ClotTriever Sheath

K233815 · Inari Medical, Inc. · QEW · Dec 18, 2023 · Cardiovascular

Device Facts

• Record ID: K233815
• Device Name: ClotTriever Sheath
• Applicant: Inari Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Dec 18, 2023
• Decision: SESE
• Submission Type: Special
• 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). The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

Device Story

ClotTriever Sheath is a single-use, over-the-wire, catheter-based system for peripheral vasculature procedures. It features a polymeric shaft, distal self-expanding nitinol mesh funnel, and proximal hub with a hemostasis valve. The mesh funnel acts as a backstop for clot removal. The device is inserted over a 0.035" guidewire under fluoroscopic guidance. The funnel is deployed proximal to the thrombus; the dilator is then removed. The sheath serves as a conduit for advancing other endovascular devices to the treatment site and facilitates their withdrawal. The integrated hemostasis valve minimizes blood loss during device exchange. The system includes a sideport for aspiration of clot via a 60 cc syringe. Used by physicians in clinical settings to treat thromboemboli, the device benefits patients by providing a minimally invasive method for clot removal and safe endovascular access.

Clinical Evidence

No clinical data; clinical testing was not required to support substantial equivalence. Verification testing from previous submissions (K180329, K192036) remains applicable.

Technological Characteristics

Polymeric shaft, distal self-expanding nitinol mesh funnel, proximal hub with hemostasis valve, sideport tubing. Guidewire compatibility: 0.035". Sterilization: EtO (SAL 10^-6). Shelf-life: 2 years. Mechanical operation via manual slide actuator for funnel deployment.

Indications for Use

Indicated for non-surgical removal of thrombi/emboli from peripheral vasculature (including DVT) and for injection/infusion/aspiration of fluids. Also indicated as a conduit for endovascular device insertion while minimizing blood loss.

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

• Protrieve Sheath (K230331)

Submission Summary (Full Text)

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December 18, 2023

Inari Medical, Inc. Tosan Eweka Principal Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618

### Re: K233815

Trade/Device Name: ClotTriever Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA, DYB Dated: November 30, 2023 Received: November 30, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Image /page/1/Picture/6 description: This image shows the name Gregory W. O'connell -S. The image also shows that it was digitally signed by Gregory W. O'connell -S on 2023.12.18. The time stamp is 11:55:40 -05'00'.

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

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## Indications for Use

510(k) Number (if known) K233815

Device Name ClotTriever Sheath

#### 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 in the peripheral vasculature including deep vein thrombosis (DVT).

The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

| | 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 | November 30, 2023 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>949.600.8433 |
| Contact person | Tosan Eweka<br>Principal Regulatory Affairs Specialist |
| Trade Name | ClotTriever Sheath |
| Device Name | ClotTriever Sheath |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification<br>number | 21 CFR 870.5150 |
| Product code | QEW, KRA, DYB |
| Regulatory class | II |
| Predicate device | Protrieve Sheath (K230331) |
| Description | The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-<br>the-wire catheter-based system used for the minimally invasive treatment of<br>thromboemboli in the peripheral vasculature. The system consists of ClotTriever<br>Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately.<br>The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding<br>nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing.<br>The mesh funnel is deployed by retracting the slide actuator back until it snaps into<br>place. The mesh funnel self-expands to the diameter of the vessel and serves as a<br>backstop as clot is removed through the lumen of the sheath. A hemostasis valve is<br>integrated into the proximal hub of the sheath to prevent blood loss from devices<br>passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-<br>disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration<br>of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target<br>vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning<br>of the sheath, while the loading tool facilitates insertion of the mesh funnel into the<br>dilator. |
| Indications for Use | The ClotTriever Thrombectomy System is indicated for:<br>• The non-surgical removal of thrombi and emboli from blood vessels.<br>• Injection, infusion, and/or aspiration of contrast media and other fluids into<br>or from a blood vessel.<br>The ClotTriever Thrombectomy System is intended for use in the peripheral<br>vasculature including deep vein thrombosis (DVT). |

