(90 days)
The AXS Lift Intracranial Base Catheter is introduction of interventional devices into the peripheral and neurovasculature.
The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal 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. The distal end of the catheter contains bovine derived tallow. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.
The provided text, K243593 for the AXS Lift Intracranial Base Catheter, describes the predicate device equivalence testing rather than a study proving the device meets acceptance criteria for an AI/ML algorithm. The document focuses on the mechanical and material performance of a catheter, not the performance of a software algorithm.
Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), cannot be extracted from this document as it does not contain information about an AI/enabled medical device.
The document definitively states on page 9:
"No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."
This reinforces that the approval is based on physical and material device characteristics, not an AI/ML algorithm's performance on clinical data or human-in-the-loop studies.
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February 18, 2025
Stryker Neurovascular Natalie Allen Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K243593
Trade/Device Name: AXS Lift Intracranial Base Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 20, 2024 Received: November 20, 2024
Dear Natalie Allen:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K243593
Device Name
AXS Lift Intracranial Base Catheter
Indications for Use (Describe)
The AXS Lift Intracranial Base Catheter is introduction of interventional devices into the peripheral and neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary: | K243593 |
|---|---|
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Facility Registration # 3008853977 |
| Contact: | Natalie Allen |
| Phone Number: | 956-501-5049 |
| Date Prepared: | January 28, 2025 |
| Device Name: | AXS Lift™ Intracranial Base Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature, 21 CFR 870.1250 |
| Product Codes: | QJP, DQY |
| Device Classification: | Class II |
| Predicate Device: | Benchmark™ Intracranial Access System (K212838) |
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Device Description
The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal 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. The distal end of the catheter contains bovine derived tallow. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.
Accessories
Peel-Away Introducer Sheath Double Port Rotating Hemostasis Valve (RHV)
Indications for Use
The AXS Lift Intracranial Base Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the AXS Lift Intracranial Base Catheter is substantially equivalent to the predicate device (K212838) based on the same intended use and principle of operation, and similar materials and design characteristics. A comparison of the subject device and the predicate device is summarized in Table 1 below.
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| Device Attribute | Subject Device | Predicate Device |
|---|---|---|
| Product Name | AXS Lift Intracranial Base Catheter | Benchmark Intracranial Access System |
| 510(k) Number | K243593 | K212838 |
| Indications for Use | The AXS Lift Intracranial BaseCatheter is indicated for theintroduction of interventionaldevices into the peripheral andneurovasculature. | The Benchmark IntracranialAccess System is indicated for theintroduction of interventionaldevices into the peripheral,coronary, and neuro vasculature. |
| Product Codes | QJP, DQY | SAME |
| Regulation Number | 21 CFR 870.1250 | SAME |
| Classification | Class II | SAME |
| Components Supplied | AXS Lift Intracranial Base Catheter,Peel-Away Introducer, Double PortRotating Hemostasis Valve | Benchmark Delivery Catheter soldindividually or pre-packaged withPenumbra 5F Select Catheter. |
| Catheter Materials | Commonly used medical gradeplastics and metals. Distal endcontains bovine derived tallow. | Commonly used medical gradeplastics and metals. |
| Lubricious Coating | Hydrophilic Coating | SAME |
| Effective Length | 95, 105, 110, 115 cm | 95, 105, 115 cm |
| Outer Diameter | 0.097" (7F) | 0.081-0.083" (6F) |
| Internal Diameter | 0.074" | 0.070" min |
| Radiopaque | Yes | SAME |
| Luer Tapered Hub | Yes | SAME |
| Tip Shapes | Straight | Straight, Multi-Purpose |
| Condition Supplied | Sterile, Single-Use Only | SAME |
| Sterilization | Ethylene Oxide(SAL 10-6) | SAME |
| Shelf Life | 6 months(36 months in process) | 36 months |
| Packaging Materials | Tyvek/Nylon Pouch, PolyethyleneSupport Tube, Packaging Card, SBSCarton | SAME |
Table 1: Comparison of Subject and Predicate Devices
Risk Assessment
Risk assessment of the AXS Lift Intracranial Base Catheter has been conducted in accordance with EN ISO 14971 and Stryker Neurovascular risk management procedures. Stryker Neurovascular has determined that the AXS Lift Intracranial Base Catheter raises no new questions of safety or effectiveness.
