The Infusion Aspiration Catheter System consists of the Infusion Wireform Catheter, Aspiration Guide Catheter, and Retraction Aspirator Device. The Infusion Aspiration Catheter 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 Infusion Aspiration Catheter System is intended for use in the peripheral vasculature.

Device Description

The Infusion Wireform Catheter consists of a single lumen Delivery Catheter containing a second internal catheter. The internal Wireform Catheter has a hollow flexible shaft with self-expanding wireform disks attached to its distal end. The wireform disks are available in 3 sizes for treatment of vessels with diameter of 6-10 mm, 11-14 mm, or 15-18 mm.
The Aspiration Guide Catheter is introduced over a previously placed 0.035" exchange length guidewire. A dilator compatible with the 0.035" guidewire is provided for the Guide Catheter to assist in its advancement.
The Dilator/Guide Catheter assembly is advanced in the patient's vasculature to a location proximal of the obstruction. The dilator is withdrawn and replaced with the Infusion Wireform Catheter which is advanced distal to the obstruction. The wireform disks are deployed by retracting Delivery Catheter.
By aspiration and withdrawal of the Infusion Wireform Catheter into the Guide Catheter, the obstructing material may be disrupted or removed.
The Retraction Aspirator Device is available to facilitate the simultaneous aspiration and withdrawal of the Infusion Wireform Catheter into the Guide Catheter. The hand-lever operated Retraction Aspirator Device is fitted with a vacuum syringe and collection container. Operating the Retraction Aspirator Device lever simultaneously retracts the Infusion Wireform Catheter into the Guide Catheter and aspirates fluids.

AI/ML Overview

The provided document describes the Infusion Aspiration Catheter System and details the non-clinical testing performed to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria or quantitative performance measures for the device. Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed.

Based on the available information, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated in the document, this table cannot be fully completed with numerical values. The document generally states that "Test results demonstrated that all acceptance criteria were met, and, therefore, the device conforms to expected device performance and intended use."

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Package Integrity	Compliance with ISO 11607-1/2	Met (pouch bubble emission, pouch peel, seal strength)
Device Specifications (e.g., dimensions, flexibility, torque, retraction/deployment force, kink radius, leakage, suction volume, flow rate, tensile strength, corrosion resistance, burst pressure, particulate matter)	Compliance with relevant standards (e.g., ISO 10555-1, ISO 594-1/2) and product specifications.	Met (all tested parameters)
Biocompatibility	Compliance with ISO 10993-1	Met (MEM elution, sensitization, intracutaneous toxicity, acute systemic toxicity, pyrogen, hemolysis, complement activation, thrombogenicity, mutagenicity)
Shelf Life	6 months	Met through accelerated aging studies
Simulated Thrombus Removal (Simulated Use Tracking)	Consistent removal of simulated thrombus from simulated vessels.	Demonstrated consistent removal
Acute Safety and Performance (Animal Model)	Safe and effective performance in a bovine model.	Successfully performed

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

The document does not explicitly state the sample sizes for each non-clinical test. It mentions:

Accelerated aging studies: Conducted on "sterilized (ethylene oxide), accelerated-aged devices." The specific number of devices is not provided.
Simulated Use Tracking: Refers to "consistent removal of simulated thrombus from the simulated vessels in testing." The number of simulated vessels or test iterations is not specified.
Animal study: "Acute evaluation of the safety and performance of the Inari Infusion Wireform Catheter, Aspiration Guide Catheter, and the Retraction Aspirator Device were successfully performed in a bovine model." The number of bovine subjects is not specified.

Data Provenance: The testing appears to be internal validation testing conducted by Inari Medical, Inc. The data is prospective in nature, as it was generated specifically for the purpose of demonstrating device performance and substantial equivalence. The country of origin of the data is not specified but would likely be the USA, given the FDA submission.

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

This information is not provided in the document. The non-clinical testing and animal study do not typically involve human expert readers establishing "ground truth" in the same way clinical image analysis studies would. Instead, performance is measured against engineering specifications, standard protocols, and physiological outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical and animal testing, not a study involving human readers or subjective interpretations that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to this device. The Infusion Aspiration Catheter System is a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI is irrelevant.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical and animal studies was established through:

Engineering Specifications: For tests like tensile strength, burst pressure, flow rate, leakage, etc., the ground truth is predefined and measurable physical and mechanical properties.
Validated Standards: Compliance with ISO standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 10993-1, ISO 11607-1/2) serves as the "ground truth" for many tests.
Simulated Conditions: For simulated use tracking, the "ground truth" is the successful and consistent removal of simulated thrombus in a controlled, simulated vascular environment.
Physiological Outcomes (Animal Model): For the bovine model, the ground truth would be the assessment of the device's acute safety and performance within a living system, likely based on observations of tissue damage, device functionality, and physiological response.