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| Device<br>Modifications | The ClotTriever Sheaths are indicated for use as a conduit for the insertion of<br>endovascular devices into the vasculature while minimizing blood loss associated<br>with such insertions. | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Modifications | The purpose of this submission is to modify the indications for use statement to<br>include use of the ClotTriever Sheaths as conduits for the insertion of endovascular<br>devices into the vasculature while minimizing blood loss associated with such<br>insertions. | | |
| Summary of<br>substantial<br>equivalence | The subject device and predicate device have the same intended use and indications<br>for use. Both devices are intended to be used as conduits for the insertion of<br>endovascular devices into the vasculature while minimizing blood loss associated<br>with such insertions. The subject device has the same principle of operation and<br>similar technological characteristics as the predicate device. A tabular comparison<br>between the predicate and subject device is provided below: | | |
| | ClotTriever Sheaths<br>(Subject Device) | Protrieve Sheath<br>(Predicate Device) | |
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. | |
| Model<br>Designators | 50-101 (13 Fr ClotTriever<br>Sheath)<br>51-101 (16 Fr ClotTriever<br>Sheath) | 60-101 (20 Fr Protrieve<br>Sheath) | |
| Product Code | QEW, KRA, DYB | QEW, KRA, DYB | |
| Indications for<br>Use | The ClotTriever<br>Thrombectomy System is<br>indicated for:<br>• The non-surgical removal<br>of thrombi and emboli from<br>blood vessels.<br>• Injection, infusion, and/or<br>aspiration of contrast media<br>and other fluids into or from<br>a blood vessel.<br>The ClotTriever<br>Thrombectomy System is<br>intended for use in the<br>peripheral vasculature<br>including deep vein<br>thrombosis (DVT).<br>The ClotTriever Sheaths are<br>indicated for use as a conduit | The ClotTriever<br>Thrombectomy System is<br>indicated for:<br>• The non-surgical removal<br>of thrombi and emboli from<br>blood vessels.<br>• Injection, infusion, and/or<br>aspiration of contrast media<br>and other fluids into or from<br>a blood vessel.<br>The ClotTriever<br>Thrombectomy System is<br>intended for use in the<br>peripheral vasculature<br>including deep vein<br>thrombosis (DVT).<br>The Protrieve Sheath is<br>indicated for use as a conduit | |
| | | for the insertion of<br>endovascular devices into<br>the vasculature while<br>minimizing blood loss<br>associated with such<br>insertions. | for the insertion of<br>endovascular devices into<br>the vasculature while<br>minimizing blood loss<br>associated with such<br>insertions. |
| Principles of<br>Operation | | The ClotTriever Sheath and<br>dilator are inserted over a<br>pre-placed 0.035" guidewire<br>into the vessel. Under<br>fluoroscopic guidance, the<br>Sheath's mesh funnel is<br>deployed proximal to the<br>thrombus targeted for<br>extraction. After<br>deployment of the funnel,<br>the dilator is withdrawn<br>through the Sheath and from<br>the patient entirely. The<br>catheter or other<br>endovascular device is then<br>advanced over the guidewire<br>through the ClotTriever<br>Sheath to the targeted<br>treatment site. Following the<br>diagnostic or therapeutic<br>procedure, the endovascular<br>device is retracted through<br>the ClotTriever Sheath and<br>removed from the patient.<br>The user-actuated<br>hemostasis valve integrated<br>into the Sheath hub allows<br>for Insertion and withdrawal<br>of endovascular devices. | The Protrieve Sheath and<br>dilator are inserted over a<br>pre-placed 0.035" guidewire<br>into the vessel. Under<br>fluoroscopic guidance, the<br>Sheath's mesh funnel is<br>deployed proximal to the<br>thrombus targeted for<br>extraction. After deployment<br>of the funnel, the dilator is<br>withdrawn through the<br>Sheath and from the patient<br>entirely. The catheter or<br>other endovascular device is<br>then advanced over the<br>guidewire through the<br>Protrieve Sheath to the<br>targeted treatment site.<br>Following the diagnostic or<br>therapeutic procedure, the<br>endovascular device is<br>retracted through the<br>Protrieve Sheath and<br>removed from the patient.<br>The user-actuated hemostasis<br>valve integrated into the<br>Sheath hub allows for<br>Insertion and withdrawal of<br>endovascular devices. |
| Target Vessel | | Peripheral vessels | Peripheral vessels |
| Guidewire<br>compatibility | | 0.035" | 0.035" |
| Sheath shaft<br>ID/OD | | 13 Fr ID - 0.180"<br>16 Fr ID - 0.215"<br>13 Fr OD - 0.210"<br>16 Fr OD - 0.248" | ID - 0.270"<br>OD - 0.345" |
| Sheath length<br>(deployed) | | 15 cm | 32 cm |
| Dilator OD | 13 Fr Sheath - 0.178" | 0.264" | |
| | 16 Fr Sheath - 0.206" | | |
| Dilator Length | 10" | 25" | |
| Sterilization | SAL 10-6, EtO | SAL 10-6, EtO | |
| Shelf-Life | 2 years | 2 years | |
| Non-Clinical Testing | | | |
| Verification testing provided in K180329 and K192036 remains applicable to support<br>use of the ClotTriever Sheaths as conduits for the insertion of endovascular<br>devices into the peripheral vasculature. | |…