(108 days)
The Artix AX aspiration catheter 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 AX aspiration catheter is intended for use in the peripheral vasculature.
The Artix AX is a single-use, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system comprises two catheter lengths, 85 cm and 115 cm, packaged separately.
The Artix AX is inserted over a pre-placed guidewire and advanced to the thrombus, which can then be removed via aspiration with the provided 30 mL Large Bore Vacuum Syringe. The Artix MT may also be deployed through the Artix AX to engage thrombus before being retracted through the Artix AX. Additional clot may be removed by aspiration through the Artix AX as necessary. After the procedure is complete, the Artix AX is removed from the patient.
The provided text describes the regulatory clearance for the Artix AX aspiration catheter and details several non-clinical tests conducted to support its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or study results related to AI/algorithm performance, human reader improvement with AI assistance, MRMC studies, or any form of AI ground truth establishment. The tests listed are primarily related to the physical and functional characteristics of the medical device itself, not an AI component.
Therefore, I cannot fulfill the request to describe acceptance criteria and study proving an AI device meets those criteria, as the provided text pertains to a traditional medical device (a catheter) and not an AI-powered one.
Based on the provided text, the device in question is a medical catheter, not an AI/algorithm-powered device. The acceptance criteria and study details discussed in the document relate to the physical and functional performance of the catheter itself, to demonstrate its "substantial equivalence" to a predicate device.
Here's what the document does say about acceptance criteria and testing, in relation to the Artix AX catheter:
1. A table of acceptance criteria and the 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 provide a specific table listing the acceptance criteria and the numerical performance results for each test. It simply states that they were met.
2. Sample sized used for the test set and the data provenance:
The document lists various non-clinical bench tests (e.g., Pouch Seal Visual Inspection, Kink Radius, Clot Burden Removal Validation, etc.). For these types of non-clinical tests, "samples" would refer to physical units of the device. The exact sample sizes for each specific test are not explicitly stated in this document. The data provenance is also not applicable in the context of clinical/radiological data as these are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the tests performed are non-clinical, bench-top tests of the physical device's performance, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable as there is no clinical test set requiring 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:
No, an MRMC study was not conducted. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This device is a catheter, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
This question is not applicable. The "ground truth" for the non-clinical tests would be the established engineering specifications and physical properties that the device must meet to function as intended (e.g., a specific flow rate, a certain burst pressure, absence of leaks). There is no clinical or pathological "ground truth" involved in these specific tests.
8. The sample size for the training set:
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This question is not applicable. There is no "training set" or "ground truth" in the context of an AI model for this device.
In summary, the provided document is a 510(k) clearance letter for a medical device (a catheter) and details non-clinical bench testing to demonstrate "substantial equivalence." It does not contain any information related to AI or algorithmic performance evaluation.
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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.
March 2, 2023
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618
Re: K223436
Trade/Device Name: Artix AX Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW. KRA Dated: January 30, 2023 Received: January 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
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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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Pate: 2023.03.02
O'connell -S 16:27:18 -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)
Device Name Artix AX
| Indications for Use ( Describe ) |
|---|
| ----------------------------------------- |
The Artix AX aspiration catheter 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 AX aspiration catheter 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 5
510(K) SUMMARY
| Date prepared | March 1, 2023 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 |
| Contact person | Ellen NguyenRegulatory Affairs Specialist |
| Name of Device | Artix AX |
| 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 (K213402) |
| References devices | Penumbra Indigo System CAT RX Aspiration Catheter (K163618) |
| Description | The Artix AX is a single-use, over-the-wire catheter used for the minimally invasivetreatment of thromboemboli in the peripheral vasculature. The system comprisestwo catheter lengths, 85 cm and 115 cm, packaged separately.The Artix AX is inserted over a pre-placed guidewire and advanced to thethrombus, which can then be removed via aspiration with the provided 30 mLLarge Bore Vacuum Syringe. The Artix MT may also be deployed through theArtix AX to engage thrombus before being retracted through the Artix AX.Additional clot may be removed by aspiration through the Artix AX as necessary.After the procedure is complete, the Artix AX is removed from the patient. |
| Indications for Use | The Artix AX aspiration catheter 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 intoor from a blood vessel.The Artix AX aspiration catheter is intended for use in the peripheral vasculature. |
| Device Modifications | The proposed modifications are to the Triever16 component and includedimensional and material changes to the catheter and removal of the dilator.These modifications introduce the Artix AX, a smaller embolectomy catheter usedfor aspiration thrombectomy in the peripheral vasculature.There have been no changes to the Triever20 Fr/20 Curve and the Triever24 FrCatheters or the FlowTriever Catheters. |
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Comparison of Technological Characteristics with the Predicate Device
The proposed modifications do not change the intended use or principles of operation from the predicate device. The modified and predicate device have a similar design and mainly differ in dimensions and materials.
The Artix AX and Triever16 are both tracked over a pre-placed compatible guidewire. The Artix MT or FlowTriever Catheter can then be deployed through the Artix AX or Triever 16/20/24 Fr catheters respectively to engage and withdraw thrombus. Additional clot can be aspirated through the Artix AX or Triever16 using the provided 30 ml or 60 mL Large Bore Syringe.
