ClotTriever BOLD Catheter by Inari Medical, Inc.

· 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 the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever 13 Fr and 16 Fr Sheaths, and Protrieve Sheath, each packaged separately.

The ClotTriever BOLD Catheter is 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 Catheter, ClotTriever BOLD Catheter, ClotTriever Sheaths, and Protrieve Sheath have radiopaque distal tips.

AI/ML Overview

The provided text is a 510(k) summary for the ClotTriever BOLD® Catheter, describing modifications to an existing device and demonstrating substantial equivalence to its predicate. The assessment focuses on non-clinical testing, as no clinical testing was required.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests performed to ensure the modified device meets specified requirements, asserting that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, specific numerical acceptance criteria (e.g., minimum force, maximum leakage) and the quantitative reported performance values are not explicitly detailed in this summary. Instead, it provides a list of tests and a general statement of compliance.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with relevant product specifications	All acceptance criteria were met.
Optimal Packaging Usability	Tested, and criteria met.
Acceptable Visual and dimensional inspections	Tested, and criteria met.
Effective Deairing/Flushing	Tested, and criteria met.
Adequate Radial force	Tested, and criteria met.
Acceptable Deployment force of ClotTriever BOLD from delivery catheter	Tested, and criteria met.
Adequate Retraction force of handle	Tested, and criteria met.
Acceptable Retraction force of ClotTriever BOLD into delivery catheter	Tested, and criteria met.
No/Minimal Leakage (ClotTriever BOLD Catheter)	Tested, and criteria met.
Sufficient Corrosion resistance	Tested, and criteria met.
Satisfactory Simulated use, track and tensile (ClotTriever BOLD Catheter)	Tested, and criteria met.
Adequate Torque testing (ClotTriever BOLD handle)	Tested, and criteria met.
Acceptable Particulate matter levels	Tested, and criteria met.
Effective Performance (Clot removal from collection bag)	Tested, and criteria met.
Successful Narrow occlusion test	Tested, and criteria met.
Pouch seal integrity (visual inspection, dye penetration, peel and seal strength, bubble leak)	Leveraged from predicate, deemed met.
Visual and dimensional inspections post-simulated use	Leveraged from predicate, deemed met.
Guidewire compatibility	Leveraged from predicate, deemed met.
Conical fitting with 6% luer taper	Leveraged from predicate, deemed met.
Proper Insertion/Retraction through ClotTriever Sheath	Leveraged from predicate, deemed met.
ClotTriever BOLD Catheter kink radius	Leveraged from predicate, deemed met.
Leakage/Air leakage/Vacuum testing (ClotTriever Sheath)	Leveraged from predicate, deemed met.
Simulated use, track, and rotation/tensile (non-affected components)	Leveraged from predicate, deemed met.
ClotTriever BOLD Catheter radiopacity	Leveraged from predicate, deemed met.
Compatibility with Protrieve Sheath (insertion, retraction, leakage, air leakage, vacuum)	Leveraged from Protrieve Sheath (K220415), deemed met.
Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility)	Leveraged from predicate (no new materials), deemed met.
Sterilization validation (SAL 10-6, EO)	Leveraged from predicate (no greater challenge), deemed met.

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

The document does not explicitly state the sample sizes (number of devices or tests performed) for the non-clinical tests. It only lists the types of tests conducted.

The data provenance is from non-clinical (bench and in-vitro) laboratory testing performed by the manufacturer, Inari Medical, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location in Irvine, California, USA. All testing appears to be prospective in the sense that it was conducted specifically for this submission to verify the modified device's performance.

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 evaluation relies solely on non-clinical, objective engineering and materials testing. There's no "ground truth" in the clinical sense established by human experts, but rather adherence to predefined engineering specifications and standards.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above. Non-clinical tests typically involve objective measurement against predetermined pass/fail criteria, rather than subjective adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device (ClotTriever BOLD® Catheter) is a mechanical medical device for thrombectomy and does not involve AI or human "readers" in its operation or assessment as described in this 510(k) summary. No MRMC study was mentioned or performed.

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

This information is not applicable as the device is not an algorithm or AI system. Its performance is assessed through its physical characteristics and mechanical functionality.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering specifications, performance standards, and established biocompatibility and sterilization requirements. For comparative purposes, the predicate device (ClotTriever BOLD® Catheter, K212632) serves as a benchmark for equivalence, and its performance data established the precedent for acceptable parameters.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this mechanical device submission. The device is not learning from data.

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

This information is not applicable for the same reason as above.

