(105 days)
The Artix BG balloon thrombectomy 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.
• Use as a conduit for retrieval devices.
• 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.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
The Artix BG 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 and interventional procedures. The Artix BG also non-surgically aspirates thromboemboli from selected vessels and is 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
The Artix BG is comprised of a single through lumen shaft with four (4) embedded lumens for balloon inflation and deflation, a proximal integrated hemostasis valve to minimize blood loss, a stopcock with flush port, and a balloon port. To assist with insertion of the sheath into the vasculature, a hydrophilic coating covers a portion of the distal sheath shaft. The distal tip of the sheath shaft contains two (2) radiopaque marker bands to aid with angiographic visualization: The distal marker indicates the location of the sheath's tip, while the proximal marker band marks the location of a compliant balloon mounted at the distal end. The balloon provides temporary vascular occlusion during angiographic and interventional procedures.
The provided text is a 510(k) summary for the Inari Medical Artix BG balloon thrombectomy sheath. It describes the device, its indications for use, and a comparison to predicate and reference devices. It also outlines the non-clinical testing performed to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sheath Visual & Dimensional | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Simulated Use Cycling | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Sheath Aspirational Flowrate | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Clot Burden Removal | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Biocompatibility | Meet biological safety requirements per ISO 10993-1. | Previous passing results for Artix BG (K221846) are applicable. |
| Sterilization | Achieve a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016. | Previous sterilization process (validated per K221846) remains applicable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (Sheath Visual & Dimensional, Simulated Use Cycling, Sheath Aspirational Flowrate, Clot Burden Removal). It only mentions that "verification and validation testing were identified."
The data provenance is not specified regarding country of origin, but it is clear these were pre-market, non-clinical tests as indicated by "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This implies the tests were conducted in a lab setting by the manufacturer, Inari Medical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are non-clinical engineering and performance tests, not studies requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are non-clinical engineering and performance tests, not studies requiring expert adjudication.
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
Not applicable. This device is a medical instrument (balloon thrombectomy sheath), not an AI/software as a medical device (SaMD) that would typically undergo MRMC studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was adherence to established product specifications and recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR 28 for sterilization). For tests like "Sheath Visual & Dimensional" or "Sheath Aspirational Flowrate," the ground truth would be the engineering specifications the device was designed to meet.
8. The Sample Size for the Training Set
Not applicable. This device is a medical instrument, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
In summary, the provided document focuses on non-clinical testing to establish substantial equivalence for a medical device (Artix BG balloon thrombectomy sheath). The "study" proving the device meets acceptance criteria consists of various engineering and performance tests, biocompatibility assessments, and sterilization validation. These tests were conducted against pre-defined product specifications and international standards, and all were reported as successfully meeting their respective acceptance criteria.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2023
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K223000
Trade/Device Name: Artix BG Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, DQY Dated: December 9, 2022 Received: December 9, 2022
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 ○'connell -S Date: 2023.01.11
05:00 nell -S 09:19:48 -05'00'
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) K223000
Device Name Artix BG
Indications for Use (Describe)
The Artix BG balloon thrombectomy 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.
· Use as a conduit for retrieval devices.
· 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.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
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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PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | January 10, 2023 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 |
| Contact person | Ellen NguyenRegulatory Affairs Specialist |
| Trade name | Artix BG |
| Common name | Balloon thrombectomy sheath |
| Regulation name | Percutaneous catheter |
| Classification number | 21 CFR 870.1250 |
| Product code | QEW |
| Secondary productcode | DQY |
| Regulatory class | II |
| Predicate device | Inari Medical, ClotTriever Thrombectomy System (K212632) |
| Reference device | Inari Medical, Artix Balloon Guiding Sheath (K221846) |
| Description | The Artix BG is a single-use, over-the-wire system designed to facilitate theinsertion and guidance of an intravascular catheter into a selected peripheralblood vessel and act as a conduit for retrieval devices. A compliant balloonmounted at the sheath's distal tip provides temporary vascular occlusionduring angiographic and interventional procedures. The Artix BG also non-surgically aspirates thromboemboli from selected vessels and is capable ofinfusion/aspiration of fluids into or from a selected vessel. The Artix BG ispackaged 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:• Use in facilitating the insertion and guidance of an intravascularcatheter into a selected blood vessel. The balloon provides temporaryvascular occlusion during these and other angiographic procedures.• Use as a conduit for retrieval devices.• The non-surgical aspiration of emboli and thrombi from bloodvessels. |
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PAGE 2 OF 5
- Injection, infusion, and/or aspiration of contrast media and other ● fluids into or from a blood vessel.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
The predicate ClotTriever Thrombectomy System is indicated for "The nonsurgical removal of emboli and thrombi from blood vessels and injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." The Artix BG's expanded indications for use are identical. Both devices are intended for use in the peripheral vasculature, with the only difference being that the predicate device is also intended for the treatment of deep vein thrombosis (DVT).
