(89 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 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.
The provided document describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the AXS Catalyst 7 Distal Access Catheter to its predicate devices, rather than proving it meets specific acceptance criteria for a new, non-predicate device. The entire submission focuses on establishing substantial equivalence for 510(k) clearance.
Here's an analysis of the provided information, framed around the requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of "acceptance criteria" alongside specific numerical "reported device performance." Instead, for each test, it outlines the "Purpose" (which implicitly defines the acceptance criteria) and a "Conclusion" stating whether the device "meets acceptance criteria" or was "acceptable."
Here's a summary derived from the "Performance Data – Bench Testing" section:
| Test | Acceptance Criteria (Derived from Purpose) | Reported Device Performance/Conclusion |
|---|---|---|
| Dimensional Verification | Verified dimensions using specified measurement tool. | Dimensional verification meets acceptance criteria. |
| Tip Configuration | Catheter tip is smooth, rounded, tapered, or similarly finished to minimize trauma. | Tip configuration meets acceptance criteria. |
| Surface Integrity | External surface free from extraneous matter, defects, and lubricant drops. | Surface integrity meets acceptance criteria. |
| Tip Buckling | Withstand a maximum force before buckling. | Tip buckling meets acceptance criteria. |
| Catheter Lubricity & Durability | Lubricity and durability of the coating on the outer shaft. | Coating lubricity and durability meets acceptance criteria. |
| Particulate Characterization | Acceptable levels of particulates generated during simulated use (≥10µm, ≥25µm, ≥50µm). | Particulate generation was acceptable. |
| Coating Integrity | Visual absence of coating anomalies, defects, or artifacts pre and post-simulated use. | Coating integrity was acceptable. |
| Trackability | Acceptable track advance force of catheter over microcatheter. | Track advance force meets acceptance criteria. |
| Tensile Strength | Withstand tensile force before failure of fused joints, shaft junctions, and marker band. | Tensile strength meets acceptance criteria. |
| Liquid Leak Resistance | Meets freedom from leakage-liquid leak requirement (EN ISO 10555-1, EN 1707). | Liquid leak resistance of catheter meets acceptance criteria. |
| Air Leak Resistance | Meets freedom from leakage-air aspiration requirement (EN ISO 10555-1, EN 1707). | Air leak resistance of catheter meets acceptance criteria. |
| Catheter Torsional Bond Strength | Withstand a specified number of rotations before failure when torque is applied. | Catheter torsional bond strength meets acceptance criteria. |
| Flexural Fatigue | Absence of kinks or damage after repeated advancement and withdrawal through a model. | Flexural fatigue meets acceptance criteria. |
| Catheter Kink Radius | Acceptable kink radius at distal and mid-shaft joint sections. | Catheter kink radius meets acceptance criteria. |
| Catheter Tip and Lumen Integrity (Adjunctive Aspiration) | Ability to deliver and withdraw retrieval device 3 times without negative impact on function/integrity. | Catheter tip and lumen integrity during adjunctive aspiration meets acceptance criteria. |
| Chemical Compatibility | Visual and dimensional integrity after exposure to saline and non-ionic contrast. | Chemical compatibility meets acceptance criteria. |
| Hub Gauging | Meets gauging requirement (EN 1707). | Hub gauging meets acceptance criteria. |
| In-vitro Simulated Use Study | Durability and kink resistance of devices, successful interventional device delivery. | All test samples meet acceptance criteria. (Evaluated subject and primary predicate devices in a tortuous model). |
Biocompatibility Testing (Table 3):
| Test Performed | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| MEM Elution Cytotoxicity | No biological activity (Grade < 2) in L929 mammalian cells at 48 hours post exposure to extract. Test system suitability confirmed by positive and negative controls. | PASS: No biological activity (Grade 0) observed in L929 mammalian cells at 48 hours. Test article met requirements. Positive control (Grade 4) and negative control (Grade 0) confirmed suitability. |
| Hemolysis Extract/Direct Contact | Exhibited < 2% hemolysis above the negative control level via direct and indirect methods. | PASS: 0.0% hemolysis above negative control via direct and indirect methods. |
| USP Physiochemical <661> | Non-volatile residue: ≤ 10 mg; residue on ignition: ≤ 1 mg; heavy metal: ≤ 1 ppm; buffering capacity: ≤ 1.0 ml. | PASS: Non-volatile residue: 7 mg; Residue on ignition: < 1 mg; Heavy metal: < 1 ppm; Buffering capacity: < 1.0 ml. |
| Chemistry (Heptane) Analysis | Chemical compounds below level of detection. | PASS: Below level of detection. |
| FTIR | Scan conducted to establish baseline. Implies chemical composition is consistent and referenceable. | PASS: Scan conducted to establish baseline for the AXS Catalyst 7 Distal Access Catheter device. |
| Natural Rubber Latex ELISA | Latex antigenic protein below level of detection. | PASS: Below level of detection. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact numerical sample sizes for each bench test conducted. It generally refers to "sample" or "test sample."
