria. The evaluating physicians confirmed that the DFU and labeling of all test articles clearly identify the product and provide information adequate to ensure the safe use of the device. Substantial Equivalence: XT-27 and AXS Offset meet the labeling requirements acceptance criteria.
- Intended Use Environment: Meets acceptance criteria. The evaluating physicians confirmed that all Test articles withstand conditions that can typically be seen during use environment of the product. Substantial Equivalence: XT-27 and AXS Offset meet the same intended use environment acceptance criteria.
- Visibility: Meets acceptance criteria. The evaluating physicians confirmed that all test articles are visible under fluoroscopy during delivery to and withdrawal from the intended location. Substantial Equivalence: XT-27 and AXS Offset meet the same visibility acceptance criteria.
- Packaging: Packaging visual, dimensional, and performance testing meets the acceptance criteria for all packaging components (carton, labels, DFU, and pouch). Substantial Equivalence: XT-27 and AXS Offset meet the same packaging visual, dimensional, and performance acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/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 to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2017
Stryker Neurovascular Angelica Beckmann Director, Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538
Re: K163259
Trade/Device Name: AXS Offset Delivery Assist Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 29, 2017 Received: June 30, 2017
Dear Ms. Beckmann:
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 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/Resourcesfor You/Industry/default.htm.
Sincerely,
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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3
510(k) Summary
| Device Trade Name: | AXS Offset Delivery Assist 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 | |||||
| Facility Registration #2954917 | |||||
| Contact: | Angelica Beckmann | ||||
| Director, Regulatory Affairs | |||||
| Tel 510 - 413-2900 | |||||
| Fax 510 - 413-2588 | |||||
| Date Prepared: | July 27, 2017 | ||||
| Predicate Device: | Primary Predicate Device K113778 | ||||
| (clearance granted | |||||
| April 20, 2012) Excelsior XT-27 Microcatheter Reference Predicate Device |
| K122576 | Transform Occlusion Balloon Catheter |
|---|---|
| (clearance granted | |
| January 11, 2013) |
4
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
Device Description
The AXS Offset Delivery Assist Catheter ("AXS Offset") is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and delivery of appropriately sized interventional devices, such as distal access catheters (DAC), into a selected blood vessel in the neurovascular system.
The AXS Offset catheter, when used in conjunction with an appropriately sized steerable guidewire and DAC, provides a smooth interventional device system profile. The distal outer diameter (OD) of the AXS Offset catheter gradually increases from 0.036in at the RO Marker to 0.050in, 2 cm proximal to the RO marker. The bulb section with a 0.050in OD is maintained for 28 cm. then gradually decreases towards the proximal section. The overall distal profile of the AXS Offset catheter acts as a smooth transition and reduces the gap between the outer diameter of a steerable guidewire and inner diameter of a DAC while allowing for continuous saline flush through the DAC.
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.
Accessories
No accessories are provided with the AXS Offset.
Indications for Use
The Indications for Use are similar to the predicate devices and are as follows: The AXS Offset Delivery Assist Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
Technological Characteristics and Product Feature Comparison
The subject device, AXS Offset Delivery Assist Catheter is substantially equivalent to the predicate devices in terms of:
- indications for use ●
- fundamental scientific technology
- fundamental design ●
- materials and processes for packaging and sterilization of devices ●
A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below.
