Protrieve Sheath

K220415 · Inari Medical, Inc. · QEW · Jul 12, 2022 · Cardiovascular

Device Facts

• Record ID: K220415
• Device Name: Protrieve Sheath
• Applicant: Inari Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Jul 12, 2022
• 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

The Protrieve Sheath is an introducer sheath component of the ClotTriever Thrombectomy System, used for peripheral vascular thrombus removal. The system includes a catheter with a self-expanding nitinol wire net that cores, separates, and entraps thrombus; the sheath provides a funnel for capturing the entrapped clot. The device is used in clinical settings by physicians under fluoroscopic visualization. The sheath features a distal self-expanding funnel, aspiration port, and proximal hub. A 60cc syringe provides vacuum for aspiration. The device facilitates the mechanical removal of clots, potentially benefiting patients by restoring blood flow. The Protrieve variant offers larger diameters and additional lengths compared to the predicate, but maintains the same fundamental design and principle of operation.

Clinical Evidence

No clinical data was required to support substantial equivalence. Evidence consists of bench testing, including verification and validation of design failure modes and effects analysis (FMEA). Testing included radial force, kink radius, simulated use (track, insertion, retraction), fluid/air leakage, vacuum testing, and biocompatibility (ISO 10993-1). All acceptance criteria were met.

Technological Characteristics

Single-use, sterile introducer sheath. Materials: Pebax (polyether block amide), Nitinol (mesh funnel), HDPE, LDPE, ABS, Polycarbonate, and thermoplastic polyurethane elastomer. Dimensions: ID 0.270", OD 0.345". Connectivity: None. Energy: Mechanical (manual aspiration via syringe). Sterilization: Ethylene Oxide (EO) to SAL 10^-6.

Indications for Use

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

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

• Triever24 Catheter (K191710)
• Triever20 Catheter (K211013, K173672)

Submission Summary (Full Text)

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July 12, 2022

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

Re: K220415

Trade/Device Name: Protrieve Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: June 8, 2022 Received: June 9, 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

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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,

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) K220415

Device Name Protrieve 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 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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Page 1 of 6

## 510(K) SUMMARY

| Date prepared | July 11, 2022 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>949-600-8433 |
| Contact<br>person | Kaitlyn Weinkauf<br>Sr. Regulatory Affairs Specialist |
| Name of<br>Device | ClotTriever® Thrombectomy System |
| Device Trade<br>Name | Protrieve™ Sheath |
| Common<br>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 Thrombectomy System (K212632) |
| Reference<br>device | Triever24 Catheter (K191710)<br>Triever20 Catheter (K211013, K173672) |
| 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 ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the<br>ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.<br><br>The sheath is an introducer sheath with a distal self-expanding funnel, aspiration port, and<br>proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided<br>accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated<br>contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator<br>tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target<br>vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena<br>cava (IVC), and superior vena cava (SVC). |

