· 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 intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

Device Description

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths, Protrieve Sheath, ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter, each packaged separately.
The ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in two stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Sheaths, Protrieve Sheath, and ClotTriever Catheters have radiopaque distal tips. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature.

AI/ML Overview

The ClotTriever XL Catheter is an accessory to the ClotTriever Thrombectomy System and is used for non-surgical removal of thrombi and emboli from blood vessels. It is also used for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel within the peripheral vasculature, including deep vein thrombosis (DVT).

Here's an overview of the acceptance criteria and study information for the ClotTriever XL Catheter based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Pouch Seal Visual Inspection	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Dye Penetration Packaging Usability	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Visual and Dimensional Inspection	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Guidewire Compatibility	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Protrieve and ClotTriever Sheath Compatibility	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Radial Force	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Retraction Force into ClotTriever Sheath	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Deployment/Retraction Force	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Retraction force to expand the collection bag	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Kink Radius	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Fluid Leakage - Protrieve, ClotTriever Sheath, Catheter	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Vacuum Testing - Protrieve, ClotTriever Sheath	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Simulated Use, Track and Rotation (Torque)	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Simulated Use, Track and Tensile	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Particulate Matter	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Conical Fitting with 6% Luer Taper	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Pre-clinical/GLP Animal Safety Evaluation (including In Vivo Functional Testing/Radiopacity Verification)	Not explicitly stated (Implied to meet specifications)	All acceptance criteria were met.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility - Hemolysis, Complement Activation, Thrombogenicity (in vivo/in vitro))	As suggested by ISO 10993-1	All acceptance criteria were met.

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It mentions that "verification and validation tests were identified to support the substantial equivalence" and that "test results demonstrated that all acceptance criteria were met."

The provenance of the data is from non-clinical testing conducted by Inari Medical, Inc. The nature of these tests (e.g., mechanical, simulated use, biocompatibility) implies laboratory-based testing rather than patient data. Therefore, the data would be considered prospective from a testing perspective, as the tests were conducted specifically for this submission. There is no information about country of origin, but it is typically assumed to be where the manufacturer is based (USA).

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

Since this submission is based on non-clinical testing (mechanical, performance, and biocompatibility), there is no mention of "experts" in the context of establishing ground truth for a test set based on patient data (e.g., radiologists, pathologists). The "truth" for these tests is based on predefined engineering and scientific specifications, and compliance with standards like ISO 10993-1.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is based on objective, quantifiable non-clinical test results against established specifications, not subjective interpretation of medical images or patient outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to support substantial equivalence." This means the submission did not involve studies comparing human readers' performance with and without AI assistance, as the device is a medical instrument (catheter), not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The ClotTriever XL Catheter is a medical device for clot removal, not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not through standalone algorithm performance metrics.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on engineering specifications, established industry standards (e.g., ISO 10993-1 for biocompatibility), and pre-defined performance benchmarks relevant to the safe and effective operation of the catheter. For the animal safety evaluation, the ground truth would be based on in-vivo observations of safety and functional performance.

8. The Sample Size for the Training Set

Not applicable. The ClotTriever XL Catheter is a physical medical device and does not involve AI algorithms that require a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 27, 2023

Inari Medical, Inc. Kaitlyn Weinkauf Senior Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618

Re: K223210

Trade/Device Name: ClotTriever XL Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: October 14, 2022 Received: October 17, 2022

Dear Kaitlyn Weinkauf:

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

{1}------------------------------------------------

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/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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by
Gregory W. Gregory W. O'connell
-S
O'connell -S Date: 2023.04.27
12:05:46 -04'00'

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223210

Device Name ClotTriever XL Catheter

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 Thrombectorny System is intended for use 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Page 1 of 5

