(89 days)
Not Found
No
The 510(k) summary describes a physical medical device (catheter) and its accessories, with no mention of software, algorithms, or AI/ML capabilities.
No.
This device is designed to facilitate the insertion and guidance of other interventional devices and act as a conduit for retrieval devices, rather than directly treating a disease or condition itself.
No
This device is an access catheter used to facilitate the insertion and guidance of interventional devices, and as a conduit for retrieval devices. It does not perform any diagnostic function.
No
The device description clearly outlines physical components such as a catheter shaft, hydrophilic coating, radiopaque marker, luer hub, and accompanying accessories like valves and sheaths. This indicates a hardware-based 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The AXS Catalyst Distal Access Catheter is a physical tool used to facilitate the insertion and guidance of other interventional devices within the body's blood vessels. It acts as a conduit and access point.
- Intended Use: The intended use clearly states its purpose is to facilitate the insertion and guidance of devices into a blood vessel and as a conduit for retrieval devices. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details the physical components of a catheter designed for insertion into the body.
- Lack of Diagnostic Testing: There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
Therefore, the AXS Catalyst Distal Access Catheter is an interventional medical device used within the body, not an IVD.
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™ 7 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. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel away introducer sheaths. The RHV and Tuohy Borst valve with sideport are used 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
angiographic visualization, fluoroscopic guidance
Anatomical Site
peripheral and neurovascular systems, vasculature (neuro vasculature, intracranial vasculature)
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)
Performance Data – Bench Testing:
- Design Verification Testing:
- Dimensional Verification: Verify dimensions using specified measurement tool. "Dimensional verification meets acceptance criteria."
- Tip Configuration: Visually inspect distal tip at 10X magnification to verify distal tip end is smooth, rounded, tapered or similarly finished. "Tip configuration meets acceptance criteria."
- Surface Integrity: Visually inspect external surface of catheter for extraneous matter, process and surface defects, and drops of lubricant fluids. "Surface integrity meets acceptance criteria."
- Tip Buckling: Measure the maximum force required to cause a test sample to buckle. "Tip buckling meets acceptance criteria."
- Catheter lubricity and durability: Measure the frictional force of the device sample when pulled between two clamped pads. Record the peak frictional force over 5 cycles. "Coating lubricity and durability meets acceptance criteria."
- Particulate characterization: Use light obscuration particle counting to measure the total number of particulates generated during simulated use in each of three size ranges: ≥ 10 µm, ≥ 25 µm, and ≥ 50 µm. "Particulate generation was acceptable."
- Coating integrity: Visually inspect for coating anomalies, defects or artifacts pre and post simulated use using a simulated in vitro test model. "Coating integrity was acceptable."
- Trackability: Advance catheter through model and determine peak tracking force. "Track advance force meets acceptance criteria."
- Tensile Strength: Use tensile tester to determine applied peak tensile force. "Tensile strength meets acceptance criteria."
- Liquid Leak Resistance: Apply pressure of 300kPa minimum and maintain pressure for 30s. Visually inspect catheter/hub joint and catheter shaft for leaks. "Liquid leak resistance of catheter meets acceptance criteria."
- Air Leak Resistance: 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. "Air leak resistance of catheter meets acceptance criteria."
- Catheter Torsional Bond Strength: Apply torque to catheter shaft and observe number of 360-degree rotations before failure occurs. "Catheter torsional bond strength meets acceptance criteria."
- Flexural Fatigue: Advance entire assembly of guide wire, microcatheter, and test sample into test model and track it through test model. Repeat for nine more runs. After run number ten, remove guide wire and microcatheter out of test sample and inspect sample for kink or damage. "Flexural fatigue meets acceptance criteria."
- Catheter Kink Radius: Calculate kink radius using measurement of 2nd to final loop OD and sample OD. "Catheter kink radius meets acceptance criteria."
