(109 days)
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.
The Artix™ MT is a single-use, over-the-wire catheter device used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The 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 Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to the target thrombus. The self-expanding element is deployed by retracting the delivery catheter. Thrombus is engaged and removed by retracting the Artix MT into the sheath and out of the patient. Once the procedure is complete, the system is completely withdrawn from the patient.
The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for endovascular devices. The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix Sheath is packaged with the following components: 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. Any compatible endovascular device, such as the Artix MT, can then be inserted through the Artix Sheath for access into the peripheral vasculature. The provided funnel catheter accessory can also be inserted through the Sheath and deployed to provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media and other fluids as required. Once the procedure is complete, the funnel catheter (if used) is removed prior to withdrawal of the entire system from the patient, and standard 7 Fr closure devices can be used.
The provided document describes the 510(k) premarket notification for two devices: Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria or studies involving human expert performance (such as MRMC studies, specific ground truth established by experts, or sample sizes for test/training sets relevant to AI/software performance).
Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving device meets those criteria in the context of AI/software performance with human-in-the-loop. The document exclusively discusses the substantial equivalence of physical medical devices based on their design, materials, and non-clinical performance (e.g., burst strength, tensile strength, simulated use, biocompatibility).
The "study" mentioned in the document refers to a series of non-clinical tests conducted to demonstrate that the devices perform as intended and are as safe and effective as their predicate devices. These tests are not related to AI or human reader performance.
Here's an overview of the information that is available in the document, which primarily concerns the physical characteristics and performance of the devices:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present acceptance criteria in a quantitative table with reported device performance in the way one might expect for AI or software. Instead, it lists various non-clinical tests (e.g., Biocompatibility, Sterilization, Packaging Testing, Visual and Dimensional Inspections, Simulated Use Testing, Hemostasis, Burst, Corrosion, Radiopacity, Radial Force, Chronic Clot Analog for Artix MT; and similar tests for Artix Thin-Walled Sheath) and states that "The passing results demonstrate that the subject device meets biological safety requirements" (for biocompatibility) and that "verification and validation testing were identified to support the substantial equivalence" and "The testing provided supports the Artix MT's substantial equivalence." This implies that the devices met their internal acceptance criteria for these physical and functional tests. However, the specific numerical acceptance criteria and performance outcomes for each test are not detailed in this summary.
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical): The document does not specify the sample sizes for the individual non-clinical tests conducted (e.g., how many units were tested for burst strength, or simulated use).
- Data Provenance: Not applicable in the context of device performance data presented, as it refers to non-clinical, lab-based testing of the physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the performance of these physical medical devices is established through engineering specifications, material science, and physical testing protocols, not through expert consensus on interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to human reader studies where disagreements in interpretations need to be resolved. For non-clinical device testing, results are typically objective measurements against pre-defined specifications.
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. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This means no human-in-the-loop or clinical studies were performed or are discussed here. MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are physical thrombectomy devices, not AI algorithms.
7. The type of ground truth used:
- For the non-clinical tests ("verification and validation testing"), the "ground truth" is defined by engineering specifications, material properties, and performance benchmarks established through industry standards and the predicate device's known performance. For example, a "burst" test would have a pre-defined pressure or force target that the device must withstand to pass.
8. The sample size for the training set:
- Not applicable. This concept is for machine learning models. These devices are physical products.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided FDA 510(k) summary is for physical medical devices and does not describe acceptance criteria or studies related to AI performance or human reader studies. The "studies" mentioned are non-clinical verification and validation tests to ensure the physical device meets its design specifications and is substantially equivalent to existing predicate devices.
{0}------------------------------------------------
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).
{1}------------------------------------------------
2
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,
{2}------------------------------------------------
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
{3}------------------------------------------------
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)
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."
