Artix MT; Artix Thin-Walled Thrombectomy Sheath
Device Facts
| Record ID | K241894 |
|---|---|
| Device Name | Artix MT; Artix Thin-Walled Thrombectomy Sheath |
| Applicant | Inari Medical, Inc. |
| Product Code | QEW · Cardiovascular |
| Decision Date | Oct 15, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Artix™ MT thrombectomy device is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature. The Artix™ Thin-Walled Sheath is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. · Use as a conduit for endovascular devices. · Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures. The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.
Device Story
Artix™ MT and Artix™ Thin-Walled Sheath are single-use, over-the-wire peripheral thrombectomy systems. Artix™ MT uses a self-expanding nitinol element to capture thrombus; deployed by retracting delivery catheter; retrieved through sheath. Artix™ Thin-Walled Sheath facilitates catheter guidance and provides a conduit for endovascular devices; includes a funnel catheter for temporary vascular occlusion to aid clot ingestion. Operated by physicians in clinical settings under fluoroscopic guidance. Output is physical removal of thrombus from peripheral vasculature. Benefits include minimally invasive clot removal without surgery. System includes cleaning accessories and syringes for aspiration/infusion.
Clinical Evidence
No clinical or animal testing was required. Substantial equivalence is supported by bench testing, including packaging, tensile, burst, corrosion, radiopacity, radial force, chronic clot analog, hemostasis, particulate, and simulated use testing.
Technological Characteristics
Materials: Nitinol, Pebax, Tungsten, biocompatible polymers. Sensing/Actuation: Mechanical self-expanding element (MT) and funnel-based flow occlusion (Sheath). Energy: Manual. Connectivity: None. Sterilization: EtO (SAL 10^-6) per ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016. Form factor: Over-the-wire catheter system.
Indications for Use
Indicated for non-surgical removal of emboli/thrombi from peripheral blood vessels, injection/infusion/aspiration of fluids/contrast media, and as a conduit for endovascular devices in adults. Contraindicated for pulmonary, cerebral, carotid, or coronary arteries; endarterectomy; vessel dilation; removal of fibrous/adherent/calcified material; vessels < 3 mm; and use with power injectors.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Predicate Devices
Reference Devices
- Surmodics, Pounce LP Thrombectomy System (K231022)
- Vascular Medcure, CAPERE Thrombectomy System (K203476)
- Inari Medical, FlowTriever2 Catheter (K201541)
- Inari Medical, InThrill Thrombectomy System (K223613)
- Capture Vascular, MegaVac Mechanical Thrombectomy System (K171493)
- Inari Medical, ClotTriever Sheath (K233815)
Related Devices
- K223436 — Artix AX · Inari Medical · Mar 2, 2023
- K220887 — Mini-ClotTriever Thrombectomy System · Inari Medical · Aug 4, 2022
- K163549 — ClotTriever Thrombectomy System · Inari Medical, Inc. · Feb 16, 2017
- K192036 — ClotTriever Thrombectomy System · Inari Medical · Aug 29, 2019
- K230912 — Artix BG · Inari Medical · May 2, 2023
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Inari Medical, Inc. Ellen Nguyen Senior Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K241894
Trade/Device Name: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA, DQY Dated: June 28, 2024 Received: June 28, 2024
Dear Ellen Nguyen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
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Image /page/2/Picture/1 description: The image shows a digital signature. The signature is from Ariel G. Ash-shakoor -S. The date of the signature is 2024.10.15, and the time is 14:40:21 -04'00'.
# For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K241894
Device Name Artix™ MT; Artix™ Thin-Walled Sheath
#### Indications for Use (Describe)
The Artix™ MT thrombectomy device is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature.
The Artix™ Thin-Walled Sheath is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
· Use as a conduit for endovascular devices.
· Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures.
The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.