- Catheter Tip and Lumen Integrity (Adjunctive Aspiration): Visually inspect test sample to verify absence of no tip or lumen collapse. "Catheter tip and lumen integrity during adjunctive aspiration meets acceptance criteria."
- Chemical Compatibility: Flush sample with appropriate chemical. Measure ID and OD using RAM optical measurement system. Insert mandrel through sample to verify inner lumen integrity. Visually inspect distal end of sample for any chemical effects on the shaft, inner lumen and cross-sectional areas. "Chemical compatibility meets acceptance criteria."
- Hub Gauging: Using the appropriate gauge, apply gauge to the conical fitting with a total axial force of 5N without use of torque. Remove axial load and inspect sample. "Hub gauging meets acceptance criteria."
- Design Validation Testing:
- In-vitro Simulated Use Study: Evaluate interventional device delivery, and the durability and kink resistance of the Subject and Primary Predicate devices in a tortuous anatomical model with multiple physician users. "All test samples meet acceptance criteria."
Performance Data – Animal Study:
- An animal study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate navigation safety of the AXS Catalyst 7 Distal Access Catheter in clinically relevant vessel sizes.
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 7 Distal Access Catheter is one year. 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.
Biocompatibility:
- MEM Elution Cytotoxicity/Part 5: "No biological activity (Grade 0) was observed in the L929 mammalian cells at 48 hours post exposure to the test article extract." "PASS No cytotoxicity or cell lysis"
- Hemolysis Extract/Direct Contact Method /Part 4: "The test article exhibited 0.0% hemolysis above the level of hemolysis exhibited by the negative control via the direct method and 0.0% hemolysis above the level of hemolysis exhibited by the negative control via the indirect method." "PASS Non-hemolytic"
- USP Physiochemical / Part 18: Non-volatile residue: 7 mg; Residue on ignition:
§ 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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 13, 2019
Stryker Neurovascular Germaine Fu. PhD Associate Project Manager, Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538
Re: K183463
Trade/Device Name: AXS Catalyst Distal Access Catheter (AXS Catalyst 7) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 13, 2018 Received: December 14, 2018
Dear Germaine Fu, PhD:
We have reviewed vour 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 Mav 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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed
by Xiaolin Zheng
Lin Zheng -s
Date: 2019.03.13
11:43:51 -04'00'
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
Indications for Use
510(k) Number (if known) K183463
Device Name
AXS Catalyst Distal Access Catheter (AXS Catalyst 7)
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 K183463
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: | Germaine Fu
Associate Project Manager, Regulatory Affairs
Phone: 510-413-2862
Fax: 510-413-2588
Email: germaine.fu@stryker.com |
| Date Prepared: | December 13, 2018 |
| Device Name and Classification: | |
| Trade/Proprietary Name: | AXS Catalyst Distal Access Catheter (AXS Catalyst 7) |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | DQY |
4
| Legally Marketed | Primary Predicate Device | Additional Predicate Device | |
|---|---|---|---|
| Predicate | AXS Catalyst Distal Access Catheter | ||
| (K151667) | React™ 68 Catheter | ||
| (K180715) | |||
| Device(s): | |||
| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | |||
| Detail | Submission Subject | ||
| Device | Primary Predicate | ||
| Device | Additional Predicate | ||
| Device | |||
| AXS Catalyst 7 Distal | |||
| Access Catheter | AXS Catalyst 5 and | ||
| 6 Distal Access | |||
| Catheter | React 68 Catheter | ||
| Manufacturer | Stryker Neurovascular | Stryker | |
| Neurovascular | Micro Therapeutics, | ||
| Inc. d/b/a ev3 | |||
| Neurovascular | |||
| 510(k) Number | K183463 | K151667 | K180715 |
| Device Trade | |||
| Name | AXS Catalyst® 7 Distal | ||
| Access Catheter | AXS Catalyst® 5 | ||
| and 6 Distal Access | |||
| Catheter | React™ 68 Catheter | ||
| Regulation | |||
