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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.

Device Description

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately: Aspiration Guide Catheter (AGC), FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm), Retraction Aspirator.

The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FlowTriever Retrieval/Aspiration System. However, it does not include detailed acceptance criteria or a comprehensive study report with quantified performance metrics to address all aspects of your request.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Device Performance:

The document states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." However, the specific quantitative acceptance criteria and the actual reported device performance (e.g., success rates, flow rates, pressure tolerances) are not provided in this summary. The table below lists the types of tests performed, implying their successful outcome met an unstated acceptance criterion for each.

Acceptance Criteria (Implied from tests performed)	Reported Device Performance (Implied as "Met")
Visual & Dimensional Inspections	Met
Leakage Testing: Guide Catheter Hemostasis Valve and Devices	Met
Air Leakage from Guide Catheter Hemostasis Valve During Syringe Pullback	Met
Retraction Testing: Retraction Aspirator	Met
Check Valve & Vent Plug Testing: Tube set	Met
Leakage Verification: Tube Set, Clot Reservoir	Met
Valve Cracking Pressure: Clot Reservoir	Met
Simulated use Track and Tensile: Guidewire Compatibility	Met
Simulated use Track and Tensile: Flush Port, Guide Catheter, Tube Set	Met
Vacuum Testing: Guide Catheter, Clot Reservoir, Tube Set	Met
Torque Testing: Clot Reservoir Luer Activated Valve	Met
Clot Burden: Clot Reservoir	Met
Valve Dilator Insertion Force: Guide Catheter	Met
Corrosion Resistance: Clot Reservoir	Met

Study Details:

The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This means that the information you've requested regarding test sets, ground truth establishment, expert involvement, and MRMC studies is not applicable to the non-clinical testing presented here.

Therefore, for your specific questions:

A table of acceptance criteria and the reported device performance: This is partially addressed above, with implied "Met" for performance as no quantitative values are given.
Sample size used for the test set and the data provenance: Not applicable, as clinical testing was not performed. The non-clinical tests would have internal sample sizes (e.g., N units tested for leakage), but these are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical testing was not performed, and thus no expert ground truth was established for a test set in this context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no clinical study or AI component is described. The device is a physical medical device (embolectomy catheter).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, the device is a physical catheter system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be engineering specifications and standards (e.g., a specific leakage rate is acceptable, a certain tensile strength is required).
The sample size for the training set: Not applicable, no AI algorithm is involved that would require a training set.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, this 510(k) submission relies on non-clinical (bench and physical) testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies with human subjects or AI performance evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2016

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

Re: K162970

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: October 21, 2016 Received: October 24, 2016

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, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Brian D. Pullin -S

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) K162970

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 FlowTriever Retrieval/Aspiration 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 13, 2016
Name	Inari Medical, Inc.9272 Jeronimo Road, Suite 124Irvine, CA 92618949.600.8433 x114
Contact person	Eben GordonVice 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 devices	Inari Medical Infusion Aspiration Catheter System (K143563)
Description	The FlowTriever Retrieval/Aspiration System is a single-use over-the-wirecatheter-based system for the minimally invasive treatment ofthromboemboli in the peripheral vasculature. The system is comprised ofthree main components packaged separately:Aspiration Guide Catheter (AGC) FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and15-18 mm) Retraction Aspirator
	The FlowTriever Catheter is inserted through the Aspiration Guide Catheterand advanced to the thrombus. Self-expanding wireform disks are deployedto engage thrombus by retracting the outer delivery catheter. The hand-leveroperated Retraction Aspirator simultaneously aspirates fluids and retracts theFlowTriever Catheter with thrombus into the Aspiration Guide Catheter tocapture clot and restore blood flow.
Device Modifications	The change to the FlowTriever Retrieval/Aspiration System allows theremoval of the FlowTriever Catheter from the patient without thesimultaneous removal of the Aspiration Guide Catheter. The modificationsbeing implemented are:Retraction Aspirator Tubing Set1. The checkvalve in the tubing arm is replaced with the clot reservoir. Theformer in-line checkvalve component is now integrated into the clot

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reservoir cap.

1. The connection to the AGC is achieved via a quick-release coupling rather than a Luer connection. Aspiration Guide Catheter
- 1. Increasing the side port tubing inner diameter from 0.098" to 0.188".
- 1. Replacing the stopcock with an on/off clamp and the larger lumen quickrelease coupling.
- 1. Opening the hub's tubing connection lumen diameter from 0.096" to 0.235'' to accommodate the larger inner diameter tubing.

New Aspiration Guide Catheter Components

1. Flush Port Adapter Luer female connector on one end and a quickrelease coupling on the other for attachment to the AGC.
1. Hub Valve Insert Inserted into the AGC hub to open the hemostasis valve as the FlowTriever Catheter is drawn through it.
1. Aspiration Insert Seals on the guidewire and in the hub to allow a vacuum to transport any thrombus (and blood) to the clot reservoir.

Indications for 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.

There is no change of intended use or fundamental scientific technology Summary of substantial equivalence between 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 safety and effectiveness of the modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included:

Visual & Dimensional Inspections
Leakage Testing: Guide Catheter Hemostasis Valve and Devices ●
Air Leakage from Guide Catheter Hemostasis Valve During Syringe ● Pullback
Retraction Testing: Retraction Aspirator
Check Valve & Vent Plug Testing: Tube set ●
Leakage Verification: Tube Set, Clot Reservoir
Valve Cracking Pressure: Clot Reservoir
Simulated use Track and Tensile: Guidewire Compatibility
Simulated use Track and Tensile: Flush Port, Guide Catheter, Tube Set
. Vacuum Testing: Guide Catheter, Clot Reservoir, Tube Set
Torque Testing: Clot Reservoir Luer Activated Valve ●

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Clot Burden: Clot Reservoir .
Valve Dilator Insertion Force: Guide Catheter .
. Corrosion Resistance: Clot Reservoir

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 non-clinical testing, it is concluded that the modified FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).