(79 days)
No
The summary describes a mechanical aspiration system and does not mention any AI/ML components or capabilities. The performance studies are benchtop tests of mechanical properties.
Yes
The device is used for revascularization in patients with acute ischemic stroke, which is a medical treatment/therapy.
No
The device is indicated for revascularization and treatment of acute ischemic stroke, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components, including an aspiration catheter, introducers, a hemostasis valve, tubing, a pump, and a liner set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease". This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is an "aspiration catheter" and its accessories, designed to physically remove blockages from blood vessels.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device is a medical device used for a therapeutic intervention within the patient's body.
N/A
Intended Use / 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 - 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.
Product codes
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Animal Testing:
GLP animal testing performed with the System included a safety evaluation and an efficacy evaluation at a maximum pressure rating of -27 inHq.
AXS Vecta Performance Testing:
- Simulated Use - Bench (AXS Vecta Aspiration System): AXS Vecta Aspiration System underwent simulated use testing by a physician in a benchtop model. Test samples met the acceptance criteria for Simulated Use - Bench.
- Simulated Use Testing – Usability (AXS Vecta Aspiration System): AXS Vecta Aspiration System underwent simulated use testing by a physician in a benchtop model. Test samples met the acceptance criteria for Simulated Use - Usability.
- Vacuum Drop / Suction Connector Secure Attachment (Aspiration Tubing Set): Vacuum pressure measured at source and tip to evaluate pressure difference. Test samples met the acceptance criteria for Vacuum Drop.
- Lumen Patency (Aspiration Tubing Set): Samples were evaluated for lumen collapse during aspiration. Test samples met the acceptance criteria for Lumen Patency.
Clinical Performance Data:
No clinical study was conducted. A review was conducted considering published clinical study articles that featured the Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by using clinical outcomes from devices that are considered technologically similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring an abstract symbol. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 24, 2019
Stryker Neurovascular Shazia Hakim Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K190212
Trade/Device Name: AXS Vecta Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 22, 2019 Received: March 25, 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
1
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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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 him in the many of the subject of the subject of the station of the subject of the subject of the station of the station of the subject of the subjection of the subjection o -5 J Date: 2019.04.24 14:13:14 -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) K190212
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
Submitter's Name and Address
Stryker Neurovascular 47900 Bayside Parkway Fremont, California 94538 Telephone: 1-510-413-2636 Facsimile: 1-510-413-2588
Contact Information
Shazia Hakim Staff Regulatory Affairs Specialist Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 510-413-2636 (phone) 510-413-2588 (fax) Shazia.Hakim@stryker.com
Secondary Contact
Angelica Beckmann Director of Regulatory Affairs Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 650-224-9823 (phone) angelica.beckmann@stryker.com
Date Prepared
January 31, 2019
Device Trade or Proprietary Name
AXS Vecta Aspiration System
4
Device Common or Classification Name:
Catheter, Percutaneous, 21 CFR 870.1250, Class II
Product Code:
NRY (Catheter)
ldentification of the Legally Marketed Devices to which Equivalence is Being Claimed
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| Zenith Flex Aspiration System | InNeuroCo, Inc | K181354 |
| Name of Reference Device | Name of Manufacturer | 510(k) Number |
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.
