(58 days)
The FlowTriever2 Catheter is indicated for:
• The non-surgical removal of emboli and thrombi from peripheral blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).
The Inari FlowTriever Retrieval/Aspiration System is a single-use, sterile medical device comprised of the following components, each packaged separately:
• FlowTriever2 Catheter - Model 11-102
• Triever20® - Model 21-101
• Triever24® - Model 22-101
• Triever16® - Model 25-101
The FlowTriever2 Catheter is used to engage and retrieve emboli and thrombi. It consists of a coaxial catheter assembly with an outer Delivery Catheter and an inner catheter having a flexible shaft attached to distal self-expanding wireform element. A "Y" connector with a rotatable hemostatic valve and stopcock is attached to the proximal end of the outer Delivery Catheter. Radiopaque markers are positioned near the distal tip of the Delivery Catheter and at the proximal and distal ends of the self-expanding FlowTriever element to aid with fluoroscopic visualization.
The Triever20 and Triever24 (packaged separately) provides a conduit for FlowTriever2 Catheter deployment, aspiration, and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. A Dilator compatible with a 0.035" guidewire is provided for the Triever20 and Triever24 to aid insertion.
Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass using the FlowTriever2 Catheter or through the Triever16 using aspiration alone.
The Inari FlowTriever Retrieval/Aspiration System has not been evaluated for use in the neurovasculature.
The provided text is related to the FDA 510(k) premarket notification for the FlowTriever2 Catheter, specifically for an expanded indication for the treatment of pulmonary embolism (PE). This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical and clinical testing.
The information primarily describes the device, its indications for use, comparison with a predicate device, and the specifics of a clinical study (FLARE-FT2) to support the expanded indication. However, it does not delineate specific acceptance criteria with reported device performance in a table format as requested. Furthermore, it does not specify details about sample sizes for test sets, ground truth establishment methods for test/training sets, or specific information about MRMC studies, as the device is not an AI/ML diagnostic system.
Based on the provided text, here's an attempt to extract the requested information, with notable limitations due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the primary safety and effectiveness endpoints of the FLARE-FT2 clinical study. These endpoints serve as the "acceptance criteria" and the study results are the "reported device performance."
| Acceptance Criteria (Endpoint) | Reported Device Performance (FLARE-FT2 Study Result) |
|---|---|
| Primary Safety Endpoint: Incidence of Serious Adverse Events (SAE), defined as a composite of device-related mortality, major bleeding, and intra-procedural device or procedure-related adverse events (clinical deterioration, pulmonary vascular injury, or cardiac injury) measured at 48 hours. | The study met the performance goal for the primary safety endpoint. (Specific rates not provided in this summary) |
| Primary Effectiveness Endpoint: Change in mean and systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure. | The study met the performance goal for the primary effectiveness endpoint. (Specific changes not provided in this summary) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): A total of 50 patients were enrolled in the FLARE-FT2 clinical study.
- Data Provenance: The study was a prospective, single-arm, multicenter confirmatory study. The country of origin is not explicitly stated, but clinical studies are generally conducted in a controlled, multi-center environment, likely within the US given FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes a clinical study for a medical device (catheter) used for embolectomy/thrombectomy, not an AI/ML diagnostic software. Therefore, the concept of "ground truth" established by experts for a "test set" in the context of an algorithm's performance is not directly applicable here. The outcomes measured in the clinical study (SAE, changes in pulmonary arterial pressure) are direct physiological measurements or clinical events, not classifications requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As this is a clinical trial evaluating a medical device, not an AI/ML diagnostic, adjudication methods like N+1 consensus are not detailed for establishing ground truth of image interpretations. Clinical trials typically have a different structure for reviewing and adjudicating adverse events and clinical outcomes, often involving independent clinical event committees (CECs) or data safety monitoring boards (DSMBs), but the specifics are not included in this 510(k) summary.
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. This document does not mention an MRMC study. The device is a physical catheter for thrombectomy and embolectomy, not an AI/ML-driven diagnostic or assistive software requiring comparison of human reader performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This question is irrelevant as the device is a physical catheter, not an algorithm.
7. The type of ground truth used:
The "ground truth" in the context of this device's clinical study refers to directly measured safety and effectiveness outcomes in patients.
- Safety: Incidence of Serious Adverse Events (SAE), including device-related mortality, major bleeding, and intra-procedural adverse events. These are clinical outcomes directly observed and recorded.
- Effectiveness: Change in mean and systolic pulmonary arterial pressure (a physiological measurement).
8. The sample size for the training set:
As this is a physical medical device and its clearance is based on a clinical trial for effectiveness and safety, not on an AI/ML model for which a "training set" would be used, this concept is not applicable here. The 50 patients in the FLARE-FT2 study represent the clinical evaluation data.
9. How the ground truth for the training set was established:
Not applicable, as no AI/ML model with a separate training set is described. The "ground truth" for the clinical study was established through direct patient observation and physiological measurements.
