(108 days)
No
The summary describes a mechanical aspiration catheter and syringe system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical and fluid dynamics properties.
Yes
The device is used for the non-surgical removal of emboli and thrombi from blood vessels in the peripheral vasculature to treat thromboemboli, which is a therapeutic action.
No
The device is an aspiration catheter used for the removal of emboli and thrombi and the injection/aspiration of fluids from blood vessels, which are interventional or therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical catheter and syringe, and the performance studies detail testing of physical properties and simulated use with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Artix AX aspiration catheter is a physical device used within the body (in the peripheral vasculature) to remove emboli and thrombi, and to inject/aspirate fluids. It does not analyze specimens outside the body.
- Intended Use: The intended use clearly describes a therapeutic and procedural function within the patient's blood vessels, not the analysis of biological samples.
Therefore, the Artix AX aspiration catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Artix AX aspiration catheter 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 AX aspiration catheter is intended for use in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
OEW, KRA
Device Description
The Artix AX is a single-use, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system comprises two catheter lengths, 85 cm and 115 cm, packaged separately.
The Artix AX is inserted over a pre-placed guidewire and advanced to the thrombus, which can then be removed via aspiration with the provided 30 mL Large Bore Vacuum Syringe. The Artix MT may also be deployed through the Artix AX to engage thrombus before being retracted through the Artix AX. Additional clot may be removed by aspiration through the Artix AX as necessary. After the procedure is complete, the Artix AX is removed from the patient.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 AX. These tests included:
- Pouch Seal Visual Inspection and Dye Penetration
- Visual & Dimensional Inspection
- Guidewire Compatibility
- Cheater Sheath Compatibility
- Artix MT/BG Compatibility and Simulated Use
- Kink Radius
- Air Leakage During Aspiration
- Leakage Testing
- Vacuum Testing
- Liquid Leakage Under Pressure (300 kPa) Testing
- Determination of Flowrate Through Catheter
- Burst Testing
- Clot Burden Removal Validation
- Simulated Use, Track & Tensile Catheter
- Simulated Use, Track & Torque Catheter
- 30 mL Large Bore Syringe Leak Testing
- 30 mL Large Bore Syringe Vacuum Testing
- Simulated Use & Tensile 30 mL Large Bore Syringe
- Simulated Use & Torque - 30 mL Large Bore Syringe
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 FlowTriever Retrieval/Aspiration System (K213402)
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.
Penumbra Indigo System CAT RX Aspiration Catheter (K163618)
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.
March 2, 2023
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618
Re: K223436
Trade/Device Name: Artix AX Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW. KRA Dated: January 30, 2023 Received: January 31, 2023
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
1
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 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 (QS) 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 medical devices and radiation-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 O'connell -S Pate: 2023.03.02
O'connell -S 16:27:18 -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)
Device Name Artix AX
| Indications for Use ( Describe ) |
|---|
| ----------------------------------------- |
The Artix AX aspiration catheter 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 AX aspiration catheter is intended for use in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | March 1, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Ellen Nguyen |
| Regulatory Affairs Specialist | |
| Name of Device | Artix AX |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K213402) |
| References devices | Penumbra Indigo System CAT RX Aspiration Catheter (K163618) |
| Description | The Artix AX is a single-use, over-the-wire catheter used for the minimally invasive |
| treatment of thromboemboli in the peripheral vasculature. The system comprises | |
| two catheter lengths, 85 cm and 115 cm, packaged separately. |
The Artix AX is inserted over a pre-placed guidewire and advanced to the
thrombus, which can then be removed via aspiration with the provided 30 mL
Large Bore Vacuum Syringe. The Artix MT may also be deployed through the
Artix AX to engage thrombus before being retracted through the Artix AX.
Additional clot may be removed by aspiration through the Artix AX as necessary.
After the procedure is complete, the Artix AX is removed from the patient. |
| Indications for Use | The Artix AX aspiration catheter 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 AX aspiration catheter is intended for use in the peripheral vasculature. |
| Device Modifications | The proposed modifications are to the Triever16 component and include
dimensional and material changes to the catheter and removal of the dilator.
These modifications introduce the Artix AX, a smaller embolectomy catheter used
for aspiration thrombectomy in the peripheral vasculature.
There have been no changes to the Triever20 Fr/20 Curve and the Triever24 Fr
Catheters or the FlowTriever Catheters. |
4
Comparison of Technological Characteristics with the Predicate Device
The proposed modifications do not change the intended use or principles of operation from the predicate device. The modified and predicate device have a similar design and mainly differ in dimensions and materials.
The Artix AX and Triever16 are both tracked over a pre-placed compatible guidewire. The Artix MT or FlowTriever Catheter can then be deployed through the Artix AX or Triever 16/20/24 Fr catheters respectively to engage and withdraw thrombus. Additional clot can be aspirated through the Artix AX or Triever16 using the provided 30 ml or 60 mL Large Bore Syringe.
Although the predicate and subject devices have different technological characteristics, all leveraged and performed design verification and validation tests confirm that these differences do not raise any new or different questions of safety or effectiveness.
There have been no changes to the Triever20 Fr/20 Curve or the Triever24 Fr Catheters or the FlowTriever Catheters.
Summary of substantial There is no change of intended use or fundamental scientific technology between the equivalence proposed device and predicate device. The Artix AX's indications for use falls within those of the predicate device. K213402: both are indicated for the non-surgical removal of emboli and thrombi from blood vessels and the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. Both are intended for use in the peripheral vasculature. The Triever16 is additionally intended for the treatment of pulmonary embolism and for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:
| Feature | Artix AX
Subject (TBD) | Triever16
Predicate (K213402) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| Intended
use/Indications for
use | The Artix AX aspiration
catheter 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 AX aspiration
catheter is intended for use in
the peripheral vasculature. | The Triever16 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 Triever16 is intended for
use in the peripheral
vasculature and for the
treatment of pulmonary
embolism.
Triever Catheters are also |
| Feature | Artix MT
Subject (TBD) | Triever16
Predicate (K213402) |
| | | intended for use in treating clot
in transit in the right atrium but
not in conjunction with
FlowTriever Catheters. |
| Principles of
operation | The Artix AX is inserted over a
pre-placed guidewire and
advanced to the thrombus. The
Artix MT can then be deployed
through the Artix AX to engage
thrombus before being
retracted through the Artix AX.
Additional clot may be
removed by aspiration through
the Artix AX with the provided
30 mL Large Bore Vacuum
syringe. After the procedure is
complete, the Artix AX is
removed from the patient. | The Triever16 is inserted over
a pre-placed guidewire and
advanced to the thrombus. The
FlowTriever Catheter can then
be deployed through the
Triever16 to engage thrombus
before being retracted through
the Triever16. Additional clot
may be removed by aspiration
through the Triever16 with the
provided 60 mL Large Bore
Vacuum syringe. After the
procedure is complete, the
Triever 16 is removed from the
patient. |
| Target vessel | Peripheral vessels ≥ 3 mm | Peripheral vessels ≥ 6 mm,
pulmonary arteries, right heart |
| Contraindicated
vessels | Cerebral, carotid, coronary,
pulmonary arteries | Cerebral, carotid, coronary
arteries |
| Guidewire
compatibility | Up to 0.035" | Up to 0.035" |
| Shelf-life | 6 months | 2 years |
| Sterilization | EtO | EtO |
| Single-use | Yes | Yes |
| Dimensions | OD/ID: 2.8 mm/2.4 mm
Working length: 85 cm, 115 cm | OD/ID: 5.3 mm/4.5 mm
Working length: 107 cm |
| Outer Shaft
material | Pebax 35D with ProPell, Pebax
45D with ProPell, Pebax 55D
with ProPell, Pebax 63D,
Pebax 72D | Pebax 35D, Pebax 63D |
| Inner Shaft
Material | Etched PTFE | Etched PTFE |
| Metal support | Stainless steel coil | Stainless steel coil and braid |
| Hemostasis valve | Mini Garrote valve | Garrote valve |
| Tip bevel | 30° | No bevel |
5
PAGE 3 OF 5
Biocomnatibility
The following biocompatibility tests were completed for the subject device:
- . Cytotoxicity
- . Sensitization
- . Intracutaneous Reactivity
- Acute Systemic Toxicity
6
PAGE 4 OF 5
- Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis, Complement Activation, o Thromboresistance, Platelet and Leukocyte Count, and Partial Thromboplastin Time)
The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 106. The subject device has been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 (Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E. Single batch release) and AAMI TIR 28:2016 (Product adoption and process equivalence for ethylene oxide sterilization) without deviations.
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 AX. These tests included:
- Pouch Seal Visual Inspection and Dye Penetration ●
- Visual & Dimensional Inspection ●
- Guidewire Compatibility ●
- Cheater Sheath Compatibility ●
- Artix MT/BG Compatibility and Simulated Use ●
- Kink Radius ●
- Air Leakage During Aspiration
- Leakage Testing ●
- Vacuum Testing ●
- Liquid Leakage Under Pressure (300 kPa) Testing
- Determination of Flowrate Through Catheter ●
- Burst Testing
- Clot Burden Removal Validation ●
- Simulated Use, Track & Tensile Catheter ●
- Simulated Use, Track & Torque Catheter ●
- 30 mL Large Bore Syringe Leak Testing ●
- 30 mL Large Bore Syringe Vacuum Testing
- Simulated Use & Tensile 30 mL Large Bore Syringe .
- . Simulated Use & Torque - 30 mL Large Bore Syringe
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.
7
Conclusion
The Artix AX has the same intended use/indications for use and principles of operation as the predicate. Performance data shows that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness. Non-clinical bench testing supports the Artix AX's substantial equivalence to the predicate device.