8. Sample Size for the Training Set

This information is not applicable. The Infusion Aspiration Catheter System is a physical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable, as it is a physical device and not an AI/ML algorithm.

Summary

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

February 3, 2015

Inari Medical, Inc. c/o Mark Job Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K143563

Trade/Device Name: Infusion Aspiration Catheter System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: December 2, 2014 Received: December 16, 2014

Dear Mr. Job:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Bram D. Zuckerman -S

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)

Device Name Infusion Aspiration Catheter System

Indications for Use (Describe)

The Infusion Aspiration Catheter System consists of the Infusion Wire Catheter, Aspiration Guide Catheter, and Retraction Aspirator Device. The Infusion Aspiration Catheter 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 Infusion Aspiration Catheter System is intended for use in the peripheral vasculature.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image contains the logo for Inari Medical. The logo features a stylized purple circle with three curved orange lines emanating from the left side. To the right of the circle is the word "INARI" in large, bold, purple letters. Below "INARI" is the word "MEDICAL" in smaller, gray letters.

5 510(K) SUMMARY

Date prepared	November 30, 2014
Name	Inari Medical, Inc.8 Argonaut, Suite 100Aliso Viejo, CA 92656949.598.0300 x114
Contact person	Eben GordonVice President, Regulatory Affairs & Quality Assurance
Trade name	Infusion Aspiration Catheter System
Common name	Embolectomy catheter
Regulation Name	Embolectomy catheter
Classification number	21 CFR 870.5150
Product code	DXE
Regulatory class	II
Predicate devices	Genesis Medical Interventional F.A.S.T. System (K040010)Fogarty Thru-Lumen Embolectomy Catheter (K892410)Fogarty Venous Embolectomy Catheter (510[k] unknown)
Description	The Infusion Wireform Catheter consists of a single lumen Delivery Cathetercontaining a second internal catheter. The internal Wireform Catheter has ahollow flexible shaft with self-expanding wireform disks attached to its distal end.The wireform disks are available in 3 sizes for treatment of vessels with diameterof 6-10 mm, 11-14 mm, or 15-18 mm.
	The Aspiration Guide Catheter is introduced over a previously placed 0.035"exchange length guidewire. A dilator compatible with the 0.035" guidewire isprovided for the Guide Catheter to assist in its advancement.
	The Dilator/Guide Catheter assembly is advanced in the patient's vasculature to alocation proximal of the obstruction. The dilator is withdrawn and replaced withthe Infusion Wireform Catheter which is advanced distal to the obstruction. Thewireform disks are deployed by retracting Delivery Catheter.
	By aspiration and withdrawal of the Infusion Wireform Catheter into the GuideCatheter, the obstructing material may be disrupted or removed.
	The Retraction Aspirator Device is available to facilitate the simultaneousaspiration and withdrawal of the Infusion Wireform Catheter into the GuideCatheter. The hand-lever operated Retraction Aspirator Device is fitted with a
	vacuum syringe and collection container. Operating the Retraction AspiratorDevice lever simultaneously retracts the Infusion Wireform Catheter into theGuide Catheter and aspirates fluids.
Indications for use	The Infusion Aspiration Catheter System consists of the Infusion WireformCatheter, Aspiration Guide Catheter, and Retraction Aspirator Device. TheInfusion Aspiration Catheter 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 fluidsinto or from a blood vessel.
	The Infusion Aspiration Catheter System is intended for use in the peripheralvasculature.
Summary ofsubstantial equivalence	The Infusion Aspiration Catheter System and the predicate devices have the sameintended use: removal of obstructing material (including emboli and thrombi)from blood vessels. The Indications for Use of the Infusion Aspiration CatheterSystem is a subset of that of the F.A.S.T. System. The F.A.S.T. System hasadditional uses in synthetic grafts and temporary blood vessel/graft occlusions.The Fogarty Thru-Lumen Embolectomy Catheter ("FTLEC") is indicated forvessels in the arterial system while the Fogarty Venous Embolectomy Catheter isindicated for the venous system. The F.A.S.T., FTLEC, and Fogarty VenousThrombectomy Catheter are also indicated for temporary occlusion of bloodvessels.
	Lacking temporary use in vessel occlusions and synthetic grafts does not affectthe safety or effectiveness of the Infusion Aspiration Catheter System when usedas labeled.
	The principle of operation is the same for Inflation Aspiration Catheter andF.A.S.T. Systems - expanding Nitinol braids are withdrawn through the vesselobstruction to restore blood flow. While the FTLEC and Fogarty VenousThrombectomy Catheters are withdrawn through the vessel obstruction, theydiffer in that it is an elastomeric balloon that is being withdrawn. In all cases, theprinciple of operation is the same.
	The Infusion Aspiration Catheter and the F.A.S.T. Systems have similar materialsof construction. Both use Nitinol metal features to remove the obstruction andhave thermoplastic polymer catheter shafts. Again, they differ from the FTLECwhich has a latex balloon. The effect on the vessel caused by the InflationAspiration Catheter System was demonstrated to be similar to that of the FTLECin the study entitled: A GLP Evaluation of the Inari Embolectomy Device in aBovine Model. The Infusion Aspiration Catheter and the F.A.S.T. Systems carrythe same hazard of a broken or protruding Nitinol wire causing vessel puncture.To mitigate this possibility, the Wireform Catheter is 100% inspected for brokenand protruding Nitinol braids during manufacture.

