Artix BG by Inari Medical | FDA 510(k) Summary

· The non-surgical aspiration of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
· Use as a conduit for retrieval devices.
· Use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.

Device Description

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

AI/ML Overview

The provided text is a 510(k) summary for the Inari Medical Artix BG device. This document is a regulatory submission for medical devices to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document does not describe a study proving the device meets acceptance criteria in the context of comparing its performance to a defined set of clinical or technical metrics for a novel technology.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (Inari Medical, Artix BG K223000) based on a device modification (addition of two alternate suppliers for the PTFE liner). Therefore, the "acceptance criteria" and "study" described in the prompt are not applicable in the way they would be for a direct performance validation of a new device.

Here's an breakdown based on the information provided, highlighting why it doesn't fit the typical "acceptance criteria and study" mold for a new device's performance:

1. Table of acceptance criteria and the reported device performance:

This document doesn't provide a table of acceptance criteria and device performance in the sense of clinical metrics (e.g., sensitivity, specificity, accuracy, or a specific functional performance threshold for a new technology).

Instead, the document's "acceptance criteria" is implicitly demonstrating that the modified device (Artix BG with new PTFE suppliers) performs equivalently to the predicate device (the original Artix BG). The "reported device performance" is that the modified device "continues to apply" to previous performance test results.

Acceptance Criteria (Implied): The modified device must perform equivalently to the predicate device, as demonstrated through non-clinical testing. This means:
- No change in intended use, design, fundamental scientific technology, or principles of operation.
- Meeting biocompatibility requirements per ISO 10993-1.
- Maintaining sterility assurance level (SAL) of 10-6.
Reported Device Performance:
- "As there were no proposed design changes, previous performance test results that demonstrated that all acceptance criteria were met continue to apply; therefore, the device conforms to established product specifications."
- Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis)) were completed and passed.
- Sterilization using EtO to achieve SAL of 10-6 was validated.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific non-clinical tests. The statement "previous performance test results that demonstrated that all acceptance criteria were met continue to apply" implies reliance on prior testing of the original Artix BG device. For the biocompatibility tests, typically a sufficient number of samples are used to meet the standards (e.g., ISO 10993-1), but the exact numbers are not provided.
Data Provenance: Not specified. The document is a regulatory submission to the FDA, likely based on internal company testing or contracted lab testing. It's not clinical data (retrospective or prospective) in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This document refers to non-clinical (laboratory/bench) testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of outcomes. Biocompatibility and sterility testing follow established international standards and protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. This applies to clinical studies or studies involving human assessment of data. The testing mentioned in this document is non-clinical.

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:

N/A. This is a non-clinical device modification submission, not an AI or imaging diagnostic study.

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

N/A. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

N/A (for clinical ground truth). The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization) that define what constitutes a "passing" or "acceptable" result for each test.

8. The sample size for the training set:

N/A. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established:

N/A. This is not an AI or machine learning device.

Summary of the "Study" provided in the document:

The "study" or rather the evidence provided to support substantial equivalence after the modification (new PTFE suppliers) primarily consists of:

Non-Clinical Testing: The document states that "previous performance test results...continue to apply" due to "no proposed design changes" affecting those aspects.
Biocompatibility Testing:
- Tests conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis).
- Proof: Passing results demonstrated meeting biological safety requirements per ISO 10993-1.
Sterilization Validation:
- Method: EtO sterilization to achieve a sterility assurance level (SAL) of 10-6.
- Proof: Validated process in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.

Conclusion from the document:

"The Artix BG has the same intended use/indications for use and principles of operation as the predicate. The testing provided supports the Artix BG's substantial equivalence to the predicate device."

Summary

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May 2, 2023

Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618

Re: K230912

Trade/Device Name: Artix BG Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, DQY Dated: March 31, 2023 Received: March 31, 2023

Dear Ellen Nguyen:

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,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S 08:47:10 -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

Submission Number (if known)

K230912

Device Name

Artix BG

Indications for Use (Describe)

The Artix BG balloon thrombectomy sheath is indicated for:

· The non-surgical aspiration of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
· Use as a conduit for retrieval devices.
· Use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The Artix BG balloon thrombectomy 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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K230912

PAGE 1 OF 2

510(K) SUMMARY

Date prepared	March 31, 2023
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433
Contact person	Ellen NguyenRegulatory Affairs Specialist
Name of Device	Artix BG
Common name	Embolectomy catheter
Regulation name	Embolectomy catheter
Classification number	21 CFR 870.5150
Product code	QEW
Secondary product code	DQY
Regulatory class	II
Predicate device	Inari Medical, Artix BG (K223000)This device has not been subject to a design-related recall.
Description	The Artix BG is a single-use, over-the-wire system designed to aspirate thrombiand emboli from the peripheral vasculature, facilitate the insertion and guidance ofan intravascular catheter into selected peripheral blood vessels, and act as a conduitfor retrieval devices. A compliant balloon mounted at the sheath's distal tipprovides temporary vascular occlusion during angiographic and interventionalprocedures. The Artix BG is also capable of infusion/aspiration of fluids into orfrom a selected vessel. The Artix BG is packaged with the following components:Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm) 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility) Balloon Inflation Syringe, 1 mL Large Bore Syringe, 30 mL 3-way Stopcock
Indications for Use	The Artix BG balloon thrombectomy sheath is indicated for:The non-surgical aspiration of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. Use as a conduit for retrieval devices. 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 BG balloon thrombectomy sheath is intended for use in the peripheralvasculature.
Device Modifications	The proposed modification to the Artix BG is the addition of two alternate suppliersfor the device's PTFE liner.
Comparison ofTechnologicalCharacteristics withthe Predicate Device	The proposed device and predicate device have the same design and materials ofconstruction. The modification does not change the basic design, the indications foruse, or the principles of operation from the predicate device.
Summary ofsubstantial equivalence	There is no change of intended use, design, fundamental scientific technology, orprinciples of operation between the proposed device and predicate device. TheArtix BG has the same indication for use as the predicate device, K223000.
Biocompatibility
The following biocompatibility tests were completed for the subject device:
	Cytotoxicity ●	Sensitization ●
	Intracutaneous Reactivity ●	Acute Systemic Toxicity ●
	Material-Mediated ●Pyrogenicity	Hemocompatibility ●(Hemolysis)
The passing results demonstrate that the subject device and accessories meetbiological safety requirements per ISO 10993-1.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve asterility assurance level (SAL) of 10-6 using a validated sterilization process inaccordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR28:2016.
Non-Clinical Testing
As there were no proposed design changes, previous performance test results thatdemonstrated that all acceptance criteria were met continue to apply; therefore, thedevice conforms to established product specifications.
Neither animal testing nor clinical testing were required for the determination ofsubstantial equivalence.
Conclusion
The Artix BG has the same intended use/indications for use and principles ofoperation as the predicate. The testing provided supports the Artix BG's substantialequivalence to the predicate device.

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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).