Summary

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April 18, 2023

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

Re: K230494

Trade/Device Name: ClotTriever BOLD® Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 23, 2023 Received: February 23, 2023

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 (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: 2023.04.18
17:38:53 -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

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Indications for Use

510(k) Number (if known) K230494

Device Name ClotTriever BOLD® 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® Thrombectomy 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)

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510(K) SUMMARY

Date prepared	April 18, 2023
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949-600-8433
Contact person	Kaitlyn WeinkaufSr. Regulatory Affairs Specialist
Device name	ClotTriever® Thrombectomy System
Trade name	ClotTriever BOLD® Catheter
Common name	Embolectomy catheter
Regulationname	Embolectomy catheter
Classificationnumber	21 CFR 870.5150
Primaryproduct code	QEW
Secondaryproduct code	KRA
Regulatoryclass	II
Predicatedevice	ClotTriever BOLD® Catheter (K212632)
Description	The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to removethrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy Systemconsists of the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever 13 Fr and 16 FrSheaths, and Protrieve Sheath, each packaged separately.The ClotTriever BOLD Catheter is comprised of reinforced polymeric coaxial shafts terminatingin an expandable coring element and thrombus collection bag. Three ports terminating in twostopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid influoroscopic visualization, the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTrieverSheaths, and Protrieve Sheath have radiopaque distal tips.
Indications forUse	The proposed modifications of the ClotTriever BOLD Catheter do not change the indications foruse of the ClotTriever Thrombectomy System.The ClotTriever Thrombectomy System is indicated for:

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	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).
Devicemodifications	The proposed modifications to the ClotTriever BOLD Catheter include: addition of a surfacetreatment process to the existing titanium oxide layer of the collection bag resulting in a smootherthin uniform oxide layer; dimensional change to the collection bag; dimensional change to thehandle plunger shaft and addition of a hypotube in the handle; dimensional change to the coringelement weld ring; change to the plunger inner compression spring; and a change to the short innercompression spring.There are no proposed changes to the intended use or design of the ClotTriever Catheter,ClotTriever Sheaths (13 Fr and 16 Fr), and Protrieve Sheath as part of this submission.
Comparison ofTechnologicalCharacteristicswith thePredicateDevice	The proposed device and predicate device have a similar design and materials of construction. Withthe exception of the modifications listed above, the predicate and proposed devices are the same.The modifications do not change the basic design or the principles of operation from the predicatedevice. There are no new or different questions of safety or efficacy.There is no change of intended use or fundamental scientific technology between the proposeddevice and predicate device.
	Device	ClotTriever BOLD Catheter(Proposed)	ClotTriever Thrombectomy SystemClotTriever BOLD Catheter Predicate(K212632)
	Manufacturer	Inari Medical	Inari Medical
	Product Code	QEW, KRA	QEW
	Intended Use	The ClotTriever Thrombectomy System isintended for use in the peripheralvasculature including deep veinthrombosis (DVT).	The ClotTriever Thrombectomy System isintended for use in the peripheralvasculature including deep vein thrombosis(DVT).
	Indications forUse	The ClotTriever Thrombectomy System isindicated for:	The ClotTriever Thrombectomy System isindicated for:
		• The non-surgical removal of thrombi andemboli from blood vessels.	• The non-surgical removal of thrombi andemboli from blood vessels.
		• Injection, infusion, and/or aspiration ofcontrast media and other fluids into orfrom a blood vessel.	• Injection, infusion, and/or aspiration ofcontrast media and other fluids into orfrom a blood vessel.
		The ClotTriever Thrombectomy System isintended for use in the peripheralvasculature including deep veinthrombosis (DVT).	The ClotTriever Thrombectomy System isintended for use in the peripheralvasculature including deep vein thrombosis(DVT).
	DeviceDescription	The ClotTriever Thrombectomy Systemconsists of the ClotTriever Sheaths, theProtrieve Sheath, the ClotTriever Catheter,and the ClotTriever BOLD Catheter. TheClotTriever/Protrieve Sheaths arecomprised of a reinforced polymeric	The ClotTriever Thrombectomy Systemconsists of the ClotTriever Sheaths, theClotTriever Catheter, and the ClotTrieverBOLD Catheter. The ClotTriever Sheathsare comprised of a reinforced polymericsheath equipped with a self-expanding distal

