The Artix Balloon Guiding Sheath is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Artix Balloon Guiding Sheath is also indicated for use as a conduit for retrieval devices.
The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.

Device Description

The Artix Balloon Guiding Sheath is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic procedures. The Artix Balloon Guiding Sheath is packaged with the following components: Artix Balloon Guiding Sheath (8 Fr, 65 cm or 105 cm) Two 8 Fr Introducer Dilators (0.014" and 0.035" guidewire compatibility) Balloon Inflation Syringe, 1 mL Large Bore Syringe, 30 mL 3-way Stopcock

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is not explicitly detailed.

Acceptance Criteria and Reported Device Performance

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and claims that the results met the criteria.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not explicitly detailed in the provided text for individual tests. The general statement is that "all acceptance criteria were met."	Not explicitly detailed in the provided text for individual tests. The general statement is that "all acceptance criteria were met."

Study Information:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each non-clinical test. The document lists the types of tests performed (e.g., Pouch Seal Peel Test, Simulated Use Cycling, Balloon Fatigue Test, Sheath Kink to Failure, etc.) but does not provide the number of units tested for each.
- Data Provenance: The tests are non-clinical, likely performed in an Inari Medical lab or by a contract testing organization. The document does not specify a country of origin for the data or whether it was retrospective or prospective, as these terms are more applicable to clinical studies. These are laboratory/benchtop tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the non-clinical (benchtop) tests described. Ground truth for these types of tests would be established by predefined engineering specifications, industry standards (e.g., ISO, AAMI), and the performance characteristics of the predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or image interpretation studies where human judgment is involved in establishing ground truth. For non-clinical tests, the criteria are objective and measurable.
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:
- No. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Therefore, no MRMC study, human reader improvement analysis, or AI assistance was involved since this submission is for a medical device (Balloon Guiding Sheath) and not an AI/Software as a Medical Device (SaMD).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm or SaMD.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" or reference for comparison would be:
  - Predetermined engineering specifications: Based on the device's design requirements.
  - Relevant industry standards: Such as ISO 10993-1 for biocompatibility and ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 for sterilization.
  - Performance of the predicate device: To demonstrate substantial equivalence in key performance characteristics relevant to safety and effectiveness.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 11, 2022

Inari Medical % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K221846

Trade/Device Name: Artix Ballon Guiding Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: June 23, 2022 Received: June 24, 2022

Dear Prithul Bom:

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

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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) 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,

For Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221846

Device Name Artix Balloon Guiding Sheath

Indications for Use (Describe)

The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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PAGE 1 OF 6

510(K) SUMMARY

Date prepared	June 9, 2022
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747
Contact person	Ellen NguyenRegulatory Affairs Specialist
Trade name	Artix Balloon Guiding Sheath
Common name	Balloon guiding sheath
Regulation name	Percutaneous catheter
Classification number	21 CFR 870.1250
Product code	DQY
Regulatory class	II
Predicate device	Concentric Medical, 8F FlowGate2 Balloon Guide Catheter (K153729)
Reference device	Medtronic Vascular, Inc., Sentrant Introducer Sheath with Hydrophilic Coating (K171866)
Description	The Artix Balloon Guiding Sheath is a single-use, over-the-wire system designed tofacilitate the insertion and guidance of an intravascular catheter into a selectedperipheral blood vessel and act as a conduit for retrieval devices. A compliantballoon mounted at the sheath's distal tip provides temporary vascular occlusionduring angiographic procedures. The Artix Balloon Guiding Sheath is packaged withthe following components:Artix Balloon Guiding Sheath (8 Fr, 65 cm or 105 cm)Two 8 Fr Introducer Dilators (0.014" and 0.035" guidewire compatibility)Balloon Inflation Syringe, 1 mLLarge Bore Syringe, 30 mL3-way Stopcock
Indications for Use	The Artix Balloon Guiding Sheath is indicated for use in facilitating the insertionand guidance of an intravascular catheter into a selected blood vessel. The balloonprovides temporary vascular occlusion during these and other angiographicprocedures. The Artix Balloon Guiding Sheath is also indicated for use as a conduitfor retrieval devices.The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.