- Bench Testing: The methods described ("Prepare sample for test," "Insert sample") suggest individual samples were tested per criteria. No specific number (e.g., n=3, n=5) is given for any test.
- Animal Study: An animal study was conducted. No sample size (number of animals) is provided.
- Data Provenance: All testing appears to be prospective bench and animal testing conducted by Stryker Neurovascular. No country of origin is explicitly stated for the testing data, but the company address is in Fremont, California, USA, implying the studies were likely conducted in the USA or supervised by the US entity.
- Retrospective/Prospective: All described studies are prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Bench Testing: For most bench tests, "ground truth" is typically an objective measurement against a standard or specification. Human interpretation is minimal for these.
- In-vitro Simulated Use Study: This study involved "multiple physician users." No specific number of physicians is given, nor are their qualifications (e.g., specialty, years of experience). Their role was to perform simulated procedures and evaluate device performance.
- Animal Study: The study evaluated "navigation safety" in clinically relevant vessel sizes, likely involving veterinary or medical experts for assessment, but no details are provided on their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any formal adjudication method (like 2+1, 3+1 consensus) for establishing ground truth within the described studies. The bench tests rely on objective measurements and visual inspections. The "In-vitro Simulated Use Study" likely involved expert user feedback, but no formal adjudication process is outlined.
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
- MRMC Study: No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or mentioned. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a primary component of performance. The AXS Catalyst 7 is a physical medical device (catheter) for interventional procedures, not an AI diagnostic tool.
- AI Assistance: There is no mention of AI assistance in the context of this device or its studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned, as this device is a physical catheter and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Ground truth for bench tests is based on objective physical measurements and adherence to engineering specifications and international standards (e.g., EN ISO 10555-1, EN 1707).
- In-vitro Simulated Use Study: Ground truth here would be the successful completion of simulated procedures, device durability, and kink resistance as observed by "multiple physician users." This is effectively expert observation and anecdotal feedback within a simulated environment.
- Animal Study: Ground truth would be the observed "navigation safety" and lack of adverse events in live animal models, determined by veterinary and/or medical experts.
- Biocompatibility: Ground truth involved laboratory analysis against established biological safety standards (e.g., ISO 10993 series) and specific test methodologies (e.g., cytotoxicity, hemolysis assays).
8. The sample size for the training set
This question 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 question is not applicable, as there is no training set for this device.
