ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath

K173470 · Inari Medical · QEW · Dec 4, 2017 · Cardiovascular

Device Facts

• Record ID: K173470
• Device Name: ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Dec 4, 2017
• 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. Comprises ClotTriever Catheter and ClotTriever Sheath. Catheter features expandable coring element and collapsible thrombus collection bag; handle enables tensioning of coring element. Sheath includes self-expanding distal mesh funnel, hemostatic valve, and flush/aspiration ports. Operated by physician under fluoroscopic guidance. Device inserted into blood vessel; coring element expands to capture thrombi; thrombi collected in bag and retrieved through sheath. Radiopaque markers aid visualization. System facilitates mechanical removal of soft clots without surgery, potentially reducing need for thrombolytic drugs or invasive procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including visual/dimensional inspections, guidewire compatibility, deployment/retraction force testing, kink resistance, leakage verification, and simulated use clot burden removal tests.

Technological Characteristics

Polymeric coaxial catheter system with expandable coring element and collection bag. Sheath includes self-expanding mesh funnel. Radiopaque markers on dilator, catheter tips, and coring element shaft. Single-use, sterile. Mechanical operation via manual handle tensioning. No electronic components or software.

Indications for Use

Indicated for non-surgical removal of soft thrombi and emboli from peripheral blood vessels and for injection, infusion, or aspiration of fluids/contrast media in patients requiring peripheral vascular intervention.

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 ClotTriever Thrombectomy System (K163549)

Submission Summary (Full Text)

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December 4, 2017

Inari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs and Quality Assurance 9272 Jeronimo Road, Suite 124 Irvine, California 92618

Re: K173470

Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 7, 2017 Received: November 8, 2017

Dear Mr. 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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

M. G. Hillemann

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) K173470

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.

| 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 7, 2017 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 number | 21 CFR 870.5150 |
| Product code | DXE |
| Regulatory class | II |
| Predicate devices | Inari ClotTriever Thrombectomy System (K163549) |
| 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 with tubing clamp, and a<br>proximal hemostatic valve. A dilator is provided to aid insertion. Other provided<br>accessories include a clot reservoir, a flush port adapter, an aspiration insert,<br>funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four<br>pre- assembled polymeric coaxial catheters terminating in an expandable coring<br>element and thrombus collection bag. At the proximal end of the catheter is a<br>handle used to enable tensioning of the coring element. Two ports terminating in<br>stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic<br>visualization, the dilator and ClotTriever Catheter distal tips are radiopaque, and<br>radiopaque marker bands are located on the coring element shaft at the proximal<br>end of the expandable coring element, and at the distal ends of the ClotTriever<br>Sheath and ClotTriever Catheter outer shaft. |
| Indications for 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>●<br>Injection, infusion, and/or aspiration of contrast media and other fluids<br>●<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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Device modifications

The changes to the ClotTriever Thrombectomy System are:

- . Implement a collapsible clot collection bag
- Shortening the handle from approximately 23.5 cm to approximately 12.7 ● cm
- Switch to a 0.018" guidewire compatibility for the ClotTriever Catheter ●

There is no change of intended use or fundamental scientific technology between Summary of substantial equivalence the proposed 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
- Packaging Inspection ●
- Visual & Dimensional Inspections ●
- Guidewire Compatibility Verification ●
- Deployment Force Net/Coring Element from Delivery Catheter ●
- Retraction Force - Net/Coring Element into Delivery Catheter
- Retraction Force ClotTriever Catheter Thru ClotTriever Sheath ●
- Kink Resistance/ Radius Verification - ClotTriever Catheter
- Leakage Verification, ClotTriever Catheter ●
- Leakage Verification, ClotTriever Catheter ID with Guidewire in Place
- Simulated Use Track and Tensile ClotTriever Catheter ●
- Clot Burden Removal Test ●
- . Performance Test - Thrombus Removal Characterization

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.