(147 days)
The AXS Catalyst™ Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
The AXS 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.
The medical device in question is the AXS Catalyst™ Distal Access Catheter.
Here's an analysis of its acceptance criteria and the studies that prove its compliance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present acceptance criteria in a quantitative table format for all tests. Instead, it states conclusions for each test, indicating whether the device "meets acceptance criteria" or for biocompatibility, "PASS" and a conclusion.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Bench Performance | Dimensional Verification | Dimensions conform to specifications. | Dimensional verification meets acceptance criteria. |
| Tip Configuration | Distal tip is smooth, rounded, tapered, or similarly finished to minimize trauma to vessels during use (per EN ISO 10555-1). | Tip configuration meets acceptance criteria. | |
| Surface Integrity | External surface is free from extraneous matter, process and surface defects, and drops of lubricant fluids. | Surface integrity meets acceptance criteria. | |
| Tip Buckling | Maximum force required to cause buckling is within specified limits. | Tip buckling meets acceptance criteria. | |
| Catheter lubricity and durability | Frictional force of the device sample when pulled between two clamped pads is within specified limits after 5 cycles. (Implied: acceptable lubricity and durability as per performance expectations). | Coating lubricity and durability meets acceptance criteria. | |
| Trackability | Peak tracking force through a neurovascular model over a microcatheter is within specified limits. | Track advance force meets acceptance criteria. | |
| Tensile Strength | Tensile force required to induce failure of fused joints, shaft junctions, and marker band is above specified minimums (based on EN ISO 10555-1). | Tensile strength meets acceptance criteria. | |
| Liquid Leak Resistance | Meets freedom from leakage-liquid leak requirement 4.7.1 of EN ISO 10555-1 and catheter hub meets liquid leakage requirement 4.2.1 of EN 1707 (no visible leaks at 300kPa for 30s). | Liquid leak resistance of catheter meets acceptance criteria. | |
| Air Leak Resistance | Meets freedom from leakage-air aspiration requirement 4.7.2 of EN ISO 10555-1 and catheter hub meets air leakage requirement 4.2.2 of EN 1707 (no air bubbles upon withdrawal of syringe plunger to 10cc mark for 15s). | Air leak resistance of catheter meets acceptance criteria. | |
| Catheter Torsional Bond Strength | Torque strength (number of rotations before failure) is above specified minimums. | Catheter torsional bond strength meets acceptance criteria. | |
| Flexural Fatigue | Catheter shaft shows no functional impact or degradation after specified number of cycles through a tortuous model. | Flexural fatigue meets acceptance criteria. | |
| Catheter Kink Radius | Kink radius at distal and specific mid-shaft joint sections is within acceptable limits. | Catheter kink radius meets acceptance criteria. | |
| Catheter Tip and Lumen Patency (Adjunctive Aspiration) | No tip or lumen collapse and tip integrity maintained during aspiration with a 60cc syringe in a simulated use model. | Catheter tip and lumen patency during adjunctive aspiration meets acceptance criteria. | |
| Catheter Tip and Lumen Patency (with retrieval device) | Ablility to deliver and withdraw retrieval device 3 times in a tortuous path without functional impact and integrity to the tip. | Catheter tip and lumen patency meets acceptance criteria. | |
| Chemical Compatibility | Visual and dimensional integrity of catheter maintained after exposure to saline, non-ionic, and ionic contrast liquids; inner lumen integrity maintained. | Chemical compatibility meets acceptance criteria. | |
| Hub Gauging | Catheter hub meets gauging requirement 4.1 of EN 1707. | Hub gauging meets acceptance criteria. | |
| Simulated Use | Performance design attributes are deemed acceptable through user evaluation in an in vitro flow model that replicates neurovasculature tortuosity, diameter, and location in simulated arterial circulation. | Simulated use meets acceptance criteria. | |
| Biocompatibility | MEM Elution Cytotoxicity (ISO 10993-5) | No biological activity (e.g., Grade 0 cytotoxicity) in specified mammalian cells at 48 hours post exposure; suitability of test system confirmed by controls. | PASS: No cytotoxicity or cell lysis. |
| Guinea Pig Maximization Sensitization (ISO 10993-10) | No reaction at challenge (0% sensitization) following induction phase with specified extracts. | PASS: No evidence of sensitization. | |