| 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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PAGE 1 OF 4
# 510(K) SUMMARY
| Date prepared | October 10, 2024 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>949.600.8433 |
| Contact person | Ellen Nguyen<br>Senior Regulatory Affairs Specialist |
| Name of Device | Artix™ MT |
| Product code(s) | QEW; KRA |
| Regulation(s) | 21 CFR 870.5150 Embolectomy catheter |
| Regulatory class | II |
| Predicate device | Inari Medical, Artix Thrombectomy Device (K220600)<br>This device has not been subject to a design-related recall. |
| Reference devices | Surmodics, Pounce LP Thrombectomy System (K231022)<br>Vascular Medcure, CAPERE Thrombectomy System (K203476)<br>Inari Medical, FlowTriever2 Catheter (K201541)<br>Inari Medical, InThrill Thrombectomy System (K223613) |
| Description | The Artix™ MT is a single-use, over-the-wire catheter device used for the<br>minimally invasive treatment of thromboemboli in the peripheral vasculature. The<br>Artix MT is packaged with the following components: Artix MT (3-6 mm or 4-8 mm) Cleaning accessory 1-Way Stopcock The Artix MT is inserted over-the-wire through a compatible sheath (such as the<br>Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to<br>the target thrombus. The self-expanding element is deployed by retracting the<br>delivery catheter. Thrombus is engaged and removed by retracting the Artix MT<br>into the sheath and out of the patient. Once the procedure is complete, the system is<br>completely withdrawn from the patient. |
| Indications for Use | The Artix™ MT thrombectomy device is indicated for: The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature. |
| Comparison of<br>Technological | The Artix MT and Artix Thrombectomy Device are both delivered over a previously placed 0.014" guidewire through a compatible sheath, such as the Artix Thin- |
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#### Characteristics with the Predicate Device
Walled Sheath, to a location proximal of the target thrombus. Under fluoroscopic guidance, both devices are advanced until the proximal marker band is distal to and/or within the clot. The delivery catheter is retracted to allow the nitinol element to expand and capture thrombus. The entire device is manually retracted inside the sheath and out of the patient to remove the thrombus.
Changes to the predicate device that have led to the submission of this new 510(k) are a modification of the element geometry, catheter length increase, material changes, an update to the packaging dispenser card configuration, and the addition of a cleaning accessory. These changes result in characteristics that are similar to those of the predicate and reference devices.
The proposed modifications do not change the intended use or principles of operation from the predicate device. The modified and predicate devices have similar designs. All leveraged and performed design verification and validation tests confirm that the differences between the devices do not raise any new or different questions of safety or effectiveness.
## Summary of substantial equivalence
There is no change of intended use or fundamental scientific technology between the proposed device and predicate device. The indications for use remain the same.
| Device | Artix™ MT<br>Proposed (TBD) | Artix™ Thrombectomy Device<br>Predicate (K220600) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Regulations | 21 CFR 870.5150<br>Embolectomy catheter<br>21 CFR 870.1210 Continuous<br>flush catheter | 21 CFR 870.5150<br>Embolectomy catheter<br>21 CFR 870.1210 Continuous<br>flush catheter |
| Product code | QEW, KRA | QEW, KRA |
| Intended<br>use/Indications<br>for use | The Artix MT thrombectomy<br>device is indicated for:<br>• The non-surgical removal<br>of emboli and thrombi<br>from blood vessels.<br>• Injection, infusion, and/or<br>aspiration of contrast<br>media and other fluids<br>into or from a blood<br>vessel.<br>The Artix MT thrombectomy<br>device is intended for use in<br>the peripheral vasculature. | The Artix Thrombectomy<br>Device is indicated for:<br>• The non-surgical removal<br>of emboli and thrombi<br>from blood vessels.<br>• Injection, infusion, and/or<br>aspiration of contrast<br>media and other fluids<br>into or from a blood<br>vessel.<br>The Artix Thrombectomy<br>Device is intended for use in<br>the peripheral vasculature. |
| Contraindications | • Not intended for use in<br>the pulmonary, cerebral,<br>carotid, or coronary<br>arteries.<br>• Not intended for use in<br>endarterectomy<br>procedures or vessel<br>dilation. | • Not intended for use in<br>the pulmonary, cerebral,<br>carotid, or coronary<br>arteries.<br>• Not intended for use in<br>endarterectomy<br>procedures or vessel<br>dilation. |
| | Not indicated for the removal of fibrous, adherent, or calcified material (e.g., atherosclerotic plaque). Not intended for use in vessels < 3 mm. Not intended for use with power injectors. | Not indicated for the removal of fibrous, adherent, or calcified material (e.g., atherosclerotic plaque). Not intended for use in vessels < 3 mm. Not intended for use with power injectors. |
| Principles of operation | A compatible sheath is placed over a guidewire to a location proximal of the target thrombus.<br>The Artix MT can be used for mechanical thrombectomy by advancing and deploying directly through the sheath. | A compatible sheath is placed over a guidewire to a location proximal of the target thrombus.<br>The Artix Thrombectomy Device can be used for mechanical thrombectomy by advancing and deploying directly through the sheath. |
| Intended patient population | Same | Adults undergoing interventional procedures |
| Target vessel | Same | Peripheral vasculature |
| Sterile | Same | SAL 10-6, EO |
| Device and packaging materials | Same | Biocompatible, commonly used materials for medical devices |
| Shelf-life | 6 months | 2 years* |
| Single use | Yes | Yes |
| Vessel diameters treated | 3-6 mm<br>4-8 mm | 3-8 mm |
| Device dimensions | Same with longer total lengths for the new models and different element lengths/diameters | Appropriately sized for the target vessel treatment range |
| Radiopaque element(s) | Platinum wire<br>Pebax, Tungsten marker band | Platinum-iridium marker band |
| Guidewire compatibility | Same | 0.014" |
| Accessories provided | Stopcock<br>Cleaning accessory | Stopcock |
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# Biocompatibility
The following biocompatibility tests were completed for the subject devices:
- . Cytotoxicity . Sensitization
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PAGE 4 OF 4
- . Intracutaneous Reactivity
- Material-Mediated Pyrogenicity
- . Acute Systemic Toxicity
- Hemocompatibility (Hemolysis)
- Genotoxicity
The passing results demonstrate that the subject device meets biological safety requirements per ISO 10993-1.
