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 Description

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.

AI/ML Overview

The ClotTriever Thrombectomy System underwent non-clinical testing to demonstrate substantial equivalence to its predicate device, specifically ClotTriever Thrombectomy System (K173470). The device is used for the non-surgical removal of soft thrombi and emboli from blood vessels and for the injection/aspiration of fluids in the peripheral vasculature.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text lists numerous tests conducted to ensure the device's performance meets established specifications. For each test, the "reported device performance" is a blanket statement indicating that: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."

Without specific numerical or qualitative results for each individual test, a detailed table with specific acceptance criteria and performance metrics cannot be generated. However, the types of tests conducted serve as proxies for the acceptance criteria for various aspects of the device's functionality and safety.

Test Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Packaging & Sterility	Pouch Seal Inspection	Seal integrity adequate to maintain sterility	All acceptance criteria met
	Dye Penetration Inspection	No dye penetration, indicating seal integrity	All acceptance criteria met
	Pouch Peel Test	Appropriate peel strength for safe opening	All acceptance criteria met
Physical & Dimensional	Visual & Dimensional Inspections (Sheath, Dilator, Clot Reservoir, Loading Tool)	Conformance to design specifications and tolerances	All acceptance criteria met
Functional - Insertion & Retraction	Guidewire Compatibility Verification	Smooth passage and compatibility with guidewires	All acceptance criteria met
	Insertion Force - ClotTriever Dilator Handle into Sheath Hub	Within specified force limits for user ease	All acceptance criteria met
	Retraction Force - Dilator Handle from Sheath Hub	Within specified force limits for user ease	All acceptance criteria met
	Deployment Force - ClotTriever Sheath from Dilator	Within specified force limits for reliable deployment	All acceptance criteria met
	Engagement Force - Dilator Handle	Secure engagement	All acceptance criteria met
	Retraction Force - Dilator Thru ClotTriever Sheath	Within specified force limits for smooth retraction	All acceptance criteria met
	Retraction Force - Dilator Handle	Within specified force limits for user ease	All acceptance criteria met
	Insertion Verification ClotTriever Delivery Catheter thru Sheath	Smooth and unobstructed passage	All acceptance criteria met
	Retraction of the ClotTriever Catheter Thru ClotTriever Sheath	Smooth and unobstructed retraction	All acceptance criteria met
Mechanical Integrity	Kink Resistance/Radius Verification ClotTriever Sheath & Dilator	Resistance to kinking at specified radii	All acceptance criteria met
	Leakage Verification (ClotTriever Sheath, Dilator, Clot Reservoir)	No fluid leakage	All acceptance criteria met
	Air Leakage, ClotTriever Sheath	No air leakage	All acceptance criteria met
	Clot Reservoir Check Valve Cracking Pressure	Within specified pressure range for proper function	All acceptance criteria met
	Vacuum Testing (ClotTriever Sheath, Clot Reservoir)	Ability to maintain specified vacuum levels	All acceptance criteria met
	Push-Button Force Testing Garrote Valve	Within specified force limits for user operation	All acceptance criteria met
	Fluid Test Thru ClotTriever Sheath/Dilator	Unobstructed fluid flow	All acceptance criteria met
	Corrosion Resistance	No corrosion observed	All acceptance criteria met
	ClotTriever Dilator Retraction in Clot Analog	Effective retraction in a simulated clot environment	All acceptance criteria met
	Simulated Use, Track and Tensile (ClotTriever Dilator, Sheath)	Mechanical integrity and tracking performance in simulated use	All acceptance criteria met
	Simulated Use, Tensile – ClotTriever Clot Reservoir	Mechanical integrity under tensile stress	All acceptance criteria met
	Simulated Use Track and Turn-to-Failure, ClotTriever Sheath	Durability and functionality in simulated extreme use	All acceptance criteria met
	Torque Testing (Dilator, Garrote Valve, Flushing Stopcock)	Resistance to breakage or failure under torque	All acceptance criteria met
	Burst Testing (Garrote Valve, Flushing Stopcock)	Resistance to bursting at specified pressures	All acceptance criteria met
	Particulate Evaluation	Within acceptable limits for biocompatibility	All acceptance criteria met

2. Sample Size Used for the Test Set and Data Provenance

The provided information focuses on non-clinical testing (e.g., bench testing, mechanical tests). There is no information provided regarding a "test set" in the context of patient data.

Sample Size: Not applicable for a clinical test set as no clinical testing was performed for this submission. For the non-clinical tests, specific sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were used to meet the verification and validation requirements.
Data Provenance: Not applicable for a clinical test set. For the non-clinical tests, the data provenance is from the manufacturer's (Inari Medical) internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the submission states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no clinical ground truth was established by experts for a test set in this context.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication was utilized.

