(23 days)
The Artix Thrombectomy Device 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 Artix Thrombectomy Device is intended for use in the peripheral vasculature.
The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature.
Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and advanced to the thrombus. A self-expanding nitinol element is deployed to engage thrombus by retracting the outer delivery catheter. Artix is then retracted into the sheath to capture the targeted thrombus. Additional clot may be removed by aspiration with a Luer syringe (not provided). After the procedure is complete, the Artix and sheath are removed from the patient.
The provided document is a 510(k) summary for the Artix Thrombectomy Device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, or training set information for an AI/CADe device.
The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Instead, it relies on non-clinical testing to demonstrate substantial equivalence to the predicate device.
Therefore, most of the requested information regarding acceptance criteria and studies for an AI/CADe device cannot be extracted from this document because it describes a medical device (thrombectomy catheter), not an AI/CADe system.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."
However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance of the device against those criteria. It only confirms that some acceptance criteria (identified through Design Failure Modes and Effects Analysis) were met by non-clinical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly specified in the document) | "All acceptance criteria were met" |
2. Sample size used for the test set and the data provenance
N/A. The document describes non-clinical bench testing for a physical medical device, not a diagnostic AI/CADe system. Therefore, there is no "test set" in the context of image data or clinical data for an AI algorithm. The document mentions "verification and validation testing" but does not specify sample sizes or data provenance for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is not an AI/CADe system, there's no "ground truth" for a test set established by experts in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable for a physical medical device clearance based on non-clinical testing.
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
No. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. No clinical "ground truth" was used for this device clearance, as it relied on non-clinical bench testing to demonstrate substantial equivalence.
8. The sample size for the training set
N/A. This is a physical medical device, not an AI/CADe system, so there is no training set.
9. How the ground truth for the training set was established
N/A. Not applicable.
In summary, the provided FDA 510(k) document is for a physical medical device (thrombectomy catheter) and does not contain the information typically required for an AI/CADe device, as it did not involve clinical trials, expert reviews of diagnostic images, or AI algorithm performance evaluation.
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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 25, 2022
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K220600
Trade/Device Name: Artix Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 28, 2022 Received: March 3, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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 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)
K220600
Device Name Artix Thrombectomy Device
| Indications for Use ( Describe ) |
|---|
| ----------------------------------------- |
The Artix Thrombectomy Device 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 Artix Thrombectomy Device 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 2
510(K) SUMMARY
| Date prepared | February 28, 2022 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 |
| Contact person | Ellen NguyenRegulatory Affairs Specialist |
| Name of Device | Artix Thrombectomy Device |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K201541) |
| References devices | ReVive PV Thrombectomy Device (K132281)NeVa PV Thrombectomy Device (K201085) |
| Description | The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheterused for the minimally invasive treatment of thromboemboli in the peripheralvasculature.Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire andadvanced to the thrombus. A self-expanding nitinol element is deployed to engagethrombus by retracting the outer delivery catheter. Artix is then retracted into thesheath to capture the targeted thrombus. Additional clot may be removed byaspiration with a Luer syringe (not provided). After the procedure is complete, theArtix and sheath are removed from the patient. |
| Indications for Use | The Artix Thrombectomy Device 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 Artix Thrombectomy Device is intended for use in the peripheral vasculature. |
| Device Modifications | The proposed modifications to the FlowTriever2 Catheter include a modifiedthrombectomy element, dimensional changes, minor material changes, theaddition of a proximal hub, packaging updates, and a contraindication update.These modifications introduce the Artix Thrombectomy Device, a FlowTriever2catheter variant used for mechanical thrombectomy device in the peripheralvasculature. |
| There have been no changes to the Triever or FlowTriever Catheters. | |
| Comparison ofTechnologicalCharacteristics with thePredicate Device | The proposed modifications do not change the intended use or principles ofoperation from the predicate device. The modified and predicate device have asimilar design and mainly differ in dimensions and element geometry. |
| The information provided in this submission demonstrates that the differences intechnological characteristics between the predicate and proposed devices do notraise any new questions of safety and effectiveness. | |
| There have been no changes to the Triever or FlowTriever Catheters. | |
| Summary of substantialequivalence | There is no change of intended use or fundamental scientific technology betweenthe proposed device and predicate device. The Artix Thrombectomy Device has thesame indication for use as the predicate FlowTriever2 Catheter device, K201541. |
| Non-Clinical Testing | |
| In accordance with the Design Failure Modes and Effects Analysis, verification andvalidation testing were identified to support the substantial equivalence of the ArtixThrombectomy Device. | |
| Test results demonstrated that all acceptance criteria were met; therefore, thedevices conform to established product specifications. | |
| Neither animal testing nor clinical testing were required for the determination ofsubstantial equivalence. | |
| Conclusion | |
| The proposed device modifications to the FlowTriever2 Catheter do not change itsintended use, principles of operation, or fundamental design. Non-clinical benchtesting supports the Artix Thrombectomy Device's substantial equivalence to thepredicate device. |
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§ 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).