| Number | 21 CFR 870.1250 | Same | Same |
| Regulation | |||
| Name | Percutaneous Catheter | Same | Same |
| Classification | II | Same | Same |
| Product Code | DQY | Same | Same |
| Intended | |||
| Use/Indication | |||
| 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. | Same | The React™ 68 Catheter | |
| is indicated for the | |||
| introduction of | |||
| interventional devices | |||
| into the peripheral and | |||
| neuro vasculature. | |||
| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | |||
| Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device |
| AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 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 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. | Same | The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 68 Catheter is |
| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | |||
| Detail | Submission Subject | ||
| Device | Primary Predicate | ||
| Device | Additional Predicate | ||
| Device | |||
| AXS Catalyst 7 Distal | |||
| Access Catheter | AXS Catalyst 5 and | ||
| 6 Distal Access | |||
| Catheter | React 68 Catheter | ||
| designed with a | |||
| hydrophilic coating. | |||
| Accessory | |||
| Devices | |||
| Provided (not in | |||
| direct contact | |||
| with patient) | Rotating Hemostasis | ||
| Valve, Tuohy Borst | |||
| Valve with Sideport, (2) | |||
| Peel-Away Introducer | |||
| Sheaths | Same | Peelable Sheath, | |
| Rotating Hemostasis | |||
| Valve | |||
| Outer Jacket | Pebax with Nylon, | ||
| Tecoflex | Same | Grilamid, Pebax | |
| Reinforcement | Nitinol wire and | ||
| polymer fiber | Stainless steel, | ||
| Nitinol wire, and | |||
| polymer fiber | Nitinol | ||
| Strain Relief | Thermoplastic rubber | ||
| (Polyolefin) | Thermoplastic | ||
| rubber | |||
| (Santoprene) | DynaFlex | ||
| Inner Layer | PTFE | Same | Same |
| Catheter Hub | Nylon | Same | Trogamid |
| Marker Band | Platinum/Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Outer Jacket | |||
| Coating | Hydrophilic Coating | Same | Same |
| Labeled Shaft | |||
| Outer Diameter | Distal OD: 6.2F (0.082 | ||
| in.) | |||
| Proximal OD: 6.3F | |||
| (0.0825 in.) | Distal OD: | ||
| CAT 5: 5.3F (0.0696 | |||
| in.) | |||
| CAT 6: 5.4F (0.0709 | |||
| in.) | |||
| Proximal OD: | Distal OD: 0.083 in | ||
| Proximal OD: 0.083 in | |||
| Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device |
| AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 Catheter | |
| CAT 5: 5.6F (0.0735 in.) | |||
| CAT 6: 6.0F (0.0787 in.) | |||
| Effective Lengths | 115cm | ||
| 125cm | |||
| 132cm | CAT 5: 115cm,132cm | ||
| CAT 6: 132cm | 132cm | ||
| Distal ID | 0.068 in. | CAT 5: 0.058 in. | |
| CAT 6: 0.060 in. | Same | ||
| Proximal ID | 0.068 in. | CAT 5: 0.058 in. | |
| CAT 6: 0.060 in. | Same | ||
| Packaging Materials and Configuration | Polyethylene Tube and HDPE Packaging Card | Same | Polyethylene Packaging Card and Hoop |
| Sterilization Method | EO Sterilization | Same | Same |
| How Supplied | Single Use/Sterile | Same | Same |
| Principles of Operation | 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 | Same | The catheter is introduced through a guide catheter or femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire and/or microcatheter. The proximal end of the catheter has a luer fitting to allow attachment of |
| Table 1: Product Feature Comparison of Subject Device to Predicate Devices | |||
| Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device |
| AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 Catheter | |
| 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. If | |||
| used with a retriever, | |||
| aspiration may be | |||
| applied to the catheter | |||
| using a 60mL syringe | |||
| during withdrawal of the | |||
| retrieval device, until | |||
| the retriever and | |||
| microcatheter are | |||
| withdrawn from the | |||
| catheter | accessories and | ||
| infusion of liquids | |||
| through the system. |
Device Description
The AXS Catalyst® 7 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. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel away introducer sheaths. The RHV and Tuohy Borst valve with sideport are used 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.