Although the predicate and subject devices have different technological characteristics, all leveraged and performed design verification and validation tests confirm that these differences do not raise any new or different questions of safety or effectiveness.
There have been no changes to the Triever20 Fr/20 Curve or the Triever24 Fr Catheters or the FlowTriever Catheters.
Summary of substantial There is no change of intended use or fundamental scientific technology between the equivalence proposed device and predicate device. The Artix AX's indications for use falls within those of the predicate device. K213402: both are indicated for the non-surgical removal of emboli and thrombi from blood vessels and the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. Both are intended for use in the peripheral vasculature. The Triever16 is additionally intended for the treatment of pulmonary embolism and for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:
| Feature | Artix AXSubject (TBD) | Triever16Predicate (K213402) |
|---|---|---|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| Intendeduse/Indications foruse | The Artix AX aspirationcatheter is indicated for:The non-surgical removalof emboli and thrombifrom blood vessels. Injection, infusion, and/oraspiration of contrastmedia and other fluidsinto or from a bloodvessel. The Artix AX aspirationcatheter is intended for use inthe peripheral vasculature. | The Triever16 is indicated for:The non-surgical removalof emboli and thrombifrom blood vessels. Injection, infusion, and/oraspiration of contrastmedia and other fluidsinto or from a bloodvessel. The Triever16 is intended foruse in the peripheralvasculature and for thetreatment of pulmonaryembolism.Triever Catheters are also |
| Feature | Artix MTSubject (TBD) | Triever16Predicate (K213402) |
| intended for use in treating clotin transit in the right atrium butnot in conjunction withFlowTriever Catheters. | ||
| Principles ofoperation | The Artix AX is inserted over apre-placed guidewire andadvanced to the thrombus. TheArtix MT can then be deployedthrough the Artix AX to engagethrombus before beingretracted through the Artix AX.Additional clot may beremoved by aspiration throughthe Artix AX with the provided30 mL Large Bore Vacuumsyringe. After the procedure iscomplete, the Artix AX isremoved from the patient. | The Triever16 is inserted overa pre-placed guidewire andadvanced to the thrombus. TheFlowTriever Catheter can thenbe deployed through theTriever16 to engage thrombusbefore being retracted throughthe Triever16. Additional clotmay be removed by aspirationthrough the Triever16 with theprovided 60 mL Large BoreVacuum syringe. After theprocedure is complete, theTriever 16 is removed from thepatient. |
| Target vessel | Peripheral vessels ≥ 3 mm | Peripheral vessels ≥ 6 mm,pulmonary arteries, right heart |
| Contraindicatedvessels | Cerebral, carotid, coronary,pulmonary arteries | Cerebral, carotid, coronaryarteries |
| Guidewirecompatibility | Up to 0.035" | Up to 0.035" |
| Shelf-life | 6 months | 2 years |
| Sterilization | EtO | EtO |
| Single-use | Yes | Yes |
| Dimensions | OD/ID: 2.8 mm/2.4 mmWorking length: 85 cm, 115 cm | OD/ID: 5.3 mm/4.5 mmWorking length: 107 cm |
| Outer Shaftmaterial | Pebax 35D with ProPell, Pebax45D with ProPell, Pebax 55Dwith ProPell, Pebax 63D,Pebax 72D | Pebax 35D, Pebax 63D |
| Inner ShaftMaterial | Etched PTFE | Etched PTFE |
| Metal support | Stainless steel coil | Stainless steel coil and braid |
| Hemostasis valve | Mini Garrote valve | Garrote valve |
| Tip bevel | 30° | No bevel |
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PAGE 3 OF 5
Biocomnatibility
The following biocompatibility tests were completed for the subject device:
- . Cytotoxicity
- . Sensitization
- . Intracutaneous Reactivity
- Acute Systemic Toxicity
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PAGE 4 OF 5
- Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis, Complement Activation, o 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.
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 AX. These tests included:
- Pouch Seal Visual Inspection and Dye Penetration ●
- Visual & Dimensional Inspection ●
- Guidewire Compatibility ●
- Cheater Sheath Compatibility ●
- Artix MT/BG Compatibility and Simulated Use ●
- Kink Radius ●
- Air Leakage During Aspiration
- Leakage Testing ●
- Vacuum Testing ●
- Liquid Leakage Under Pressure (300 kPa) Testing
- Determination of Flowrate Through Catheter ●
- Burst Testing
- Clot Burden Removal Validation ●
- Simulated Use, Track & Tensile Catheter ●
- Simulated Use, Track & Torque Catheter ●
- 30 mL Large Bore Syringe Leak Testing ●
- 30 mL Large Bore Syringe Vacuum Testing
- Simulated Use & Tensile 30 mL Large Bore Syringe .
- . Simulated Use & Torque - 30 mL Large Bore Syringe
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.
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Conclusion
The Artix AX has the same intended use/indications for use and principles of operation as the predicate. Performance data shows that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness. Non-clinical bench testing supports the Artix AX's substantial equivalence to the predicate device.
§ 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).