(340 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a catheter, with no mention of AI or ML.
No.
This device is described as a catheter used to facilitate the insertion and guidance of interventional devices and for use as a conduit for retrieval devices, rather than directly treating a disease or condition.
No
This device is an intermediate catheter used for guiding and inserting interventional devices, and as a conduit for retrieval devices in the neurovascular system. It facilitates procedures, but it does not diagnose medical conditions.
No
The device description clearly outlines physical components like a catheter shaft, radiopaque marker band, Luer hub, and hydrophilic coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the insertion and guidance of interventional devices into blood vessels and to act as a conduit for retrieval devices. This is a therapeutic or interventional use, not a diagnostic one.
- Device Description: The description details a catheter used for physical access and delivery within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Input Imaging Modality: Fluoroscopic guidance is used to visualize the placement of the device within the body, which is typical for interventional procedures, not for analyzing samples.
- Performance Studies: The performance studies focus on the physical properties and functionality of the catheter (torque, ID, burst pressure, particulate generation) and its ability to facilitate the delivery of other devices. They do not involve the analysis of biological samples or the generation of diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Internediate Catheter is also indicated for use as a conduit for retrieval devices.
Product codes (comma separated list FDA assigned to the subject device)
OJP
Device Description
The AXS Vecta 46 Intermediate Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 46 Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal 25cm) to reduce friction during use. It is packaged with one hemostasis valve, and one peel-away introducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovascular system, blood vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician trained in interventional endovascular procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Simulated Use (Torque, ID, Product Compatibility):
- Purpose: to provide objective evidence that test catheter meets applicable user needs: the introduction of interventional devices into the neuro vasculature.
- Method: Perform a simulated thrombectomy procedure. Track the devices to the target site for endovascular device delivery using a neurovascular in vitro model that replicates the vascular characteristics of human ICA and MCA arteries.
- Conclusions: All test samples met the applicable user needs and design specifications.
- Burst Testing:
- Purpose: to measure the maximum static burst pressure of AXS Vecta 46 Intermediate Catheter and to ensure the device can withstand the pressures that may be generated with manual delivery of contrast media after simulated delivery of the most clinically challenging interventional device.
- Method: Testing was conducted on conditioned AXS Vecta 46 units. The catheter was connected via its hub or proximal end to a pressure generating device. Fluid was applied at a constant rate until product leak or burst while device pressure was monitored.
- Conclusions: All test samples met the applicable user needs and acceptance criteria.
- Supplemental Confirmatory Particulate Testing:
- Purpose: The purpose of this test was to document and assess the particulate matter generated from the delivery of neuro-interventional devices through the inner lumen of the AXS Vecta 46 Intermediate Catheter.
- Method: Particulate testing was conducted with AXS Vecta 46 in a simulated use condition based on the device IFU and a clinically relevant tortuous model.
- Conclusions: All test samples met the applicable user needs and acceptance criteria.
Animal Study:
- The Simulated Use-Animal testing is focused on the safety and efficacy of the device and was performed to support the previously cleared AXS Vecta 46 Intermediate Catheter as part of the system and can be found in K190338 (cleared as 046 Zenith Flex). Although the addition of the QJP product code will expand the use of the device, the "worst case" use of the device in terms of safety and efficacy is as a Thrombectomy System; therefore, Simulated Use-Animal testing is leveraged to support the QJP product code.
Clinical Study:
- No clinical study was conducted as bench testing was determined sufficient for validation purposes.
Shelf Life Testing:
- The labeled shelf life for the AXS Vecta® 46 Intermediate Catheter is three years. Shelf life testing was performed on the Reference device and the results met the established acceptance criteria. Testing results were reviewed and cleared in K190338 Zenith Flex Aspiration System (046 Zenith Flex Catheter). Additionally, particulate testing and subsequent analysis between the Predicate and Subject devices confirmed that shelf-life was not impacted by the addition of the QJP product code.