5
| Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Device Name | AXS Offset Delivery Assist | ||
| Catheter | Excelsior® XT-27 | ||
| Microcatheter | Transform Occlusion Balloon | ||
| Catheter | |||
| 510(k) | Current Notification | K113778 | K122576 |
| Device | |||
| Classification/ | |||
| Product Code | Class II/ DQY | ||
| (Percutaneous catheters) | Class II/ DQY | ||
| (Percutaneous catheters) | Class II/MJN | ||
| (Temporary Intravascular | |||
| Occluding Catheter) | |||
| Intended Use | The AXS Offset Delivery | ||
| Assist Catheter is intended to | |||
| assist in the delivery of | |||
| interventional devices, such | |||
| as distal access catheters, in | |||
| the neurovasculature. | Stryker Neurovascular | ||
| Excelsior XT-27 | |||
| Microcatheter is intended to | |||
| assist in the delivery of | |||
| diagnostic agents (such as | |||
| contrast media), therapeutic | |||
| agents, and non-liquid | |||
| interventional devices (such | |||
| as stents) that are indicated | |||
| for use in the | |||
| neurovasculature and with a | |||
| catheter of 0.027 inches in | |||
| inner diameter. | The Stryker Neurovascular | ||
| TransForm Occlusion Balloon | |||
| Catheters are indicated for use | |||
| in the neuro and peripheral | |||
| vasculature to temporarily stop | |||
| or control blood flow and for | |||
| balloon assisted embolization of | |||
| intracranial aneurysms. | |||
| Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device |
| Device Name | AXS Offset Delivery Assist | ||
| Catheter | Excelsior® XT-27 | ||
| Microcatheter | Transform Occlusion Balloon | ||
| Catheter | |||
| 510(k) | Current Notification | K113778 | K122576 |
| Principle of | |||
| Operations | Delivery Assist Catheters are | ||
| used to access and navigate | |||
| the vasculature as well as to | |||
| deliver Distal Access | |||
| Catheters (DAC). The AXS | |||
| Offset Delivery Assist | |||
| Catheter is inserted through a | |||
| DAC and guided through the | |||
| vasculature with the aid of a | |||
| guidewire (over-the-wire | |||
| catheter). | Microcatheters are used to | ||
| access and navigate the | |||
| vasculature as well as to | |||
| deliver diagnostic therapeutic | |||
| agents, and/or interventional | |||
| devices. Typically these | |||
| vascular microcatheters are | |||
| inserted with a guide catheter | |||
| and guided through the | |||
| vasculature with the aid of a | |||
| guidewire (over-the-wire | |||
| microcatheters). | The device is advanced into the | ||
| vasculature using an 0.014 inch | |||
| OD guidewire and inside a | |||
| 5F or larger guide catheter | |||
| placed in the femoral artery. | |||
| The radiopaque markers are | |||
| observed under fluoroscopy as a | |||
| guide to positioning the balloon | |||
| at the intended treatment site. | |||
| Once at the treatment site, the | |||
| guidewire is used to seal the | |||
| distal end of the catheter | |||
| allowing inflation of the | |||
| balloon. A mixture of saline and | |||
| contrast is injected into the | |||
| catheter lumen to inflate the | |||
| balloon to its nominal volume; | |||
| fluoroscopy is used to ensure | |||
| proper positioning. Once | |||
| beyond the distal tip of the | |||
| catheter, the guidewire can be | |||
| moved distally or proximally | |||
| while maintaining balloon | |||
| inflation. |
Product Feature Comparison of Subject Device with Predicate Devices (K113778, K122576)
6
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
7
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
| Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Device Name | AXS Offset Delivery Assist | Excelsior ® XT-27 | Transform Occlusion Balloon |
| Catheter | Microcatheter | Catheter | |
| 510(k) | Current Notification | K113778 | K122576 |
| Sterilization | |||
| Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
Design Comparison of Subject Device with Predicate Devices (K113778, K122576)
| | Proposed Device | Predicate Device | Predicate Device | Rationale for difference
(if applicable) |
|-----------------------------------------------------|----------------------------------------|------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | AXS Offset Delivery
Assist Catheter | Excelsior® XT-27
Microcatheter | Transform Occlusion
Balloon Catheter | |
| | Current Notification | K113778 | K122576 | |
| Proximal OD | 3.0F (1.0mm) | 2.9F (0.97mm) | 2.8F (0.95mm) | No significant difference |
| Distal OD | 2.7F (0.91mm) | 2.7F (0.91mm) | 2.7F (0.95mm) | N/A - Same as primary predicate |
| Feature | Proposed Device | Predicate Device | Predicate Device | Rationale for difference
(if applicable) |
| | AXS Offset Delivery
Assist Catheter | Excelsior® XT-27
Microcatheter | Transform Occlusion
Balloon Catheter | |
| | Current Notification | K113778 | K122576 | |
| Maximum
Catheter
Diameter
(distal section) | 3.8F (1.27mm)
*reference figure | 2.7F (0.91mm)
*reference figure | 3.8F(1.27mm)
*reference figure | The AXS Offset outside diameter
is similar to the predicate devices.
AXS Offset has the same
materials as the predicate as seen
in table 13-7. Thrombogenicity
testing demonstrated no risk of
thrombosis for the AXS Offset
Catheter like the predicate device.
