(105 days)
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML algorithms or data processing.
Yes
The device is used for the non-surgical aspiration of emboli and thrombi from blood vessels, which is a therapeutic intervention.
No
The device is primarily used for interventional procedures such as facilitating catheter insertion, acting as a conduit for retrieval devices, aspirating emboli and thrombi, and injecting/aspirating fluids and contrast media. While it aids in "angiographic visualization" and procedures, its core function is procedural and therapeutic rather than solely diagnostic.
No
The device description clearly outlines physical components such as a sheath, dilator, syringes, and a stopcock, indicating it is a hardware-based medical device.
Based on the provided information, the Artix BG balloon thrombectomy sheath is not an IVD (In Vitro Diagnostic) device.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Artix BG Function: The Artix BG is a medical device used within the body (in vivo) to facilitate procedures in blood vessels. Its functions include:
- Guiding catheters
- Providing temporary vascular occlusion
- Retrieving thrombi/emboli
- Injecting/aspirating fluids
The device's purpose is to directly interact with the patient's vasculature during a procedure, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
The Artix BG balloon thrombectomy sheath is indicated for:
• Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
• Use as a conduit for retrieval devices.
• The non-surgical aspiration 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 BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEW, DQY
Device Description
The Artix BG 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 retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic and interventional procedures. The Artix BG also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix BG is packaged with the following components:
• Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm)
• 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility)
• Balloon Inflation Syringe, 1 mL
• Large Bore Syringe, 30 mL
• 3-way Stopcock
The Artix BG is comprised of a single through lumen shaft with four (4) embedded lumens for balloon inflation and deflation, a proximal integrated hemostasis valve to minimize blood loss, a stopcock with flush port, and a balloon port. To assist with insertion of the sheath into the vasculature, a hydrophilic coating covers a portion of the distal sheath shaft. The distal tip of the sheath shaft contains two (2) radiopaque marker bands to aid with angiographic visualization: The distal marker indicates the location of the sheath's tip, while the proximal marker band marks the location of a compliant balloon mounted at the distal end. The balloon provides temporary vascular occlusion during angiographic and interventional procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization, fluoroscopic visualization
Anatomical Site
selected blood vessel, peripheral vasculature
Indicated Patient Age Range
Adults
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:
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the Artix BG to the ClotTriever Thrombectomy System. These tests included:
- Sheath Visual & Dimensional
- Simulated Use Cycling
- Sheath Aspirational Flowrate
- Clot Burden Removal
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
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, ClotTriever Thrombectomy System (K212632)
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.
Inari Medical, Artix Balloon Guiding Sheath (K221846)
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2023
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K223000
Trade/Device Name: Artix BG Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, DQY Dated: December 9, 2022 Received: December 9, 2022
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 (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2023.01.11
05:00 nell -S 09:19:48 -05'00'
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
2
Indications for Use
510(k) Number (if known) K223000
Device Name Artix BG
Indications for Use (Describe)
The Artix BG balloon thrombectomy sheath is indicated for:
· Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
· Use as a conduit for retrieval devices.
· The non-surgical aspiration 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 BG balloon thrombectomy 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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3
PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | January 10, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Ellen Nguyen |
| Regulatory Affairs Specialist | |
| Trade name | Artix BG |
| Common name | Balloon thrombectomy sheath |
| Regulation name | Percutaneous catheter |
| Classification number | 21 CFR 870.1250 |
| Product code | QEW |
| Secondary product | |
| code | DQY |
| Regulatory class | II |
| Predicate device | Inari Medical, ClotTriever Thrombectomy System (K212632) |
| Reference device | Inari Medical, Artix Balloon Guiding Sheath (K221846) |
| Description | The Artix BG 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 retrieval devices. A compliant balloon | |
| mounted at the sheath's distal tip provides temporary vascular occlusion | |
| during angiographic and interventional procedures. The Artix BG also non- | |
| surgically aspirates thromboemboli from selected vessels and is capable of | |
| infusion/aspiration of fluids into or from a selected vessel. The Artix BG is | |
| packaged with the following components: | |
| • Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm) | |
| • 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility) | |
| • Balloon Inflation Syringe, 1 mL | |
| • Large Bore Syringe, 30 mL | |
| • 3-way Stopcock | |
| Indications for Use | The Artix BG balloon thrombectomy sheath is indicated for: |
| • Use in facilitating the insertion and guidance of an intravascular | |
| catheter into a selected blood vessel. The balloon provides temporary | |
| vascular occlusion during these and other angiographic procedures. | |
| • Use as a conduit for retrieval devices. | |
| • The non-surgical aspiration of emboli and thrombi from blood | |
| vessels. |
4
PAGE 2 OF 5
- Injection, infusion, and/or aspiration of contrast media and other ● fluids into or from a blood vessel.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
The predicate ClotTriever Thrombectomy System is indicated for "The nonsurgical removal of emboli and thrombi from blood vessels and injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." The Artix BG's expanded indications for use are identical. Both devices are intended for use in the peripheral vasculature, with the only difference being that the predicate device is also intended for the treatment of deep vein thrombosis (DVT).