## Sterilization
The subject device is sterilized using EtO to achieve a sterility assurance level (SAL) of 106 using a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.
## Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the Artix MT. These tests included:
- Packaging Testing
Inspections
Hemostasis
Particulate
Tensile
Visual and Dimensional
Simulated Use Testing
- Liquid Leakage
- Burst ●
- Corrosion ●
- Radiopacity
- Radial Force ●
- Chronic Clot Analog ●
Neither animal testing nor clinical testing were required for the determination of substantial equivalence.
# Conclusion
●
●
●
●
●
The Artix™ MT has the same intended use/indications for use and principles of operation as its predicate. The testing provided supports the Artix MT's substantial equivalence to the predicate device.
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PAGE 1 OF 5
# 510(K) SUMMARY
| Date prepared | October 10, 2024 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>949.600.8433 |
| Contact person | Ellen Nguyen<br>Senior Regulatory Affairs Specialist |
| Name of Device | Artix™ Thin-Walled Sheath |
| Product code(s) | QEW; DQY |
| Regulation | 21 CFR 870.5150 Embolectomy catheter |
| Regulatory class | II |
| Predicate device | Inari Medical, Artix BG (K230912)<br>This device has not been subject to a design-related recall. |
| Reference device(s) | Surmodics, Pounce Thrombectomy System (K231022)<br>Capture Vascular, MegaVac Mechanical Thrombectomy System (K171493)<br>Inari Medical, ClotTriever Sheath (K233815) |
| Description | The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wire<br>system designed to facilitate the insertion and guidance of an intravascular catheter<br>into a selected peripheral blood vessel and act as a conduit for endovascular devices.<br>The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels<br>and is capable of infusion/aspiration of fluids into or from a selected vessel. The<br>Artix Sheath is packaged with the following components:<br>Artix Thin-Walled Sheath (65 cm or 90 cm) Sheath Dilator (0.035" guidewire compatibility) Funnel Catheter and Funnel Catheter Dilator (0.035" guidewire compatibility) Funnel Loading Tool (2) Large Bore Syringe, 30 mL The Artix Sheath is inserted over-the-wire and advanced to a desirable position.<br>Any compatible endovascular device, such as the Artix MT, can then be inserted<br>through the Artix Sheath for access into the peripheral vasculature. The provided<br>funnel catheter accessory can also be inserted through the Sheath and deployed to<br>provide flow occlusion of the vessel during the procedure to aid with the system's<br>clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used<br>through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL<br>syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media<br>and other fluids as required. Once the procedure is complete, the funnel catheter (if<br>used) is removed prior to withdrawal of the entire system from the patient, and<br>standard 7 Fr closure devices can be used. |
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#### PAGE 2 OF 5
#### Indications for Use
The Artix™ Thin-Walled Sheath is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels. ●
- . Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
- Use as a conduit for endovascular devices.
- Use in facilitating the insertion and guidance of an intravascular catheter into a ● selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures.
The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.
## Comparison of Technological Characteristics with the Predicate Device
The Artix Thin-Walled Sheath and Artix BG are both tracked over a pre-placed compatible guidewire. Compatible endovascular devices, such as the Artix MT, can then be deployed through the sheath to engage and withdraw thrombus. The funnel and balloon respectively provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Additional clot can be aspirated through the Artix Sheath or Artix BG using the provided 30 mL Large Bore Syringe.