Sterilization Testing:
- Sterilization testing was performed on the Reference device and the results met the established acceptance criteria. Testing results leveraged from the Reference device were reviewed and cleared in K190338, Zenith Flex Aspiration System (046 Zenith Flex Catheter).
- The AXS Vecta 46 Intermediate Catheter and all system components are currently sterilized with 100% Ethylene Oxide and provided sterile. A sterility assurance level (SAL) of 10° has been demonstrated. The AXS Vecta 46 Intermediate Catheter and all system components are for single use only.
Biocompatibility:
- The AXS Vecta 46 Intermediate Catheter is identical to the catheter component in the Reference device cleared under K190338, Zenith Flex Aspiration System (046 Zenith Flex Catheter). No catheter materials are changing; therefore, biocompatibility is not impacted by the addition of the OJP product code. The completed biocompatibility testing was used to support the biocompatibility of the Subject device.
- The AXS Vecta 46 Intermediate Catheter was assessed for biocompatibility in accordance with 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
August 27, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Neurovascular Shivani Patel Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K202752
Trade/Device Name: AXS Vecta 46 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP Dated: July 23, 2021 Received: July 26, 2021
Dear Shivani Patel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 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
1
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/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 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 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-regulatoryassistance/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,
Xiaolin Zheng -S
Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202752
Device Name AXS Vecta 46 Intermediate Catheter
Indications for Use (Describe)
The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Internediate 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) |
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 K202752
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: | Shivani Patel
Senior Staff Regulatory Affairs Specialist
Phone: 341-465-2199
Email: shivani.patel2@stryker.com |
| Date Prepared: | August 24, 2021 |
| Device Name and Classification: | Trade/Proprietary Name: AXS Vecta® 46 Intermediate Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | QJP |
4
| Legally Marketed
Predicate
| Devices: | Predicate Devices | Reference Device | |
|---|---|---|---|
| AXS Vecta Intermediate | |||
| Catheter (K190833) | Zenith Flex Aspiration | ||
| System (046 Zenith Flex | |||
| Catheter) (K190338) | |||
| Detail | Submission Subject | ||
| Device | Predicate Device | Reference Device | |
| Manufacturer | Stryker Neurovascular | Stryker Neurovascular | Stryker Neurovascular |
| 510(k) Number | K202752 | K190833 | K190338 |
| Device Trade | |||
| Name | AXS Vecta 46 | ||
| Intermediate Catheter | AXS Vecta Intermediate | ||
| Catheter | Zenith Flex Aspiration | ||
| System (046 Zenith Flex | |||
| Catheter) | |||
| Regulation | |||
| Number | 21 CFR 870.1250 | Same | Same |
| Regulation | |||
| Name | Percutaneous Catheter | Same | Same |
| Classification | II | Same | Same |
| Product Code | QJP | DQY | NRY |
| Intended | |||
| Use/Indication | |||
| for Use | The AXS Vecta | ||
| Intermediate | |||
| Catheter is indicated | |||
| for use in | |||
| facilitating the | |||
| insertion and | |||
| guidance of | |||
| appropriately sized | |||
| interventional | |||
| devices into a | |||
| selected blood | |||
| vessel in the | |||
| neurovascular | |||
| system. The AXS | |||
| Vecta Intermediate | |||
