FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24

Q: Who is the manufacturer of FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

Inari Medical, Inc. filed the 510(k) submission for FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 (K211013).

Q: What is the FDA product code for FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

QEW. It is classified under 21 CFR 870.5150 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

Inari FlowTriever Retrieval/Aspiration System (K202345).

Q: Who can help prepare an FDA 510(k) submission like FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K211013 · Inari Medical, Inc. · QEW · Apr 30, 2021 · Cardiovascular

Device Facts

Record ID	K211013
Device Name	FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
Applicant	Inari Medical, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Apr 30, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The FlowTriever Retrieval/Aspiration System 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

Device Story

FlowTriever Retrieval/Aspiration System is a single-use, over-the-wire, catheter-based system for minimally invasive thromboemboli removal. System components include Triever Catheters (16, 20, 20 Curve, 24 Fr) and FlowTriever Catheters (6-25 mm sizes). Procedure involves advancing Triever catheter over a 0.035" guidewire to the thrombus site; removing the dilator; and applying aspiration via a 60 cc VacLok Vacuum syringe. Used in clinical settings by physicians for peripheral vasculature and pulmonary embolism treatment. Output is the physical removal of thrombus/emboli, facilitating blood flow restoration. Benefits include minimally invasive clot removal without surgery.

Clinical Evidence

No clinical data was required to support the change to the contraindications.

Technological Characteristics

Single-use, over-the-wire, catheter-based system. Comprised of Triever Catheters (16, 20, 20 Curve, 24 Fr) and FlowTriever Catheters (6-25 mm). Utilizes manual aspiration via 60 cc VacLok Vacuum syringe. No electronic components or software.

Indications for Use

Indicated for patients requiring non-surgical removal of emboli and thrombi from peripheral vasculature, treatment of pulmonary embolism, or treatment of clot in transit in the right atrium.

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

Inari FlowTriever Retrieval/Aspiration System (K202345)

Reference Devices

Inari FlowTriever Retrieval/Aspiration System (K201541)

Related Devices

K191710 — FlowTriever Retrieval/Aspiration System · Inari Medical · Sep 5, 2019
K191368 — FlowTriever Retrieval/Aspiration System · Inari Medical · Jun 17, 2019
K173672 — FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter · Inari Medical · Feb 5, 2018
K182233 — FlowTriever Retrieval/Aspiration System · Inari Medical · Oct 15, 2018
K213402 — Triever24, Triever20 · Inari Medical · May 23, 2022

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 30, 2021 Inari Medical, Inc. Larry Boucher Regulatory Affairs Manager 9 Parker. Suite 100 Irvine, California 92618 ## Re: K211013 Trade/Device Name: FlowTriever Retrieval/Aspiration System. FlowTriever Catheters: Triever 16. Triever 20, Triever 20 Curve, Triever 24 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: April 2, 2021 Received: April 5, 2021 Dear Larry Boucher: 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 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) K211013 #### Device Name FlowTriever Retrieval/Aspiration System, FlowTriever Catheters: Triever 20, Triever 20 Curve, Triever 24 Indications for Use (Describe) The FlowTriever Retrieval/Aspiration System 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters. 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) ## 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}------------------------------------------------ K211013 PAGE 1 OF 2 # 510(K) SUMMARY | Date prepared | April 2, 2021 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical, Inc. 9 Parker, Suite 100 Irvine, CA 92618 949.600.8433 | | Contact person | Larry Boucher Regulatory Affairs Manager | | Trade name | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters: Triever 16, Triever 20, Triever 20 Curve, Triever 24 | | 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 (K202345) | | Reference Device | Inari FlowTriever Retrieval/Aspiration System (K201541) | | Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately: • Triever Catheters (available in 3 sizes: 16, 20 (and 20 Curved) and 24 Fr) • FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient. | | Indications for Use | The FlowTriever Retrieval/Aspiration System 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. | | | Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters. | | {4}------------------------------------------------ {5}------------------------------------------------ | Device modifications | The contraindication for FlowTriever and Triever Catheter has been changed by deleting "chronic clot" from the examples given "…for removal of fibrous, adherent, or calcified material…". | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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, K202345. Non-Clinical Testing Non-clinical testing was not required to support the change to the contraindications. Clinical Testing No clinical data was required to support the change to the contraindications. Conclusion Removing "chronic clot" from the example "of fibrous, adherent, or calcified material" of a contraindication for the FlowTriever Retrieval/Aspiration System does not raise new or different questions of safety or and effectiveness. Therefore, the FlowTriever Retrieval/Aspiration System with the modified contraindication is substantially equivalent to the predicate device. |