ClotTriever Thrombectomy System

K182531 · Inari Medical · QEW · Oct 10, 2018 · Cardiovascular

Device Facts

• Record ID: K182531
• Device Name: ClotTriever Thrombectomy System
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Oct 10, 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 embolectomy system for peripheral vasculature; comprises ClotTriever Sheath (with self-expanding distal mesh funnel, hemostatic valve) and ClotTriever Catheter (coaxial shafts, expandable coring element, thrombus collection bag). Operated by physician under fluoroscopic guidance. Catheter handle tensions coring element to capture thrombus; collection bag stores retrieved material. System facilitates mechanical removal of soft thrombi/emboli without surgery. Modifications include reduced collection bag length (34cm to 19cm), reduced deployed length (125cm to 105cm), and updated 60cc VacLok syringe. Benefits include minimally invasive thrombus removal.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including visual/dimensional inspections, handle retraction force, syringe performance (leak, vacuum, tensile), and simulated use/clot removal performance testing.

Technological Characteristics

Polymeric coaxial catheter shafts; self-expanding distal mesh funnel; radiopaque distal tips; manual handle-actuated coring element; 60cc VacLok syringe. Sterile, single-use. Mechanical principle of operation. No software or electronic components.

Indications for Use

Indicated for non-surgical removal of soft thrombi and emboli from peripheral blood vessels; also for injection, infusion, or aspiration of fluids/contrast media. No specific age or gender restrictions provided.

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 (K180329)

Reference Devices

• ClotTriever Thrombectomy System (K173470)
• ClotTriever Thrombectomy System (K163549)

Submission Summary (Full Text)

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October 10, 2018

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

Re: K182531

Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: September 13, 2018 Received: September 14, 2018

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. 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

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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 and Part 809); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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.

Gregory O'Connell 2018.10.10 19:33:20 -04'00" 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) K182531

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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K182531

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# 510(K) SUMMARY

| Date prepared | September 13, 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 (K180329) |
| Reference<br>devices | Inari Medical's ClotTriever Thrombectomy System (K173470)<br>Inari Medical's ClotTriever Thrombectomy System (K163549) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device<br>designed for use in the peripheral vasculature. The ClotTriever Thrombectomy<br>System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The<br>ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding<br>distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A<br>dilator is provided to aid insertion. Other provided accessories include the funnel<br>loading tool and a 60 cc syringe. The ClotTriever Catheter consists of polymeric<br>coaxial shafts terminating in an expandable coring element and thrombus<br>collection bag. At the proximal end of the catheter is a handle used to enable<br>tensioning of the coring element. Two ports terminating in stopcocks are<br>provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the<br>dilator and 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.Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.<br>The ClotTriever Thrombectomy System is intended for use in the peripheral<br>vasculature. |
| Device<br>modifications | The changes to the ClotTriever Thrombectomy System are: |

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- . Decrease in the length of the ClotTriever Catheter's thrombus collection bag from 34 cm to 19 cm
- Decrease in the deployed length from 125 cm to 105 cm ●
- Replacement of the off-the-shelf 60 cc VacLok Syringe and Clot Reservoir with a large bore 60 cc VacLok Syringe.

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

## 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:

- Visual & Dimensional Inspections
- Retraction Force of Handle
- Syringe Leak Testing ●
- Syringe Vacuum Testing
- Syringe Tensile Testing ●
- Clot burden Removal Performance Test ●
- Simulated Use, Tensile Test ●

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.