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The range of vessel diameter treated for the Infusion Aspiration Catheter System

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(6 mm - 18 mm) is within the combined ranges of the predicate devices (5 mm -19 mm).

The Infusion Aspiration Catheter System is provided with a 20 Fr Guide Catheter. The F.A.S.T. System, FTLEC, and Fogarty Venous Thrombectomy Catheters are used with commercially available guide catheters which can be smaller than 20 Fr. The larger Infusion Aspiration System's guide catheter limits the range of vessels it can be used in. The restriction of vessels sizes does not affect the effectiveness of the Infusion Aspiration Catheter System as demonstrated in the consistent removal of simulated thrombus from the simulated vessels in testing.

Non-Clinical Testing

In alignment with the Design Failure Modes and Effects Analysis, verification and validation testing was identified to support the safety and effective of the Infusion Aspiration Catheter System.

This testing demonstrated compliance with relevant standards (e.g. ISO 10555-1, ISO 594-1/2, etc.) and product specifications. These tests included:

. Package integrity and accelerated aging inspection
Pouch bubble emission
Pouch peel, seal strength
Visual and dimensional inspections ●
Guidewire compatibility
Snap fit, Dilator Luer to Guide Catheter hemostasis valve
System flexibility and torque
. Retraction force of Wireform Catheter into Delivery Catheter
. Deployment force of Wireform Catheter from Delivery Catheter
Guide Catheter/Dilator kink radius
Retraction force of Wireform Catheter into Guide Catheter
Leakage testing, hemostasis valves with guidewire
Guide Catheter/Infusion Wireform Catheter kink radius
Liquid leakage under pressure (300 kPa)
Leakage testing, devices with Guide Catheter hemostasis valve ●
Test of conical fittings with 6% Luer taper
Air leakage into hub assembly during aspiration
Suction volume, RA device
Retraction, RA device (15 cycles) ●
. Tube set, leakage
. Suction and exhaust check valve testing
Power injection testing
Determination of flow rate through catheter
Tensile strength
Corrosion resistance
Particulate matter ●
Burst Pressure
Simulated Use Tracking

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Biocompatibility testing in accordance with ISO 10993-1:

. MEM elution
. Guinea pig maximization sensitization
Intracutaneous toxicity ●
Acute systemic toxicity
Material mediated pyrogen ●
Hemolysis, direct contact and extract method
. Complement activation
Thrombogenicity
Mutagenicity

The shelf life of the Infusion Aspiration Catheter System is six (6) months from the date of manufacture based on accelerated aging studies. Verification testing was conducted on sterilized (ethylene oxide), accelerated-aged devices to support the 6 months shelf life.

Package integrity testing was conducted according to ISO 11607-1/2 guidelines. These tests included:

Pouch bubble emission
Pouch peel, seal strength

Acute evaluation of the safety and performance of the Inari Infusion Wireform Catheter, Aspiration Guide Catheter, and the Retraction Aspirator Device were successfully performed in a bovine model.

Clinical testing was not required for the determination of substantial equivalence.

Conclusion

Test results demonstrated that all acceptance criteria were met, and, therefore, the device conforms to expected device performance and intended use.

Based upon the technology, materials, intended use, non-clinical testing, and animal study results, it is concluded that the Infusion Aspiration Catheter System is substantially equivalent to the F.A.S.T. System, Fogarty Thru-Lumen Embolectomy Catheter, and Fogarty Venous Thrombectomy Catheter. These results demonstrate that the Infusion Aspiration Catheter System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices identified above.

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).