Biocompatibility testing was also
completed to show no increased
risk compared to the predicate
devices. The bench testing was
performed in a neurovascular
tortuosity model to confirm the
continuous flush solution will be
adequately maintained between
the AXS Offset and DAC during
use. |
| ID | 0.53mm (.021in) | 0.69mm (0.027in) | 0.31mm (.0124in) | AXS Offset ID of .021" is within
the ranges of both predicate
devices. .021" ID is a common
size for a catheter of this length
and OD. |
| Feature | Proposed Device | Predicate Device | Predicate Device | Rationale for difference
(if applicable) |
| | AXS Offset Delivery
Assist Catheter | Excelsior® XT-27
Microcatheter | Transform Occlusion
Balloon Catheter | |
| | Current Notification | K113778 | K122576 | |
| Hydrophilic
Coating
Length | 80cm | 80cm | 80cm - 83cm | N/A - Same as primary predicate |
| Effective
Length | 150cm | 135 cm
150 cm | 150 cm - 153cm | N/A - Same as primary predicate |
| Tip Length | 2cm | 6 cm
18 cm | 1cm - 3cm | AXS Offset tip length of 2cm is
similar to the predicate devices.
The tip length is used to describe
the section distal of the bulb
feature of the AXS Offset but the
tip length does not significantly
affect the product performance.
The materials of the tip are more
impactful to product
performance. Both AXS Offset
and Excelsior XT-27 have the
same distal tip materials and
distal OD and thus have similar
performance. |
| Tip Shape | Straight | Straight | Straight | N/A - Same as primary predicate |
8
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
9
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
10
Risk Assessment
Risk assessment of the AXS Offset Delivery Assist Catheter has been conducted in accordance with EN ISO 14971 and Stryker Neurovascular's risk management procedures. Stryker Neurovascular has determined that the AXS Offset Delivery Assist Catheter raises no new safety or effectiveness issues.
Results of verification and validation testing have demonstrated the subject device is substantially equivalent to the predicate devices.
Testing Summary
The results of verification and validation testing conducted on the subject device demonstrate that it performs as designed, and is suitable for its intended use. Specifically, the following tests were performed on the subject device:
11
Stryker Neurovascular
Premarket Notification, Traditional 510(k)
AXS Offset Delivery Assist Catheter
| Test | Test Method | Results |
|---|---|---|
| Dimensional | ||
| Verification | Verified dimensions | |
| using specified | ||
| measurement tool | Dimensional verification meets acceptance criteria for catheter | |
| effective length, uncoated length, distal tip outer diameter, and | ||
| inner diameter | ||
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| dimensional effective length, uncoated length, and distal tip outer | ||
| diameter acceptance criteria | ||
| For inner diameter, XT-27 and AXS Offset meet their respective | ||
| dimensional inner diameter acceptance criteria. The inner lumens | ||
| of both devices are compatible with standard neurovascular guide | ||
| wires. | ||
| Dimensional: | ||
| Maximum Outer | ||
| Diameter | Verified dimensions | |
| using specified | ||
| measurement tool | Dimensional verification meets acceptance criteria for maximum | |
| outer diameter | ||
| Substantial Equivalence: XT-27 and AXS Offset meet their | ||
| respective dimensional (maximum outer diameter) acceptance | ||
| criteria. The differences in the max OD between the XT27 and | ||
| AXS Offset are related to the differences in the indications for use | ||
| of both devices. | ||
| Friction Force | Measured friction | |
| force to determine | ||
| the lubricity and | ||
| durability of the | ||
| coating on a catheter | ||
| shaft using a friction | ||
| tester | Friction force meets acceptance criteria | |
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| friction force acceptance criteria. | ||
| Catheter Distal Tip | ||
| Buckling | Measured force | |
| required to buckle | ||
| distal shaft using tip | ||
| buckling tester | Distal tip buckling meets acceptance criteria | |
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| distal tip buckling acceptance criteria. | ||
| Catheter Tensile | ||
| Strength | Measured catheter | |
| shaft peak tensile | ||
| strength using Instron | ||
| tensile tester per test | ||
| guideline, ISO10555- | ||
| 1 Peak Tensile Force | Catheter tensile strength meets acceptance criteria | |
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| catheter tensile strength acceptance criteria. | ||
| Catheter Hub Tensile | ||
| Strength | Measured catheter | |
| shaft to hub tensile | ||
| junction strength | ||
| using Instron tensile | ||
| tester per test | ||
| guideline, ISO10555- | ||