| Intracutaneous Reactivity (ISO 10993-10) | Test article sites do not show a significantly greater biological reaction than control sites (e.g., difference of overall mean score = 0.0). | PASS: Non-irritant. | |
| Acute Systemic Injection (ISO 10993-11) | Specified extracts do not induce a significantly greater biological reaction than control extracts in test animals (e.g., no mortality or systemic toxicity). | PASS: No mortality or evidence of systemic toxicity. | |
| Rabbit Pyrogen (ISO 10993-11) | No rabbit injected with test article extract shows an individual rise in temperature of 0.5°C or more. | PASS: Non-pyrogenic. | |
| Hemolysis Extract/Direct Contact Method (ISO 10993-4) | Hemolysis percentage is within acceptable limits (e.g., low percentage above negative control). | PASS: Non-hemolytic (0.17% above negative control via direct, 0.12% via indirect). | |
| In Vitro Hemocompatibility (ISO 10993-4) | Results for WBC, RBC, platelets, hematocrit, and hemoglobin are comparable to the Negative Control (e.g., within specific percentage ranges 89%-105%). | PASS. (Group 1: 89%-98%, Group 2: 97%-103%, Group 3: 100%-105%, Group 4: 98%-105%). | |
| Complement Activation (SC5b-9) (ISO 10993-4) | Concentration of SC5b-9 in test articles is not statistically higher than negative control; not considered potential activator of complement system. | PASS. | |
| Complement Activation (C3a) (ISO 10993-4) | Concentration of C3a in test articles is not statistically higher than negative control; not considered potential activator of complement system. | PASS. | |
| Partial Thromboplastin (PTT) (ISO 10993-4) | Clotting time of test sample is comparable to predicate sample and meets requirements of the test (e.g., considered minimal activators with clotting time >= 90.0% of Negative Control). | PASS. Results comparable to Negative Control. Test articles considered minimal activators with clotting time being 90.0% (catheter) and 92.1% (tubing) of the Negative Control and, therefore, met the requirements of the test. | |
| Shelf Life/Sterility | Shelf Life Testing (Product and Packaging) | Meets established criteria for product and packaging integrity and functionality after 6 months. | Results met established criteria. |
| Sterilization (Ethylene Oxide Residuals) | Ethylene Oxide residuals < 4 mg/device average daily dose. Ethylene Chlorohydrin residuals < 9 mg/device average daily dose (per EN ISO 10993-7 for limited contact delivery system - externally communicating). | EO Results: 2.29 mg/device extracted residuals. Ethylene Chlorohydrin Results: 0.07 mg/device extracted residuals. These are less than the maximum allowed. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document does not specify the exact sample size for each bench test beyond "Prepare sample for test" or "test sample." However, bench tests are inherently prospective, performed on newly manufactured devices. No country of origin for the data is specified, but as the submitter is Stryker Neurovascular in Fremont, California, the testing likely occurred in the USA or through contracted labs.
- Animal Study: The document states "An animal study was conducted... to evaluate performance design attributes... in an acute animal model." The sample size (number of animals) is not specified. The study was conducted "in compliance with applicable requirements in the GLP regulation (21 CFR Part 58)," typically indicative of prospective, controlled studies, likely in the USA.
- Biocompatibility Testing: The document doesn't explicitly state the sample size for each biocompatibility test (e.g., number of replicates for MEM Elution, number of animals for Sensitization tests). However, these are standard biological tests performed on material samples from the device. These tests are prospective. No specific country of origin is listed for the data, but compliance with ISO 10993 implies internationally recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. The studies conducted are primarily bench (in vitro physical and chemical) and animal (in vivo non-human) performance tests, and biocompatibility tests. These types of studies do not typically involve human expert adjudication of "ground truth" in the same way clinical image interpretation or diagnostic performance studies would. The "ground truth" for these tests is based on objective physical measurements, chemical analyses, or biological reactions against established scientific and regulatory standards (e.g., ISO, EN standards, GLP regulations).
