Who is the manufacturer of ClotTriever Thrombectomy System?

Inari Medical, Inc. filed the 510(k) submission for ClotTriever Thrombectomy System (K221531).

What is the FDA product code for ClotTriever Thrombectomy System?

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

What is the regulatory pathway for ClotTriever Thrombectomy System?

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

Who can help prepare an FDA 510(k) submission like ClotTriever Thrombectomy System?

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.

ClotTriever Thrombectomy System

Q: What are the predicate devices for ClotTriever Thrombectomy System?

ClotTriever Thrombectomy System (K212632).

K221531 · Inari Medical, Inc. · QEW · Feb 6, 2023 · Cardiovascular

Device Facts

Record ID	K221531
Device Name	ClotTriever Thrombectomy System
Applicant	Inari Medical, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Feb 6, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ClotTriever Thrombectomy System is indicated for: · The non-surgical removal of thrombi and emboli from blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

Device Story

Single-use, sterile mechanical thrombectomy system for peripheral vasculature. Comprises ClotTriever Sheath (reinforced polymer, self-expanding distal mesh funnel, hemostatic valve) and ClotTriever Catheter (reinforced coaxial shafts, expandable coring element, thrombus collection bag). Operated by physician in clinical setting; uses fluoroscopic guidance via radiopaque tips. Device mechanically cores and captures thrombi/emboli into collection bag for removal. Modification involves updated labeling of contraindications regarding fibrous/adherent materials. Benefits include non-surgical thrombus removal.

Clinical Evidence

Clinical evidence provided via CLOUT registry data (originally submitted in K193462) and peer-reviewed literature/case reports. No new clinical testing performed for this specific labeling modification.

Technological Characteristics

Reinforced polymeric sheath with self-expanding distal mesh funnel; reinforced polymeric coaxial catheter shafts with expandable coring element and collection bag. Radiopaque markers on sheath dilator and catheter distal tips for fluoroscopic visualization. Single-use, sterile.

Indications for Use

Indicated for non-surgical removal of thrombi/emboli from peripheral vasculature, including deep vein thrombosis (DVT), and for injection/infusion/aspiration of fluids/contrast media.

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

ClotTriever Thrombectomy System (K212632)

Reference Devices

ClotTriever Thrombectomy System (K193462)

Related Devices

K192036 — ClotTriever Thrombectomy System · Inari Medical · Aug 29, 2019
K173470 — ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath · Inari Medical · Dec 4, 2017
K192332 — ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath · Inari Medical · Sep 20, 2019
K182531 — ClotTriever Thrombectomy System · Inari Medical · Oct 10, 2018
K180329 — ClotTriever Thrombectomy System · Inari Medical, Inc. · Apr 9, 2018

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 in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". February 6, 2023 Inari Medical, Inc. Tosan Eweka Principal Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618 Re: K221531 Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: December 22, 2022 Received: December 23, 2022 Dear Tosan Eweka: 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 W. Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.02.06 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 K221531 Device Name ClotTriever Thrombectomy System | Indications for Use (Describe) | | |--------------------------------|--| |--------------------------------|--| The ClotTriever Thrombectomy System is indicated for: · The non-surgical removal of thrombi and emboli from blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | X Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the alphanumeric string "K221531" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, creating a clear and legible presentation. Image /page/3/Picture/1 description: The image shows the logo for Inari Medical. The logo consists of a circular graphic on the left and the text "INARI MEDICAL" on the right. The circular graphic is purple with orange lines inside. The text "INARI" is in large, purple letters, and the text "MEDICAL" is in smaller, gray letters below "INARI". PAGE 1 OF 2 ## 510(K) Summary | Date prepared | February 3, 2023 | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical—Oak Canyon 6001 Oak Canyon, Suite 100 Irvine, CA 92618 | | Contact person | Tosan Eweka Principal Regulatory Affairs Specialist | | Trade name | ClotTriever® Thrombectomy System | | Common name | Embolectomy catheter | | Regulation name | Embolectomy catheter | | Classification number | 21 CFR 870.5150 | | Product code | QEW | | Regulatory class | II | | Predicate device | ClotTriever Thrombectomy System (K212632) | | Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath is made of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port and a proximal hemostatic valve. A dilator is included to aid insertion. Other provided accessories include the funnel loading tool and a large bore 60 cc syringe. The ClotTriever Catheter is made of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the sheath dilator and ClotTriever Catheter distal tips are radiopaque. | | Indications for Use | The ClotTriever Thrombectomy System is indicated for: 1. The non-surgical removal of thrombi and emboli from blood vessels. 2. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Inari Medical. The logo consists of a circular design on the left, with three orange curved lines inside of it. To the right of the circle is the word "INARI" in large, purple letters. Below that is the word "MEDICAL" in smaller, gray letters. | Device modifications | Inari is updating the labeling to replace "fibrous" and "adherent' with "predominantly fibrous” and “firmly adherent” from the list of materials contraindicated for removal using the ClotTriever Thrombectomy system. | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of substantial equivalence | The ClotTriever Thrombectomy System and predicate device have the same indications for use statements. | | | Non-Clinical Testing Non-clinical testing was not required to support the change to the contraindications. Clinical Testing The CLOUT registry clinical data supporting this labeling change was originally submitted in the ClotTriever Thrombectomy System 510(k) (K193462, cleared on September 9, 2020). Peer-reviewed literature and published case reports were also submitted in support of this labeling change. The change to contraindications does not raise any new issues of safety or effectiveness. Conclusion The modification to replace "fibrous" and "adherent" with "predominantly fibrous" and "firmly adherent" from the list of materials contraindicated for removal using the ClotTriever Thrombectomy system aligns with the currently cleared indications for use and does not raise any new questions of safety and effectiveness. Therefore, the ClotTreiver Thrombectomy system is substantially equivalent to the predicate device |