| 1 Peak Tensile Force | Catheter hub tensile strength meets acceptance criteria | |
| Substantial Equivalence: XT-27, Transform, and AXS Offset meet | ||
| the same catheter hub tensile strength acceptance criteria. | ||
| Liquid-Leakage | Determined whether | |
| liquid leaks from the | ||
| catheter under | ||
| pressure per EN ISO | ||
| 10555- | ||
| 1:2013 and EN | ||
| 1707:1996 | Liquid-leakage meets acceptance criteria | |
| Substantial Equivalence: XT-27, Transform, and AXS Offset meet | ||
| the same liquid-leakage acceptance criteria. | ||
| Air Aspiration Leakage | Determined whether | |
| air leaks into the hub | ||
| assembly during | ||
| aspiration per EN | ||
| ISO 10555-1:2013 | ||
| and EN 1707:1996. | Air aspiration leakage meets acceptance criteria | |
| Substantial Equivalence: XT-27, Transform, and AXS Offset meet | ||
| the same air aspiration leakage acceptance criteria. | ||
| Particle Analysis for | ||
| Catheters | Performed simulated | |
| use procedures for in vitro acute phase | ||
| particulate | ||
| characterization | ||
| using a particle | ||
| counter | Particle analysis characterization testing completed and is for | |
| reference only. | ||
| Particulate count results for the AXS Offset in all particulate size | ||
| ranges are similar or lower than the predicate device XT-27 | ||
| Coating Integrity | Checked visual | |
| condition of catheter | ||
| and noted | ||
| observations of the | ||
| catheter coatings | ||
| before and after | ||
| simulated use | Neither the Baseline test articles nor the Post-tracking test articles | |
| exhibited any delamination at coating edges (either proximal or | ||
| distal). The Baseline test articles did not exhibit any coating defects | ||
| (voids or scratches). The post tracking devices exhibited no | ||
| anomolies along the 80cm coating length. When considered in | ||
| conjunction with coating lubricity and durability results and the | ||
| particulate generation results, the coating functions as intended and | ||
| has exhibited appropriate integrity (via visual assessment) post | ||
| simulated use. | ||
| Track and Advance | ||
| Force | Measured the | |
| advance and | ||
| retraction force in | ||
| simulated use | ||
| conditions from the | ||
| petrous segment of | ||
| the internal carotid | ||
| artery to the M1 of | ||
| the middle cerebral | ||
| artery. | AXS Offset catheter advance and retraction force in simulated use | |
| testing has been demonstrated to be equivalent or lower than the | ||
| predicate XT-27. | ||
| Flow Rate | Measured flow rate | |
| for saline infusion | ||
| through a Distal | ||
| Access Catheter | ||
| (DAC) when the | ||
| AXS Offset catheter | ||
| was positioned within | ||
| the lumen of the | ||
| DAC. | Testing has demonstrated a continuous positive displacement of | |
| saline fluid through the lumen of the DAC with the AXS Offset | ||
| catheter positioned in the DAC lumen. Testing was conducted in a | ||
| simulated neurovascular tortuosity model. | ||
| Catheter Kink Radius | Measured the kink | |
| radius of catheter | ||
| using a fixture | Catheter kink radius meets acceptance criteria | |
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| kink radius acceptance criteria. | ||
| Catheter Torsional | ||
| Resistance | Measured the | |
| strength of catheter | ||
| shaft while it rotates | ||
| in a clinically | ||
| relevant vascular path | ||
| to determine how | ||
| many turns (360- | ||
| degree rotations) are | ||
| required to break the | ||
| shaft | Catheter torsional resistance meets acceptance criteria | |
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| torsional resistance acceptance criteria. | ||
| Visual Standards | Visually checked | |
| catheter length for | ||
| extraneous matter | ||
| and process defects. | ||
| Additionally, | ||
| checked for smooth | ||
| and rounded distal tip | ||
| using specified | ||
| measurement tools | Visual standards meet acceptance criteria for catheter length being | |
| free from extraneous matter and process defects and for catheter | ||
| distal tip being smooth and rounded. | ||
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| visual standards acceptance criteria. | ||
| Visual and | ||
| Dimensional Integrity | ||
| – Chemical | ||
| Compatibility | Performed visual, | |
| dimensional, and | ||
| mandrel passage | ||
| examinations to | ||
| determine visual and | ||
| dimensional integrity | ||
| of the hub, inner | ||
| lumen, and outer | ||
| distal region of | ||
| catheter after | ||
| exposure to saline, | ||
| non-ionic contrast, | ||
| and ionic contrast. | Visual and Dimensional Integrity - Chemical Compatibility meets | |
| acceptance criteria | ||