5
Comparison to Predicate Device
| | Predicate Device
Stryker AXS Vecta
Aspiration System
(formerly
InNeuroCo Zenith
Flex System) | Reference Device
Stryker AXS
Universal
Aspiration System | Subject Device
AXS Vecta
Aspiration System
(with the Medela
Dominant Flex
Pump) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Number | K181354 | K173841 | K190212 |
| Classification | Class II | Class II | Same |
| Product Code | NRY | NRY | Same |
| Review Panel | Neurology | Neurology | Same |
| Indications For
Use | The Zenith Flex
System, including the
Zenith Flex 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. | The AXS Catalyst
Distal Access
Catheter as part of
the AXS Universal
Aspiration System is
indicated for use in
the
revascularization of
patients with acute
ischemic stroke
secondary to
intracranial large
vessel occlusive
disease (in 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
are candidates
for treatment. | Same |
6
| | Predicate Device
Stryker AXS Vecta
Aspiration System
(formerly
InNeuroCo Zenith
Flex System) | Reference Device
Stryker AXS
Universal
Aspiration System | Subject Device
AXS Vecta
Aspiration System
(with the Medela
Dominant Flex
Pump) | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------|----------------------------|
| Patient Contacting
Components | AXS Vecta Aspiration
Catheter and its
Accessories | AXS Catalyst Distal
Access Catheter | Same as AXS Vecta
Aspiration System | | | |
| Pump | Cliq VC-701
Aspirator | Medela Dominant
Flex Pump | Same as AXS
Universal Aspiration
System | | | |
| Aspiration Tubing | Aspiration Tubing Set | AXS Universal
Aspiration Tubing | Same as AXS
Universal Aspiration
System | | | |
| Replacement
Components | Canister Set | AXS Universal Liner
Set | Same as AXS
Universal Aspiration
System | | | |
| Aspiration Method | Pump | Pump | Same | | | |
| Single Use
Components | Catheter and its
accessories,
Aspiration Tubing,
Canister Sets | Catheter and its
accessories, Aspiration
Tubing, Liner Set | Same as AXS
Universal Aspiration
System | | | |
| Reusable
Components | Pump | Pump | Same | | | |
| Maximum
Aspiration
Pressure | 27 in Hg | 28 in Hg | Same as AXS
Universal Aspiration
System | | | |
| Calculated Force
at Tip | Catheter ID | Calculated
Force at tip | Catheter ID | Calculated
Force at tip | Catheter ID | Calculated
Force at tip |
| | 0.071 in | 0.024 kgf | 0.060 in | 0.018 kgf | 0.071 in | 0.025 kgf |
| | 0.074 in | 0.026 kgf | | | 0.074 in | 0.027 kgf |
| Pressure
Regulator Method | Adjustable vacuum
pressure dial | Same | | Same | | |
| Flow Rate | Non-adjustable Flow
Rate | Three Selectable Air
Flow Rates: 40, 50,
60 mL | | Same as AXS
Universal Aspiration
System | | |
7
Summary of Non-Clinical Data
The subject device has the same materials, packaging, manufacturing process, and sterilization process as the predicate device. Therefore, testing was only conducted for specifications that were affected by changing the pump and the tubing.
Animal Testing
Animal testing previously conducted for the Zenith Flex System was used to support this change. The GLP animal testing performed with the System included a safety evaluation and an efficacy evaluation at a maximum pressure rating of -27 inHq. However, a calculation of the force at the tip demonstrated that the pressure differences and forces exhibited on the product with the different pumps are minimal. Therefore, this is a modification of an interchangeable component. Since both components have already received clearance for this indication and because the bench top data supports that the catheter still works within the pressure ranges previously established as safe, the animal testing previously conducted can be used to support this change as well.
AXS Vecta Performance Testing
To demonstrate substantial equivalence between the subject AXS Vecta Aspiration System and the predicate Zenith Flex System and the reference Stryker AXS Universal Aspiration System, 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 characteristics as the predicate device and the reference device. All the testing conducted to demonstrate substantial equivalence are presented in the following table.
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use - Bench
(AXS Vecta Aspiration
System) | AXS Vecta Aspiration
System underwent
simulated use testing by
a physician in a
benchtop model | Test samples must meet
predetermined user needs | AXS Vecta Aspiration System
test samples met the
acceptance criteria for
Simulated Use
- Bench to demonstrate that
the AXS Vecta System is
substantially equivalent to the
predicate device. |
8
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use Testing
– Usability
(AXS Vecta Aspiration
System) | AXS Vecta Aspiration
System underwent
simulated use testing by a
physician in a benchtop
model | Test samples must meet
predetermined user needs | AXS Vecta Aspiration System
test samples met the
acceptance criteria for
Simulated Use
- Usability to demonstrate that
the AXS Vecta Aspiration
System is substantially
equivalent to the predicate
device. |
| Vacuum Drop / Suction
Connector Secure
Attachment
(Aspiration Tubing Set) | Vacuum pressure
measured at source and
tip to evaluate pressure
difference | Test sample results must
meet or exceed existing
pressure specifications. | AXS Vecta Aspiration System
test samples met the
acceptance criteria for
Vacuum Drop to demonstrate
that the AXS Vecta Aspiration
System is substantially
equivalent to the predicate
device. |
| Lumen Patency
(Aspiration Tubing Set) | Samples were evaluated
for lumen collapse during
aspiration | Test sample results must
meet or exceed existing
lumen patency
specifications. | AXS Vecta Aspiration System
test samples met the
acceptance criteria for Lumen
Patency to demonstrate that
the AXS Vecta Aspiration
System is substantially
equivalent to the predicate
device. |
Performance Data - Clinical
No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by using clinical outcomes from devices that are considered technologically similar. This documentation was reviewed within the scope of this change and determined to be applicable.
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.