(29 days)
The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI 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.
The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.
This document is a 510(k) summary for the AXS Vecta Aspiration System, which is a percutaneous catheter used for revascularization in patients with acute ischemic stroke. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (K190212).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Performance Testing Summary" table (Table 2) which includes the "Test" conducted and the "Conclusion". While it states "All units met the acceptance criteria and passed," the specific acceptance criteria values for each test are not explicitly listed in this document. The table implicitly states that the device met the unlisted criteria.
| Test | Reported Device Performance (Conclusion) | Explicit Acceptance Criteria |
|---|---|---|
| Visual Inspection (Packaging: Pouch Visual) | All units met the acceptance criteria and passed Packaging Visual Inspection. | Not explicitly stated |
| Visual Inspection (Packaging: Undamaged Product) | All units met the acceptance criteria and passed Packaging Visual Inspection. | Not explicitly stated |
| Tensile Strength | All units met the acceptance criteria and passed Tensile Strength testing. | Not explicitly stated |
| PTFE Delamination | All units met the acceptance criteria and passed PTFE Delamination testing. | Not explicitly stated |
| Torque Strength | All samples met acceptance criteria and passed Torque Strength testing. | Not explicitly stated |
| Catheter Burst | All samples met acceptance criteria and passed Catheter Burst testing. | Not explicitly stated |
| Leak (Liquid)Leak (Air) | All samples met acceptance criteria and passed the Air and Liquid Leakage testing. | Not explicitly stated |
| Dimensional (ID, OD, & Working Length) | All samples met acceptance criteria and passed Dimensional testing. | Not explicitly stated |
| Kink Resistance | All samples met acceptance criteria and passed Kink Resistance testing. | Not explicitly stated |
| Visual Inspection (Transition & Tip) | All samples met acceptance criteria and passed both the transition and tip visual inspections. | Not explicitly stated |
| Lumen Patency | All samples met acceptance criteria and passed Lumen Patency testing. | Not explicitly stated |
| Vacuum Drop | All samples met acceptance criteria and passed Vacuum Drop testing. | Not explicitly stated |
| Tip Flexibility | All samples met acceptance criteria and passed Tip Flexibility testing. | Not explicitly stated |
| Friction Force | All samples met acceptance criteria and passed Friction Force testing. | Not explicitly stated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "All units met the acceptance criteria" or "All samples met acceptance criteria" for each test, implying that the acceptance criteria were met by all tested units/samples. However, the specific number of samples used for each non-clinical bench test is not explicitly mentioned.
No animal or clinical studies were performed for the current submission. The document states that animal testing previously conducted for the AXS Vecta Aspiration System was leveraged (from K190212, K172167, and K181354). The provenance of this leveraged animal data (country of origin, retrospective/prospective) is not specified in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This 510(k) summary primarily relies on non-clinical bench testing. Therefore, there are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for bench tests is defined by engineering specifications and test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no clinical or human-reader studies were conducted for this submission, an adjudication method for a test set is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done as this is a medical device (catheter) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human interaction. This is not applicable as the device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench tests (e.g., tensile strength, burst pressure, dimensions), the ground truth is based on engineering specifications and established test methods that define what constitutes acceptable performance for a medical device of this type.
8. The sample size for the training set
This is not applicable as the device is a physical medical device (catheter) and not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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July 30, 2019
Stryker Neurovascular Shazia Hakim Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K191768
Device Name: AXS Vecta Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 28, 2019 Received: July 1, 2019
Dear Shazia Hakim:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
for Xiaolin Zheng, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K191768
Device Name
AXS Vecta Aspiration System
Indications for Use (Describe)
The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI 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.
| 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
Introduction:
According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence.
Submitter Name, Address, and Content:
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977) |
|---|---|
| Contact: | Shazia Hakim |
| Senior Staff Regulatory Affairs Specialist | |
| Phone: 510-413-2636 | |
| Fax: 510-413-2588 | |
| Email: shazia.hakim@stryker.com | |
| Date Prepared: | June 28, 2019 |
| Trade/Proprietary Name: | AXS Vecta® Aspiration System (formerly known as the InNeuroCoZenith Flex System and InNeuroCo 071 & 074 Zenith Flex Catheters) |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | NRY |
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Legally Marketed Predicate Devices
| Name of Predicate Device | Name ofManufacturer | 510(k)Number |
|---|---|---|
| AXS Vecta AspirationSystem | StrykerNeurovascular | K190212 |
Device Description
The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.
Indications for Use
The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System 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.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the AXS Vecta® Aspiration Catheter (AXS Vecta® 71 & 74 Aspiration Catheters) is substantially equivalent to the Predicate device, AXS Vecta Aspiration System (K190212) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device is summarized in table below.