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| visual and dimensional integrity - chemical compatibility | ||
| acceptance criteria. | ||
| Device Trackability | The device was | |
| advanced to the M1 | ||
| using standard access | ||
| methods similar to | ||
| XT-27. In order to | ||
| meet acceptance | ||
| criteria, the evaluating | ||
| physician/s must state | ||
| that the test articles | ||
| can advance to the | ||
| M1 in conjunction | ||
| with the intermediate | ||
| catheter in the bench | ||
| model. | Device Trackability meets acceptance criteria | |
| Substantial equivalence: XT-27 and AXS Offset meet the same | ||
| device trackability acceptance criteria. | ||
| After advancing the Test article with the intermediate catheters in | ||
| the model, the physicians confirmed that all of the test articles were | ||
| able to advance to the M1 using standard access methods similar to | ||
| XT-27. | ||
| Device - Durability | ||
| and Integrity | The integrity of the | |
| device was assessed | ||
| throughout the | ||
| duration of the | ||
| procedure using the | ||
| bench model. In order | ||
| to meet acceptance | ||
| criteria, the evaluating | ||
| physician/s must state | ||
| that all test articles | ||
| maintain their | ||
| integrity throughout | ||
| procedure. | Device Durability and Integrity meets acceptance criteria | |
| The evaluating physicians confirmed that the all test articles | ||
| maintained their integrity throughout procedure. | ||
| Substantial Equivalence: XT-27 and AXS Offset meet the device- | ||
| durability and integrity acceptance criteria. | ||
| Guidewire | ||
| Compatibility | Guidewires up to | |
| 0.018in OD were | ||
| allowed to advance | ||
| and withdraw from | ||
| the AXS Offset | ||
| device during the | ||
| procedure using the | ||
| bench model. In | Guidewire Compatibility meets acceptance criteria | |
| The evaluating physicians confirmed that all test articles allowed | ||
| smooth advancement and withdrawal of standard guidewires up to | ||
| 0.018in OD. | ||
| order to meet | ||
| acceptance criteria, | ||
| the evaluating | ||
| physician/s must state | ||
| that all test articles | ||
| allow smooth | ||
| advancement and | ||
| withdrawal of | ||
| standard guidewires | ||
| up to 0.018in OD. | Substantial Equivalence: XT-27 and AXS Offset meet the same | |
| guidewire compatibility acceptance criteria. | ||
| Labelling requirements | The physician read | |
| the DFU and labeling. | ||
| In order to meet | ||
| acceptance criteria, | ||
| the evaluating | ||
| physician/s must state | ||
| that DFU and labeling | ||
| of all test articles | ||
| clearly identify the | ||
| product and provide | ||
| information adequate | ||
| to ensure the safe use | ||
| of the device. | Labelling Requirements meet acceptance criteria | |
| The evaluating physicians confirmed that the DFU and labeling of | ||
| all test articles clearly identify the product and provide information | ||
| adequate to ensure the safe use of the device. | ||
| Substantial Equivalence: XT-27 and AXS Offset meet the labeling | ||
| requirements acceptance criteria. | ||
| Intended Use | ||
| Environment | During the procedure | |
| using the bench | ||
| model, the device was | ||
| assessed whether it | ||
| withstood the | ||
| simulated use | ||
| conditions. In order | ||
| to meet acceptance | ||
| criteria, the evaluating | ||
| physician/s must state | ||
| that all test articles | ||
| can withstand | ||
| conditions that can | ||
| typically be seen | ||
| during use | ||
| environment of the | ||
| product. | Intended Use Environment meets acceptance criteria | |
| The evaluating physicians confirmed that all Test articles withstand | ||
| conditions that can typically be seen during use environment of the | ||
| product. | ||
| Substantial Equivalence: XT-27 and AXS Offset meet the same | ||
| intended use environment acceptance criteria. |
12
Stryker Neurovascular
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
13
Stryker Neurovascular
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
14
Stryker Neurovascular
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
15
Stryker Neurovascular Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
| Visibility | The visibility of the
tip of the AXS Offset
(marker) was assessed
using fluoroscopy
during delivery to and
withdrawal from the
intended location in
the bench model. In
order to meet
acceptance criteria,
the evaluating
physician/s must state
that all test articles are
visible under
fluoroscopy during
delivery to and
withdrawal from the
intended location. | Visibility meets acceptance criteria
The evaluating physicians confirmed that all test articles are visible
under fluoroscopy during delivery to and withdrawal from the
intended location.
