(109 days)
No
The summary describes a mechanical thrombectomy device and sheath, focusing on their physical components and operational procedures. There is no mention of AI, ML, image processing for analysis, or any software-driven decision-making or data analysis that would typically indicate the presence of AI/ML.
Yes
The device is indicated for "non-surgical removal of emboli and thrombi from blood vessels" and for "injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel," which are therapeutic actions.
No
The device is primarily intended for the mechanical removal of emboli and thrombi, injection/infusion/aspiration of fluids, and as a conduit for other devices. Its functions are interventional and therapeutic rather than diagnostic.
No
The device description clearly outlines physical components like catheters, sheaths, dilators, syringes, and a stopcock, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body.
- Device Function: The Artix™ MT thrombectomy device and Artix™ Thin-Walled Sheath are designed for the direct removal of emboli and thrombi from blood vessels within the body (in vivo). They are also used for the injection, infusion, and aspiration of fluids directly into or from blood vessels.
- Intended Use: The stated intended uses clearly describe procedures performed directly on the patient's vasculature, not on samples taken from the patient.
- Device Description: The description details a catheter-based system inserted into the body to physically interact with and remove clots.
The device is an interventional medical device used for therapeutic procedures within the peripheral vasculature.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA, DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Adults undergoing interventional procedures
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)
Non-Clinical Testing was performed.
For Artix MT: Packaging Testing, Inspections (Hemostasis, Particulate, Tensile, Visual and Dimensional), Simulated Use Testing (Liquid Leakage, Burst, Corrosion, Radiopacity, Radial Force, Chronic Clot Analog).
For Artix Thin-Walled Sheath: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Inari Medical, Artix Thrombectomy Device (K220600), Inari Medical, Artix BG (K230912)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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PAGE 1 OF 4
510(K) SUMMARY
| Date prepared | October 10, 2024 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 | |
| Contact person | Ellen Nguyen |
| 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) |
| 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 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. | |
| 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 | |
| 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- |
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™ MT
Proposed (TBD) | Artix™ Thrombectomy Device
Predicate (K220600) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. |
| Regulations | 21 CFR 870.5150
Embolectomy catheter
21 CFR 870.1210 Continuous
flush catheter | 21 CFR 870.5150
Embolectomy catheter
21 CFR 870.1210 Continuous
flush catheter |
| Product code | QEW, KRA | QEW, KRA |
| Intended
use/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. | The Artix 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 Thrombectomy
Device is intended for use in
the peripheral vasculature. |
| Contraindications | • Not intended for use in
the pulmonary, cerebral,
carotid, or coronary
arteries.
• Not intended for use in
endarterectomy
procedures or vessel
dilation. | • Not intended for use in
the pulmonary, cerebral,
carotid, or coronary
arteries.
• Not intended for use in
endarterectomy
procedures or vessel
dilation. |
| | Not indicated for the removal of fibrous, adherent, or calcified material (e.g., atherosclerotic plaque). Not intended for use in vessels