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Image /page/0/Picture/0 description: The image contains 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
March 13, 2025
Inari Medical, Inc. Rayee Patil Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618
Re: K250088
Trade/Device Name: FlowTriever2 Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: January 13, 2025 Received: January 14, 2025
Dear Rayee Patil:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Digitally signed by ARIEL G. ASH- ARIEL G. ASH-SHAKOOR -2 SHAKOOR -S Date: 2025.03.13 08:47:06 -04'00'
For
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) K250088
Device Name FlowTriever2 Catheter
Indications for Use (Describe)
The FlowTriever2 Catheter is indicated for:
· The non-surgical removal of emboli and thrombi from peripheral blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Flow Triever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).
| 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 4
510(k) Summary
| Date prepared | March 12, 2025 | |
|---|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 | |
| Contact person | Rayee PatilRegulatory Affairs Specialist | |
| Trade name | FlowTriever2 Catheter | |
| Common name | Embolectomy Catheter | |
| Regulation name | Embolectomy Catheter | |
| Classification number | 21 CFR 870.5150 | |
| Product code | QEW, KRA | |
| Regulatory class | II | |
| Predicate device(s) | Inari Medical, FlowTriever2 Catheter (K201541) | |
| Description | The Inari FlowTriever Retrieval/Aspiration System is a single-use, sterilemedical device comprised of the following components, each packagedseparately:• FlowTriever2 Catheter - Model 11-102• Triever20® - Model 21-101• Triever24® - Model 22-101• Triever16® - Model 25-101The FlowTriever2 Catheter is used to engage and retrieve emboli and thrombi.It consists of a coaxial catheter assembly with an outer Delivery Catheter andan inner catheter having a flexible shaft attached to distal self-expandingwireform element. A "Y" connector with a rotatable hemostatic valve andstopcock is attached to the proximal end of the outer Delivery Catheter.Radiopaque markers are positioned near the distal tip of the Delivery Catheterand at the proximal and distal ends of the self-expanding FlowTriever elementto aid with fluoroscopic visualization.The Triever20 and Triever24 (packaged separately) provides a conduit forFlowTriever2 Catheter deployment, aspiration, and clot removal. It consists ofa single lumen catheter with a proximal hemostasis valve and stopcock withflush port. A radiopaque marker is positioned near the distal tip to aid withfluoroscopic visualization. A Dilator compatible with a 0.035" guidewire isprovided for the Triever20 and Triever24 to aid insertion. | |
| Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or24 Fr) over the pre-inserted guidewire to a location proximal to the targetedthrombus. Thrombus is removed via aspiration using the Triever16, afterwhich it can be withdrawn and flushed to remove residual thrombus, leavingthe Triever Catheter in place as a conduit for subsequent thrombectomy passes.The user may elect to perform a thrombectomy pass using the FlowTriever2Catheter or through the Triever16 using aspiration alone. | ||
| The Inari FlowTriever Retrieval/Aspiration System has not been evaluated foruse in the neurovasculature. | ||
| Indications for Use | The FlowTriever2 Catheter is indicated for: | |
| • The non-surgical removal of emboli and thrombi from peripheral bloodvessels.• Injection, infusion, and/or aspiration of contrast media and other fluids intoor from a blood vessel. | ||
| The FlowTriever2 Catheter is intended for use in the peripheral vasculatureand for the treatment of pulmonary embolism (PE). | ||
| Device modifications | The purpose of this submission is to expand the indications of theFlowTriever2 Catheter for the treatment of pulmonary embolism. | |
| Comparison ofTechnologicalCharacteristics withPredicate Device | There is no change to the intended use, principles of operation, orfundamental scientific technology between the proposed FlowTriever2Catheter and the predicate device. | |
| Summary ofsubstantial equivalence | A tabular comparison of the predicate and subject devices is provided below: | |
| Device | FlowTriever2 Catheter | FlowTriever2 Catheter |
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| Device | FlowTriever2 CatheterProposed (K250088) | FlowTriever2 CatheterPredicate (K201541) |
|---|---|---|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW, KRA | QEW, KRA |
| Indications for use | The FlowTriever2 Catheter is indicatedfor: | The FlowTriever2 Catheter is indicatedfor: |
| • The non-surgical removal of emboli andthrombi from peripheral blood vessels. | • The non-surgical removal of emboli andthrombi from peripheral blood vessels. | |
| • Injection, infusion, and/or aspiration ofcontrast media and other fluids into orfrom a blood vessel. | • Injection, infusion, and/or aspiration ofcontrast media and other fluids into orfrom a blood vessel. | |
| The FlowTriever2 Catheter is intended foruse in the peripheral vasculature and forthe treatment of pulmonary embolism. | The FlowTriever2 Catheter is intendedfor use in the peripheral vasculature. | |