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus building among human experts, usually radiologists or clinicians, to establish ground truth in diagnostic studies. The studies presented here (bench, animal, biocompatibility) rely on objective measurements and established protocols rather than human expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone (algorithm only) performance study was done. This question is relevant to AI/software as a medical device, which this device is not.
7. The Type of Ground Truth Used
- Bench Performance Tests: The ground truth is based on objective physical and mechanical measurements, as compared to pre-defined engineering specifications and relevant international standards (e.g., EN ISO 10555-1, EN 1707). For instance, for Dimensional Verification, the truth is the actual measured dimension compared to a design specification. For Tensile Strength, the truth is the force at which failure occurs compared to a minimum required force.
- Animal Study: The ground truth is derived from in vivo physiological observations and assessments of performance design attributes in an acute animal model, conducted under GLP regulations. This includes direct observation of the device's behavior and effects within the animal's neurovascular system.
- Biocompatibility Tests: The ground truth is based on biological reactions and analytical measurements as defined by the specific protocols in ISO 10993 series of standards. For example, for cytotoxicity, the ground truth is the observed cellular response (e.g., cell lysis grade); for pyrogenicity, it's the temperature rise in rabbits; for hemolysis, it's the percentage of red blood cell lysis.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical catheter, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
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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.
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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
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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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| 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 Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977) | |
| Contact: | Rhoda M. SantosPrincipal Regulatory Affairs SpecialistPhone: 510-413-2269Fax: 510-413-2588Email: rhoda.santos@stryker.com | |
| Legally MarketedPredicate 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.
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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 | ReferencePredicate DeviceHD Guide Catheter(DAC®) (K090335) | ReferencePredicate DeviceModified HD GuideCatheter (DAC®)(K110483) | Primary PredicateDeviceModified HD GuideCatheter (DAC®)(K133177) | Subject DeviceAXS Catalyst DistalAccess Catheter | Rationale fordifference (ifapplicable) |
|---|---|---|---|---|---|
| Intended Use /Indications forUse | Indicated for use infacilitating theinsertion andguidance of anocclusion catheter,infusion catheter orother appropriatemicrocatheter intoa selected bloodvessel in theperipheral,coronary or neurovascular systems. Itmay also be used asa diagnosticangiographiccatheter. | Same | The Modified HDGuide Catheter isindicated for usein facilitating theinsertion andguidance of anocclusion catheter,infusion catheteror otherappropriatemicrocatheter intoa selected bloodvessel in theperipheral,coronary andneuro vascularsystems. It mayalso be used as adiagnosticangiographiccatheter and as aconduit forretrieval devices. | The AXS CatalystDistal AccessCatheter isindicated for use infacilitating theinsertion andguidance ofappropriately sizedinterventionaldevices into aselected bloodvessel in theperipheral andneurovascularsystems. The AXSCatalyst DistalAccess Catheter isalso indicated foruse as a conduit forretrieval devices. | Intended Use /Indications for Usereflect userpreferences. AXSCatalyst Catheter isnot intended to bemarketed for use incoronary systemsnor is it intended tobe used as adiagnostic catheter.Bench testing andanimal testing hasdemonstrated thatthe proposedintended use /indications for usedo not affect thesafety andeffectiveness of thedevice. |
| DeviceDescription | The HD GuideCatheter is a single-lumen, braidedshaft, variable | Same | The Modified HDGuide Catheter is asingle-lumen,braided shaft, | The AXS Catalyst™Distal AccessCatheter is a singlelumen, variable | Additionalaccessoriesincluded for ease ofuse |