| Catheter is also | |||
| indicated for use as | |||
| a conduit for | |||
| retrieval devices. | The AXS Vecta | ||
| Intermediate 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 | |||
| Vecta Intermediate | |||
| Catheter is also | |||
| indicated for use as a | |||
| conduit for retrieval | |||
| devices. | The Zenith Flex | ||
| Aspiration System, | |||
| including the 046 Zenith | |||
| Flex Aspiration Catheter, | |||
| Aspiration Tubing Set, | |||
| and VC-701 Cliq | |||
| Aspirator Pump, is | |||
| indicated in the | |||
| revascularization of | |||
| patients with acute | |||
| ischemic stroke | |||
| secondary to intracranial | |||
| large vessel occlusive | |||
| disease (within the | |||
| internal carotid, middle | |||
| cerebral – M1 and M2 | |||
| segments, basilar, and | |||
| vertebral arteries) within | |||
| 8 hours of symptom | |||
| onset. Patients who are | |||
| ineligible for intravenous | |||
| tissue plasminogen | |||
| activator (IV t-PA) or | |||
| who failed IV t-PA | |||
| therapy are candidates | |||
| for treatment. | |||
| Device | |||
| Description | The AXS Vecta 46 | ||
| Intermediate Catheter | |||
| is advanced into the | The AXS Vecta | ||
| Intermediate Catheter is | |||
| advanced into the | The InNeuroCo 046 | ||
| Zenith Flex Catheter is a | |||
| variable stiffness catheter | |||
| neurovasculature by a | |||
| physician trained in | |||
| interventional | |||
| endovascular | |||
| procedures using a | |||
| compatible sheath or | |||
| guide catheter, and | |||
| over an appropriately | |||
| sized microcatheter or | |||
| guide wire. One peel- | |||
| away introduce sheath | |||
| is provided in the | |||
| package to provide | |||
| support and facilitate | |||
| the introduction of the | |||
| AXS Vecta 46 | |||
| Intermediate Catheter | |||
| tip into the | |||
| sheath/guide catheter | |||
| valve. Once the | |||
| assembly is inserted, | |||
| the peel-away | |||
| introducer sheath can | |||
| be removed. Under | |||
| fluoroscopic guidance, | |||
| the assembly can be | |||
| advanced through the | |||
| vasculature to the | |||
| desired location. | neurovasculature by a | ||
| physician trained in | |||
| interventional | |||
| endovascular | |||
| procedures using a | |||
| compatible sheath or | |||
| guide catheter, and over | |||
| an appropriately sized | |||
| microcatheter, guide | |||
| wire, and/or the Scout | |||
| Introducer. Two peel- | |||
| away introducer sheaths | |||
| are provided in the | |||
| package to provide | |||
| support and facilitate | |||
| the introduction of the | |||
| AXS Vecta Intermediate | |||
| Catheter tip into the | |||
| sheath/guide catheter | |||
| valve. Once the | |||
| assembly is inserted, the | |||
| peel-away introducer | |||
| sheath can be removed. | |||
| Under fluoroscopic | |||
| guidance, the assembly | |||
| can be advanced | |||
| through the vasculature | |||
| to the desired location. | that has a catheter shaft | ||
| reinforced with Nitinol to | |||
| provide support. The | |||
| proximal section has an | |||
| embedded nitinol flat | |||
| wire cross coil that | |||
| transitions to a nitinol | |||
| round wire single coil in | |||
| the distal end. It has a | |||
| radiopaque | |||
| Platinum/Iridium marker | |||
| band on the distal end. | |||
| The 046 Zenith Flex | |||
| Catheter is available with | |||
| an internal diameter of | |||
| 0.046 inches. The outer | |||
| diameter is 0.058 inches | |||
| along the proximal shaft | |||
| and 0.056 inches at the | |||
| distal tip. The 046 Zenith | |||
| Flex Catheter is available | |||
| in two working lengths: | |||
| 153 cm, and 160 cm. The | |||
| 046 Zenith Flex Catheter | |||
| has a PTFE-lined lumen | |||
| to reduce friction as it | |||