510(K) SUMMARY

Date prepared	April 27, 2023
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949-600-8433
Contact person	Kaitlyn WeinkaufSr. Regulatory Affairs Specialist
Name of Device	ClotTriever® Thrombectomy System
Device Trade Name	ClotTriever® XL Catheter
Common name	Embolectomy catheter
Regulation name	Embolectomy catheter
Classification number	21 CFR 870.5150
Primary product code	QEW
Secondary productcode	KRA
Regulatory class	II
Predicate device	ClotTriever® Thrombectomy System (K212632)
Description	The ClotTriever Thrombectomy System is a single-use, sterile medical device designed toremove thrombi and emboli from the peripheral vasculature. The ClotTrieverThrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths, Protrieve Sheath,ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter, eachpackaged separately.The ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter arecomprised of reinforced polymeric coaxial shafts terminating in an expandable coringelement and thrombus collection bag. Three ports terminating in two stopcocks and a luerlock connection are provided for de-airing the catheter shafts. To aid in fluoroscopicvisualization, the ClotTriever Sheaths, Protrieve Sheath, and ClotTriever Catheters haveradiopaque distal tips. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm inthe peripheral vasculature.
Indications for Use	The introduction of the ClotTriever XL Catheter variant does not change the indications foruse of the ClotTriever Thrombectomy System.The ClotTriever Thrombectomy System is indicated for:● The non-surgical removal of thrombi and emboli from blood vessels.

{4}------------------------------------------------

	• 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 modifications	The purpose of this submission is to introduce a ClotTriever BOLD Catheter variant, the ClotTriever XL Catheter, that is larger in diameter and longer in length.There have been no changes to the ClotTriever 13 Fr and 16 Fr Sheaths, the Protrieve Sheath, the ClotTriever Catheter, or the ClotTriever BOLD Catheter.
Comparison ofTechnologicalCharacteristics withthe Predicate Device	The proposed device and predicate device have a similar design and materials of construction. With the exception of the modifications to the catheter OD, catheter length, bag length, coring element length and diameter, and a minor material change, the predicate and proposed devices are the same. These modifications do not change the basic design or the principles of operation from the predicate device.There are no new or different questions of safety or efficacy.There is no change of intended use or fundamental scientific technology between the proposed device and predicate device. The changes made for the ClotTriever XL Catheter do not change the technological characteristics of the ClotTriever Thrombectomy System.
	Device	ClotTriever XL Catheter(Proposed)	ClotTriever ThrombectomySystemClotTriever BOLD CatheterPredicate (K212632)
	Manufacturer	Inari Medical	Inari Medical
	Product Code	QEW, KRA	QEW
	Intended Use	The ClotTriever ThrombectomySystem is intended for use in theperipheral vasculature includingdeep vein thrombosis (DVT).	The ClotTriever ThrombectomySystem is intended for use in theperipheral vasculature includingdeep vein thrombosis (DVT).
	Indications for Use	The ClotTriever ThrombectomySystem is indicated for:• The non-surgical removal ofthrombi and emboli from bloodvessels.• Injection, infusion, and/oraspiration of contrast media andother fluids into or from a bloodvessel.The ClotTriever ThrombectomySystem is intended for use in theperipheral vasculature includingdeep vein thrombosis (DVT).	The ClotTriever ThrombectomySystem is indicated for:• The non-surgical removal ofthrombi and emboli from bloodvessels.• Injection, infusion, and/oraspiration of contrast media andother fluids into or from a bloodvessel.The ClotTriever ThrombectomySystem is intended for use in theperipheral vasculature includingdeep vein thrombosis (DVT).
	Device Description	The ClotTriever ThrombectomySystem consists of theClotTriever Sheaths, the	The ClotTriever ThrombectomySystem consists of theClotTriever Sheaths, the
	Catheter, the ClotTriever BOLDCatheter, and the ClotTriever XLCatheter. TheClotTriever/Protrieve Sheathsare comprised of a reinforcedpolymeric sheath equipped witha self-expanding distal meshfunnel, a flush/aspiration port,and a proximal hemostasis valve.The ClotTriever Catheter,ClotTriever BOLD Catheter, andClotTriever XL Catheter arecomprised of reinforcedpolymeric coaxial shaftsterminating in an expandablecoring element and thrombuscollection bag. Other accessoriesprovided include a pre-dilator,the funnel loading tool, and alarge bore 60 cc syringe.	ClotTriever Catheter, and theClotTriever BOLD Catheter.The ClotTriever/ProtrieveSheaths are comprised of areinforced polymeric sheathequipped with a self-expandingdistal mesh funnel, aflush/aspiration port, and aproximal hemostasis valve. TheClotTriever and ClotTrieverBOLD Catheters are comprisedof reinforced polymeric coaxialshafts terminating in anexpandable coring element andthrombus collection bag. Otheraccessories provided include apre-dilator, the funnel loadingtool, and a large bore 60 ccsyringe.
