(58 days)
Not Found
No
The summary describes a mechanical thrombectomy device and does not mention any AI or ML components or functions.
Yes
The device is used for the non-surgical removal of emboli and thrombi (clots) from blood vessels and for the treatment of pulmonary embolism, which directly addresses a medical condition and aims to improve a patient's health.
No
The device is indicated for the non-surgical removal of emboli and thrombi and for injection, infusion, and/or aspiration of fluids, which are therapeutic and interventional functions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components (catheters, dilator, etc.) and their physical functions in a medical procedure. There is no mention of software as a primary or standalone component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The FlowTriever2 Catheter is a medical device used within the body to physically remove blood clots (emboli and thrombi) from blood vessels. It is an interventional device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states "non-surgical removal of emboli and thrombi" and "injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." These are therapeutic and procedural actions, not diagnostic testing of samples.
- Device Description: The description details the physical components used for mechanical retrieval and aspiration within the vasculature.
- Performance Studies: The clinical study evaluates the safety and effectiveness of the device in treating pulmonary embolism by measuring physiological changes (pulmonary arterial pressure), not by analyzing in vitro samples.
The device is used for treatment and intervention within the patient's body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
Peripheral blood vessels, peripheral vasculature, pulmonary embolism (PE)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary safety endpoint: 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. Primary effectiveness endpoint: change in mean and systolic pulmonary arterial pressure from baseline pre-procedure to postprocedure.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Inari Medical, FlowTriever2 Catheter (K201541)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
3
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 100 | ||
| Irvine, CA 92618 | ||
| 877.923.4747 | ||
| Contact person | Rayee Patil | |
| Regulatory 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, 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. | |
| Indications for Use | 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). | |
| Device modifications | The purpose of this submission is to expand the indications of the
FlowTriever2 Catheter for the treatment of pulmonary embolism. | |
| Comparison of
Technological
Characteristics with
Predicate Device | There is no change to the intended use, principles of operation, or
fundamental scientific technology between the proposed FlowTriever2
Catheter and the predicate device. | |
| Summary of
substantial equivalence | A tabular comparison of the predicate and subject devices is provided below: | |
| Device | FlowTriever2 Catheter | FlowTriever2 Catheter |
5
| Device | FlowTriever2 Catheter
Proposed (K250088) | FlowTriever2 Catheter
Predicate (K201541) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW, KRA | QEW, KRA |
| Indications for use | The FlowTriever2 Catheter is indicated
for: | The FlowTriever2 Catheter is indicated
for: |
| | • The non-surgical removal of emboli and
thrombi from peripheral blood vessels. | • 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. | • 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. | The FlowTriever2 Catheter is intended
for use in the peripheral vasculature. |
| | | |
| Principals of Operation | The Triever Catheter (20 or 24 Fr) is
placed over a 0.035" guidewire to a
location proximal of the target thrombus.
The FlowTriever2 Catheter is advanced
over the guidewire, through the Triever
Catheter to a location with its tip
positioned just beyond the thrombus. The
self-expanding disk is deployed by
manually retracting the outer Delivery
Catheter into the Triever Catheter. The
FlowTriever2 Catheter is manually
retracted inside the Triever Catheter to
capture the targeted thrombus. The
FlowTriever2 Catheter is removed from
the Triever Catheter. Thrombus is
aspirated by attaching the Large Bore 60
cc Syringe to the Triever Catheter's side
port connector. 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 Triever Catheter (20 or 24 Fr) is
placed over a 0.035" guidewire to a
location proximal of the target thrombus.
The FlowTriever2 Catheter is advanced
over the guidewire, through the Triever
Catheter to a location with its tip
positioned just beyond the thrombus. The
self-expanding disk is deployed by
manually retracting the outer Delivery
Catheter into the Triever Catheter. The
FlowTriever2 Catheter is manually
retracted inside the Triever Catheter to
capture the targeted thrombus. The
FlowTriever2 Catheter is removed from
the Triever Catheter. Thrombus is
aspirated by attaching the Large Bore 60
cc Syringe to the Triever Catheter's side
port connector. 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 through
the Triever16 using aspiration alone, or in
combination with the FlowTriever2
Catheter. |
| 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 catheter
materials | Proximal - Pebax 7233 SA01 MED, 20%
BaSO4
Distal - Pebax 4033 SA01 MED, 20%
BaSO4
PTFE Liner | Proximal - Pebax 7233 SA01 MED, 20%
BaSO4
Distal - Pebax 4033 SA01 MED, 20%
BaSO4
PTFE 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 |
6
K250088
7
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.