Who is the manufacturer of ClotTriever XL Catheter?

Inari Medical, Inc. filed the 510(k) submission for ClotTriever XL Catheter (K223210).

What is the FDA product code for ClotTriever XL Catheter?

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 XL Catheter?

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

Who can help prepare an FDA 510(k) submission like ClotTriever XL Catheter?

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 XL Catheter

Q: What are the predicate devices for ClotTriever XL Catheter?

ClotTriever Thrombectomy System (K212632).

K223210 · Inari Medical, Inc. · QEW · Apr 27, 2023 · Cardiovascular

Device Facts

Record ID	K223210
Device Name	ClotTriever XL Catheter
Applicant	Inari Medical, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Apr 27, 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

ClotTriever XL Catheter is a single-use, sterile embolectomy catheter for peripheral vasculature (10-28 mm vessels). Device consists of reinforced polymeric coaxial shafts with an expandable nitinol coring element and thrombus collection bag. Operated by physician under fluoroscopic guidance; catheter advanced beyond clot; self-expanding net deployed to core, separate, and entrap thrombus; net collapsed and retracted into ClotTriever/Protrieve sheath for removal. Syringe provided for aspiration and fluid infusion. Benefits include non-surgical thrombus removal, reducing need for invasive procedures.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing (packaging, mechanical, simulated use, vacuum, leakage) and GLP animal safety/functional testing. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, reactivity, systemic toxicity, and hemocompatibility.

Technological Characteristics

Reinforced polymeric coaxial shafts; expandable nitinol wire net coring element; thrombus collection bag. Materials include Pebax, PTFE, and radiopaque markers. Dimensions: 16 Fr OD, 105 cm length. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 10^-6.

Indications for Use

Indicated for non-surgical removal of thrombi and emboli from peripheral blood vessels, including deep vein thrombosis (DVT), and for injection, infusion, or 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)

Related Devices

K230494 — ClotTriever BOLD Catheter · Inari Medical, Inc. · Apr 18, 2023
K210689 — ClotTriever Thrombectomy System · Inari Medical, Inc. · May 12, 2021
K192036 — ClotTriever Thrombectomy System · Inari Medical · Aug 29, 2019
K212632 — ClotTriever Thrombectomy System · Inari Medical, Inc. · Oct 18, 2021
K210190 — ClotTriever Thrombectomy System · Irani Medical, Inc. · Feb 23, 2021