Principles of Operation	The ClotTriever XL Catheter isadvanced into the vessel andbeyond the clot. The self-expanding braided nitinol wirenet is deployed. The expandednet cores, separates, and entrapsthrombus from the vessel as it isbeing drawn to the funnelopening of theClotTriever/Protrieve Sheath.The net is collapsed and pulledinto and through theClotTriever/Protrieve Sheathwith the entrapped clot. A 60 ccsyringe is provided for theaspiration of clot in the sheathand the infusion of contrastmedia and other fluids.	The ClotTriever BOLDCatheter is advanced into thevessel and beyond the clot. Theself-expanding braided nitinolwire net is deployed. Theexpanded net cores, separates,and entraps thrombus from thevessel as it is being drawn to thefunnel opening of theClotTriever/Protrieve Sheath.The net is collapsed and pulledinto and through theClotTriever/Protrieve Sheathwith the entrapped clot. A 60 ccsyringe is provided for theaspiration of clot in the sheathand the infusion of contrastmedia and other fluids.
Target Vessel	Peripheral vessels 10-28 mm	Peripheral vessels 6-16 mm
Catheter OD/ID	OD: 16 FrID: 0.178"	OD: 12 FrID: 0.124"
Catheter Length	105 cm	80 cm
Collection Bag	Length: 10 cmWire Diameter: 0.0040"	Length: 18 cmWire Diameter: 0.0045"
Catheter Deployed Length	126 cm	111cm
Coring Element OD	30 mm	16 mm
Delivery Catheter Materials	Liner:Pebax 72D, Propell	Liner:PTFE
		Proximal segment:	Proximal segment:
		Pebax 63D, Cool Grey 4C	Pebax 63D, Cool Grey 4C
		Intermediate segment:Pebax 63D, Violet C, fluoro-safemarker	Intermediate segment:Pebax 63D, Violet C, fluoro-safe marker
		Distal segment:Pebax 63D, Cool Grey 4CPebax 55D, Violet C (distal tip)	Distal segment:Pebax 55D, Violet C
	Guidewire compatibility	0.035"	0.035"
	Shelf-Life	6 months	2 years
	Sterile	SAL 10-6, EO	SAL 10-6, EO
	How provided	Sterile, single use	Sterile, single use
Summary ofsubstantialequivalence	The proposed device, the ClotTriever XL Catheter, and the predicate device, the ClotTrieverBOLD Catheter, have the same indications for use, intended use, principles of operation,and fundamental scientific technology.
	Non-Clinical Testing
	In accordance with the design failure modes and effects analysis, verification and validationtests were identified to support the substantial equivalence of the ClotTriever XL Catheterto the predicate device. This testing demonstrated compliance with relevant productspecifications.
	The following tests were performed on the proposed device to establish substantialequivalence:
	Pouch Seal Visual Inspection and Dye Penetration Packaging Usability Visual and Dimensional Inspection Guidewire Compatibility Protrieve and ClotTriever Sheath Compatibility Radial Force Retraction Force into ClotTriever Sheath Deployment/Retraction Force Retraction force to expand the collection bag Kink Radius Fluid Leakage - Protrieve, ClotTriever Sheath, Catheter Vacuum Testing - Protrieve, ClotTriever Sheath Simulated Use, Track and Rotation (Torque) Simulated Use, Track and Tensile Particulate Matter Conical Fitting with 6% Luer Taper Pre-clinical/GLP Animal Safety Evaluation (including In Vivo FunctionalTesting/Radiopacity Verification)

{5}------------------------------------------------

K223210

{6}------------------------------------------------

{7}------------------------------------------------

The following testing was leveraged from the predicate ClotTriever BOLD Catheter (K212632):Pouch peel and seal strength Corrosion Resistance Handle Torque Sterilization Validation
The following biocompatibility tests were performed on the proposed device as suggested by ISO 10993-1:Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity (Systemic Injection Test and Rabbit Pyrogen Test) Hemocompatibility - Hemolysis Hemocompatibility - Complement Activation Hemocompatibility – Thrombogenicity ( in vivo ) Hemocompatibility - Thrombogenicity ( in vitro ) (Platelet and Leukocyte) Hemocompatibility - Thrombogenicity ( in vitro ) (Partial Thromboplastin Time Test)
Clinical testing was not required to support substantial equivalence.
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Conclusion
The proposed device modifications to the ClotTriever Thrombectomy System do not change its intended use nor do they change the principles of operation. The verification and validation results demonstrate that the proposed ClotTriever XL Catheter 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).