Substantial Equivalence: XT-27 and AXS Offset meet the same
visibility acceptance criteria. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging | Performed packaging
visual, dimensional,
and performance
testing on carton,
labels, DFU, and
pouch | Packaging visual, dimensional, and performance testing meets the
acceptance criteria for all packaging components (carton, labels,
DFU, and pouch).
Substantial Equivalence: XT-27 and AXS Offset meet the same
packaging visual, dimensional, and performance acceptance criteria. |
Biocompatibility
The AXS Offset Delivery Assist Catheter was assessed for impact to biocompatibility. All proposed materials to be used in the AXS Offset Delivery Assist Catheter as per this assessment have a history of safe clinical use throughout the medical device industry and/or within Stryker Neurovascular and have supporting biocompatibility data. The materials used and the manufacturing process used in the AXS Offset Delivery Assist Catheter are the same or very similar to materials used in the cleared reference predicate Transform Occlusion Balloon Catheter (K122576).
The history of safe use and supporting biological test data leveraged from for the reference predicate devices noted above, indicates potential exposure to these existing materials at the amounts present under the proposed clinical conditions of use for the AXS Offset Delivery Assist Catheter will be toxicologically insignificant.
The minor material and manufacturing differences between the AXS Offset Delivery Assist Catheter and the cleared reference predicate device are considered low risk in terms of impact to the biocompatibility of the AXS Offset Delivery Assist Catheter. Therefore, the supporting Transform Occlusion Balloon Catheter (K122576) biocompatibility test data presented in Transform Occlusion Balloon Catheter Biocompatibility Results Summary Table are applicable to the AXS Offset Delivery Assist Catheter.
Although these differences are considered low risk for the biocompatibility of the AXS
16
Offset Delivery Assist Catheter, screening tests were conducted to further provide supporting evidence that these differences do not adversely impact the product. The AXS Offset Delivery Assist Catheter Biocompatibility Results Summary table summarizes the biocompatibility tests that were conducted using the AXS Offset Delivery Assist Catheter. EN ISO 10993 parts are referenced where applicable.
| Test | Test Summary | Conclusion |
|---|---|---|
| MEM Elution | ||
| Cytotoxicity/Part 5 | The test article extract | |
| showed no evidence of | ||
| causing cell lysis or toxicity, | ||
| with a grade of 0 (no | ||
| reactivity). | Pass. | |
| No cytotoxicity or cell lysis. | ||
| The test article is considered | ||
| non-cytotoxic. | ||
| Hemolysis Extract/Direct | ||
| Contact Method/Part 4 | The hemolytic index for the | |
| test article in direct contact | ||
| with blood and for the | ||
| extractwas /Part 18 | The results for the test article | |
| were: | ||
| Non-volatile residue: 7 mg | ||
| Residue on ignition: / | ||
| Part 18 | The results for the test article | |
| were: | ||
| Non-volatile residue: 1 mg | ||
| Residue on ignition: 0.1ug/dm2 | Pass. | |
| The results for the test article were | ||
| considered passing. | ||
| In-Vivo Thromboresistance | For both the test article and | |
| control, platelet counts and | ||
| APTT time were within normal | ||
| ranges. The test article and | ||
| control article scored the same | ||
| for thrombosis and vessel | ||
| patency. | Pass. | |
| The test article demonstrated | ||
| comparable thromboresistance to | ||
| the control article. |
AXS Offset Delivery Assist Catheter Biocompatibility Results Summary
The following tests were leveraged from biocompatibility testing conducted with the Transform Occlusion Balloon Catheter:
17
Transform Occlusion Balloon Catheter Biocompatibility Results Summary
18
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
Biocompatibility testing previously conducted for Transform Occlusion Balloon Catheter product is representative of the AXS Offset Delivery Assist Catheter product due to similarity of materials, manufacturing processes and design. There are no new manufacturing processes, processing aids or chemicals (fillers, additives, cleaning agents etc.) for the manufacture of the AXS Offset device. Screening tests were conducted on AXS Offset Delivery Assist Catheter devices to further provide supporting evidence that the minor differences do not adversely impact the product.