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| Indications for Use | The introduction of the Protrieve Sheath variant does not change the indications for use of the<br>ClotTriever Thrombectomy System. | | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ClotTriever Thrombectomy System is indicated for: | | |
| | • The non-surgical removal of thrombi and emboli from blood vessels.<br>• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood<br>vessel. | | |
| | The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including<br>deep vein thrombosis (DVT). | | |
| Device<br>modifications | The purpose of this submission is to introduce a ClotTriever Sheath variant, the Protrieve Sheath,<br>that is larger in diameter and comes in two additional lengths. | | |
| | There have been no changes to the ClotTriever 13 Fr and 16 Fr Sheaths, the ClotTriever Catheter<br>or the ClotTriever Bold Catheter. | | |
| Comparison<br>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.<br>With the exception of the modifications to the sheath ID/OD, dilator OD, sheath/dilator overall<br>length, sheath/dilator durometer, funnel OD, and the funnel being preloaded in the sheath cover<br>shaft, the predicate and proposed devices are the same. These modifications do not change the<br>basic design or the principles of operation from the predicate device. There are no new questions<br>of safety or efficacy. See table below for the comparison of the technological characteristics of the<br>Protrieve Sheath with the predicate device.<br>There is no change of intended use or fundamental scientific technology between the proposed<br>device and predicate device. The changes made for the Protrieve Sheath do not change the<br>technological characteristics of the ClotTriever Thrombectomy System.<br>There have been no changes made to the ClotTriever Catheter or the ClotTriever Bold Catheter. | | |
| | Device | Protrieve Sheath (Proposed) | ClotTriever Thrombectomy System<br>Predicate (K212632) |
| | Manufacturer | Inari Medical | Inari Medical |
| | Product Code | QEW | QEW |
| | Intended Use | Removal of thrombus and emboli from, and<br>infusion of fluids into, the peripheral<br>vasculature. | Removal of thrombus and emboli<br>from, and infusion of fluids into, the<br>peripheral vasculature. |
| | Indications for<br>Use | The ClotTriever Thrombectomy System is<br>indicated for:<br>• The non-surgical removal of thrombi and<br>emboli from blood vessels.<br>• Injection, infusion, and/or aspiration of<br>contrast media and other fluids into or from a<br>blood vessel. | The ClotTriever Thrombectomy<br>System is indicated for:<br>• The non-surgical removal of thrombi<br>and emboli from blood vessels.<br>• Injection, infusion, and/or aspiration<br>of contrast media and other fluids into<br>or from a blood vessel.<br>The ClotTriever Thrombectomy<br>System is intended for use in the |
| | | | Page 3 of 6 |
| Comparison<br>of<br>Technological<br>Characteristics<br>with the<br>Predicate<br>Device | Device<br>Description | The ClotTriever Thrombectomy System is<br>intended for use in the peripheral vasculature<br>including deep vein thrombosis (DVT).<br><br>The ClotTriever Thrombectomy System is a<br>single-use, sterile medical device designed to<br>remove thrombi and emboli from the<br>peripheral vasculature. The ClotTriever<br>Thrombectomy System consists of<br>ClotTriever 13 Fr, 16 Fr, and 20 Fr Sheaths<br>("Sheath") and the ClotTriever/ClotTriever<br>Bold Catheter ("Catheter"), each packaged<br>separately.<br>The sheath is an introducer sheath with a<br>distal self-expanding funnel, aspiration port,<br>and proximal hub. A dilator is provided to aid<br>insertion and positioning of the sheath. Other<br>provided accessories include a 60 cc large<br>bore syringe that provides a vacuum source<br>and collects aspirated contents. Radiopaque<br>markers aid sheath positioning under<br>fluoroscopic visualization. The dilator tip is<br>radiopaque, and there is a radiopaque marker<br>band near the distal end of the sheath. | peripheral vasculature including deep<br>vein thrombosis (DVT).<br><br>The ClotTriever Thrombectomy<br>System is a single-use, sterile medical<br>device designed to remove thrombi<br>and emboli from the peripheral<br>vasculature. The ClotTriever<br>Thrombectomy System consists of<br>ClotTriever 13 Fr and 16 Fr Sheaths<br>("Sheath") and the<br>ClotTriever/ClotTriever Bold Catheter<br>("Catheter"), each packaged<br>separately.<br>The sheath is an introducer sheath<br>with a distal self-expanding funnel,<br>aspiration port, and proximal hub. A<br>dilator is provided to aid insertion and<br>positioning of the sheath. Other<br>provided accessories include a 60 cc<br>large bore syringe that provides a<br>vacuum source and collects aspirated<br>contents. Radiopaque markers aid<br>sheath positioning under fluoroscopic<br>visualization. The dilator tip is<br>radiopaque, and there is a radiopaque<br>marker band near the distal end of the<br>sheath. |
| | Principles of<br>Operation | The ClotTriever/ClotTriever Bold Catheter is<br>advanced into the vessel and beyond the clot.<br>The self-expanding braided nitinol wire net is<br>deployed. The expanded net cores, separates,<br>and entraps thrombus from the vessel as it is<br>being drawn to the funnel opening of the<br>ClotTriever Sheath/ClotTriever 20 Fr Sheath.<br>The net is collapsed and pulled into and<br>through the ClotTriever Sheath with the<br>entrapped clot. A 60 cc syringe is provided<br>for the aspiration of clot in the sheath and the<br>infusion of contrast media and other fluids. | The ClotTriever/ClotTriever Bold<br>Catheter is advanced into the vessel<br>and beyond the clot. The self-<br>expanding braided nitinol wire net is<br>deployed. The expanded net cores,<br>separates, and entraps thrombus from<br>the vessel as it is being drawn to the<br>funnel opening of the ClotTriever<br>Sheath. The net is collapsed and<br>pulled into and through the<br>ClotTriever Sheath with the entrapped<br>clot. A 60 cc syringe is provided for<br>the aspiration of clot in the sheath and<br>the infusion of contrast media and<br>other fluids. |
| | Sheath Shaft<br>Materials | Proximal segment:<br>Pebax 4533 (45D) SA 01 MED, 4% Violet C<br>Hydrophilic Coating<br><br>Distal segment:<br>Pebax 3533 (35D) SA 01 MED, Propell, 4%<br>Violet C | Proximal segment:<br>Pebax 6333 (63D) SA 01 MED;<br>Propell, 20% Barium Sulfate, 4%<br>Violet C<br><br>Distal segment:<br>Pebax 7233 (72D) SA 01 MED;<br>Propell, 20% Barium Sulfate,<br>4%Violet C |
| Sheath Shaft ID/OD | ID: 0.270"<br>OD: 0.345" | ID: 0.215"<br>OD: 0.248" | |
| Sheath Shaft Length | Model 60-100<br>Overall Length: 72 cm<br>Effective Length: 54 cm<br>Model 60-101<br>Overall Length: 50cm<br>Effective Length: 32cm | Overall Length: 32 cm<br>Effective Length: 15 cm |…