ClotTriever BOLD Catheter

K230494 · Inari Medical, Inc. · QEW · Apr 18, 2023 · Cardiovascular

Device Facts

• Record ID: K230494
• Device Name: ClotTriever BOLD Catheter
• Applicant: Inari Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Apr 18, 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 BOLD Catheter is a single-use, sterile embolectomy catheter for peripheral vasculature. Device consists of reinforced polymeric coaxial shafts with an expandable nitinol coring element and thrombus collection bag. Operated by physicians in clinical settings; advanced into vessel beyond clot; self-expanding net deployed to core, separate, and entrap thrombus; net collapsed and retracted into sheath with entrapped clot. Aspiration performed via 60 cc syringe. Modifications include surface treatment of collection bag, dimensional changes to bag, handle plunger, and coring element weld ring, and spring adjustments. Radiopaque distal tips aid fluoroscopic visualization. Benefits include non-surgical thrombus removal.

Clinical Evidence

Bench testing only. No clinical data required. Verification and validation testing included packaging, de-airing/flushing, radial force, deployment/retraction forces, leakage, corrosion resistance, simulated use, torque, particulate matter, and clot removal performance.

Technological Characteristics

Reinforced polymeric coaxial shafts; nitinol coring element and collection bag; titanium oxide surface treatment on collection bag; radiopaque distal tips; 12 Fr OD; 0.035" guidewire compatibility; EO sterilization (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 BOLD® Catheter (K212632)

Reference Devices

• Protrieve Sheath (K220415)

Submission Summary (Full Text)

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April 18, 2023

Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canvon. Suite 100 Irvine, California 92618

Re: K230494

Trade/Device Name: ClotTriever BOLD® Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 23, 2023 Received: February 23, 2023

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.04.18
17:38:53 -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

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## Indications for Use

510(k) Number (if known) K230494

Device Name ClotTriever BOLD® 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® 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 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(K) SUMMARY

| Date prepared | April 18, 2023 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>949-600-8433 |
| Contact person | Kaitlyn Weinkauf<br>Sr. Regulatory Affairs Specialist |
| Device name | ClotTriever® Thrombectomy System |
| Trade name | ClotTriever BOLD® Catheter |
| Common name | Embolectomy catheter |
| Regulation<br>name | Embolectomy catheter |
| Classification<br>number | 21 CFR 870.5150 |
| Primary<br>product code | QEW |
| Secondary<br>product code | KRA |
| Regulatory<br>class | II |
| Predicate<br>device | ClotTriever BOLD® Catheter (K212632) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove<br>thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System<br>consists of the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever 13 Fr and 16 Fr<br>Sheaths, and Protrieve Sheath, each packaged separately.<br><br>The ClotTriever BOLD Catheter is comprised of reinforced polymeric coaxial shafts terminating<br>in an expandable coring element and thrombus collection bag. Three ports terminating in two<br>stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in<br>fluoroscopic visualization, the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever<br>Sheaths, and Protrieve Sheath have radiopaque distal tips. |
| Indications for<br>Use | The proposed modifications of the ClotTriever BOLD Catheter do not change the indications for<br>use of the ClotTriever Thrombectomy System.<br>The ClotTriever Thrombectomy System is indicated for: |