Following completion of testing and review of materials, the AXS Offset Delivery Assist Catheter is considered to have no residual risk of biological hazards. It meets requirements as outlined in EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process for an externally communicating, circulating blood and limited contact (≤24 hrs) duration device.
19
Sterilization and Shelf life
The AXS Catalyst Distal Access Catheter and all system components are sterilized with100% Ethylene Oxide. The AXS Catalyst Distal Access Catheter is provided sterile to a sterility assurance level (SAL) of 10-6, and is for single use only.
The test results for this device are within the ANSI/AAMI ST72:2011 Endotoxin Limit of 20 Endotoxin Units per device (EU/device). Bacterial endotoxin (pyrogen) testing of the AXS Offset Delivery Assist Catheter will be monitored to ensure product release meets specifications.
Ethylene oxide (EO) residuals on a sample representative of the AXS Catalyst DistalAccess Catheter are less than the maximum allowed for EO residuals per EN ISO 10993-7 for a limited contact delivery system -externally communicating.
The labeled shelf life for the AXS Offset is 3 years. Bench testing was conducted on accelerated aged AXS Offset Delivery Assist Catheters to confirm the shelf-life of the device is maintained over the duration of the labeled shelf-life.
Summary of Substantial Equivalence
The subject device is substantially equivalent to the predicate devices based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same fundamental operating principles. Minor differences between the subject and predicate devices do not introduce different questions of safety and effectiveness. The conclusions drawn from risk assessments and the bench testing conducted using the subject device demonstrate that the device performs as designed, is suitable for its intended use, and that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.
20
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
| Feature | Proposed Device
AXS Offset
Delivery Assist
Catheter
Current
Notification | Predicate Device
Excelsior® XT-
27 Microcatheter
K113778 | Predicate
Device
Transform
Occlusion
Balloon
Catheter
K122576 | Rationale for difference
(if applicable) |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proximal
Outer
Diameter | 3.0F (1.0mm) | 2.9F (0.97mm) | 2.8F (0.95mm) | No significant difference |
| Distal Tip
Outer
Diameter | 2.7F (0.91mm) | 2.7F (0.91mm) | 2.7F (0.95mm) | N/A - Same as primary
predicate |
| Maximum
Catheter
Diameter
(distal
section) | 3.8F (1.27mm) | 2.7F (0.91mm) | 3.8F(1.27mm) | The AXS Offset outside
diameter is the same as
the Transform and
similar to the XT-27
predicate devices. The
differences between
XT27 and AXS Offset
are related to the
differences in the
indications for use. |
| Inner
Diameter | 0.53mm (.021in) | 0.69mm (0.027in) | 0.31mm
(.0124in) | AXS Offset ID of .021"
is within the ranges of
both predicate devices.
.021" ID is a common
size for a catheter of this
length and OD. |
| Hydrophilic
Coating
Length | 80cm | 80cm | 80cm - 83cm | N/A - Same as primary
predicate |
| Feature | Proposed Device
AXS Offset
Delivery Assist
Catheter
Current
Notification | Predicate Device
Excelsior® XT-
27 Microcatheter
K113778 | Predicate
Device
Transform
Occlusion
Balloon
Catheter
K122576 | Rationale for difference
(if applicable) |
| Effective
Length | 150cm | 135 cm
150 cm | 150 cm - 153cm | N/A - Same as primary
predicate |
| Tip Length | 2cm | 6 cm
18 cm | 1cm - 3cm | AXS Offset tip length of
2cm is in the range of the
predicate Transform, but
much shorter than the
XT-27 predicate. Tip
materials impact product
performance more than
tip length. Both AXS
Offset and Excelsior XT-
27 have the same distal
tip materials and distal
OD and thus have similar
performance. |
| Tip Shape | Straight | Straight
Pre-shaped | Straight | N/A - Same as primary
predicate |
Comparison Summary Table for Design
21
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter