(23 days)
No
The provided text describes a mechanical thrombectomy device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature," which directly addresses and treats a medical condition.
No
The device is designed for the removal of thrombi and emboli, and for injection/aspiration of fluids, which are therapeutic/interventional actions, not diagnostic ones.
No
The device description clearly states it is a single-use over-the-wire catheter with a self-expanding nitinol element, indicating it is a physical hardware device, not software only.
Based on the provided information, the Artix Thrombectomy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Artix Device Function: The description clearly states that the Artix Thrombectomy Device is a catheter used for the 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. This is a therapeutic and interventional procedure performed within the patient's body.
The device is used to treat a condition directly within the patient's vasculature, not to analyze a sample taken from the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
QEW, KRA
Device Description
The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature.
Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and advanced to the thrombus. A self-expanding nitinol element is deployed to engage thrombus by retracting the outer delivery catheter. Artix is then retracted into the sheath to capture the targeted thrombus. Additional clot may be removed by aspiration with a Luer syringe (not provided). After the procedure is complete, the Artix and sheath are 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
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 Thrombectomy Device.
Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications.
Neither animal testing nor clinical testing were required for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Inari FlowTriever Retrieval/Aspiration System (K201541)
Reference Device(s)
ReVive PV Thrombectomy Device (K132281), NeVa PV Thrombectomy Device (K201085)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 25, 2022
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K220600
Trade/Device Name: Artix Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 28, 2022 Received: March 3, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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 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)
K220600
Device Name Artix Thrombectomy Device
| Indications for Use ( Describe ) |
|---|
| ----------------------------------------- |
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.
| 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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PAGE 1 OF 2
510(K) SUMMARY
| Date prepared | February 28, 2022 |
|---|---|
| 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 Thrombectomy Device |
| 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 (K201541) |
| References devices | ReVive PV Thrombectomy Device (K132281) |
| NeVa PV Thrombectomy Device (K201085) | |
| Description | The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter |
| used for the minimally invasive treatment of thromboemboli in the peripheral | |
| vasculature. |
Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and
advanced to the thrombus. A self-expanding nitinol element is deployed to engage
thrombus by retracting the outer delivery catheter. Artix is then retracted into the
sheath to capture the targeted thrombus. Additional clot may be removed by
aspiration with a Luer syringe (not provided). After the procedure is complete, the
Artix and sheath are removed from the patient. |
| Indications for Use | 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. |
| Device Modifications | The proposed modifications to the FlowTriever2 Catheter include a modified
thrombectomy element, dimensional changes, minor material changes, the
addition of a proximal hub, packaging updates, and a contraindication update.
These modifications introduce the Artix Thrombectomy Device, a FlowTriever2
catheter variant used for mechanical thrombectomy device in the peripheral
vasculature. |
| | There have been no changes to the Triever or FlowTriever Catheters. |
| 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 element geometry. |
| | The information provided in this submission demonstrates that the differences in
technological characteristics between the predicate and proposed devices do not
raise any new questions of safety and effectiveness. |
| | There have been no changes to the Triever or FlowTriever Catheters. |
| Summary of substantial
equivalence | There is no change of intended use or fundamental scientific technology between
the proposed device and predicate device. The Artix Thrombectomy Device has the
same indication for use as the predicate FlowTriever2 Catheter device, K201541. |
| | 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
Thrombectomy Device. |
| | Test results demonstrated that all acceptance criteria were met; therefore, the
devices conform to established product specifications. |
| | Neither animal testing nor clinical testing were required for the determination of
substantial equivalence. |
| | Conclusion |
| | The proposed device modifications to the FlowTriever2 Catheter do not change its
intended use, principles of operation, or fundamental design. Non-clinical bench
testing supports the Artix Thrombectomy Device's substantial equivalence to the
predicate device. |
4