FlowTriever Retrieval/Aspiration System

K201541 · Inari Medical · QEW · Dec 4, 2020 · Cardiovascular

Device Facts

Record IDK201541
Device NameFlowTriever Retrieval/Aspiration System
ApplicantInari Medical
Product CodeQEW · Cardiovascular
Decision DateDec 4, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.5150
Device ClassClass 2
AttributesTherapeutic

Intended Use

The FlowTriever2 Catheter is indicated for: - The non-surgical removal of emboli and thrombi from peripheral blood vessels. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature.

Device Story

FlowTriever Retrieval/Aspiration System is a single-use, over-the-wire, catheter-based system for minimally invasive treatment of peripheral thromboemboli. System components include Triever Catheters (16, 20, 24 Fr) and FlowTriever2 Catheter. Procedure: FlowTriever2 is advanced through Triever Catheter to thrombus; self-expanding laser-cut nitinol disk is deployed to engage clot; device is retracted into Triever Catheter to capture thrombus; aspiration is performed via 60 cc VacLok vacuum syringe. Used in clinical settings by physicians. Proximal stop feature alerts user to deployment status. Benefits include effective thrombus removal with reduced risk of vessel damage via optimized single-disk geometry.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (visual/dimensional inspection, guidewire compatibility, radial expansion/deployment/retraction forces, leak/vacuum tests, kink resistance, clot analog removal validation, simulated use, tensile/burst pressure, torque, corrosion resistance, particulate testing) and animal testing, all meeting predetermined acceptance criteria.

Technological Characteristics

Catheter-based system; materials include laser-cut nitinol (disk), Polyimide/braid/Polyimide-PTFE composite (inner shaft), and polycarbonate (Luer). Features single self-expanding disk geometry. Dimensions: 120 cm delivery catheter length. Manual operation via vacuum syringe aspiration. Non-patient contacting proximal stop feature. No software or electronic components.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from peripheral blood vessels and for injection, infusion, or aspiration of fluids/contrast media in the peripheral vasculature.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 4, 2020 Inari Medical Eben Gordon Vice President, RA/QA 9 Parker. Suite 100 Irvine, California 92618 Re: K201541 Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: November 2, 2020 Received: November 3, 2020 Dear Eben Gordon: 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 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 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) K201541 Device Name FlowTriever Retrieval/Aspiration System Indications for Use (Describe) The FlowTriever2 Catheter is indicated for: - · The non-surgical removal of emboli and thrombi from peripheral blood vessels. - · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature. Type of Use (Select one or both, as applicable) | <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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}------------------------------------------------ PAGE 1 OF 3 # 510(K) SUMMARY | Date prepared | December 2, 2020 | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical, Inc.<br>9 Parker, Suite 100<br>Irvine, CA 92618<br>949.418.4095 | | Contact person | Eben Gordon<br>Vice President, Regulatory Affairs & Quality Assurance | | Trade name | FlowTriever Retrieval/Aspiration System | | Common name | Embolectomy catheter | | Regulation name | Embolectomy catheter | | Classification number | 21 CFR 870.5150 | | Product code | QEW | | Secondary Product<br>code | KRA | | Regulatory class | II | | Predicate device | Inari FlowTriever Retrieval/Aspiration System (K143563) | | Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire<br>catheter-based system for the minimally invasive treatment of thromboemboli in<br>the peripheral vasculature. The system is comprised of two main components<br>packaged separately:<br>• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)<br>• FlowTriever2 Catheter<br><br>The FlowTriever2 Catheter is inserted through the Triever Catheter and advanced<br>to the thrombus. Self-expanding disk(s) are deployed to engage thrombus by<br>retracting the outer delivery catheter. The FlowTriever2 Catheter is retracted into<br>the Triever Catheter to capture the targeted thrombus. Additional clot may be<br>removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the<br>procedure is complete, the Triever Catheter and FlowTriever2 Catheter are<br>removed from the patient. | | Indications for Use | The FlowTriever2 Catheter is indicated for:<br>The non-surgical removal of emboli and thrombi from peripheral blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature. | | Explanation of differences in indications for use | The indications for use of the FlowTriever2 Catheter is the same as the predicate device, i.e., use in the peripheral vasculature. | | Device modifications | The reason for this submission is to introduce a FlowTriever Catheter variant with these changes:<br>Redesign of the FlowTriever Catheter disk geometry Reduction of FlowTriever Catheter disks from 3 to 1 FlowTriever Catheter disk changed from formed nitinol wire to laser cut nitinol FlowTriever Catheter inner shaft material change to Polyimide/braid/Polyimide-PTFE composite FlowTriever Delivery Catheter length increased by 5 cm to 120 cm FlowTriever Delivery Catheter proximal Luer material changed to polycarbonate Non-patient contacting proximal stop feature added to alert user when the device is deployed | | Technological characteristics comparison | The proposed modifications to the FlowTriever Catheter principally involve the optimizing the disk geometry and reducing the number of disks from 3 to 1. The FlowTriever2's single disk shortens the treatment segment affording less risk of vessel damage while maintaining thrombus removal performance. The remaining incremental changes either improve manufacturability (laser cut nitinol disk, polyimide/braid/Polyimide-PTFE composite inner catheter material, polycarbonate Luer) or improve usability (5 cm longer Delivery Catheter, proximal stop feature). | {4}------------------------------------------------ K201541 ## PAGE 2 OF 3 {5}------------------------------------------------ | Summary of substantial equivalence | There is no change of intended use or fundamental scientific technology between the proposed and predicate device. The FlowTriever Retrieval/Aspiration System has the same indication for use as the predicate. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>Non-Clinical Testing</b><br>In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included: | | | | Visual & Dimensional Inspection Guidewire Compatibility Verification Radial Expansion Force Deployment Force Retraction Force Element Visual Inspection; Post Retraction Cycles Leak and Vacuum Test; Post Retraction Cycles Kink Resistance Clot Analog Burden Removal Validation Chronic Clot Analog Burden Removal Validation Simulated Use, Track and Tensile Liquid Leakage under Pressure Burst Pressure Simulated Use, Torque Corrosion Resistance Particulate testing | | | Animal testing met predetermined acceptance criteria. Clinical testing was not required for the determination of substantial equivalence.<br>Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. | | | <b>Conclusion</b><br>The proposed device modifications to the FlowTriever Retrieval/Aspiration System do not change its intended use or raise new or different questions of safety and effectiveness. With consideration of the results of the testing, it can be concluded that the proposed FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device. |
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%