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Summary of substantial equivalence

The Artix Balloon Guiding Sheath and predicate device have the same indications for use statement: both are indicated for vascular access, facilitating the insertion and guidance of intravascular devices into selected blood vessels in the peripheral vasculature, providing temporary vessel occlusion during angiographic procedures, and to act as a conduit for retrieval devices. Unlike the predicate device, the Artix Balloon Guiding Sheath is not indicated for use in the neurovasculature.

A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:

Feature	Subject Device	8F FlowGate2 BalloonGuide Catheter - Predicate(K153729)
Manufacturer	Inari Medical	Concentric Medical
Product code	DQY	DQY
Intendeduse/Indications foruse	The Artix Balloon GuidingSheath is indicated for use infacilitating the insertion andguidance of an intravascularcatheter into a selected bloodvessel. The balloon providestemporary vascular occlusionduring these and otherangiographic procedures. TheArtix Balloon Guiding Sheath isalso indicated for use as aconduit for retrieval devices.The Artix Balloon GuidingSheath is intended for use in theperipheral vasculature.	FlowGate2 Balloon GuideCatheters are indicated foruse in facilitating theinsertion and guidance of anintravascular device into aselected blood vessel in theperipheral and neurovascularsystems. The balloonprovides temporary vascularocclusion during these andother angiographicprocedures. The BalloonGuide Catheter is alsoindicated for use as a conduitfor retrieval devices.
Device description	The Artix Balloon GuidingSheath is comprised of a singlethrough lumen shaft with four(4) embedded lumens forballoon inflation and deflation, aproximal integrated hemostasisvalve to minimize blood loss, astopcock with flush port, and aballoon port. To assist withinsertion of the sheath into thevasculature, a hydrophiliccoating covers a portion of thedistal sheath shaft. The distal tipof the sheath shaft contains two(2) radiopaque marker bands toaid with angiographicvisualization: The distal markerindicates the location of thesheath's tip, while the proximalmarker band marks the locationof a compliant balloon mounted	The FlowGate2 BalloonGuide Catheters are coaxial-lumen, braid-reinforced,variable stiffness cathetersdesigned for use infacilitating the insertion andguidance of an intravascularcatheter into a selected bloodvessel in the peripheral andneurovascular systems. Aradiopaque marker isincluded on the distal end forangiographic visualization. Acompliant balloon ismounted on the distal end toprovide temporary vascularocclusion duringangiographic procedures. Abifurcated luer hub on theproximal end allowsattachments for flushing,inflation, and aspiration.
Feature	Subject Device	8F FlowGate2 Balloon Guide Catheter - Predicate (K153729)
	at the distal end. The balloon provides temporary vascular occlusion during angiographic procedures.	Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.
Principles of operation	After the target vessel is accessed and dilated, the Artix Balloon Guiding Sheath is inserted into the vessel over a guidewire. Once the Artix Balloon Guiding Sheath is in position, the dilator is removed, and all compatible catheter devices can be inserted through the Artix Balloon Guiding Sheath for access into the peripheral vasculature. The sheath's balloon can also be inflated using a 1 mL syringe to provide flow occlusion of the vessel during the procedure.	After the target vessel is accessed and dilated, the 8F FlowGate2 Balloon Guide Catheter is inserted into the vessel. The dilator can then be removed to allow compatible working devices to be inserted through the catheter. The balloon can also be inflated to provide flow occlusion of the vessel.
Intended patient population	Adults undergoing interventional procedures	Adults undergoing interventional procedures
Target vessel	Peripheral vasculature	Peripheral and neurovasculature
Placement duration	< 24 hours	< 24 hours
Guidewire compatibility	0.014" or 0.035"	0.035"
Sterilization	EtO	EtO
Single-use	Yes	Yes
Dimensions
Sheath dimensions	OD/ID: 11 Fr/8 Fr Effective Lengths: 105 cm and 65 cm	OD/ID: 8 Fr/6.4 Fr Effective Lengths: 100 cm and 95 cm
Balloon dimensions	Ø 11 mm maximum OD Length: 10 mm	Ø 10 mm maximum OD Length: 10 mm
Materials
Shaft material	Pebax 4033	Proximal: Pebax 7233
		Distal: Pebax 6333
		Tip: Pebax 2533, Pebax 3533, BaSO4
Coating	Hydrophilic, biocompatible	None
Balloon	Chronoprene 40A thermoplastic elastomer	NuSil MED 4025 silicone elastomer
Feature	Subject Device	8F FlowGate2 BalloonGuide Catheter - Predicate(K153729)
Liner	Etched PTFE	Etched PTFE
Shaft support	304V Stainless Steel braid andcoil	304V Stainless Steel braid
Strain relief	Pellethane 2363-80APantone 2104C PMS	Pebax 4033, WhitePolyolefin, White
Marker band	Platinum-iridium	Platinum-iridium
Accessories
Accessoriesprovided	Dilators (2), balloon inflationsyringe, large bore syringe, 3-way stopcock, hemostasis valveand side port lumen (integratedinto sheath shaft)	Dilator, rotating hemostasisvalve, Tuohy-Borst valvewith sideport, Peel-AwaySheaths, Luer-activatedvalve, Extension Tubing
Dilator length	115 cm, 72 cm (working length)	123 cm (working length)
Dilator material	Shaft: LDPE/HDPEHub: HDPECap: ABS, 4% Cool Gray	Shaft: Pebax, BaSO4Hub: White polycarbonate
Dilator OD	0.110 in.	Distal: 0.072 in.Proximal: 0.078 in.