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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
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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
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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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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 Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977) |
|---|---|
| Contact: | Germaine FuAssociate Project Manager, Regulatory AffairsPhone: 510-413-2862Fax: 510-413-2588Email: 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 |
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| 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 SubjectDevice | Primary PredicateDevice | Additional PredicateDevice |
| AXS Catalyst 7 DistalAccess Catheter | AXS Catalyst 5 and6 Distal AccessCatheter | React 68 Catheter | |
| Manufacturer | Stryker Neurovascular | StrykerNeurovascular | Micro Therapeutics,Inc. d/b/a ev3Neurovascular |
| 510(k) Number | K183463 | K151667 | K180715 |
| Device TradeName | AXS Catalyst® 7 DistalAccess Catheter | AXS Catalyst® 5and 6 Distal AccessCatheter | React™ 68 Catheter |
| RegulationNumber | 21 CFR 870.1250 | Same | Same |
| RegulationName | Percutaneous Catheter | Same | Same |
| Classification | II | Same | Same |
| Product Code | DQY | Same | Same |
| IntendedUse/Indicationfor Use | The AXS Catalyst DistalAccess Catheter isindicated for use infacilitating the insertionand guidance ofappropriately sizedinterventional devicesinto a selected bloodvessel in the peripheraland neurovascularsystems. The AXSCatalyst Distal AccessCatheter is alsoindicated for use as aconduit for retrievaldevices. | Same | The React™ 68 Catheteris indicated for theintroduction ofinterventional devicesinto the peripheral andneuro 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 SubjectDevice | Primary PredicateDevice | Additional PredicateDevice |
| AXS Catalyst 7 DistalAccess Catheter | AXS Catalyst 5 and6 Distal AccessCatheter | React 68 Catheter | |
| designed with ahydrophilic coating. | |||
| AccessoryDevicesProvided (not indirect contactwith patient) | Rotating HemostasisValve, Tuohy BorstValve with Sideport, (2)Peel-Away IntroducerSheaths | Same | Peelable Sheath,Rotating HemostasisValve |
| Outer Jacket | Pebax with Nylon,Tecoflex | Same | Grilamid, Pebax |
| Reinforcement | Nitinol wire andpolymer fiber | Stainless steel,Nitinol wire, andpolymer fiber | Nitinol |
| Strain Relief | Thermoplastic rubber(Polyolefin) | Thermoplasticrubber(Santoprene) | DynaFlex |
| Inner Layer | PTFE | Same | Same |
| Catheter Hub | Nylon | Same | Trogamid |
| Marker Band | Platinum/Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Outer JacketCoating | Hydrophilic Coating | Same | Same |
| Labeled ShaftOuter Diameter | Distal OD: 6.2F (0.082in.)Proximal OD: 6.3F(0.0825 in.) | Distal OD:CAT 5: 5.3F (0.0696in.)CAT 6: 5.4F (0.0709in.)Proximal OD: | Distal OD: 0.083 inProximal 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 | 115cm125cm132cm | CAT 5: 115cm,132cmCAT 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 facilitatethe introduction of theAXS Catalyst Catheter tipinto the sheath/guidecatheter valve. Once thecatheter is inserted, thepeel away sheath can beremoved. Underfluoroscopic guidance,the catheter can beadvanced through thevasculature to thedesired location. Oncethe catheter is at thedesired location,appropriately sizedinterventional devicesmay be inserted into theselected blood vessel. Ifused with a retriever,aspiration may beapplied to the catheterusing a 60mL syringeduring withdrawal of theretrieval device, untilthe retriever andmicrocatheter arewithdrawn from thecatheter | accessories andinfusion of liquidsthrough 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.
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The differences between the devices are not critical as demonstrated above and through the testing referenced below.
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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 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. |
| Table 2: Performance Data - Bench Testing | ||
| Test | Test Method Summary | Conclusions |
| 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. |
| 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 over 5 cycles. | Coating lubricity anddurability meetsacceptance criteria. |
| Particulatecharacterization | Purpose: To evaluate particulates per theFDA Guidance Document: Class II SpecialControls for Certain PercutaneousTransluminal Coronary Angioplasty(PTCA) Catheters.Method: Use light obscuration particlecounting to measure the total number ofparticulates generated during simulateduse in each of three size ranges: ≥ 10µm, ≥ 25 µm, and ≥ 50 µm. | Particulate generationwas acceptable. |
| Table 2: Performance Data - Bench Testing | ||
| Test | Test Method Summary | Conclusions |
| Coating integrity | Purpose: To evaluate coating consistencypre and post simulated use.Method: Visually inspect for coatinganomalies, defects or artifacts pre andpost simulated use using a simulated invitro test model. | Coating integrity wasacceptable. |