A tabular comparison of specific technological characteristics between the predicate and subject devices is provided below:
| Feature | Artix BG - Subject Device | ClotTriever
Thrombectomy System -
Predicate (K212632) | Artix Balloon Guiding
Sheath - Reference
Device (K221846) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical | Inari Medical |
| Product code | QEW, DQY | QEW | DQY |
| Intended
use/Indications for
use | The Artix BG balloon
thrombectomy sheath is
indicated for:
Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Use as a conduit for retrieval devices. The non-surgical aspiration of thrombi and emboli from blood vessels. Infusion, injection, and/or aspiration of contrast media or other fluid into or from a blood vessel. The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature. | The ClotTriever
Thrombectomy System is
indicated for:
The non-surgical removal of thrombi and emboli from blood vessels. Infusion, injection, and/or aspiration of contrast media or other fluid into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | The Artix Balloon
Guiding Sheath is
indicated for use in
facilitating the insertion
and guidance of an
intravascular catheter
into a selected blood
vessel. The balloon
provides temporary
vascular occlusion
during these and other
angiographic procedures.
The Artix Balloon
Guiding Sheath is also
indicated for use as a
conduit for retrieval
devices.
The Artix Balloon
Guiding Sheath is
intended for use in the
peripheral vasculature. |
| Feature | Artix BG - Subject Device | ClotTriever
Thrombectomy System -
Predicate (K212632) | Artix Balloon Guiding
Sheath - Reference
Device (K221846) |
| Device description | The Artix BG is comprised
of a single through lumen
shaft with four (4)
embedded lumens for
balloon inflation and
deflation, a proximal
integrated hemostasis valve
to minimize blood loss, a
stopcock with flush port,
and a balloon port. To assist
with insertion of the sheath
into the vasculature, a
hydrophilic coating covers a
portion of the distal sheath
shaft. The distal tip of the
sheath shaft contains two
(2) radiopaque marker
bands to aid with
angiographic visualization:
The distal marker indicates
the location of the sheath's
tip, while the proximal
marker band marks the
location of a compliant
balloon mounted at the
distal end. The balloon
provides temporary vascular
occlusion during
angiographic and
interventional procedures. | The ClotTriever
Thrombectomy System
consists of ClotTriever 13
Fr and 16 Fr Sheaths
("Sheath") and the
ClotTriever/ClotTriever
Bold Catheter
("Catheter"), each
packaged separately.
The sheath is an introducer
sheath with a distal self-
expanding funnel,
aspiration port, and
proximal hub. A dilator is
provided to aid insertion
and positioning of the
sheath. Other provided
accessories include a 60 cc
large bore syringe that
provides a vacuum source
and collects aspirated
contents. Radiopaque
markers aid sheath
positioning under
fluoroscopic visualization.
The dilator tip is
radiopaque, and there is a
radiopaque marker band
near the distal end of the
sheath. | The Artix Balloon
Guiding Sheath is
comprised of a single
through lumen shaft with
four (4) embedded
lumens for balloon
inflation and deflation, a
proximal integrated
hemostasis valve to
minimize blood loss, a
stopcock with flush port,
and a balloon port. To
assist with insertion of
the sheath into the
vasculature, a
hydrophilic coating
covers a portion of the
distal sheath shaft. The
distal tip of the sheath
shaft contains two (2)
radiopaque marker bands
to aid with angiographic
visualization: The distal
marker indicates the
location of the sheath's
tip, while the proximal
marker band marks the
location of a compliant
balloon mounted at the
distal end. The balloon
provides temporary
vascular occlusion
during angiographic and
interventional
procedures. |
| Principles of
operation | After the target vessel is
accessed and dilated, the
Artix BG is inserted into the
vessel over a guidewire.
Once the Artix BG is in
position, the dilator is
removed, and all compatible
catheter devices, such as the
Artix MT (K220600), can
be inserted through the
Artix BG for access into the
peripheral vasculature. The
sheath's balloon can also be
inflated using a 1 mL
syringe to provide flow | After the target vessel is
accessed and dilated, the
ClotTriever Sheath is
inserted into the vessel
over a guidewire. The
ClotTriever/ClotTriever
Bold Catheter can then be
advanced through the
sheath and beyond the clot.
The self-expanding braided
nitinol wire net is
deployed. The expanded
net cores, separates, and
entraps thrombus from the
vessel as it is being drawn | After the target vessel is
accessed and dilated, the
Artix Balloon Guiding
Sheath is inserted into
the vessel over a
guidewire. Once the
Artix Sheath is in
position, the dilator is
removed, and all
compatible catheter
devices can be inserted
through the Artix Sheath
for access into the
peripheral vasculature.
The sheath's balloon can |
| | | | |
| Feature | Artix BG - Subject Device | ClotTriever
Thrombectomy System -
Predicate (K212632) | Artix Balloon Guiding
Sheath - Reference
Device (K221846) |
| | occlusion of the vessel
during the procedure. 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. | to the funnel opening of
the ClotTriever Sheath.
The net is collapsed and
pulled into and through the
ClotTriever Sheath with
the entrapped clot. A 60 cc
syringe is provided for the
aspiration of clot in the
sheath and the infusion of
contrast media and other
fluids. | also be inflated using a 1
mL syringe to provide
flow occlusion of the
vessel during the
procedure. |
| Intended patient
population | Adults undergoing
interventional procedures | Adults undergoing
interventional procedures | Adults undergoing
interventional procedures |
| Target vessel | Peripheral vasculature | Peripheral vasculature | Peripheral vasculature |
| Placement duration |