| Feature | ReferencePredicate DeviceHD Guide Catheter(DAC®) (K090335) | ReferencePredicate DeviceModified HD GuideCatheter (DAC®)(K110483) | Primary PredicateDeviceModified HD GuideCatheter (DAC®)(K133177) | Subject DeviceAXS Catalyst DistalAccess Catheter | Rationale fordifference (ifapplicable) |
| stiffness catheterwith a radiopaquemarker on the distalend and a luer hubon the proximalend. The cathetershaft has ahydrophilic coatingto reduce frictionduring use. Arotation hemostaticside arm adapter isprovided with eachcatheter. | variable stiffnesscatheter withradiopaque markeron the distal endand a luer hub onthe proximal end.The catheter shafthas a hydrophiliccoating to reducefriction during use.Device dimensionsand configurationare shown on theproduct label. Arotating hemostasisvalve with side-armadapter is providedwith each catheter.The rotatinghemostasis valve istypically "y" shapedwith a female luerlock and a manualhemostasis valve.The female portallows foraspiration andcontrast injectionswhile thehemostasis valveallows directarterial accesswhen using otherdevices such asguidewires and/orinterventionaldevices. | stiffness catheterdesigned for use infacilitating theinsertion andguidance ofappropriately sizedinterventionaldevices into theperipheral andneuro vascularsystem. Thecatheter shaft has ahydrophilic coatingto reduce frictionduring use. Thecatheter includes aradiopaque markeron the distal end forangiographicvisualization and aluer hub on theproximal endallowingattachments forflushing andaspiration. It ispackaged with aRotatingHemostastic Valve(RHV) and TuohyBorst valve withsideport forflushing, insertionof catheters andaspiration. The peelaway introducersheaths aredesigned to protectthe distal tip of thecatheter duringinsertion into theRHV or Tuohy Borst. | Bench testing andanimal testing hasdemonstrated thatthe proposedintended use /indications for usedo not affect the | ||
| Feature | ReferencePredicate DeviceHD Guide Catheter(DAC®) (K090335) | ReferencePredicate DeviceModified HD GuideCatheter (DAC®)(K110483) | Primary PredicateDeviceModified HD GuideCatheter (DAC®)(K133177) | Subject DeviceAXS Catalyst DistalAccess Catheter | Rationale fordifference (ifapplicable) |
| AccessoryDevicesProvided(not in directcontact withpatient) | RHV | Same | Same | RHVTuohy Borst Valvewith Sideport(2) Peel AwaySheaths | Additionalaccessoriesincluded for ease ofuse.Bench testing andanimal testing hasdemonstrated thatthe additionalaccessories do notaffect the safetyand effectiveness ofthe device. |
| RegulationNumber | 21CFR 870.1250 | Same | Same | Same | NA |
| RegulationName | PercutaneousCatheter | Same | Same | Same | NA |
| RegulatoryClass | II | Same | Same | Same | NA |
| Product Code | DQY, DQO | Same | Same | DQY | Product codereflects intendeduse / indications foruse |
| Materials | |||||
| Outer Jacket | Pebax | Same | Same | Same with Nylon | Nylon materialadded to meetperformance needsof user.Bench testing andanimal testing hasdemonstrated thatthe additional nylonmaterial does notaffect the safetyand effectiveness ofthe device. |
| Feature | ReferencePredicate DeviceHD Guide Catheter(DAC®) (K090335) | ReferencePredicate DeviceModified HD GuideCatheter (DAC®)(K110483) | Primary PredicateDeviceModified HD GuideCatheter (DAC®)(K133177) | Subject DeviceAXS Catalyst DistalAccess Catheter | Rationale fordifference (ifapplicable) |
| Reinforcement | Stainless Steel | Same | Same | Same with Nitinoland Polymer fiber | Nitinol wire andpolymer fiberadded to meetperformance needsof user.Bench testing andanimal testing hasdemonstrated thatthe additionalnitinol and polymerfiber materials donot affect the safetyand effectiveness ofthe device. |
| Strain Relief | Polyolefin | Same | Same | Thermoplasticrubber | Use ofthermoplasticrubber material isconsistent withother commerciallyavailable StrykerNeurovascularproducts.Bench testing hasdemonstrated thatthe thermoplasticrubber materialdoes not affect thesafety andeffectiveness of thedevice. |
| Inner layer | PTFE | Same | Same | Same | NA |
| Catheter Hub | Pebax | Same | Same | Nylon | Use of nylonmaterial isconsistent withother commerciallyavailable StrykerNeurovascularproducts.Bench testing hasdemonstrated thatthe nylon materialdoes not affect thesafety andeffectiveness of thedevice. |
| Feature | ReferencePredicate DeviceHD Guide Catheter(DAC®) (K090335) | ReferencePredicate DeviceModified HD GuideCatheter (DAC®)(K110483) | Primary PredicateDeviceModified HD GuideCatheter (DAC®)(K133177) | Subject DeviceAXS Catalyst DistalAccess Catheter | Rationale fordifference (ifapplicable) |