| Trackability | Purpose: To measure track advance force ofcatheter over microcatheter.Method: Place neurovascular model in a re-circulating water bath at 37°C to simulatehuman arterial circulation. Insert sample,attached to a motor drive assembly, throughmodel over a microcatheter. Advancecatheter through model and determine peaktracking force. Record results. | 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. |
| Table 2: Performance Data - Bench Testing | ||
| 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 ofthe syringe pointing down towards theground, withdraw the plunger to the 10ccmark. Hold for 15 seconds and examinethe water in the syringe for the formationof 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 assemblyback proximally until it exits the models.Repeat for nine more runs. After runnumber ten, remove guide wire andmicrocatheter out of test sample and inspectsample for kink or damage. Record results. | Flexural fatigue meetsacceptance 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 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 LumenIntegrity(Adjunctive Aspiration) | Purpose: To determine ability of catheter todeliver and withdraw retrieval device 3times when located in a simulated usetortuous path without negative impact tofunction and integrity to the tip. | Catheter tip and lumenintegrity 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. Deliver retrieval device. Aspirate testsample using 60cc syringe during retrievaldevice withdrawal. Visually inspect testsample to verify absence of no tip or lumencollapse. Record results. | |||||
| Chemical Compatibility | Purpose: To determine visual anddimensional integrity of catheter followingexposure to saline and non-ionic contrastliquids. | 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. |
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| Table 2: Performance Data - Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Conclusions |
| Hub Gauging | Purpose: To determine if catheter hubmeets gauging requirement 4.1 of EN 1707.Method: Using the appropriate gauge, applygauge to the conical fitting with a total axialforce of 5N without use of torque. Removeaxial load and inspect sample. | Hub gauging meetsacceptance criteria. |
| Design Validation Testing | ||
| In-vitro Simulated Use Study | Purpose: To evaluate interventional devicedelivery, and the durability and kinkresistance of the Subject and PrimaryPredicate devices in a tortuous anatomicalmodel with multiple physician users.Method: Perform a simulated interventionalprocedure and track the devices to thetarget site for interventional device deliveryusing a neurovascular model that replicatesthe tortuosity, diameter and location of thearteries in the neurovasculature. | All test samples meetacceptance 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 PartNo. | Results | Conclusion | ||
| MEM ElutionCytotoxicity/Part 5 | No biological activity (Grade 0) was observed inthe L929 mammalian cells at 48 hours postexposure to the test article extract. The testarticle met the requirements of the test since thegrade was less than grade 2.The observed cellular response obtained from thepositive control article extract (Grade 4) andnegative control article extract (Grade 0)confirmed the suitability of the test system. | PASSNo cytotoxicity orcell lysis | ||
| Hemolysis Extract/DirectContact Method/Part 4 | The test article exhibited 0.0% hemolysis abovethe level of hemolysis exhibited by the negativecontrol via the direct method and 0.0% hemolysisabove the level of hemolysis exhibited by thenegative control via the indirect method. | PASSNon-hemolytic | ||
| USP Physiochemical <661>/ Part 18 | Non-volatile residue: 7 mgResidue on ignition: < 1 mg | PASS |
The results of the biocompatibility testing are summarized in Table 3 below.
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| Table 3: Overview of Biocompatibility Studies Performed on the Subject Device | ||||
|---|---|---|---|---|
| Test Performed /Applicable ISO 10993 PartNo. | Results | Conclusion | ||
| Heavy metal: < 1 ppmBuffering capacity: < 1.0 ml | ||||
| Chemistry (Heptane)Analysis | Below level of detection | PASS | ||
| FTIR (ISO 10993-18) | Scan was conducted to establish baseline for theAXS Catalyst 7 Distal Access Catheter device. | PASS | ||
| Natural Rubber LatexELISA Inhibition Assay forAntigenic Protein ASTMD6499-12 | Below level of detection | PASS |
Conclusion
Stryker Neurovascular has demonstrated the AXS Catalyst 7 Distal Access Catheter is substantially equivalent to the Predicate devices (K151667 and K180715) based on same intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from risk assessments, the bench testing conducted using the Subject device compared to the Primary Predicate device, and an animal safety study demonstrate that the subject device is suitable for the indication for use with the associated DQY Product Code. Additionally, the testing results summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.
Stryker Neurovascular has demonstrated that the AXS Catalyst 7 Distal Access Catheter is as safe, as effective, and performs as well as the legally marketed Predicate devices.
§ 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).