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 has demonstrated the AXS Catalyst 7 Distal Access Catheter is substantially equivalent to the Primary Predicate device (K151667) and Additional Predicate Device (K180715) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate devices is summarized in Table 1 below.
5
6
7
8
9
The differences between the devices are not critical as demonstrated above and through the testing referenced below.
10
Risk Assessment
Risk assessment of the AXS Catalyst 7 Distal Access Catheter has been conducted in accordance with EN ISO 14971. Stryker Neurovascular has determined that the AXS Catalyst 7 Distal Access Catheter raises no new questions of safety or effectiveness. Results of testing are appropriate for determining that the AXS Catalyst 7 Distal Access Catheter is substantially equivalent to the legally marketed Primary Predicate device.
Testing Summary
Performance Data – Bench Testing
The results of design verification and design validation testing conducted on the AXS Catalyst 7 Distal Access Catheter demonstrates that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Primary Predicate device. Testing was conducted in accordance with EN ISO 10555-1 and EN 1707. The design verification and design validation bench testing are summarized in Table 2 below.
| Table 2: Performance Data - Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Conclusions |
| Design Verification Testing | ||
| 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. | ||
| Table 2: Performance Data - Bench Testing | ||
| Test | Test Method Summary | Conclusions |
| 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. | ||
| 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 over 5 cycles. | Coating lubricity and | |
| durability meets | ||
| acceptance criteria. | ||
| Particulate | ||
| characterization | Purpose: To evaluate particulates per the | |
| FDA Guidance Document: Class II Special | ||
| Controls for Certain Percutaneous | ||
| Transluminal Coronary Angioplasty | ||
| (PTCA) Catheters. | ||
| Method: Use light obscuration particle | ||
| counting to measure the total number of | ||
| particulates generated during simulated | ||
| use in each of three size ranges: ≥ 10 | ||
| µm, ≥ 25 µm, and ≥ 50 µm. | Particulate generation | |
| was acceptable. | ||
| Table 2: Performance Data - Bench Testing | ||
| Test | Test Method Summary | Conclusions |
| Coating integrity | Purpose: To evaluate coating consistency | |
| pre and post simulated use. |
Method: Visually inspect for coating
anomalies, defects or artifacts pre and
post simulated use using a simulated in
vitro test model. | Coating integrity was
acceptable. |
| Trackability | Purpose: To measure track advance force of
catheter over microcatheter.
Method: Place neurovascular model in a re-
circulating water bath at 37°C to simulate
human arterial circulation. Insert sample,
attached to a motor drive assembly, through
model over a microcatheter. 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. |
| Table 2: Performance Data - Bench Testing | | |
| 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
back 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
sample for kink or damage. Record results. | Flexural fatigue meets
acceptance criteria. |
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| Table 2: Performance Data - Bench Testing | |||||
|---|---|---|---|---|---|
| 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 | |||||
| Integrity | |||||
| (Adjunctive Aspiration) | Purpose: To determine ability of catheter to | ||||
| deliver and withdraw retrieval device 3 | |||||
| times when located in a simulated use | |||||
| tortuous path without negative impact to | |||||
| function and integrity to the tip. | Catheter tip and lumen | ||||
| integrity 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. Deliver retrieval device. Aspirate test | |||||
| sample using 60cc syringe during retrieval | |||||
| device withdrawal. Visually inspect test | |||||
| sample to verify absence of no tip or lumen | |||||
| collapse. Record results. | |||||
| Chemical Compatibility | Purpose: To determine visual and | ||||
| dimensional integrity of catheter following | |||||
| exposure to saline and non-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. |
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| Table 2: Performance Data - Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Conclusions |
| Hub Gauging | Purpose: To determine if catheter hub | |
| meets gauging requirement 4.1 of EN 1707. |
Method: Using the appropriate gauge, apply
gauge to the conical fitting with a total axial
force of 5N without use of torque. Remove
axial load and inspect sample. | Hub gauging meets
acceptance criteria. |
| Design Validation Testing | | |
| In-vitro Simulated Use Study | Purpose: To evaluate interventional device
delivery, and the durability and kink
resistance of the Subject and Primary
Predicate devices in a tortuous anatomical
model with multiple physician users.