Changes to the predicate device that have led to the submission of this new 510(k) are a change of the occlusive element from a balloon to a funnel and the inclusion of associated accessories, a reduction of the sheath's outer profile, a decrease to the working length of the longer model, material changes, and an updated packaging dispenser card configuration. These changes result in characteristics that are similar to those of the predicate and reference devices.
Although the modified and predicate devices have different designs, the proposed modifications do not change the intended use or principles of operation from the predicate device. All leveraged and performed design verification and validation tests confirm that the differences do not raise any new or different questions of safety or effectiveness.
#### Summary of substantial equivalence
There is no change of intended use or fundamental scientific technology between the proposed device and predicate device. Aside from some clarification updates, the indications for use remain the same.
| Device | ArtixTM Thin-Walled Sheath -<br>Proposed (TBD) | ArtixTM BG - Predicate<br>(K230912) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Regulations | 21 CFR 870.5150 Embolectomy<br>catheter<br>21 CFR 870.1250 Percutaneous<br>catheter | 21 CFR 870.5150 Embolectomy<br>catheter<br>21 CFR 870.1250 Percutaneous<br>catheter |
| Product code | QEW, DQY | QEW, DQY |
| Intended<br>use/Indications<br>for use | The Artix Thin-Walled Sheath is<br>indicated for:<br>• The non-surgical removal of<br>emboli and thrombi from<br>blood vessels.<br>• Injection, infusion, and/or<br>aspiration of contrast media | The Artix BG balloon<br>thrombectomy sheath is<br>indicated for:<br>• The non-surgical aspiration<br>of emboli and thrombi from<br>blood vessels.<br>• Injection, infusion, and/or<br>aspiration of contrast media |
| | | |
| | and other fluids into or from<br>a blood vessel.<br>Use as a conduit for<br>●<br>endovascular devices.<br>Use in facilitating the<br>●<br>insertion and guidance of an<br>intravascular catheter into a<br>selected blood vessel. The<br>funnel provides temporary<br>vascular occlusion during<br>these and other angiographic<br>procedures.<br>The Artix Thin-Walled Sheath is<br>intended for use in the peripheral<br>vasculature. | and other fluids into or from<br>a blood vessel.<br>Use as a conduit for retrieval<br>●<br>devices.<br>Use in facilitating the<br>●<br>insertion and guidance of an<br>intravascular catheter into a<br>selected blood vessel. The<br>balloon provides temporary<br>vascular occlusion during<br>these and other angiographic<br>procedures.<br>The Artix BG balloon<br>thrombectomy sheath is<br>intended for use in the<br>peripheral vasculature. |
| Principles of<br>operation | After the target vessel is<br>accessed and dilated, the Artix<br>Thin-Walled Sheath is inserted<br>into the vessel over a guidewire.<br>Once the Sheath is in position,<br>the dilator is removed, and all<br>compatible endovascular<br>devices, such as the Artix MT,<br>can be inserted through the Artix<br>Sheath for access into the<br>peripheral vasculature. The<br>provided Funnel Catheter<br>Accessory can also be inserted<br>through the sheath and deployed<br>to provide flow occlusion of the<br>vessel during the procedure to<br>aid with clot ingestion. The<br>provided 30 mL syringe can be<br>used to aspirate clot in the vessel<br>or sheath and infuse contrast<br>media and other fluids as<br>required. | After the target vessel is<br>accessed and dilated, the Artix<br>BG is inserted into the vessel<br>over a guidewire. Once the Artix<br>BG is in position, the dilator is<br>removed, and all compatible<br>catheter devices, such as the<br>Artix Thrombectomy Device<br>(K220600), can be inserted<br>through the Artix BG for access<br>into the peripheral vasculature.<br>The sheath's balloon can also be<br>inflated using a 1 mL syringe to<br>provide flow occlusion of the<br>vessel during the procedure. The<br>provided 30 mL syringe can be<br>used to aspirate clot in the vessel<br>or sheath and infuse contrast<br>media and other fluids as<br>required. |
| Intended<br>patient<br>population | Same | Adults undergoing<br>interventional procedures |
| Target vessel | Same | Peripheral vasculature |
| Sterile | Same | SAL 10-6, EO |
| Device and<br>packaging<br>materials | Same | Biocompatible, commonly used<br>materials for medical devices |
| Device<br>dimensions | Same with decreased OD profile<br>and length increase of the longer<br>model | Appropriately sized for the<br>introduction of interventional<br>devices into the target vessel |
| Shelf-life | 6 months | 2 years* |
| Single use | Yes | Yes |
| Marker band | Pe…