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| Detail | Submission Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | Stryker Neurovascular | Stryker Neurovascular |
| 510(k) Number | K191768 | K190212 |
| Device Trade Name | AXS Vecta® AspirationSystem (AXS Vecta® 71 & 74Aspiration Catheters) | AXS Vecta® AspirationSystem (AXS Vecta® 71 & 74Aspiration Catheters) |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | II | Same |
| Product Code | NRY | Same |
| IntendedUse/Indication forUse | The AXS Vecta AspirationCatheter, as part of the AXSVecta Aspiration System isindicated in therevascularization of patientswith acute ischemic strokesecondary to intracraniallarge vessel occlusive disease(within the internal carotid,middle cerebral – M1 andM2 segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IV t-PA) or who failed IV t-PAtherapy are candidates fortreatment. | Same |
| Device Description | The AXS Vecta AspirationCatheter is advanced into theneurovasculature by aphysician trained ininterventional endovascularprocedures using a compatiblesheath or guide catheter, andover an appropriately sizedmicrocatheter, guide wire,and/or the Scout Introducer.Two peel-away introducersheaths are provided in thepackage to provide support andfacilitate the introduction of the | Same |
| AXS Vecta Aspiration Cathetertip into the sheath/guidecatheter valve. Once theassembly is inserted, the peel-away introducer sheath can beremoved. Under fluoroscopicguidance, the assembly can beadvanced through thevasculature to the intendedvascular site, with the distalend of the AXS VectaAspiration Catheter positionedproximal to the clot. Theproximal end of the AXSUniversal Aspiration Tubing isconnected to the AXSUniversal Liner Set. The AXSUniversal Liner Set isconnected to the MedelaDominant Flex Pump, and theMedela Dominant Flex Pump isturned ON. All devices insideof the AXS Vecta AspirationCatheter are removed. Thedistal end of the AXS UniversalAspiration Tubing is attachedto the proximal end of the AXSVecta Aspiration Catheter. Tostart aspiration, the aspirationtubing clamp on the AXSUniversal Aspiration Tubing isopened, and the clot is engagedwith the AXS Vecta AspirationCatheter. | ||
| Accessory DevicesProvided (not indirect contact withpatient) | Hemostasis Valve, 2 Peel-Away IntroducersScout Introducer | Same |
| Outer Jacket | Polymeric catheter | Same |
| Reinforcement | Stainless Steel/Nitinol | Same |
| Strain Relief | Polyolefin | Same |
| Inner Layer | PTFE | Same |
| Catheter Hub | Nylon | Same |
| Marker Band | Platinum/Iridium | Same |
| Adhesive | Cyanoacrylate | Same |
| Outer Jacket Coating | Hydrophilic Coating | Same |
| Labeled Shaft OuterDiameter | Distal OD: | Distal OD: |
| Vecta 71: 0.082 in.Vecta 74: 0.083 in. | Same | |
| Proximal OD:Vecta 71: 0.085 in.Vecta 74: 0.087 in. | Proximal OD:Same | |
| Effective Lengths | 115, 125, 132 cm | Same |
| Distal ID | 0.071 in.0.074 in. | Same |
| Proximal ID | 0.071 in.0.074 in. | Same |
| Packaging Materialsand Configuration | Tyvek/Nylon Pouch,polyethylene support tube,packaging card, SBS carton | Same |
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Principles ofOperation | The AXS Vecta AspirationCatheter is advanced into theneurovasculature by aphysician trained ininterventional endovascularprocedures using a compatiblesheath or guide catheter, andover an appropriately sizedmicrocatheter, guide wire,and/or the Scout Introducer.Two peel-away introducersheaths are provided in thepackage to provide support andfacilitate the introduction of theAXS Vecta Aspiration Cathetertip into the sheath/guidecatheter valve. Once theassembly is inserted, the peel-away introducer sheath can beremoved. Under fluoroscopicguidance, the assembly can beadvanced through thevasculature to the intendedvascular site, with the distalend of the AXS VectaAspiration Catheter positionedproximal to the clot. Theproximal end of the AXSUniversal Aspiration Tubing is | Same |
Table 1. Product Feature Comparison of Subject Device to Predicate Device
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| Patient ContactingComponents | AXS Vecta Aspiration Catheterand its Accessories | Same | ||
|---|---|---|---|---|
| Pump | Medela Dominant Flex Pump | Same | ||
| Aspiration Tubing | AXS Universal AspirationTubing | Same | ||
| ReplacementComponents | AXS Universal Liner Set | Same | ||
| Aspiration Method | Pump | Same | ||
| Single UseComponents | Catheter and its accessories,Aspiration Tubing, Liner Sets | Same | ||
| ReusableComponents | Pump | Same | ||
| Maximum AspirationPressure | 28 in Hg | Same | ||
| Calculated Force atTip | Catheter ID | CalculatedForce at Tip | Catheter ID | CalculatedForce at Tip |
| 0.071 in | 0.024 kgf | Same | Same | |
| 0.074 in | 0.026 kgf | |||
| Pressure RegulatorMethod | Adjustable vacuum pressuredial | Same | ||
| Flow Rate | Non-adjustable flow rate | Same |
The differences between the devices are not critical as demonstrated above and through the testing referenced below.
