Who is the manufacturer of AXS Lift Intracranial Base Catheter?

Stryker Neurovascular filed the 510(k) submission for AXS Lift Intracranial Base Catheter (K243593).

What is the FDA product code for AXS Lift Intracranial Base Catheter?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AXS Lift Intracranial Base Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AXS Lift Intracranial Base Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AXS Lift Intracranial Base Catheter

Q: What are the predicate devices for AXS Lift Intracranial Base Catheter?

Benchmark Intracranial Access System (K212838).

K243593 · Stryker Neurovascular · QJP · Feb 18, 2025 · Cardiovascular

Device Facts

Record ID	K243593
Device Name	AXS Lift Intracranial Base Catheter
Applicant	Stryker Neurovascular
Product Code	QJP · Cardiovascular
Decision Date	Feb 18, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The AXS Lift Intracranial Base Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Story

Single lumen, variable stiffness catheter; facilitates insertion/guidance of interventional devices into peripheral and neurovasculature. Features hydrophilic coating for friction reduction, radiopaque distal marker for fluoroscopic visualization, and proximal luer hub. Distal end contains bovine-derived tallow. Used in clinical settings by physicians; inserted via femoral artery access using compatible short introducer sheaths (≥7Fr). Supplied with peel-away introducer sheath and double port rotating hemostasis valve. Device provides a conduit for interventional tools; enables navigation through tortuous anatomy; supports clinical decision-making by allowing delivery of therapeutic/diagnostic devices to target intracranial/peripheral sites.

Clinical Evidence

Bench testing only. No clinical or animal studies conducted. Verification and validation testing included visual inspection, dimensional verification, tensile/torque strength, kink resistance, burst pressure, liquid/air leak, coating integrity, chemical compatibility, particulate testing, radiopacity, tip flexibility, and simulated use in tortuous anatomical models. Biocompatibility testing per ISO 10993-1 confirmed non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, and non-thrombogenic properties.

Technological Characteristics

Single lumen catheter; medical grade plastics and metals; distal end contains bovine-derived tallow. Hydrophilic coating. Dimensions: 95-115 cm length, 0.097" OD, 0.074" ID. Radiopaque distal marker. Sterilized via Ethylene Oxide (SAL 10-6). Complies with EN ISO 10555-1, ISO 10993-1, ISO 80369-7, and ASTM F756/F2382 standards.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Regulatory Classification

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.

Predicate Devices

Benchmark Intracranial Access System (K212838)

Related Devices

K253032 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 11, 2026
K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter · Stryker Neurovascular · Feb 27, 2020
K233205 — Distal Access Catheter · Shanghai Heartcare Medical Technology Co., Ltd. · Dec 22, 2023
K183463 — AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm · Stryker · Mar 13, 2019
K140557 — MIVI 6F GUIDE CATHETER · Mivi, LLC · Sep 18, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | 510(k) Summary: | K243593 | |------------------------|-----------------------------------------------------------------------------------------------------------| | Submitter: | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 Facility 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) | {5}------------------------------------------------ ## 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. {6}------------------------------------------------ | 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 Base Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature. | The Benchmark Intracranial Access System is indicated for the introduction of interventional devices 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 Port Rotating Hemostasis Valve | Benchmark Delivery Catheter sold individually or pre-packaged with Penumbra 5F Select Catheter. | | Catheter Materials | Commonly used medical grade plastics and metals. Distal end contains bovine derived tallow. | Commonly used medical grade plastics 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, Polyethylene Support Tube, Packaging Card, SBS Carton | 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. {7}------------------------------------------------ ## 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 surface defects, hydrophilic coating, and atraumatic tip forming. | Pass | | Dimensional Verification | Verification of critical dimensions. | Pass | | Tensile Strength | Tensile strength measured across full length per EN ISO 10555-1. | Pass | | Torque Strength | The distal end of the catheter was constrained while the proximal end of the catheter was rotated in a tortuous model to verify that the catheter can withstand torsional load. | Pass | | Kink Resistance | Kink resistance was measured for all junctions of the catheter 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 before and after simulated use in a tortuous model. | Pass | | Chemical Compatibility | Catheter was visually inspected before and after exposure to various clinically relevant chemicals. | Pass | | Particulate Testing | Particulate was collected from simulated use in a tortuous model, characterized, and compared to the predicate. | Pass | | Radiopacity | Radiopacity was evaluated under fluoroscopy in an in vitro model with a human skull superimposed. | Pass | | Tip Flexibility | Tip stiffness tested per EN ISO 10555-1 and compared to the predicate. | Pass | | Simulated Use Test | Simulated use in a bench anatomical model using worst-case interventional devices with femoral artery access. | Pass | | Air Leak | Air leak tested per ISO 80369-7 and ISO 10555-1 Pass | | | Liner Lamination | Verification of inner liner adherence following simulated use. | Pass | | | Table 2: Non-Clinical Performance Testing and Results | | |--|-------------------------------------------------------|--| | | | | {8}------------------------------------------------ ## 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 in L929 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 complement system | | ASTM Partial Thromboplastin Time (ISO 10993-4, ASTM F2382) | Pass | No effect on PTT | | In Vitro Blood Flow Loop Assay Thromboresistance Study (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. {9}------------------------------------------------ #### 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.