| travels over a guidewire. | |||
| Accessories included | |||
| with the device are a | |||
| Tuohy-Borst Hemostasis | |||
| Valve and peel-away | |||
| introducer. | |||
| Accessory | |||
| Devices | |||
| Provided (not in | |||
| direct contact | |||
| with patient) | Hemostasis Valve, | ||
| 1 Peel-Away | |||
| Introducer | Hemostasis Valve, | ||
| 2 Peel-Away | |||
| Introducers, | |||
| Scout Introducer | Same as Subject device | ||
| Outer Jacket | Polymeric catheter | Same | Same |
| Reinforcement | Nitinol | Stainless Steel/Nitinol | Same as Subject |
| device | |||
| Strain Relief | Polyolefin | Same | Same |
| Inner Layer | PTFE | Same | Same |
| Catheter Hub | Polycarbonate | Same | Same |
| Marker Band | Platinum/Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Outer Jacket | |||
| Coating | Hydrophilic Coating | Same | Same |
| Labeled Shaft | |||
| Outer Diameter | Distal OD: 0.056 in | ||
| Proximal OD: 0.058in | Distal OD: | ||
| Vecta 71: 0.082 in. | |||
| Vecta 74: 0.083 in. | |||
| Proximal OD: | |||
| Vecta 71: 0.085 in. | |||
| Vecta 74: 0.087 in. | Same as Subject device | ||
| Effective | |||
| Lengths | 125, 146, 153, 160 cm | 115, 125, 132 cm | 153, 160 cm |
| Distal ID | 0.046 in. | Vecta 71: 0.071 in. | |
| Vecta 74: 0.074 in. | Same as Subject device | ||
| Proximal ID | 0.046 in. | Vecta 71: 0.071 in. | |
| Vecta 74: 0.074 in. | Same as Subject device | ||
| Packaging | |||
| Materials & | |||
| Configuration | Tyvek/Nylon Pouch, | ||
| polyethylene support | |||
| tube, packaging card, | |||
| SBS carton | Tyvek/Nylon Pouch, | ||
| polyethylene support | |||
| tube, packaging card, | |||
| SBS carton | Same as Subject device | ||
| Sterilization | |||
| Method | EO Sterilization | Same | Same |
| How Supplied | Single Use/Sterile | Same | Same |
| Principles of | |||
| Operation | The AXS Vecta 46 | ||
| Intermediate Catheter | |||
| is advanced into the | |||
| neurovasculature by a | |||
| physician trained in | |||
| interventional | |||
| endovascular | |||
| procedures using a | |||
| compatible sheath or | |||
| guide catheter, and | |||
| over an appropriately | |||
| sized microcatheter, or | |||
| guide wire. One peel- | |||
| away introducer | |||
| sheath is provided in | |||
| the package to provide | |||
| support and facilitate | |||
| the introduction of the | |||
| AXS Vecta 46 | |||
| Intermediate Catheter | |||
| tip into the | |||
| sheath/guide catheter | |||
| valve. Once the | |||
| assembly is inserted, | |||
| the peel-away | The AXS Vecta | ||
| Intermediate Catheter is | |||
| advanced into the | |||
| neurovasculature by a | |||
| physician trained in | |||
| interventional | |||
| endovascular | |||
| procedures using a | |||
| compatible sheath or | |||
| guide catheter, and over | |||
| an appropriately sized | |||
| microcatheter, guide | |||
| wire, and/or the Scout | |||
| Introducer. Two peel- | |||
| away introducer sheaths | |||
| are provided in the | |||
| package to provide | |||
| support and facilitate | |||
| the introduction of the | |||
| AXS Vecta Intermediate | |||
| Catheter tip and the | |||
| Scout Introducer into | |||
| the sheath/guide | |||
| catheter valve. Once the | |||
| assembly is inserted the | The 046 Zenith Flex | ||
| Aspiration Catheter is | |||
| advanced into the | |||
| neurovasculature by a | |||
| physician trained in | |||
| interventional | |||
| endovascular procedures | |||
| using a compatible | |||
| sheath or guide catheter, | |||
| and over an appropriately | |||
| sized microcatheter or | |||
| guide wire. One peel- | |||
| away introducer sheath is | |||
| provided in the package | |||
| to provide support and | |||
| facilitate the introduction | |||
| of the The 046 Zenith | |||
| Flex Aspiration Catheter | |||
| tip into the sheath/guide | |||