| Principals of Operation | The Triever Catheter (20 or 24 Fr) isplaced over a 0.035" guidewire to alocation proximal of the target thrombus.The FlowTriever2 Catheter is advancedover the guidewire, through the TrieverCatheter to a location with its tippositioned just beyond the thrombus. Theself-expanding disk is deployed bymanually retracting the outer DeliveryCatheter into the Triever Catheter. TheFlowTriever2 Catheter is manuallyretracted inside the Triever Catheter tocapture the targeted thrombus. TheFlowTriever2 Catheter is removed fromthe Triever Catheter. Thrombus isaspirated by attaching the Large Bore 60cc Syringe to the Triever Catheter's sideport connector. Alternatively, theTriever16 can be tracked through theTriever Catheter (20 or 24 Fr) over thepre-inserted guidewire to a locationproximal to the targeted thrombus.Thrombus is removed via aspiration usingthe Triever16, after which it can bewithdrawn and flushed to remove residualthrombus, leaving the Triever Catheter inplace as a conduit for subsequentthrombectomy passes. The user may electto perform a thrombectomy pass using theFlowTriever2 Catheter or through theTriever16 using aspiration alone. | The Triever Catheter (20 or 24 Fr) isplaced over a 0.035" guidewire to alocation proximal of the target thrombus.The FlowTriever2 Catheter is advancedover the guidewire, through the TrieverCatheter to a location with its tippositioned just beyond the thrombus. Theself-expanding disk is deployed bymanually retracting the outer DeliveryCatheter into the Triever Catheter. TheFlowTriever2 Catheter is manuallyretracted inside the Triever Catheter tocapture the targeted thrombus. TheFlowTriever2 Catheter is removed fromthe Triever Catheter. Thrombus isaspirated by attaching the Large Bore 60cc Syringe to the Triever Catheter's sideport connector. Alternatively, theTriever16 can be tracked through theTriever Catheter (20 or 24 Fr) over thepre-inserted guidewire to a locationproximal to the targeted thrombus.Thrombus is removed via aspiration usingthe Triever16, after which it can bewithdrawn and flushed to remove residualthrombus, leaving the Triever Catheter inplace as a conduit for subsequentthrombectomy passes. The user may electto perform a thrombectomy pass throughthe Triever16 using aspiration alone, or incombination with the FlowTriever2Catheter. |
| Vessel Diameters | 6-16 mm | 6-16 mm |
| Guidewire compatibility | 0.035" | 0.035" |
| Wireform Disk Material | Laser cut nitinol | Laser cut nitinol |
| No. of wireform disks | 1 Disk | 1 Disk |
| Delivery cathetermaterials | Proximal - Pebax 7233 SA01 MED, 20%BaSO4Distal - Pebax 4033 SA01 MED, 20%BaSO4PTFE Liner | Proximal - Pebax 7233 SA01 MED, 20%BaSO4Distal - Pebax 4033 SA01 MED, 20%BaSO4PTFE Liner |
| Delivery catheter OD | 3.8 mm | 3.8 mm |
| Delivery catheter length | 120 cm | 120 cm |
| Catheter shaft materials | Pebax 6333 SA01 MED, PTFE Liner | Pebax 6333 SA01 MED, PTFE Liner |
| Tip Materials | Pebax 7233 SA01 MED, 45% Tungsten | Pebax 7233 SA01 MED, 70% Tungsten |
| Sterile | SAL 10-6, EO | SAL 10-6, EO |
| Shelf-Life | 2 years | 6 months |
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K250088
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Summary of substantial equivalence
Biocompatibility
This submission proposes no significant design or material modifications to the FlowTriever2 Catheter. The FlowTriever2 Catheter met biological safety requirements per ISO 10993-1 per the passing results provided in K201541.
Sterilization
This submission proposes no change to the sterilization process of the FlowTriever2 Catheter. The FlowTriever2 Catheter 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 and AAMI TIR 28:2016.
Non-Clinical Testing
This submission proposes no significant design or material modifications to the FlowTriever2 Catheter. The design verification and validation test results provided in K201541 remain applicable.
Animal testing was not required for the determination of substantial equivalence. The in vivo study provided in K201541 remains applicable.
Clinical Testing
Inari Medical conducted the FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2 (FLARE-FT2), a prospective, single-arm, multicenter confirmatory study, to evaluate the safety and effectiveness of the FlowTriever2 Catheter for the treatment of acute pulmonary embolism (PE). A total of 50 patients were enrolled at 7 study sites. The primary safety endpoint was the incidence of Serious Adverse Events (SAE), which was a composite of device-related mortality, major bleeding and intra-procedural device or procedure-related adverse events (clinical deterioration, pulmonary vascular injury, or cardiac injury) measured at 48 hours. The primary effectiveness endpoint for this confirmatory study was the change in mean and systolic pulmonary arterial pressure from baseline pre-procedure to postprocedure. The study met the performance goals for the primary study endpoints.
Conclusion
The expanded indication of the FlowTriever2 Catheter does not change its intended use, principles of operation, or fundamental scientific technology between the proposed FlowTriever2 Catheter and the predicate device. Based on the results of the FLARE-FT2 Clinical Study, the data supports that the FlowTriever2 Catheter is substantially equivalent to the predicate device.
Refer to the Instruction for Use for detailed clinical study information.
§ 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).