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Biocompatibility

The following biocompatibility tests were completed for the subject device:

. Cytotoxicity
. Sensitization
. Intracutaneous Reactivity
Acute Systemic Toxicity
Material-Mediated Pyrogenicity ●
Hemocompatibility (Hemolysis, Complement Activation, ● Thromboresistance, Platelet and Leukocyte Count, and Partial Thromboplastin Time)

The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.

Sterilization

The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 106. The subject device has been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 (Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices – Amendment 1: Revision of Annex E, Single batch release) and AAMI TIR 28:2016 (Product adoption and process equivalence for ethylene oxide sterilization) without deviations.

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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 Artix Balloon Guiding Sheath to the FlowGate2 Balloon Guide Catheter. These tests included:

Pouch Seal Peel Test
Pouch Seal Inspection and Pouch Dye Penetration ●
Packaging Retention ●
Visual and Dimensional Inspections Sheath ●
Dimensional Inspections Sheath Inner Diameter ●
Visual and Dimensional Inspections - Dilator
Dimensional Inspections Dilator Outer Diameter ●
Guidewire Compatibility, Dilator ●
Visual Sheath and Dilator ●
Dimensional Inspections Sheath Working Length ●
Simulated Use Cycling
Cap Locking ●
Device Retrieval Testing ●
Device Priming ●
Air Leak Testing, Syringe Pullback ●
Fluid Leak Testing, Sheath ●
Fluid Leak Testing, Dilator
Air Leak Testing, Dilator Removal
30 mL Large Bore Syringe Vacuum ●
Balloon Fatigue Test ●
Sheath and Dilator Kink Radius ●
Dye Staining, Post-Use ●
Vacuum Testing ●
Dilator Hub to Cap Tensile ●
30 mL Large Bore Syringe, Tip Adapter to Barrel Tensile ●
Unlocking Cap, Torque ●
Insertion Force, Dilator Through Sheath ●
Flushing Side Port to Hemostasis Valve Assembly and Inflation Hub . Tensile
Hemostasis Valve Assembly to Sheath Shaft and Dilator Tensile ●
Engaged Housing, Cap Axial Detachment
Balloon Diameter, Inflated
Barbed Luer to Inflation Hub Torque ●
Balloon Burst Volume ●
Retraction Force, Dilator from Sheath ●
Lubricity, Post-Use ●
Particulate Matter Determination .
Torque. Sheath and Dilator ●
Balloon Inflation Volume to Balloon Diameter ●
Balloon Deflation Time .

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PAGE 6 OF 6

Sheath Compatibility with Intravascular Catheter and Diagnostic Catheter in Model
Sheath Kink to Failure
Sheath Torque to Failure ●
Sheath Tip Tensile
Sheath Burst ●
Manual Syringe Injection Flow Rate and Max Pressure ●

Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.

Neither animal testing nor clinical testing were required for the determination of substantial equivalence.

Conclusion

The nonclinical tests demonstrated that the device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).