{4}------------------------------------------------
PAGE 1 OF 4
510(K) SUMMARY
| Date prepared | October 10, 2024 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Ellen NguyenSenior 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)This device has not been subject to a design-related recall. |
| 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) |
| Description | The Artix™ MT is a single-use, over-the-wire catheter device used for theminimally invasive treatment of thromboemboli in the peripheral vasculature. TheArtix 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 theArtix Thin-Walled Sheath) and advanced until its proximal marker band is distal tothe target thrombus. The self-expanding element is deployed by retracting thedelivery catheter. Thrombus is engaged and removed by retracting the Artix MTinto the sheath and out of the patient. Once the procedure is complete, the system iscompletely 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 ofTechnological | 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- |
{5}------------------------------------------------
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™ MTProposed (TBD) | Artix™ Thrombectomy DevicePredicate (K220600) |
|---|---|---|
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Regulations | 21 CFR 870.5150Embolectomy catheter21 CFR 870.1210 Continuousflush catheter | 21 CFR 870.5150Embolectomy catheter21 CFR 870.1210 Continuousflush catheter |
| Product code | QEW, KRA | QEW, KRA |
| Intendeduse/Indicationsfor use | The Artix MT thrombectomydevice is indicated for:• The non-surgical removalof emboli and thrombifrom blood vessels.• Injection, infusion, and/oraspiration of contrastmedia and other fluidsinto or from a bloodvessel.The Artix MT thrombectomydevice is intended for use inthe peripheral vasculature. | The Artix ThrombectomyDevice is indicated for:• The non-surgical removalof emboli and thrombifrom blood vessels.• Injection, infusion, and/oraspiration of contrastmedia and other fluidsinto or from a bloodvessel.The Artix ThrombectomyDevice is intended for use inthe peripheral vasculature. |
| Contraindications | • Not intended for use inthe pulmonary, cerebral,carotid, or coronaryarteries.• Not intended for use inendarterectomyprocedures or vesseldilation. | • Not intended for use inthe pulmonary, cerebral,carotid, or coronaryarteries.• Not intended for use inendarterectomyprocedures or vesseldilation. |
| 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.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.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 mm4-8 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 wirePebax, Tungsten marker band | Platinum-iridium marker band |
| Guidewire compatibility | Same | 0.014" |
| Accessories provided | StopcockCleaning accessory | Stopcock |
{6}------------------------------------------------
Biocompatibility
The following biocompatibility tests were completed for the subject devices:
- . Cytotoxicity . Sensitization
{7}------------------------------------------------
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 ●
- Corrosion ●
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.
{8}------------------------------------------------
PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | October 10, 2024 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Ellen NguyenSenior 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)This device has not been subject to a design-related recall. |
| Reference device(s) | Surmodics, Pounce Thrombectomy System (K231022)Capture Vascular, MegaVac Mechanical Thrombectomy System (K171493)Inari Medical, ClotTriever Sheath (K233815) |
| Description | The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wiresystem designed to facilitate the insertion and guidance of an intravascular catheterinto a selected peripheral blood vessel and act as a conduit for endovascular devices.The Artix Sheath also non-surgically aspirates thromboemboli from selected vesselsand is capable of infusion/aspiration of fluids into or from a selected vessel. TheArtix Sheath is packaged with the following components: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.Any compatible endovascular device, such as the Artix MT, can then be insertedthrough the Artix Sheath for access into the peripheral vasculature. The providedfunnel catheter accessory can also be inserted through the Sheath and deployed toprovide flow occlusion of the vessel during the procedure to aid with the system'sclot ingestion. Compatible endovascular devices, such as the Artix MT, can be usedthrough the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mLsyringe can be used to aspirate clot in the vessel or Sheath and infuse contrast mediaand other fluids as required. Once the procedure is complete, the funnel catheter (ifused) is removed prior to withdrawal of the entire system from the patient, andstandard 7 Fr closure devices can be used. |
{9}------------------------------------------------