| Marker Band | Platinum/Iridium | Same | Same | Same | NA |
| Adhesive | Acrylic (AcrylatedUrethane) | Same | Same | Cyanoacrylate | Use ofcyanoacrylateadhesive isconsistent withother commerciallyavailable StrykerNeurovascularproducts.Bench testing hasdemonstrated thatthe cyanoacrylateadhesive does notaffect the safetyand effectiveness ofthe device. |
| Outer jacketcoating | hydrophilic coating | Same | Same | Same | NA |
| Labeled ShaftOuterDiameter | OD of effectivelength:3.9F, 5.2F | OD of effectivelength:6.3F | Same as predicatedevices, K090335and K114083 | Distal OD: 5.3F, 5.4FProximal OD: 5.6F,6.0F | NA |
| EffectiveLengths | 115 cm, 125 cm,136 cm | 105 cm, 120 cm | Same as predicatedevices, K090335and K114083 | 115 cm, 132 cm | NA |
| PackagingMaterials andConfiguration | Polyethylene Tubeand HDPEPackaging Card | Same | Same | Same | NA |
| SterilizationMethod | 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
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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.
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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 andtechnique of making dimensionalmeasurements using various measurementequipment.Method: Verify dimensions using specifiedmeasurement tool. Record measurements. | Dimensional verificationmeets acceptance criteria. |
| Tip Configuration | Purpose: To verify that the catheter tip issmooth, rounded, tapered or similarlyfinished in order to minimize trauma tovessels during use per EN ISO 10555-1.Method: Visually inspect distal tip at 10Xmagnification to verify distal tip end issmooth, rounded, tapered or similarlyfinished. Record results. | Tip configuration meetsacceptance criteria. |
| Surface Integrity | Purpose: To determine if external surface ofthe catheter is free from extraneous matter,process and surface defects, and does nothave drops of lubricant fluids.Method: Visually inspect external surface ofcatheter for extraneous matter, process andsurface defects, and drops of lubricantfluids. Record results. | Surface integrity meetsacceptance criteria. |
| Tip Buckling | Purpose: To measure the maximum forcerequired to cause a test sample to buckle.Method: Prepare sample for test. Usebuckling tester to measure the maximumforce required to cause a test sample tobuckle. Record results. | Tip buckling meetsacceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Catheter lubricity anddurability | Purpose: To determine the lubricity anddurability of the coating on the catheterouter shaft.Method: Prepare sample for test. Usefriction tester to measure the frictional forceof the device sample when pulled betweentwo clamped pads. Record the peakfrictional force after 5 cycles. | Coating lubricity anddurability meetsacceptance criteria. |
| Trackability | Purpose: To measure track advance force ofcatheter over microcatheter.Method: A neurovascular model is placed ina re-circulating water bath at 37°C tosimulate human arterial circulation. Thesample is inserted through model over amicrocatheter and attached to a tensiletester. Advance catheter through model anddetermine peak tracking force. Recordresults. | Track advance force meetsacceptance criteria. |
| Tensile Strength | Purpose: To determine tensile force tensileforce required to induce failure of fusedjoints, shaft junctions, and marker band fornon-hydratable catheters based on EN ISO10555-1.Method: Identify joint and prepare samplefor test. Use tensile tester to determineapplied peak tensile force. Record results. | Tensile strength meetsacceptance criteria. |
| Liquid Leak Resistance | Purpose:1) To determine whether catheter meetsthe freedom from leakage-liquid leakrequirement 4.7.1 of EN ISO 10555-1.2) To determine if catheter hub meets theliquid leakage requirement 4.2.1 of EN 1707.Method: Connect test hub sample to fixtureand flush with water to expel air. Occludedistal tip. Apply pressure of 300kPaminimum and maintain pressure for 30s.Visually inspect catheter/hub joint andcatheter shaft for leaks. Record results. | Liquid leak resistance ofcatheter meetsacceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Air Leak Resistance | Purpose:1) To determine whether catheter meets thefreedom from leakage-air aspirationrequirement of 4.7.2 of EN ISO 10555-1.2) To determine if catheter hub meets theair leakage requirement 4.2.2 of EN 1707.Method: Connect test hub sample to apartially filled syringe. With the nozzle of thesyringe pointing down towards the ground,withdraw the plunger to the 10cc mark. Holdfor 15 seconds and examine the water in thesyringe for the formation of air bubbles.Record results. | Air leak resistance ofcatheter meetsacceptance criteria. |