| catheter valve. Once the | |||
| assembly is inserted, the | |||
| peel-away introducer | |||
| sheath can be removed. | |||
| Under fluoroscopic | |||
| guidance, the assembly | |||
| introducer can be | peel-away introducer | can be advanced through | |
| removed. Under | |||
| fluoroscopic guidance, | |||
| the assembly can be | |||
| advanced through the | |||
| vasculature to the | |||
| desired location. | can be removed. Under | ||
| fluoroscopic guidance, | |||
| the assembly can be | |||
| advanced through the | |||
| vasculature to the | |||
| desired location. | the vasculature to the | ||
| intended vascular site, | |||
| with the distal end of the | |||
| AXS Vecta Aspiration | |||
| Catheter positioned | |||
| proximal to the clot. The | |||
| proximal end of the | |||
| Aspiration Tubing Set is | |||
| attached to the “to | |||
| patient” connection of | |||
| the canister installed to | |||
| the VC-701 Cliq | |||
| Aspirator Pump, and the | |||
| VC-701 Cliq Aspirator | |||
| Pump is turned ON. All | |||
| devices inside of the | |||
| AXS Vecta Aspiration | |||
| Catheter are removed. | |||
| The distal end of the | |||
| Aspiration Tubing Set is | |||
| attached to the proximal | |||
| end of the AXS Vecta | |||
| Aspiration Catheter. To | |||
| start aspiration, the | |||
| switch on the Aspiration | |||
| Tubing Set is turned ON, | |||
| and the clot is engaged | |||
| with the 046 Zenith Flex | |||
| Aspiration Catheter |
Device Description
The AXS Vecta 46 Intermediate Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 46 Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal 25cm) to reduce friction during use. It is packaged with one hemostasis valve, and one peel-away introducer.
Indications for Use
The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the AXS Vecta® 46 Intermediate Catheter is substantially equivalent to the Predicate device, AXS Vecta Intermediate Catheters (K190833) and Reference Device (K190338) based on the same or similar materials, same or similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device and Reference device is summarized in Table 1: Product Feature Comparison of Subject Device to Predicate Device below.
5
Table 1: Product Feature Comparison of Subject Device to Predicate and Reference Device
6
7
8
The differences between the devices are not critical as demonstrated above and through the testing referenced below.
9
Testing Summary
The purpose of this notification is to add functionality to the catheters by adding a new indication for use. All design verification testing which utilized the catheters were reviewed to assess the impact due to the QJP product code. The design of the AXS Vecta 46 Intermediate Catheters and accessories, including device configurations, materials, or dimensions are not changing and therefore had no impact on Design Verification. Therefore, design verification was leveraged from previous AXS Vecta 46 Intermediate Catheter submissions in K190338. The impact assessment of the AXS Vecta 46 Intermediate Catheter Verification and Validation activities, including impact to risk management, yielded the following additional Validation study summarized in the section below.
Performance Data - Bench Testing
The results of design validation testing (TP-13700/TR-13700), particulate testing and 3-year aging analysis, (NV00045476 and NV00045788, respectively) conducted on the AXS Vecta 46 Intermediate Catheter demonstrates that it performs as designed, is suitable for the addition of the QJP product code, indication for use, and is substantially equivalent to the legally marketed Predicate devices. Testing was conducted in accordance with ISO 10555-1. The design validation/supplemental confirmatory bench testing is summarized in Table 2 below.
