ClotTriever Thrombectomy System

K193462 · Inari Medical · QEW · Sep 9, 2020 · Cardiovascular

Device Facts

• Record ID: K193462
• Device Name: ClotTriever Thrombectomy System
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Sep 9, 2020
• 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 in the peripheral vasculature including deep vein thrombosis (DVT).

Device Story

Single-use, sterile thrombectomy system for peripheral vasculature; includes ClotTriever Sheath (reinforced polymeric, self-expanding distal mesh funnel, hemostatic valve) and ClotTriever Catheter (reinforced coaxial shafts, expandable coring element, thrombus collection bag). Used by physicians in clinical settings for DVT treatment. Operates via mechanical coring and collection of thrombi; radiopaque tips aid fluoroscopic visualization. Output is physical removal of thrombus; healthcare providers use fluoroscopy to guide catheter and confirm thrombus extraction. Benefits include non-surgical thrombus removal, reduced post-thrombotic syndrome, and improved patient quality of life.

Clinical Evidence

CLOUT Registry study: 133 patients (16 sites) with acute/non-acute lower extremity proximal DVT. 99.2% treated in single session. 75.2% achieved ≥75% thrombus removal (core lab Marder scores). 6.8% major adverse events (none device-related); 0.8% access-site hematoma; 0% acute renal injury. 30-day follow-up showed significant decrease in post-thrombotic syndrome (p<0.0001) and significant improvement in quality of life scores (Villalta, rVCSS, EQ-5D, NPRS).

Technological Characteristics

Reinforced polymeric coaxial shafts; self-expanding distal mesh funnel; radiopaque distal tips for fluoroscopic visualization. Single-use, sterile. Mechanical thrombectomy principle. No software or electronic components.

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 contrast media and fluids.

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

• ZelanteDVT Thrombectomy Set (K151313)

Reference Devices

• ClotTriever Thrombectomy System (K192332)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 9, 2020

Inari Medical Eben Gordon Vice President, RA/QA 9 Parker. Suite 100 Irvine, California 92618

Re: K193462

Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: July 29, 2020 Received: August 3, 2020

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. 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 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

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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 (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 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) K193462

Device Name ClotTriever Thrombectomy System

#### 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 Thrombectomy System is 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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# 510(K) SUMMARY

| Date prepared | September 9, 2020 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>9 Parker, Suite 100<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 | QEW |
| Regulatory class | II |
| Predicate device | ZelanteDVT Thrombectomy Set (K151313) |
| Reference device | ClotTriever Thrombectomy System (K192332) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device<br>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 comprises a reinforced polymeric sheath<br>equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and<br>a proximal hemostatic valve. A dilator is provided to aid insertion. Other<br>provided accessories include the funnel loading tool and a Large Bore 60 cc<br>syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial<br>shafts terminating in an expandable coring element and thrombus collection<br>bag. Two ports terminating in stopcocks are provided for de-airing the<br>catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and<br>ClotTriever Catheter distal tips are radiopaque. |
| Indications for Use | 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 vessel. |
| | The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). |
| Device modification | The Indications for Use has been changed to include the treatment of DVT and removal of the soft thrombi and emboli limitation. |

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Summary of substantial equivalence

The ClotTriever Thrombectomy System, predicate and reference devices have the same intended use: removal of thrombus and emboli from and infusion of fluids into the peripheral vasculature.

## Non-Clinical Testing

Non-clinical testing was not required to support the change to the Indications for Use.

### Clinical Testing

The ClotTriever Outcomes (CLOUT) Registry has generated real-world patient outcome information following treatment of acute and non-acute lower extremity proximal deep vein thrombosis (DVT) with the ClotTriever System. Procedural and acute data of 133 patients across 16 sites and 30-day follow-up data of 98 patients was assessed. 99.2% of patients were treated in a single session. Thrombus removal of ≥75% via core lab Marder scores was achieved in 75.2% of treated limbs, including those with chronic disease. There were 9 (6.8%) major adverse events through 30 days, none of which were device related, one (0.8%) access-site hematoma, and no acute renal injuries. At 30-day follow-up, compared to baseline, the number of patients with post-thrombotic syndrome (PTS) as well as moderate or severe PTS had both significantly decreased (p<0.0001). Additionally, quality of life scores, including Villalta, revised venous clinical severity score (rVCSS), EO-5D. and numeric pain rating scale (NPRS), all showed statistically significant improvement at 30 days.

## Conclusion

The specific use of treating DVT falls within the current cleared general use and real world clinical data supports the including the treatment of DVT and the removal of the soft thrombi and emboli limitation in the Indications for Use. The proposed changes to the Indications for Use do not raise new or different questions of safety and effectiveness, therefore, it can be concluded that the modified ClotTriever Catheter is substantially equivalent to the predicate device.