A tabular comparison of specific technological characteristics between the predicate and subject devices is provided below:
| Feature | Artix BG - Subject Device | ClotTrieverThrombectomy System -Predicate (K212632) | Artix Balloon GuidingSheath - ReferenceDevice (K221846) |
|---|---|---|---|
| Manufacturer | Inari Medical | Inari Medical | Inari Medical |
| Product code | QEW, DQY | QEW | DQY |
| Intendeduse/Indications foruse | The Artix BG balloonthrombectomy sheath isindicated 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. Use as a conduit for retrieval devices. The non-surgical aspiration of thrombi and emboli from blood vessels. Infusion, injection, and/or aspiration of contrast media or other fluid into or from a blood vessel. The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature. | The ClotTrieverThrombectomy System isindicated for:The non-surgical removal of thrombi and emboli from blood vessels. Infusion, injection, and/or aspiration of contrast media or other fluid into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | The Artix BalloonGuiding Sheath isindicated for use infacilitating the insertionand guidance of anintravascular catheterinto a selected bloodvessel. The balloonprovides temporaryvascular occlusionduring these and otherangiographic procedures.The Artix BalloonGuiding Sheath is alsoindicated for use as aconduit for retrievaldevices.The Artix BalloonGuiding Sheath isintended for use in theperipheral vasculature. |
| Feature | Artix BG - Subject Device | ClotTrieverThrombectomy System -Predicate (K212632) | Artix Balloon GuidingSheath - ReferenceDevice (K221846) |
| Device description | The Artix BG is comprisedof a single through lumenshaft with four (4)embedded lumens forballoon inflation anddeflation, a proximalintegrated hemostasis valveto minimize blood loss, astopcock with flush port,and a balloon port. To assistwith insertion of the sheathinto the vasculature, ahydrophilic coating covers aportion of the distal sheathshaft. The distal tip of thesheath shaft contains two(2) radiopaque markerbands to aid withangiographic visualization:The distal marker indicatesthe location of the sheath'stip, while the proximalmarker band marks thelocation of a compliantballoon mounted at thedistal end. The balloonprovides temporary vascularocclusion duringangiographic andinterventional procedures. | The ClotTrieverThrombectomy Systemconsists of ClotTriever 13Fr and 16 Fr Sheaths("Sheath") and theClotTriever/ClotTrieverBold Catheter("Catheter"), eachpackaged separately.The sheath is an introducersheath with a distal self-expanding funnel,aspiration port, andproximal hub. A dilator isprovided to aid insertionand positioning of thesheath. Other providedaccessories include a 60 cclarge bore syringe thatprovides a vacuum sourceand collects aspiratedcontents. Radiopaquemarkers aid sheathpositioning underfluoroscopic visualization.The dilator tip isradiopaque, and there is aradiopaque marker bandnear the distal end of thesheath. | The Artix BalloonGuiding Sheath iscomprised of a singlethrough lumen shaft withfour (4) embeddedlumens for ballooninflation and deflation, aproximal integratedhemostasis valve tominimize blood loss, astopcock with flush port,and a balloon port. Toassist with insertion ofthe sheath into thevasculature, ahydrophilic coatingcovers a portion of thedistal sheath shaft. Thedistal tip of the sheathshaft contains two (2)radiopaque marker bandsto aid with angiographicvisualization: The distalmarker indicates thelocation of the sheath'stip, while the proximalmarker band marks thelocation of a compliantballoon mounted at thedistal end. The balloonprovides temporaryvascular occlusionduring angiographic andinterventionalprocedures. |
| Principles ofoperation | After the target vessel isaccessed and dilated, theArtix BG is inserted into thevessel over a guidewire.Once the Artix BG is inposition, the dilator isremoved, and all compatiblecatheter devices, such as theArtix MT (K220600), canbe inserted through theArtix BG for access into theperipheral vasculature. Thesheath's balloon can also beinflated using a 1 mLsyringe to provide flow | After the target vessel isaccessed and dilated, theClotTriever Sheath isinserted into the vesselover a guidewire. TheClotTriever/ClotTrieverBold Catheter can then beadvanced through thesheath and beyond the clot.The self-expanding braidednitinol wire net isdeployed. The expandednet cores, separates, andentraps thrombus from thevessel as it is being drawn | After the target vessel isaccessed and dilated, theArtix Balloon GuidingSheath is inserted intothe vessel over aguidewire. Once theArtix Sheath is inposition, the dilator isremoved, and allcompatible catheterdevices can be insertedthrough the Artix Sheathfor access into theperipheral vasculature.The sheath's balloon can |
| Feature | Artix BG - Subject Device | ClotTrieverThrombectomy System -Predicate (K212632) | Artix Balloon GuidingSheath - ReferenceDevice (K221846) |
| occlusion of the vesselduring the procedure. Theprovided 30 mL syringe canbe used to aspirate clot inthe vessel or sheath andinfuse contrast media andother fluids as required. | to the funnel opening ofthe ClotTriever Sheath.The net is collapsed andpulled into and through theClotTriever Sheath withthe entrapped clot. A 60 ccsyringe is provided for theaspiration of clot in thesheath and the infusion ofcontrast media and otherfluids. | also be inflated using a 1mL syringe to provideflow occlusion of thevessel during theprocedure. | |
| Intended patientpopulation | Adults undergoinginterventional procedures | Adults undergoinginterventional procedures | Adults undergoinginterventional procedures |
| Target vessel | Peripheral vasculature | Peripheral vasculature | Peripheral vasculature |
| Placement duration | < 24 hours | < 24 hours | < 24 hours |
| Guidewirecompatibility | 0.014" or 0.035" | 0.035" | 0.014" or 0.035" |
| Sterilization | EtO | EtO | EtO |
| Single-use | Yes | Yes | Yes |
Summary of substantial equivalence
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Summary of substantial equivalence
Biocompatibility
This submission proposes no changes to the device materials. Therefore, the previous passing results demonstrating that the Artix BG (K221846) and accessories meet biological safety requirements per ISO 10993-1 are still applicable.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 10 6 using 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). This submission proposes no changes to the device design or materials. Therefore, the previous sterilization process per K221846 remains applicable.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial
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PAGE 5 OF 5
equivalence of the Artix BG to the ClotTriever Thrombectomy System. These tests included:
- Sheath Visual & Dimensional
- . Simulated Use Cycling
- Sheath Aspirational Flowrate ●
- Clot Burden Removal ●
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 demonstrate the Artix BG's substantial equivalence to the ClotTriever Thrombectomy System.
§ 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).