FlowTriever Retrieval/Aspiration System

K191710 · Inari Medical · QEW · Sep 5, 2019 · Cardiovascular

Device Facts

• Record ID: K191710
• Device Name: FlowTriever Retrieval/Aspiration System
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Sep 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 FlowTriever 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. Comprised of Triever Catheters (16, 20, 24 Fr) and FlowTriever Catheters (6-25 mm). Physician advances FlowTriever through Triever to thrombus site; deploys self-expanding wireform disks by retracting outer delivery catheter to engage clot. FlowTriever is retracted into Triever to capture thrombus; additional clot removal via aspiration using 60 cc VacLok syringe. Used in clinical settings for peripheral vasculature and pulmonary embolism treatment. Output is physical removal of thrombus; aids clinical decision-making by restoring blood flow. Benefits patient via minimally invasive clot extraction.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical bench testing and animal testing.

Technological Characteristics

Catheter-based system; materials include 55D Pebax and 72D durometer polymers. Features self-expanding wireform disks for mechanical clot engagement. Sizes: Triever (16, 20, 24 Fr), FlowTriever (6-25 mm). Manual operation via VacLok vacuum syringe. Single-use, sterile.

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 (K191368)

Reference Devices

• Inari FlowTriever Retrieval/Aspiration System (K173672)
• Inari FlowTriever Retrieval/Aspiration System (K181325)

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 5, 2019

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

Re: K191710

Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW Dated: July 9, 2019 Received: July 11, 2019

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 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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

#### K191710

Device Name FlowTriever Retrieval/Aspiration System

Indications for Use (Describe)

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 FlowTriever 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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K191710

PAGE 1 OF 3

# 510(K) SUMMARY

| Date prepared | June 24, 2019 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | QEW |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K191368) |
| Reference devices | Inari FlowTriever Retrieval/Aspiration System (K173672)<br>Inari FlowTriever Retrieval/Aspiration System (K181325) |
| 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 and for the treatment of pulmonary embolism. The<br>system is comprised of two main components packaged separately:<br>• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)<br>• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18<br>mm, and 19-25 mm)<br><br>The FlowTriever Catheter is inserted through the Triever Catheter and advanced<br>to the thrombus. Self-expanding wireform disks are deployed to engage thrombus<br>by retracting the outer delivery catheter. The FlowTriever Catheter is retracted<br>into the Triever Catheter to capture the targeted thrombus. Additional clot may be<br>removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the<br>procedure is complete, the Triever Catheter and FlowTriever Catheter are<br>removed from the patient. |
| Indications for Use | The FlowTriever 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. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. |
| Device modifications | The device modifications proposed are associated with increasing the Triever Catheter from 20 to 24 Fr. Specifically, these changes are: Catheter ID increase of 0.048" Catheter OD increase of 0.046" Proximal shaft material durometer changed to 72D 6.4 cm of the proximal shaft material replaced with 55D Pebax Dilator shaft OD increase of 0.048" |
| Summary of substantial equivalence | There is no change of intended use or fundamental scientific technology between the proposed and predicate device. The FlowTriever Retrieval/Aspiration System has the same indication for use as the predicate, K191368.<br><br><b>Non-Clinical Testing</b><br>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 Inspection - Triever24 Catheter/dilator Guidewire and Sheath Compatibility Verification Snap Fit, Dilator Luer to Guide Catheter Hemostasis Valve Leakage Testing – Triever24 Catheter/ Dilator Vacuum Testing – Triever24 Catheter Air leakage During Aspiration – Triever24 Catheter Retraction Force Testing Kink Radius Testing Determination of Flowrate Burst Testing – Triever24 Catheter/Dilator Clot Burden Removal Validation Push Button Force Simulated Use and Tensile Testing - Triever24 Large Bore Syringe Simulated Use and Tensile Testing – Triever24 Catheter/Dilator Simulated Use and Torque |
| Animal testing confirmed the safety and performance of the Triever24 Catheter. | |
| Clinical testing was not required for the determination of substantial equivalence. | |
| Test results demonstrated that all acceptance criteria were met; therefore, the device<br>conforms to established product specifications. | |
| <b>Conclusion</b> | |
| The proposed device modifications to the FlowTriever Retrieval/Aspiration System<br>do not change its intended use nor does it change the principles of operation. With<br>consideration of the results of the testing leveraged from K191368, it can be<br>concluded that the proposed FlowTriever Retrieval/Aspiration System is<br>substantially equivalent to the predicate device. | |

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# K191710

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