Artix Thrombectomy Device

K220600 · Inari Medical · QEW · Mar 25, 2022 · Cardiovascular

Device Facts

Record IDK220600
Device NameArtix Thrombectomy Device
ApplicantInari Medical
Product CodeQEW · Cardiovascular
Decision DateMar 25, 2022
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 870.5150
Device ClassClass 2
AttributesTherapeutic

Intended 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 Story

Single-use over-the-wire embolectomy catheter; used for minimally invasive treatment of thromboemboli in peripheral vasculature. Inserted through 8 Fr sheath over 0.014" guidewire; advanced to thrombus. Self-expanding nitinol element deployed by retracting outer delivery catheter to engage thrombus; device retracted into sheath to capture clot. Additional aspiration performed via Luer syringe. Used by physicians in clinical setting. Benefits include mechanical removal of obstructive thrombi from peripheral blood vessels.

Clinical Evidence

Bench testing only. Verification and validation testing performed per Design Failure Modes and Effects Analysis. All acceptance criteria met. No animal or clinical testing required.

Technological Characteristics

Single-use over-the-wire catheter; self-expanding nitinol thrombectomy element; 8 Fr sheath compatibility; 0.014" guidewire compatible. Mechanical aspiration via Luer syringe. Sterile.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from peripheral vasculature; also for injection, infusion, or aspiration of contrast media and fluids.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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 ( <i>Describe</i> ) | |-----------------------------------------| |-----------------------------------------| 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) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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." {3}------------------------------------------------ K220600 PAGE 1 OF 2 # 510(K) SUMMARY | Date prepared | February 28, 2022 | |--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>877.923.4747 | | Contact person | Ellen Nguyen<br>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)<br>NeVa PV Thrombectomy Device (K201085) | | Description | The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter<br>used for the minimally invasive treatment of thromboemboli in the peripheral<br>vasculature.<br><br>Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and<br>advanced to the thrombus. A self-expanding nitinol element is deployed to engage<br>thrombus by retracting the outer delivery catheter. Artix is then retracted into the<br>sheath to capture the targeted thrombus. Additional clot may be removed by<br>aspiration with a Luer syringe (not provided). After the procedure is complete, the<br>Artix and sheath are removed from the patient. | | Indications for Use | The Artix Thrombectomy Device is indicated for:<br>• The non-surgical removal of emboli and thrombi from blood vessels.<br>• Injection, infusion, and/or aspiration of contrast media and other fluids<br>into or from a blood vessel.<br>The Artix Thrombectomy Device is intended for use in the peripheral vasculature. | | Device Modifications | The proposed modifications to the FlowTriever2 Catheter include a modified<br>thrombectomy element, dimensional changes, minor material changes, the<br>addition of a proximal hub, packaging updates, and a contraindication update.<br><br>These modifications introduce the Artix Thrombectomy Device, a FlowTriever2<br>catheter variant used for mechanical thrombectomy device in the peripheral<br>vasculature. | | | There have been no changes to the Triever or FlowTriever Catheters. | | Comparison of<br>Technological<br>Characteristics with the<br>Predicate Device | The proposed modifications do not change the intended use or principles of<br>operation from the predicate device. The modified and predicate device have a<br>similar design and mainly differ in dimensions and element geometry. | | | The information provided in this submission demonstrates that the differences in<br>technological characteristics between the predicate and proposed devices do not<br>raise any new questions of safety and effectiveness. | | | There have been no changes to the Triever or FlowTriever Catheters. | | Summary of substantial<br>equivalence | There is no change of intended use or fundamental scientific technology between<br>the proposed device and predicate device. The Artix Thrombectomy Device has the<br>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<br>validation testing were identified to support the substantial equivalence of the Artix<br>Thrombectomy Device. | | | Test results demonstrated that all acceptance criteria were met; therefore, the<br>devices conform to established product specifications. | | | Neither animal testing nor clinical testing were required for the determination of<br>substantial equivalence. | | | Conclusion | | | The proposed device modifications to the FlowTriever2 Catheter do not change its<br>intended use, principles of operation, or fundamental design. Non-clinical bench<br>testing supports the Artix Thrombectomy Device's substantial equivalence to the<br>predicate device. | {4}------------------------------------------------ K220600
Innolitics
510(k) Summary
Decision Summary
Classification Order
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