FlowTriever Retrieval/Aspiration System

K181694 · Inari Medical · QEW · Jul 27, 2018 · Cardiovascular

Device Facts

• Record ID: K181694
• Device Name: FlowTriever Retrieval/Aspiration System
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlowTriever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels. - · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

Device Story

Single-use, over-the-wire, catheter-based system for minimally invasive thromboemboli removal. Components: Aspiration Guide Catheter, FlowTriever Catheter (with self-expanding wireform disks), and hand-lever operated Retraction Aspirator. Operation: Catheter advanced to thrombus; wireform disks deployed to engage clot; Retraction Aspirator simultaneously aspirates fluids and retracts catheter with thrombus into Aspiration Guide Catheter. Used in peripheral vasculature and pulmonary embolism treatment. Operated by clinicians. Output: Captured thrombus and restored blood flow. Benefits: Minimally invasive clot removal.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including visual/dimensional inspections, deployment/retraction force testing, simulated use track/tensile testing, simulated thrombus removal characterization, and radial expansion force testing.

Technological Characteristics

Catheter-based system; Nitinol wireform disks; hand-lever operated aspiration. Modifications: wireform disk diameter 1.10", wire diameter 0.0055", disk gap 0.75". Colorant: Cool Grey 7C. Single-use. Mechanical operation; no energy source or software.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from peripheral vasculature and treatment of pulmonary embolism; also 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

• Inari FlowTriever Retrieval/Aspiration System (K181325)

Reference Devices

• Inari ClotTriever Thrombectomy System (K180329)

Submission Summary (Full Text)

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July 27, 2018

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

Re: K181694

Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 25, 2018 Received: June 27, 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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, 2018.07.27 Eleni Whatlev 08:40:24 -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) K181694

Device Name

FlowTriever Retrieval/Aspiration System

Indications for Use (Describe)

The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

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 | June 25, 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 | FlowTriever Retrieval/Aspiration System |
| Common name | Embolectomy catheter |
| Regulation Name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | DXE |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K181325) |
| Reference device | Inari ClotTriever Thrombectomy System (K180329) |
| Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire<br>catheter-based system for the minimally invasive treatment of thromboemboli in<br>the peripheral vasculature. The system is comprised of three main components<br>packaged separately:<br>Aspiration Guide Catheter FlowTriever Catheter (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) Retraction Aspirator The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and<br>advanced to the thrombus. Self-expanding wireform disks are deployed to engage<br>thrombus by retracting the outer Delivery Catheter. The hand-lever operated<br>Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever<br>Catheter with thrombus into the Aspiration Guide Catheter to capture clot and<br>restore blood flow. |
| Indications for Use | The FlowTriever Retrieval/Aspiration System consists of the FlowTriever<br>Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever<br>Retrieval/Aspiration System is indicated for:<br>The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. |

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The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The change to the FlowTriever Retrieval/Aspiration System is to increase the Device modifications diameter of the disks of the FlowTriever Catheter to allow the treatment of vessels 19-25 mm in diameter. The modifications being implemented to the FlowTriever Catheter are:

1. Increase the wireform disk diameter from 0.88" to 1.10".

2. Increase the wire diameter from 0.0050" to 0.0055".

3. Increase the gap between the expandable disks from 0.50 to 0.75".

4. Change colorant in catheter shaft from Blue 292C to Cool Grey 7C.

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

> The FlowTriever Retrieval/Aspiration System has the same indication for use as the predicate, K181325.

## 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 FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included:

- Visual & Dimensional Inspections ●
- Deployment Force, Wireform Catheter from Delivery Catheter ●
- Retraction Force, Wireform Catheter into Delivery Catheter
- Retraction Force, Wireform Catheter into Guide Catheter ●
- Simulated use Track and Tensile
- . Simulated Thrombus Removal Characterization
- . 25 mm Wireform Radial Expansion Force

Assessment of the 2-year shelf-life data for the predicate device concluded that the existing accelerated aging studies can be leveraged to support 2-year shelf-life for the proposed 25 mm FlowTriever Catheter.

In consideration of the biological safety for the proposed 25 mm FlowTriever Catheter was leveraged off existing data for the predicate devices with regards to the new colorant (Cool Grey 7C) and the increased surface area of Nitinol.

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

Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use.

## Conclusion

The proposed device modifications to the FlowTriever Retrieval/Aspiration System do not change its intended use or raise different questions of safety and With consideration of the results of the testing leveraged from effectiveness. K181325 and K180329, it can be concluded that the proposed FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate devices.