Method: Perform a simulated interventional
procedure and track the devices to the
target site for interventional device delivery
using a neurovascular model that replicates
the tortuosity, diameter and location of the
arteries in the neurovasculature. | All test samples meet
acceptance criteria. |
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Performance Data – Animal Study
An animal study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58) to evaluate navigation safety of the AXS Catalyst 7 Distal Access Catheter in clinically relevant vessel sizes.
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 7 Distal Access Catheter is one year. 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 7 Distal Access Catheter and all system components (including the Rotating Hemostasis Valve, the Tuohy Borst Valve and the Peel-Away Introducer Sheath) are sterilized with 100% Ethylene Oxide. The AXS Catalyst 7 Distal Access Catheter and the accessories packaged with the Catheter (RHV, Tuohy Borst Valve, and the Peel-Away Introducer Sheath) are provided sterile. A sterility assurance level (SAL) of 106 has been demonstrated. The AXS Catalyst 7 Distal Access Catheter and all system components meets EO residuals per EN ISO 10993-7 for a limited contact delivery system – externally communicating. The AXS Catalyst 7 Distal Access Catheter and all system components are for single use only.
Biocompatibility
The AXS Catalyst™ 7 Distal Access Catheter was 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.
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Biocompatibility testing previously conducted for AXS Catalyst 5 & 6 Distal Access Catheter product is representative of the AXS Catalyst 7 Distal Access Catheter product due to similarity of materials, manufacturing processes and design. While there are minor differences, the biocompatibility assessment determined that these differences are low risk and do not impact product biocompatibility. Therefore, the AXS Catalyst 7 Distal Access Catheter will have the same or similar toxicological profile as the AXS Catalyst 5 and 6 Distal Access Catheter. This conclusion was confirmed by conducting selected tests in accordance with EN ISO 10993-1 and its applicable sub-parts. The AXS Catalyst 7 Distal Access Catheter, passed all required biocompatibility testing.
| Table 3: Overview of Biocompatibility Studies Performed on the Subject Device | ||||
|---|---|---|---|---|
| Test Performed / | ||||
| Applicable ISO 10993 Part | ||||
| No. | Results | Conclusion | ||
| MEM Elution | ||||
| Cytotoxicity/Part 5 | No biological activity (Grade 0) was observed in | |||
| the L929 mammalian cells at 48 hours post | ||||
| exposure to the test article extract. The test | ||||
| article met the requirements of the test since the | ||||
| grade was less than grade 2. | ||||
| The observed cellular response obtained from the | ||||
| positive control article extract (Grade 4) and | ||||
| negative control article extract (Grade 0) | ||||
| confirmed the suitability of the test system. | PASS | |||
| No cytotoxicity or | ||||
| cell lysis | ||||
| Hemolysis Extract/Direct | ||||
| Contact Method | ||||
| /Part 4 | The test article exhibited 0.0% hemolysis above | |||
| the level of hemolysis exhibited by the negative | ||||
| control via the direct method and 0.0% hemolysis | ||||
| above the level of hemolysis exhibited by the | ||||
| negative control via the indirect method. | PASS | |||
| Non-hemolytic | ||||
| USP Physiochemical | ||||
| / Part 18 | Non-volatile residue: 7 mg | |||
| Residue on ignition: |