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 -Proposed (TBD) | ArtixTM BG - Predicate(K230912) |
|---|---|---|
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Regulations | 21 CFR 870.5150 Embolectomycatheter21 CFR 870.1250 Percutaneouscatheter | 21 CFR 870.5150 Embolectomycatheter21 CFR 870.1250 Percutaneouscatheter |
| Product code | QEW, DQY | QEW, DQY |
| Intendeduse/Indicationsfor use | The Artix Thin-Walled Sheath isindicated for:• The non-surgical removal ofemboli and thrombi fromblood vessels.• Injection, infusion, and/oraspiration of contrast media | The Artix BG balloonthrombectomy sheath isindicated for:• The non-surgical aspirationof emboli and thrombi fromblood vessels.• Injection, infusion, and/oraspiration of contrast media |
| and other fluids into or froma blood vessel.Use as a conduit for●endovascular devices.Use in facilitating the●insertion and guidance of anintravascular catheter into aselected blood vessel. Thefunnel provides temporaryvascular occlusion duringthese and other angiographicprocedures.The Artix Thin-Walled Sheath isintended for use in the peripheralvasculature. | and other fluids into or froma blood vessel.Use as a conduit for retrieval●devices.Use in facilitating the●insertion and guidance of anintravascular catheter into aselected blood vessel. Theballoon provides temporaryvascular occlusion duringthese and other angiographicprocedures.The Artix BG balloonthrombectomy sheath isintended for use in theperipheral vasculature. | |
| Principles ofoperation | After the target vessel isaccessed and dilated, the ArtixThin-Walled Sheath is insertedinto the vessel over a guidewire.Once the Sheath is in position,the dilator is removed, and allcompatible endovasculardevices, such as the Artix MT,can be inserted through the ArtixSheath for access into theperipheral vasculature. Theprovided Funnel CatheterAccessory can also be insertedthrough the sheath and deployedto provide flow occlusion of thevessel during the procedure toaid with clot ingestion. Theprovided 30 mL syringe can beused to aspirate clot in the vesselor sheath and infuse contrastmedia and other fluids asrequired. | After the target vessel isaccessed and dilated, the ArtixBG is inserted into the vesselover a guidewire. Once the ArtixBG is in position, the dilator isremoved, and all compatiblecatheter devices, such as theArtix Thrombectomy Device(K220600), can be insertedthrough the Artix BG for accessinto the peripheral vasculature.The sheath's balloon can also beinflated using a 1 mL syringe toprovide flow occlusion of thevessel during the procedure. Theprovided 30 mL syringe can beused to aspirate clot in the vesselor sheath and infuse contrastmedia and other fluids asrequired. |
| Intendedpatientpopulation | Same | Adults undergoinginterventional procedures |
| Target vessel | Same | Peripheral vasculature |
| Sterile | Same | SAL 10-6, EO |
| Device andpackagingmaterials | Same | Biocompatible, commonly usedmaterials for medical devices |
| Devicedimensions | Same with decreased OD profileand length increase of the longermodel | Appropriately sized for theintroduction of interventionaldevices into the target vessel |
| Shelf-life | 6 months | 2 years* |
| Single use | Yes | Yes |
| Marker band | Pebax, Tungsten | Platinum-Iridium |
| Guidewirecompatibility | 0.035" | 0.014" or 0.035" |
| Accessoriesprovided | Dilators (2), funnel catheter,funnel loading tool (2), large-bore syringe | Dilators (2), balloon inflationsyringe, large-bore syringe |
{10}------------------------------------------------
{11}------------------------------------------------
Biocompatibility
The following biocompatibility tests were completed for the subject device:
- . Cytotoxicity
- Intracutaneous Reactivity Acute Systemic Toxicity ●
- . Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis)
Sensitization
- Genotoxicity
The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.
Sterilization
●
The subject device and its accessories are sterilized using EtO to achieve a sterility assurance level (SAL) of 10 ° 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 Thin-Walled Sheath. These tests included:
- Packaging Testing
- . Visual and Dimensional Inspections
- Simulated Use Testing
- Air Leak Testing, Syringe ● Pullback
- Hemostasis, Sheath and ● Dilator
- Clot Burden Removal ●
- Sheath Burst
- Air Leak Testing, Dilator Removal
- . Tensile
- Dye Staining
- Lubricity, Post-Use ●
- Vacuum Testing ●
- Particulate ●
- Sheath Aspirational Flow Rate ●
- Kink
- Radiopacity .
- . Torque
Neither animal testing nor clinical testing were required for the determination of substantial equivalence.
{12}------------------------------------------------
Conclusion
The Artix™ Thin-Walled Sheath has the same intended use and principles of operation as the predicate device. The testing provided supports the Artix Thin-Walled Sheath's substantial equivalence to the predicate devices.
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).