| Catheter Torsional BondStrength | Purpose: To measure the strength of acatheter shaft when torque is applied.Torque strength is defined as number ofrotations before failure occurs.Method: Prepare test sample and insert intotorsional bond strength test fixture withtortuous path model. Apply torque tocatheter shaft and observe number of 360-degree rotations before failure occurs.Record results. | Catheter torsional bondstrength meetsacceptance criteria. |
| Flexural Fatigue | Purpose: To determine the flexural fatigueon the catheter shaft.Method: Prepare test sample. Advanceentire assembly of guide wire,microcatheter, and test sample into testmodel and track it through test model.While holding the guide wire, microcatheter,and test sample, pull the whole assemblypack proximally until it exits the models.Repeat for nine more runs. After runnumber ten, remove guide wire andmicrocatheter out of test sample and inspect | Flexural fatigue meetsacceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Catheter Kink Radius | Purpose: To measure the kink radius of acatheter at its distal and specific mid-shaftjoint section. | Catheter kink radius meetsacceptance criteria. |
| Method: Prepare test sample. Thread testsample through fixture loop and lock downtest sample. Pull both ends of test sampleuntil test sample kinks. Calculate kink radiususing measurement of 2nd to final loop ODand sample OD. Record results. | ||
| Catheter Tip and LumenPatency(Adjunctive Aspiration) | Purpose: To test resistance to tip and lumencollapse during adjunctive aspiration andtest tip integrity to tears and missingmaterial. | Catheter tip and lumenpatency during adjunctiveaspiration meetsacceptance criteria. |
| Method: Prepare test sample and simulateduse model. Place test sample in the model toa specified location following proceduralinstructions outlined in the Instructions forUse. Aspirate test sample using 60cc syringe.Visually inspect test sample to verifyindication of no tip or lumen collapsed.Record results. | ||
| Catheter Tip and LumenPatency(with retrieval device) | Purpose: To determine ability of catheter todeliver and withdraw retrieval device 3times when located in a simulated usetortuous path without functional impact andintegrity to the tip. | Catheter tip and lumenpatency meets acceptancecriteria. |
| Method: Prepare test sample and simulateduse model. Place test sample in the model toa specified location following proceduralinstructions outlined in the Instructions forUse. Aspirate test sample using 60cc syringe.Visually inspect test sample to verifyindication of no tip or lumen collapsed.Record results. | ||
| Test | Test Method Summary | Conclusions |
| Chemical Compatibility | Purpose: To determine visual anddimensional integrity of catheter followingexposure to saline, non-ionic and ioniccontrast liquids. | Chemical compatibilitymeets acceptance criteria. |
| Method: Prepare sample for test. Flushsample with appropriate chemical. MeasureID and OD using RAM optical measurementsystem. Insert mandrel through sample toverify inner lumen integrity. Repeat withsecond mandrel and record results. Visuallyinspect distal end of sample for any chemicaleffects on the shaft, inner lumen and cross-sectional areas. Record results. | ||
| Hub Gauging | Purpose: To determine if catheter hubmeets gauging requirement 4.1 of EN 1707.Method: Using the appropriate gauge, thegauge was applied to the conical fitting witha total axial force of 5N without the use oftorque. The axial load was then removedand the sample inspected. | Hub gauging meetsacceptance criteria. |
| Simulated Use | Purpose: To evaluate performance designattributes through user evaluation in an invitro flow model.Method: Simulated use testing uses aneurovascular model that replicates thetortuosity, diameter and location of thearteries in the neurovasculature. The modelincorporates a re-circulating water bath atapproximately 37ºC to simulate the humanarterial circulation and interior core bodytemperature. All testing follows theprocedural instructions outlined in theInstructions for Use. | Simulated use meetsacceptance 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 < 4 mg)
- . Ethylene Chlorohydrin Results: 0.07 mg/device extracted residuals (EN ISO 10993-7 requirement is average daily dose < 9 mg)
Biocompatibility
The AXS Catalyst™ 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.