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Design Validation Testing | ||
| Simulated Use | ||
| (Torque, ID, Product | ||
| Compatibility) | Purpose: to provide objective evidence that | |
| test catheter meets applicable user needs: the | ||
| introduction of interventional devices into the | ||
| neuro vasculature. |
Method: Perform a simulated thrombectomy
procedure. Track the devices to the target site
for endovascular device delivery using a
neurovascular in vitro model that replicates the
vascular characteristics of human ICA and
MCA arteries. | All test samples met the
applicable user needs
and design
specifications. |
Table 2. Performance Data - Bench Testing
10
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Design Verification Testing | ||
| Burst Testing | Purpose: to measure the maximum static burst | |
| pressure of AXS Vecta 46 Intermediate | ||
| Catheter and to ensure the device can | ||
| withstand the pressures that may be generated | ||
| with manual delivery of contrast media after | ||
| simulated delivery of the most clinically | ||
| challenging interventional device. |
Method: Testing was conducted on
conditioned AXS Vecta 46 units. The catheter
was connected via its hub or proximal end to a
pressure generating device. Fluid was applied
at a constant rate until product leak or burst
while device pressure was monitored. | All test samples met the
applicable user needs
and acceptance criteria. |
| Supplemental Confirmatory Particulate Testing | | |
| Particulate Testing | Purpose: The purpose of this test was to
document and assess the particulate matter
generated from the delivery of neuro-
interventional devices through the inner lumen
of the AXS Vecta 46 Intermediate Catheter.
Method: Particulate testing was conducted
with AXS Vecta 46 in a simulated use
condition based on the device IFU and a
clinically relevant tortuous model. | All test samples met the
applicable user needs
and acceptance criteria. |
Performance Data – Animal Study
The Simulated Use-Animal testing is focused on the safety and efficacy of the device and was performed to support the previously cleared AXS Vecta 46 Intermediate Catheter as part of the system and can be found in K190338 (cleared as 046 Zenith Flex). Although the addition of the QJP product code will expand the use of the device, the "worst case" use of the device in terms of safety and efficacy is as a Thrombectomy System; therefore, Simulated Use-Animal testing is leveraged to support the QJP product code.
11
510(k) Summary K202752
Performance Data – Clinical
No clinical study was conducted as bench testing was determined sufficient for validation purposes.
Shelf Life Testing
The labeled shelf life for the AXS Vecta® 46 Intermediate Catheter is three years. Shelf life testing was performed on the Reference device and the results met the established acceptance criteria. Testing results were reviewed and cleared in K190338 Zenith Flex Aspiration System (046 Zenith Flex Catheter). Additionally, particulate testing and subsequent analysis between the Predicate and Subject devices confirmed that shelf-life was not impacted by the addition of the QJP product code.
Sterilization
Sterilization testing was performed on the Reference device and the results met the established acceptance criteria. Testing results leveraged from the Reference device were reviewed and cleared in K190338, Zenith Flex Aspiration System (046 Zenith Flex Catheter).
The AXS Vecta 46 Intermediate Catheter and all system components are currently sterilized with 100% Ethylene Oxide and provided sterile. A sterility assurance level (SAL) of 10° has been demonstrated. The AXS Vecta 46 Intermediate Catheter and all system components are for single use only.
Biocompatibility
The AXS Vecta 46 Intermediate Catheter is identical to the catheter component in the Reference device cleared under K190338, Zenith Flex Aspiration System (046 Zenith Flex Catheter). No catheter materials are changing; therefore, biocompatibility is not impacted by the addition of the OJP product code. The completed biocompatibility testing was used to support the biocompatibility of the Subject device.
The AXS Vecta 46 Intermediate Catheter was assessed for biocompatibility in accordance with ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within
12
510(k) Summary K202752
a Risk Management Process". The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours.
Conclusion
Stryker Neurovascular has demonstrated the AXS Vecta 46 Intermediate Catheter is substantially equivalent to the Predicate device, AXS Vecta Intermediate Catheter K190833 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 and the bench testing conducted using the Subject device demonstrate that the subject device is suitable for the indication for use with the associated QJP Product Code. Additionally, the comparison of the technological characteristics and the intended use of the Subject device and the Predicate device does not raise new questions of safety and effectiveness.
Stryker Neurovascular has demonstrated that the AXS Vecta 46 Intermediate Catheter is substantially equivalent to the legally marketed Predicate device.