ClotTriever Thrombectomy System

K180329 · Inari Medical, Inc. · QEW · Apr 9, 2018 · Cardiovascular

Device Facts

• Record ID: K180329
• Device Name: ClotTriever Thrombectomy System
• Applicant: Inari Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Apr 9, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for: • The non-surgical removal of soft 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.

Device Story

Single-use, sterile thrombectomy system for peripheral vasculature; consists of ClotTriever Catheter and ClotTriever Sheath. Catheter features four coaxial shafts, expandable coring element, and thrombus collection bag; handle enables coring element tensioning. Sheath includes self-expanding distal mesh funnel, flush/aspiration port, and proximal hemostatic valve. Physician operates device under fluoroscopic guidance; radiopaque tips aid visualization. Device removes thrombi mechanically via coring and collection; contrast/fluids managed via ports. Output is physical removal of clot; aids clinical decision-making by restoring vessel patency. Benefits patient through minimally invasive thrombus removal.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing only, including visual/dimensional inspections, guidewire compatibility, insertion/retraction/deployment forces, kink resistance, leakage, vacuum testing, torque, burst, and particulate evaluation.

Technological Characteristics

Polymeric coaxial catheter system; self-expanding distal mesh funnel; radiopaque tips. Includes hemostatic valve, stopcocks, and vacuum syringe. Manual operation; no energy source. Single-use, sterile.

Indications for Use

Indicated for non-surgical removal of soft thrombi and emboli from peripheral vasculature; also 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

• Inari Medical's ClotTriever Thrombectomy System (K173470)

Reference Devices

• Inari Medical's FlowTriever Retrieval/Aspiration System (K173672)
• Inari Medical's Infusion Aspiration Catheter System (K143563)
• Merit Medical Systems' VacLok Vacuum Syringe (K163597)

Submission Summary (Full Text)

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April 9, 2018

Inari Medical Eben Gordon Vice President, RA/QA 9272 Jeronimo Rd., Suite 124 Irvine, California 92618

Re: K180329

Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 12, 2018 Received: March 13, 2018

Dear Eben Gordon:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Eben Gordon

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K180329

Device Name ClotTriever Thrombectomy System

Indications for Use (Describe)

The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Thrombectomy System is indicated for:

- · The non-surgical removal of soft 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.

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 | February 5, 2018 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>9272 Jeronimo Road, Suite 124<br>Irvine, CA 92618<br>949.600.8433 x114 |
| Contact person | Eben Gordon<br>Vice President, Regulatory Affairs & Quality Assurance |
| Trade name | ClotTriever Thrombectomy System |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification<br>number | 21 CFR 870.5150 |
| Product code | DXE |
| Regulatory class | II |
| Predicate device | Inari Medical's ClotTriever Thrombectomy System (K173470) |
| Reference<br>devices | Inari Medical's FlowTriever Retrieval/Aspiration System (K173672)<br>Inari Medical's Infusion Aspiration Catheter System (K143563)<br>Merit Medical Systems' VacLok Vacuum Syringe (K163597) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device<br>system designed for use in the peripheral vasculature. The ClotTriever<br>Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever<br>Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a<br>self-expanding distal mesh funnel, a flush/aspiration port, and a proximal<br>hemostatic valve. A dilator is provided to aid insertion. Other provided<br>accessories include a clot reservoir, a funnel loading tool, and a 60 cc syringe.<br>The ClotTriever Catheter consists of four pre- assembled polymeric coaxial<br>catheters terminating in an expandable coring element and thrombus collection<br>bag. At the proximal end of the catheter is a handle used to enable tensioning of<br>the coring element. Two ports terminating in stopcocks are provided for de-airing<br>the catheter shafts. To aid in fluoroscopic visualization, the dilator and<br>ClotTriever Catheter distal tips are radiopaque. |
| Indications for<br>Use | The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and<br>ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:<br>• The non-surgical removal of soft thrombi and emboli from blood vessels.<br>• Injection, infusion, and/or aspiration of contrast media and other fluids<br>into or from a blood vessel.<br>The ClotTriever Thrombectomy System is intended for use in the peripheral<br>vasculature. |

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The changes to the ClotTriever Thrombectomy System are:

- modifications
equivalence

Device

- Reduction in the length of the ClotTriever Sheath from 26 cm to 15 cm.
- Reduction in the length of the Dilator to match the Sheath change.
- An outer shaft has been added to the Dilator to aid in its removal from the ClotTriever Sheath after the funnel has been deployed.
- Decrease in the Dilator tip taper and hardness. ●
- Pre-loading of the Dilator into ClotTriever Sheath prior to final packaging.
- . Replacement of the hemostasis valve with a user actuated hemostasis valve in the ClotTriever Sheath's proximal hub.
- Addition of a stopcock in the sideport tubing.
- Elimination of the Valve Dilator, Aspiration Insert, Flush Port Adapter, ● and tubing clamp components.
- Replacement of the 60 cc Monoject Syringe with the 60 cc VacLok . Vacuum Syringe.

Summary of There is no change of intended use or fundamental scientific technology between substantial the modified and predicate devices.

### Non-Clinical Testing

In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests included:

- Pouch Seal Inspection
- Dye Penetration Inspection ●
- Pouch Peel Test ●
- Visual & Dimensional Inspections: ClotTriever Sheath, Dilator, Clot ● Reservoir & Loading Tool
- Guidewire Compatibility Verification ●
- Insertion Force - ClotTriever Dilator Handle into Sheath Hub
- Retraction Force Dilator Handle from Sheath Hub ●
- Deployment Force - ClotTriever Sheath from Dilator
- Engagement Force - Dilator Handle
- Retraction Force – Dilator Thru ClotTriever Sheath
- Retraction Force – Dilator Handle
- Insertion Verification ClotTriever Delivery Catheter thru Sheath ●
- Retraction of the ClotTriever Catheter Thru ClotTriever Sheath ●
- Kink Resistance/ Radius Verification ClotTriever Sheath & Dilator ●
- Leakage Verification, ClotTriever Sheath
- Leakage Verification, ClotTriever Dilator ●
- Leakage Verification, Clot Reservoir ●
- Air Leakage, ClotTriever Sheath ●
- Clot Reservoir Check Valve Cracking Pressure ●

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- Vacuum Testing, ClotTriever Sheath ●
- Vacuum Testing, ClotTriever Clot Reservoir ●
- Push-Button Force Testing Garrote Valve ●
- Fluid Test Thru ClotTriever Sheath/Dilator ●
- . Corrosion Resistance
- ClotTriever Dilator Retraction in Clot Analog
- Simulated Use, Track and Tensile ClotTriever Dilator ●
- . Simulated Use, Track and Tensile - ClotTriever Sheath
- Simulated Use, Tensile – ClotTriever Clot Reservoir
- Simulated Use Track and Turn-to-Failure, ClotTriever Sheath ●
- Torque Testing - Dilator
- Torque Testing Garrote Valve ●
- Torque Testing - Flushing Stopcock
- Burst Testing Garrote Valve ●
- Burst Testing Flushing Stopcock ●
- . Particulate Evaluation

Clinical testing was not required for the determination of substantial equivalence.

#### Conclusion

Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the modified ClotTriever Thrombectomy System is substantially equivalent to the predicate device.