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 and 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 27, 2023 Inari Medical, Inc. Kaitlyn Weinkauf Senior Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618 Re: K223210 Trade/Device Name: ClotTriever XL Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: October 14, 2022 Received: October 17, 2022 ### Dear Kaitlyn Weinkauf: 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, Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.04.27 12:05:46 -04'00' 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) K223210 Device Name ClotTriever XL Catheter 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 Thrombectorny 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 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 5 ## 510(K) SUMMARY | Date prepared | April 27, 2023 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical, Inc. 6001 Oak Canyon, Suite 100 Irvine, CA 92618 949-600-8433 | | Contact person | Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist | | Name of Device | ClotTriever® Thrombectomy System | | Device Trade Name | ClotTriever® XL Catheter | | Common name | Embolectomy catheter | | Regulation name | Embolectomy catheter | | Classification number | 21 CFR 870.5150 | | Primary product code | QEW | | Secondary product code | KRA | | Regulatory class | II | | Predicate device | ClotTriever® Thrombectomy System (K212632) | | Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths, Protrieve Sheath, ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter, each packaged separately. The ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in two stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Sheaths, Protrieve Sheath, and ClotTriever Catheters have radiopaque distal tips. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature. | | Indications for Use | The introduction of the ClotTriever XL Catheter variant does not change the indications for use of the ClotTriever Thrombectomy System. The ClotTriever Thrombectomy System is indicated for: ● The non-surgical removal of thrombi and emboli from blood vessels. | {4}------------------------------------------------ | | • 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 modifications | The purpose of this submission is to introduce a ClotTriever BOLD Catheter variant, the ClotTriever XL Catheter, that is larger in diameter and longer in length. There have been no changes to the ClotTriever 13 Fr and 16 Fr Sheaths, the Protrieve Sheath, the ClotTriever Catheter, or the ClotTriever BOLD Catheter. | | | | Comparison of Technological Characteristics with the Predicate Device | The proposed device and predicate device have a similar design and materials of construction. With the exception of the modifications to the catheter OD, catheter length, bag length, coring element length and diameter, and a minor material change, the predicate and proposed devices are the same. These modifications do not change the basic design or the principles of operation from the predicate device. There are no new or different questions of safety or efficacy. There is no change of intended use or fundamental scientific technology between the proposed device and predicate device. The changes made for the ClotTriever XL Catheter do not change the technological characteristics of the ClotTriever Thrombectomy System. | | | | | Device | ClotTriever XL Catheter (Proposed) | ClotTriever Thrombectomy System ClotTriever BOLD Catheter Predicate (K212632) | | | Manufacturer | Inari Medical | Inari Medical | | | Product Code | QEW, KRA | QEW | | | Intended Use | The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | | | Indications for 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). | 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 Description | The ClotTriever Thrombectomy System consists of the ClotTriever Sheaths, the | The ClotTriever Thrombectomy System consists of the ClotTriever Sheaths, the | | | Catheter, the ClotTriever BOLD Catheter, and the ClotTriever XL Catheter. The ClotTriever/Protrieve Sheaths are comprised of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostasis valve. The ClotTriever Catheter, ClotTriever BOLD Catheter, and ClotTriever XL Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Other accessories provided include a pre-dilator, the funnel loading tool, and a large bore 60 cc syringe. | ClotTriever Catheter, and the ClotTriever BOLD Catheter. The ClotTriever/Protrieve Sheaths are comprised of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostasis valve. The ClotTriever and ClotTriever BOLD Catheters are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Other accessories provided include a pre-dilator, the funnel loading tool, and a large bore 60 cc syringe. | | | Principles of Operation | The ClotTriever XL Catheter is advanced into the vessel and beyond the clot. The self- expanding braided nitinol wire net is deployed. The expanded net cores, separates, and entraps thrombus from the vessel as it is being drawn to the funnel opening of the ClotTriever/Protrieve Sheath. The net is collapsed and pulled into and through the ClotTriever/Protrieve Sheath with the entrapped clot. A 60 cc syringe is provided for the aspiration of clot in the sheath and the infusion of contrast media and other fluids. | The ClotTriever BOLD Catheter is advanced into the vessel and beyond the clot. The self-expanding braided nitinol wire net is deployed. The expanded net cores, separates, and entraps thrombus from the vessel as it is being drawn to the funnel opening of the ClotTriever/Protrieve Sheath. The net is collapsed and pulled into and through the ClotTriever/Protrieve Sheath with the entrapped clot. A 60 cc syringe is provided for the aspiration of clot in the sheath and the infusion of contrast media and other fluids. | | | Target Vessel | Peripheral vessels 10-28 mm | Peripheral vessels 6-16 mm | | | Catheter OD/ID | OD: 16 Fr ID: 0.178" | OD: 12 Fr ID: 0.124" | | | Catheter Length | 105 cm | 80 cm | | | Collection Bag | Length: 10 cm Wire Diameter: 0.0040" | Length: 18 cm Wire Diameter: 0.0045" | | | Catheter Deployed Length | 126 cm | 111cm | | | Coring Element OD | 30 mm | 16 mm | | | Delivery Catheter Materials | Liner: Pebax 72D, Propell | Liner: PTFE | | | | | Proximal segment: | Proximal segment: | | | | Pebax 63D, Cool Grey 4C | Pebax 63D, Cool Grey 4C | | | | Intermediate segment: Pebax 63D, Violet C, fluoro-safe marker | Intermediate segment: Pebax 63D, Violet C, fluoro- safe marker | | | | Distal segment: Pebax 63D, Cool Grey 4C Pebax 55D, Violet C (distal tip) | Distal segment: Pebax 55D, Violet C | | | Guidewire compatibility | 0.035" | 0.035" | | | Shelf-Life | 6 months | 2 years | | | Sterile | SAL 10-6, EO | SAL 10-6, EO | | | How provided | Sterile, single use | Sterile, single use | | Summary of substantial equivalence | The proposed device, the ClotTriever XL Catheter, and the predicate device, the ClotTriever BOLD Catheter, have the same indications for use, intended use, principles of operation, and fundamental scientific technology. | | | | | Non-Clinical Testing | | | | | In accordance with the design failure modes and effects analysis, verification and validation tests were identified to support the substantial equivalence of the ClotTriever XL Catheter to the predicate device. This testing demonstrated compliance with relevant product specifications. | | | | | The following tests were performed on the proposed device to establish substantial equivalence: | | | | | Pouch Seal Visual Inspection and Dye Penetration Packaging Usability Visual and Dimensional Inspection Guidewire Compatibility Protrieve and ClotTriever Sheath Compatibility Radial Force Retraction Force into ClotTriever Sheath Deployment/Retraction Force Retraction force to expand the collection bag Kink Radius Fluid Leakage - Protrieve, ClotTriever Sheath, Catheter Vacuum Testing - Protrieve, ClotTriever Sheath Simulated Use, Track and Rotation (Torque) Simulated Use, Track and Tensile Particulate Matter Conical Fitting with 6% Luer Taper Pre-clinical/GLP Animal Safety Evaluation (including In Vivo Functional Testing/Radiopacity Verification) | | | {5}------------------------------------------------ # K223210 {6}------------------------------------------------ {7}------------------------------------------------ | The following testing was leveraged from the predicate ClotTriever BOLD Catheter (K212632): Pouch peel and seal strength Corrosion Resistance Handle Torque Sterilization Validation | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…