		sheath equipped with a self-expandingdistal mesh funnel, a flush/aspiration port,and a proximal hemostasis valve. TheClotTriever and ClotTriever BOLDCatheters are comprised of reinforcedpolymeric coaxial shafts terminating in anexpandable coring element and thrombuscollection bag. Other accessories providedinclude a pre-dilator, the funnel loadingtool, and a large bore 60 cc syringe.	mesh funnel, a flush/aspiration port, and aproximal hemostasis valve. The ClotTrieverand ClotTriever BOLD Catheters arecomprised of reinforced polymeric coaxialshafts terminating in an expandable coringelement and thrombus collection bag. Otheraccessories provided include a pre-dilator,the funnel loading tool, and a large bore 60cc syringe.
	Principles ofOperation	The ClotTriever BOLD Catheter isadvanced into the vessel and beyond theclot. The self-expanding braided nitinolwire net is deployed. The expanded netcores, separates, and entraps thrombusfrom the vessel as it is being drawn to thefunnel opening of theClotTriever/Protrieve Sheath. The net iscollapsed and pulled into and through theClotTriever/Protrieve Sheath with theentrapped clot. A 60 cc syringe is providedfor the aspiration of clot in the sheath andthe infusion of contrast media and otherfluids.	The ClotTriever BOLD Catheter isadvanced into the vessel and beyond theclot. The self-expanding braided nitinolwire net is deployed. The expanded netcores, separates, and entraps thrombus fromthe vessel as it is being drawn to the funnelopening of the ClotTriever Sheath. The netis collapsed and pulled into and through theClotTriever Sheath with the entrapped clot.A 60 cc syringe is provided for theaspiration of clot in the sheath and theinfusion of contrast media and other fluids.
	Target Vessel	Peripheral vessels 6-16 mm	Peripheral vessels 6-16 mm
	Catheter	OD: 12 Fr	OD: 12 Fr
	OD/ID	ID: 0.124"	ID: 0.124"
	Collection Bag	Collapsed: 16.5 cm	Collapsed: 24 cm
	Length	Expanded: 13.2 cm	Expanded: 19 cm
	Collection BagMaterial	Nitinol	Nitinol
	Collection BagSurface	Titanium Oxide, native oxide layer andnew surface treatment process to achieve auniform thin titanium oxide layer	Titanium Oxide, native oxide layer
	CoringElementMaterial	Nitinol	Nitinol
	CoringElementSurface	Titanium Oxide, native oxide layer	Titanium Oxide, native oxide layer
	CoringElement OD	16 mm	16 mm
	Catheter	Deployed: 103 cm	Deployed: 111 cm
	Length	Effective: 80 cm	Effective: 80 cm
	Guidewirecompatibility	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 and predicate device 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 validation testswere identified to support the substantial equivalence of the ClotTriever BOLD Catheter to thepredicate device. This testing demonstrated compliance with relevant product specifications.
	The following tests were performed on the proposed device to establish substantial equivalence andshelf-life:
	Packaging Usability Visual and dimensional inspections Deairing/Flushing Radial force Deployment force of ClotTriever BOLD from delivery catheter Retraction force of handle Retraction force of ClotTriever BOLD into delivery catheter Leakage testing, ClotTriever BOLD Catheter Corrosion resistance Simulated use, track and tensile ClotTriever BOLD Catheter Torque testing, ClotTriever BOLD handle Particulate matter Performance test Clot removal from collection bag test Narrow occlusion test
	The following testing was not impacted by the design modifications and therefore wasleveraged from the predicate ClotTriever BOLD Catheter (K212632):
	Pouch seal visual inspection Dye penetration Pouch, peel and seal strength Bubble leak test Visual and dimensional inspections post-simulated use – delivery catheter ID and markerband distance from distal tip Guidewire compatibility Conical fitting with 6% luer taper Insertion of delivery catheter through ClotTriever Sheath Retraction force of ClotTriever BOLD device through ClotTriever Sheath ClotTriever BOLD Catheter kink radius Leakage testing – ClotTriever Sheath Air leakage - ClotTriever Sheath Vacuum testing – ClotTriever Sheath Simulated use, track, and rotation, ClotTriever BOLD Catheter Simulated use, track and tensile, ClotTriever BOLD Catheter (non-affected components) ClotTriever BOLD Catheter radiopacity

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The following design verification testing to demonstrate compatibility with the Protrieve Sheathwas leveraged from the Protrieve Sheath (K220415):Insertion of delivery catheter through Protrieve Sheath Retraction force of ClotTriever BOLD device through Protrieve Sheath Leakage testing – Protrieve Sheath Air leakage - Protrieve Sheath Vacuum testing - Protrieve Sheath
As there were no new materials introduced with the design modifications, the followingbiocompatibility tests were leveraged from the predicate ClotTriever BOLD Catheter:Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity (Systemic Injection Test and Rabbit Pyrogen Test) Hemocompatibility (Hemolysis, Effect on Clotting, Complement Activation, and Thrombosis)
The proposed ClotTriever BOLD Catheter and predicate device are of the same generalconstruction and the design differences do not pose a greater challenge to the sterilization process.Therefore, the sterilization validation for the predicate device applies to the proposed ClotTrieverBOLD Catheter.
Clinical testing was not required to support substantial equivalence.
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms toestablished product specifications.
Conclusion
The proposed device modifications to the ClotTriever BOLD Catheter do not change its intendeduse nor do they change the principles of operation. The verification and validation resultsdemonstrate that the modified ClotTriever BOLD Catheter is substantially equivalent to thepredicate 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).