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Non-Clinical Performance Testing
The results of verification and validation testing conducted on the subject device demonstrate that it performs as intended and is suitable for its intended use. Specifically, the following tests were performed on the subject device:
| Test | Test Method/Applicable Standard | |
|---|---|---|
| Visual Inspection | Visual inspection per EN ISO 10555-1 for surfacedefects, hydrophilic coating, and atraumatic tipforming. | Pass |
| Dimensional Verification | Verification of critical dimensions. | Pass |
| Tensile Strength | Tensile strength measured across full length per ENISO 10555-1. | Pass |
| Torque Strength | The distal end of the catheter was constrained whilethe proximal end of the catheter was rotated in atortuous model to verify that the catheter canwithstand torsional load. | Pass |
| Kink Resistance | Kink resistance was measured for all junctions of thecatheter using progressively smaller radii. | Pass |
| Burst Pressure | Catheter static burst tested per EN ISO 10555-1. | Pass |
| Liquid Leak Test | Catheter leak tested per EN ISO 10555-1. | Pass |
| Coating Integrity | Hydrophilic coating was visually inspected beforeand after simulated use in a tortuous model. | Pass |
| Chemical Compatibility | Catheter was visually inspected before and afterexposure to various clinically relevant chemicals. | Pass |
| Particulate Testing | Particulate was collected from simulated use in atortuous model, characterized, and compared to thepredicate. | Pass |
| Radiopacity | Radiopacity was evaluated under fluoroscopy in anin vitro model with a human skull superimposed. | Pass |
| Tip Flexibility | Tip stiffness tested per EN ISO 10555-1 andcompared to the predicate. | Pass |
| Simulated Use Test | Simulated use in a bench anatomical model usingworst-case interventional devices with femoral arteryaccess. | Pass |
| Air Leak | Air leak tested per ISO 80369-7 and ISO 10555-1Pass | |
| Liner Lamination | Verification of inner liner adherence followingsimulated use. | Pass |
| Table 2: Non-Clinical Performance Testing and Results | ||
|---|---|---|
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Biocompatibility
The AXS Lift Intracranial Base Catheter is categorized as a limited exposure (<24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1 and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"." All patient contacting components used in the AXS Lift Intracranial Base Catheter have a history of safe clinical use throughout the medical device industry and/or within Stryker Neurovascular and have supporting biocompatibility data. A summary of the biocompatibility evaluation is shown in Table 3 below.
| Test | Results | Conclusion |
|---|---|---|
| Cytotoxicity Study Using the ISO Elution Method inL929 Cells (ISO 10993-5) | Pass | Non-cytotoxic |
| ISO Guinea Pig Maximization Sensitization Study -Extract (ISO 10993-10) | Pass | Non-sensitizing |
| ISO Intracutaneous Reactivity Study - Extract(ISO 10993-23) | Pass | Non-irritant |
| ISO Acute Systemic Toxicity Study - Extract(ISO 10993-11) | Pass | Non-toxic |
| USP Pyrogen Study - Material Mediated(ISO 10993-11, USP <151>) | Pass | Non-pyrogenic |
| ASTM Hemolysis Extract/Direct Contact Method(ISO 10993-4, ASTM F756) | Pass | Non-hemolytic |
| SC5b-9 Complement Activation Assay(ISO 10993-4) | Pass | Non-activator of complementsystem |
| ASTM Partial Thromboplastin Time(ISO 10993-4, ASTM F2382) | Pass | No effect on PTT |
| In Vitro Blood Flow Loop Assay ThromboresistanceStudy (ISO 10993-4) | Pass | Non-thrombogenic |
Table 3: Biocompatibility Tests and Results
Performance Data - Animal, Clinical
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
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Sterilization and Shelf life
The AXS Lift Intracranial Base Catheter and accessories are sterilized with 100% Ethylene Oxide (EO) to a sterility assurance level (SAL) of 10-6. The AXS Lift Catheter and accessories meet the requirements for EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The AXS Lift Catheter and accessories are provided for single use only.
The labeled shelf life for the AXS Lift is 6 months. Shelf-life testing (product and packaging) and distribution shipping challenge conditioning testing were performed on the subject device, and the results met established criteria.
Conclusions
The subject AXS Lift Intracranial Base Catheter is substantially equivalent to the predicate device (K212838) based on the same intended use and principle of operation and similar materials and design characteristics. The conclusions drawn from risk assessment activities demonstrate that the differences do not raise new or different questions of safety or effectiveness. The successful completion of verification and validation, shelf-life, and biocompatibility testing demonstrates that the device performs as intended.
§ 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).