AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm

Q: Who is the manufacturer of 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 filed the 510(k) submission for AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm (K183463).

Q: What is the FDA product code for AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm?

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

Q: What is the regulatory pathway for AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm?

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

Q: What are the predicate devices for AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm?

AXS Catalyst Distal Access Catheter (K151667); React™ 68 Catheter (K180715).

Q: Who can help prepare an FDA 510(k) submission like AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm?

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.

K183463 · Stryker · DQY · Mar 13, 2019 · Cardiovascular

Device Facts

Record ID	K183463
Device Name	AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
Applicant	Stryker
Product Code	DQY · Cardiovascular
Decision Date	Mar 13, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended 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.

Device Story

Sterile, single-lumen, variable-stiffness catheter; used to facilitate insertion/guidance of interventional devices into peripheral/neurovascular vessels; serves as conduit for retrieval devices. Operated by physicians trained in interventional endovascular procedures. Advanced over guidewire/microcatheter under fluoroscopic guidance. Features hydrophilic coating for friction reduction, radiopaque distal marker for visualization, and proximal luer hub for flushing/aspiration. Includes peel-away introducer sheaths, rotating hemostasis valve, and Tuohy Borst valve. Aspiration via 60mL syringe possible during retrieval device withdrawal. Benefits include improved access to target vasculature and support for interventional procedures.

Clinical Evidence

No clinical study conducted. Evidence consists of bench testing (dimensional verification, tip buckling, lubricity, particulate characterization, trackability, tensile strength, leak resistance, torsional bond strength, flexural fatigue, kink radius) and an animal study evaluating navigation safety. All testing met acceptance criteria.

Technological Characteristics

Single-lumen, variable-stiffness catheter. Materials: Pebax, Nylon, Tecoflex, Nitinol wire, polymer fiber, PTFE liner, Platinum/Iridium marker band. Hydrophilic coating. Dimensions: 115-132cm length, 6.2F-6.3F OD, 0.068" ID. Sterilization: 100% Ethylene Oxide. Standards: EN ISO 10555-1, EN 1707, EN ISO 10993-1.

Indications for Use

Indicated for patients requiring interventional device insertion and guidance into peripheral and neurovascular blood vessels, or as a conduit for retrieval devices.

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

AXS Catalyst Distal Access Catheter (K151667)
React™ 68 Catheter (K180715)

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K190833 — AXS Vecta Aspiration Catheter · Stryker Neurovascular · Dec 15, 2019

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 U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 13, 2019 Stryker Neurovascular Germaine Fu. PhD Associate Project Manager, Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538 Re: K183463 Trade/Device Name: AXS Catalyst Distal Access Catheter (AXS Catalyst 7) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 13, 2018 Received: December 14, 2018 Dear Germaine Fu, PhD: We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to Mav 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Xiaolin Zheng Lin Zheng -s Date: 2019.03.13 11:43:51 -04'00' for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183463 Device Name AXS Catalyst Distal Access Catheter (AXS Catalyst 7) Indications for Use (Describe) The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ # 510(k) Summary K183463 #### Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence. # Submitter Name, Address and Content: | Submitter: | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538-6515 (FDA Registration Number: 3008853977) | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Germaine Fu Associate Project Manager, Regulatory Affairs Phone: 510-413-2862 Fax: 510-413-2588 Email: germaine.fu@stryker.com | | Date Prepared: | December 13, 2018 | | Device Name and Classification: | | | Trade/Proprietary Name: | AXS Catalyst Distal Access Catheter (AXS Catalyst 7) | | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | | Product Code: | DQY | {4}------------------------------------------------ | Legally Marketed | Primary Predicate Device | Additional Predicate Device | | |-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate | AXS Catalyst Distal Access Catheter (K151667) | React™ 68 Catheter (K180715) | | | Device(s): | | | | | Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | | | Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device | | | AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 Catheter | | Manufacturer | Stryker Neurovascular | Stryker Neurovascular | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | | 510(k) Number | K183463 | K151667 | K180715 | | Device Trade Name | AXS Catalyst® 7 Distal Access Catheter | AXS Catalyst® 5 and 6 Distal Access Catheter | React™ 68 Catheter | | Regulation Number | 21 CFR 870.1250 | Same | Same | | Regulation Name | Percutaneous Catheter | Same | Same | | Classification | II | Same | Same | | Product Code | DQY | Same | Same | | Intended Use/Indication for Use | The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices. | Same | The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | | Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | | | Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device | | | AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 Catheter | | Device Description | The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. | Same | The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 68 Catheter is | | Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | | | Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device | | | AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 Catheter | | | | | designed with a hydrophilic coating. | | Accessory Devices Provided (not in direct contact with patient) | Rotating Hemostasis Valve, Tuohy Borst Valve with Sideport, (2) Peel-Away Introducer Sheaths | Same | Peelable Sheath, Rotating Hemostasis Valve | | Outer Jacket | Pebax with Nylon, Tecoflex | Same | Grilamid, Pebax | | Reinforcement | Nitinol wire and polymer fiber | Stainless steel, Nitinol wire, and polymer fiber | Nitinol | | Strain Relief | Thermoplastic rubber (Polyolefin) | Thermoplastic rubber (Santoprene) | DynaFlex | | Inner Layer | PTFE | Same | Same | | Catheter Hub | Nylon | Same | Trogamid | | Marker Band | Platinum/Iridium | Same | Same | | Adhesive | Cyanoacrylate | Same | Same | | Outer Jacket Coating | Hydrophilic Coating | Same | Same | | Labeled Shaft Outer Diameter | Distal OD: 6.2F (0.082 in.) Proximal OD: 6.3F (0.0825 in.) | Distal OD: CAT 5: 5.3F (0.0696 in.) CAT 6: 5.4F (0.0709 in.) Proximal OD: | Distal OD: 0.083 in Proximal OD: 0.083 in | | Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device | | | AXS Catalyst 7 Distal Access Catheter | AXS Catalyst 5 and 6 Distal Access Catheter | React 68 Catheter | | | | CAT 5: 5.6F (0.0735 in.) CAT 6: 6.0F (0.0787 in.) | | | Effective Lengths | 115cm 125cm 132cm | CAT 5: 115cm,132cm CAT 6: 132cm | 132cm | | Distal ID | 0.068 in. | CAT 5: 0.058 in. CAT 6: 0.060 in. | Same | | Proximal ID | 0.068 in. | CAT 5: 0.058 in. CAT 6: 0.060 in. | Same | | Packaging Materials and Configuration | Polyethylene Tube and HDPE Packaging Card | Same | Polyethylene Packaging Card and Hoop | | Sterilization Method | EO Sterilization | Same | Same | | How Supplied | Single Use/Sterile | Same | Same | | Principles of Operation | The AXS Catalyst Distal Access Catheter is advanced into the neuro vasculature by a physician trained in interventional endovascular procedures using a compatible sheath or guide catheter, and over an appropriately sized guide wire. A peel away sheath is provided in the package to provide | Same | The catheter is introduced through a guide catheter or femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire and/or microcatheter. The proximal end of the catheter has a luer fitting to allow attachment of | | Table 1: Product Feature Comparison of Subject Device to Predicate Devices | | | | | Detail | Submission Subject Device | Primary Predicate Device | Additional Predicate Device | | | AXS Catalyst 7 Distal Access Catheter…