Based on this classification, tests relevant to the device were selected and conducted in accordance with EN ISO 10993-1 and its applicable sub-parts. The AXS Catalyst Distal Access Catheter, including its packaging, passed all required biocompatibility testing. The results of the biocompatibility testing are summarized in the table below.
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| Test Performed /Applicable ISO 10993Part No. | Results | Conclusion |
|---|---|---|
| MEM ElutionCytotoxicity/Part 5 | No biological activity (Grade 0) wasobserved in the L929 mammalian cells at48 hours post exposure to the test articleextract. The observed cellular responseobtained from the positive control articleextract (Grade 4) and negative controlarticle extract (Grade 0) confirmed thesuitability of the test system. | PASSNo cytotoxicity or celllysis |
| Guinea Pig MaximizationSensitization/Part 10 | The USP 0.9% Sodium Chloride forInjection (NaCl) and Cottonseed Oil (CSO)extracts of the test article elicited noreaction at the challenge (0%sensitization), following an inductionphase. | PASSNo evidence ofsensitization |
| IntracutaneousReactivity/Part 10 | The test article sites did not show asignificantly greater biological reactionthan the sites injected with the controlarticle. The difference of the overall meanscore between the test article and thecontrol article was 0.0. | PASSNon-irritant |
| Acute SystemicInjection/Part 11 | The 0.9% Sodium Chloride for Injection(NaCl) and Cottonseed Oil (CSO) extracts ofthe test article did not induce asignificantly greater biological reactionthan the control extracts, when tested inSwiss Albino mice. | PASSNo mortality or evidenceof systemic toxicity |
| Rabbit Pyrogen / Part 11 | No rabbit injected with the test articleextract showed an individual rise intemperature of 0.5ºC or more. | PASSNon-pyrogenic |
| Test Performed /Applicable ISO 10993Part No. | Results | Conclusion |
| Hemolysis Extract/DirectContact Method/Part 4 | The test article exhibited 0.17% hemolysisabove the level of hemolysis exhibited bythe negative control via the direct methodand 0.12% hemolysis above the level ofhemolysis exhibited by the negativecontrol via the indirect method. | PASSNon-hemolytic |
| In VitroHemocompatibility/Part 4 | Results comparable to the NegativeControl.The test article results for WBC, RBC,platelets, hematocrit and hemoglobinwere:Group 1 89% - 98%Group 2 97% - 103%Group 3 100% - 105%Group 4 98% - 105% | PASS |
| Complement Activation(SC5b-9) /Part 4 | Concentration of SC5b-9 in the testarticles was not statistically higher thanthe negative control. The test articles arenot considered to be potential activatorsof the complement system. | PASS |
| Complement Activation(C3a) /Part 4 | Concentration of C3a in the test articleswas not statistically higher than thenegative control. The test articles are notconsidered to be a potential activator ofthe complement system. | PASS |
| Partial Thromboplastin(PTT) /Part 4 | The test sample and the predicate sampledemonstrated a shortened clotting timewhen compared to the negative control.However, the test sample demonstrated asimilar clotting time when compared tothe predicate sample. | PASSResults were comparableto the Negative Control.Test articles areconsidered minimalactivators with clottingtime being 90.0%(catheter) and 92.1%(tubing) of the NegativeControl and thereforemet the requirements ofthe test. |
Overview of Biocompatibility Studies Performed on the Subject Device
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Summary of Substantial Equivalence
Stryker Neurovascular believes the AXS Catalyst Distal Access Catheters are substantially equivalent to the predicate device (K133177, K110483, K090335) based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same fundamental operating principles. 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.
§ 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).