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Summary of Non-Clinical Data
Testing was only conducted for specifications that were impacted by the changes to the catheter proximal shaft material (coextrusion), mixed coil winding pattern (cross coil to single) and pitch (.026 to .012) of the stainless steel wire on the proximal section of the catheter shaft of the AXS Vecta 71 and 74 catheters, modification (tightening) of the tip length specification, as well as updating the AXS Vecta 71 marker band tacking to use the same UV adhesive and adhesive curing process as the AXS Vecta 74 cleared in K181354. Although an evaluation of the packaging was not required as part of simulated use bench testing, an assessment was included as part of the design validation to confirm that the packaging configuration does not result in any damage to the catheter when opened with the typical sense of urgency; refer to Table 2 below.
Animal Testing
Animal testing previously conducted for the AXS Vecta Aspiration System was leveraged to support the changes to AXS Vecta 71 and 74 Aspiration Catheters. Prior to design changes, Simulated Use-Animal testing was performed to support the previously cleared AXS Vecta Aspiration Catheters as part of the system and can be found in K190212, K172167 and K181354 (cleared as Zenith Flex System). Additional testing was not performed because the current design changes do not impact the overall efficacy and safety of the device. The UV adhesive tacking adhesive change does not impact safety or efficacy because the tip design is not changing. The mixed coil and coextrusion changes do not change the distal tip, does not change the outer patient interacting material (Vestamid ML21), and the inner coextrusion material (Pebax 72D) is currently used in the catheter design. The new tip length specification is still within the original tip length specification window and is not anticipated to impact the safety or efficacy.
AXS Vecta Performance Data – Bench Testing
To demonstrate substantial equivalence between the Subject device, AXS Vecta Aspiration System with proposed design changes and the currently cleared AXS Vecta Aspiration System (Predicate device), performance testing was conducted. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed. Therefore, this test data supports the argument that the AXS Vecta Aspiration System has similar performance
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characteristics as the predicate device. All the testing conducted to demonstrate substantial equivalence are presented in the following table.
| Test | Conclusion |
|---|---|
| Visual Inspection (Packaging: Pouch Visual) | All units met the acceptance criteria and passed Packaging Visual Inspection. |
| Visual Inspection (Packaging: Undamaged Product) | All units met the acceptance criteria and passed Packaging Visual Inspection. |
| Tensile Strength | All units met the acceptance criteria and passed Tensile Strength testing. |
| PTFE Delamination | All units met the acceptance criteria and passed PTFE Delamination testing. |
| Torque Strength | All samples met acceptance criteria and passed Torque Strength testing. |
| Catheter Burst | All samples met acceptance criteria and passed Catheter Burst testing. |
| Leak (Liquid)Leak (Air) | All samples met acceptance criteria and passed the Air and Liquid Leakage testing. |
| Dimensional (ID, OD, & Working Length) | All samples met acceptance criteria and passed Dimensional testing. |
| Kink Resistance | All samples met acceptance criteria and passed Kink Resistance testing. |
| Visual Inspection (Transition & Tip) | All samples met acceptance criteria and passed both the transition and tip visual inspections. |
| Lumen Patency | All samples met acceptance criteria and passed Lumen Patency testing. |
| Vacuum Drop | All samples met acceptance criteria and passed Vacuum Drop testing. |
| Tip Flexibility | All samples met acceptance criteria and passed Tip Flexibility testing. |
| Friction Force | All samples met acceptance criteria and passed Friction Force testing |
Table 2. Performance Testing Summary
Performance Data – Clinical
No clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
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Shelf Life Testing
Shelf life testing previously conducted for the AXS Vecta Aspiration System was leveraged to support the changes to AXS Vecta 71 and 74 Aspiration Catheters and can be found in K172167 and K181354. Shelf life testing was not performed since it was determined that there is no impact on material degradation and the design changes do not impact the overall efficacy and safety of the device.
Sterilization
The subject device is sterilized by 100% EtO and has been adopted into a validated sterilization process in accordance with the principles of AAMI TIR 28:2016 Product Adoption & Process Equivalence for Ethylene Oxide Sterilization and per the requirements of ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.
Biocompatibility
Biocompatibility testing previously conducted for the AXS Vecta Aspiration System was leveraged to support the changes to AXS Vecta 71 and 74 Aspiration Catheters and can be found in K172167 and K181354. Additionally, though no biological risks were identified, confirmatory tests (cytotoxicity, sensitization and irritation) were conducted to confirm that there is no impact on existing biocompatibility study. Based on the testing results, the AXS Vecta 71 and 74 Aspiration Catheters with the design change is free from biological hazard per ISO 10993-1.
Summary of Substantial Equivalence
The performance characteristics and the test results demonstrate that the AXS Vecta Aspiration System meets the acceptance criteria to determine that the AXS Vecta Aspiration System is substantially equivalent to the predicate device. Furthermore, the intended use, the operating principles, and the design are all equivalent and support the conclusion that all devices are technologically similar. Additionally, the testing results summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.
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Stryker Neurovascular has demonstrated that the AXS Vecta Aspiration Catheters are as safe, as effective, and perform as well as the legally marketed Predicate device.
§ 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).