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| | 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<br>modifications | The proposed modifications to the ClotTriever BOLD Catheter include: addition of a surface<br>treatment process to the existing titanium oxide layer of the collection bag resulting in a smoother<br>thin uniform oxide layer; dimensional change to the collection bag; dimensional change to the<br>handle plunger shaft and addition of a hypotube in the handle; dimensional change to the coring<br>element weld ring; change to the plunger inner compression spring; and a change to the short inner<br>compression spring.<br>There are no proposed changes to the intended use or design of the ClotTriever Catheter,<br>ClotTriever Sheaths (13 Fr and 16 Fr), and Protrieve Sheath as part of this submission. | | |
| Comparison of<br>Technological<br>Characteristics<br>with the<br>Predicate<br>Device | The proposed device and predicate device have a similar design and materials of construction. With<br>the exception of the modifications listed above, the predicate and proposed devices are the same.<br>The modifications do not change the basic design or the principles of operation from the predicate<br>device. There are no new or different questions of safety or efficacy.<br>There is no change of intended use or fundamental scientific technology between the proposed<br>device and predicate device. | | |
| | Device | ClotTriever BOLD Catheter<br>(Proposed) | ClotTriever Thrombectomy System<br>ClotTriever BOLD Catheter Predicate<br>(K212632) |
| | Manufacturer | Inari Medical | Inari Medical |
| | Product Code | QEW, KRA | QEW |
| | Intended Use | The ClotTriever Thrombectomy System is<br>intended for use in the peripheral<br>vasculature including deep vein<br>thrombosis (DVT). | The ClotTriever Thrombectomy System is<br>intended for use in the peripheral<br>vasculature including deep vein thrombosis<br>(DVT). |
| | Indications for<br>Use | The ClotTriever Thrombectomy System is<br>indicated for: | The ClotTriever Thrombectomy System is<br>indicated for: |
| | | • The non-surgical removal of thrombi and<br>emboli from blood vessels. | • The non-surgical removal of thrombi and<br>emboli from blood vessels. |
| | | • Injection, infusion, and/or aspiration of<br>contrast media and other fluids into or<br>from a blood vessel. | • Injection, infusion, and/or aspiration of<br>contrast media and other fluids into or<br>from a blood vessel. |
| | | The ClotTriever Thrombectomy System is<br>intended for use in the peripheral<br>vasculature including deep vein<br>thrombosis (DVT). | The ClotTriever Thrombectomy System is<br>intended for use in the peripheral<br>vasculature including deep vein thrombosis<br>(DVT). |
| | Device<br>Description | The ClotTriever Thrombectomy System<br>consists of the ClotTriever Sheaths, the<br>Protrieve Sheath, the ClotTriever Catheter,<br>and the ClotTriever BOLD Catheter. The<br>ClotTriever/Protrieve Sheaths are<br>comprised of a reinforced polymeric | The ClotTriever Thrombectomy System<br>consists of the ClotTriever Sheaths, the<br>ClotTriever Catheter, and the ClotTriever<br>BOLD Catheter. The ClotTriever Sheaths<br>are comprised of a reinforced polymeric<br>sheath equipped with a self-expanding distal |
| | | | |
| | | sheath equipped with a self-expanding<br>distal mesh funnel, a flush/aspiration port,<br>and a proximal hemostasis valve. The<br>ClotTriever and ClotTriever BOLD<br>Catheters are comprised of reinforced<br>polymeric coaxial shafts terminating in an<br>expandable coring element and thrombus<br>collection bag. Other accessories provided<br>include a pre-dilator, the funnel loading<br>tool, and a large bore 60 cc syringe. | mesh funnel, a flush/aspiration port, and a<br>proximal hemostasis valve. The ClotTriever<br>and ClotTriever BOLD Catheters are<br>comprised of reinforced polymeric coaxial<br>shafts terminating in an expandable coring<br>element and thrombus collection bag. Other<br>accessories provided include a pre-dilator,<br>the funnel loading tool, and a large bore 60<br>cc syringe. |
| | Principles of<br>Operation | The ClotTriever BOLD Catheter is<br>advanced into the vessel and beyond the<br>clot. The self-expanding braided nitinol<br>wire net is deployed. The expanded net<br>cores, separates, and entraps thrombus<br>from the vessel as it is being drawn to the<br>funnel opening of the<br>ClotTriever/Protrieve Sheath. The net is<br>collapsed and pulled into and through the<br>ClotTriever/Protrieve Sheath with the<br>entrapped clot. A 60 cc syringe is provided<br>for the aspiration of clot in the sheath and<br>the infusion of contrast media and other<br>fluids. | The ClotTriever BOLD Catheter is<br>advanced into the vessel and beyond the<br>clot. The self-expanding braided nitinol<br>wire net is deployed. The expanded net<br>cores, separates, and entraps thrombus from<br>the vessel as it is being drawn to the funnel<br>opening of the ClotTriever Sheath. The net<br>is collapsed and pulled into and through the<br>ClotTriever Sheath with the entrapped clot.<br>A 60 cc syringe is provided for the<br>aspiration of clot in the sheath and the<br>infusion of contrast media and other fluids. |
| | Target Vessel | Peripheral vessels 6-16 mm | Peripheral vessels 6-16 mm |
| | Catheter | OD: 12 Fr | OD: 12 Fr |
| | OD/ID | ID: 0.124" | ID: 0.124" |
| | Collection Bag | Collapsed: 16.5 cm | Collapsed: 24 cm |
| | Length | Expanded: 13.2 cm | Expanded: 19 cm |
| | Collection Bag<br>Material | Nitinol | Nitinol |
| | Collection Bag<br>Surface | Titanium Oxide, native oxide layer and<br>new surface treatment process to achieve a<br>uniform thin titanium oxide layer | Titanium Oxide, native oxide layer |
| | Coring<br>Element<br>Material | Nitinol | Nitinol |
| | Coring<br>Element<br>Surface | Titanium Oxide, native oxide layer | Titanium Oxide, native oxide layer |
| | Coring<br>Element OD | 16 mm | 16 mm |
| | Catheter | Deployed: 103 cm | Deployed: 111 cm |
| | Length | Effective: 80 cm | Effective: 80 cm |
| | Guidewire<br>compatibility | 0.035" | 0.035" |
| | Shelf-Life | 6 months | 2 years |
| | Sterile | SAL 10-6, EO | SAL 10-6, EO…