5. 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

An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This implies no human-in-the-loop performance evaluation or comparison with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The ClotTriever Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the non-clinical testing conducted, the "ground truth" used was established product specifications, engineering standards, and the performance of the predicate device (K173470). In other words, the device's performance was compared against predetermined acceptance criteria derived from its design requirements and the known characteristics of equivalent devices.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2018

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

Re: K180329

Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 12, 2018 Received: March 13, 2018

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Eben Gordon

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -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)

K180329

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.

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	February 5, 2018
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	ClotTriever Thrombectomy System
Common name	Embolectomy catheter
Regulation name	Embolectomy catheter
Classificationnumber	21 CFR 870.5150
Product code	DXE
Regulatory class	II
Predicate device	Inari Medical's ClotTriever Thrombectomy System (K173470)
Referencedevices	Inari Medical's FlowTriever Retrieval/Aspiration System (K173672)Inari Medical's Infusion Aspiration Catheter System (K143563)Merit Medical Systems' VacLok Vacuum Syringe (K163597)
Description	The ClotTriever Thrombectomy System is a single-use, sterile medical devicesystem designed for use in the peripheral vasculature. The ClotTrieverThrombectomy System consists of the ClotTriever Sheath and the ClotTrieverCatheter. The ClotTriever Sheath consists of a polymeric sheath equipped with aself-expanding distal mesh funnel, a flush/aspiration port, and a proximalhemostatic valve. A dilator is provided to aid insertion. Other providedaccessories include a clot reservoir, a funnel loading tool, and a 60 cc syringe.The ClotTriever Catheter consists of four pre- assembled polymeric coaxialcatheters terminating in an expandable coring element and thrombus collectionbag. At the proximal end of the catheter is a handle used to enable tensioning ofthe coring element. Two ports terminating in stopcocks are provided for de-airingthe catheter shafts. To aid in fluoroscopic visualization, the dilator andClotTriever Catheter distal tips are radiopaque.
Indications forUse	The ClotTriever Thrombectomy System consists of the ClotTriever Catheter andClotTriever 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 fluidsinto or from a blood vessel.The ClotTriever Thrombectomy System is intended for use in the peripheralvasculature.

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The changes to the ClotTriever Thrombectomy System are:

modifications
equivalence

Device

Reduction in the length of the ClotTriever Sheath from 26 cm to 15 cm.
Reduction in the length of the Dilator to match the Sheath change.
An outer shaft has been added to the Dilator to aid in its removal from the ClotTriever Sheath after the funnel has been deployed.
Decrease in the Dilator tip taper and hardness. ●
Pre-loading of the Dilator into ClotTriever Sheath prior to final packaging.
. Replacement of the hemostasis valve with a user actuated hemostasis valve in the ClotTriever Sheath's proximal hub.
Addition of a stopcock in the sideport tubing.
Elimination of the Valve Dilator, Aspiration Insert, Flush Port Adapter, ● and tubing clamp components.
Replacement of the 60 cc Monoject Syringe with the 60 cc VacLok . Vacuum Syringe.

Summary of There is no change of intended use or fundamental scientific technology between substantial the modified 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 substantial equivalence of the modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests included:

Pouch Seal Inspection
Dye Penetration Inspection ●
Pouch Peel Test ●
Visual & Dimensional Inspections: ClotTriever Sheath, Dilator, Clot ● Reservoir & Loading Tool
Guidewire Compatibility Verification ●
Insertion Force - ClotTriever Dilator Handle into Sheath Hub
Retraction Force Dilator Handle from Sheath Hub ●
Deployment Force - ClotTriever Sheath from Dilator
Engagement Force - Dilator Handle
Retraction Force – Dilator Thru ClotTriever Sheath
Retraction Force – Dilator Handle
Insertion Verification ClotTriever Delivery Catheter thru Sheath ●
Retraction of the ClotTriever Catheter Thru ClotTriever Sheath ●
Kink Resistance/ Radius Verification ClotTriever Sheath & Dilator ●
Leakage Verification, ClotTriever Sheath
Leakage Verification, ClotTriever Dilator ●
Leakage Verification, Clot Reservoir ●
Air Leakage, ClotTriever Sheath ●
Clot Reservoir Check Valve Cracking Pressure ●

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Vacuum Testing, ClotTriever Sheath ●
Vacuum Testing, ClotTriever Clot Reservoir ●
Push-Button Force Testing Garrote Valve ●
Fluid Test Thru ClotTriever Sheath/Dilator ●
. Corrosion Resistance
ClotTriever Dilator Retraction in Clot Analog
Simulated Use, Track and Tensile ClotTriever Dilator ●
. Simulated Use, Track and Tensile - ClotTriever Sheath
Simulated Use, Tensile – ClotTriever Clot Reservoir
Simulated Use Track and Turn-to-Failure, ClotTriever Sheath ●
Torque Testing - Dilator
Torque Testing Garrote Valve ●
Torque Testing - Flushing Stopcock
Burst Testing Garrote Valve ●
Burst Testing Flushing Stopcock ●
. Particulate Evaluation

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.

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).