(85 days)
No
The description focuses on mechanical components and a manual aspiration process, with no mention of AI/ML terms or functionalities.
Yes
The device is indicated for the non-surgical removal of emboli and thrombi from blood vessels and for the treatment of pulmonary embolism, which are therapeutic interventions.
No
Explanation: The device is described as a "Retrieval/Aspiration System" intended for the "non-surgical removal of emboli and thrombi" and for "treatment of pulmonary embolism," indicating its primary function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components (catheters, aspirator) and a mechanical mechanism of action, indicating it is a hardware-based medical device.
Based on the provided information, the Flow Triever Retrieval/Aspiration System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Flow Triever's Function: The Flow Triever system is a catheter-based system designed for the physical removal of emboli and thrombi from blood vessels within the body. It is a therapeutic device used for intervention, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states "non-surgical 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." These are all procedures performed directly on the patient's vascular system.
- Device Description: The description details a system for physically engaging and aspirating thrombus from within blood vessels.
- Performance Studies: The performance study focuses on clinical outcomes in patients (reduction in RV/LV ratio, major adverse events), not on the accuracy or performance of a diagnostic test on a sample.
Therefore, the Flow Triever Retrieval/Aspiration System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System 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 Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of pulmonary embolism. The system is comprised of three main components packaged separately:
● Aspiration Guide Catheter
● FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm)
● Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, pulmonary embolism (blood vessels, pulmonary arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 perforamnce, key results)
Non-Clinical Testing:
In alignment with the Design Failure Modes and Effects Analysis, verification and validation testing was identified in support of the FlowTriever Retrieval/Aspiration System. These tests included:
Pouch seal visual inspection and dye penetration Pouch peel, seal strength Visual and dimensional inspections Guidewire compatibility Snap fit, Dilator Luer to Guide Catheter hemostasis valve Deployment force of Wireform Catheter from Delivery Catheter Retraction force of Wireform Catheter into Delivery Catheter Retraction force of Wireform Catheter into Guide Catheter Leakage testing of Wireform Catheter with guidewire in place Guide Catheter/Infusion Wireform Catheter kink radius Liquid leakage under pressure Leakage testing, devices with Guide Catheter hemostasis valve Test of conical fittings with 6% Luer taper Air leakage into hub assembly during aspiration Retraction Aspirator retraction testing Tube Set Check Valve and vent plug inspection Tube set, leakage Tube Set check valve cracking pressure Determination of flow rate through catheter, Corrosion resistance, Tube set tensile strength, Particulate matter evaluation, Burst pressure and burst testing, Simulated Use Tracking and tensile, Delivery Catheter, Guide Catheter, Dilator, Wireform Catheter, Simulated Use tracking and torque.
Biocompatibility testing in accordance with ISO 10993-1:
MEM elution, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous Irritation, Acute systemic toxicity, Hemolysis, direct contact and extract method, Complement Activation, C3a and SC5b-9 Assay, Unactivated Partial Thromboplastin Time (UPTT) Test.
Acute evaluation of the safety and performance of the FlowTriever Retrieval/Aspiration System was successfully performed in swine pulmonary arteries. Specifically the ability to place and deploy the device, the fluoroscopic visibility and the ability to infuse fluid through the catheters was evaluated, and all acceptance criteria were successfully met. In addition, the histological evaluation of the vessel specimens after use of the test devices was performed and demonstrated no significant gross or histopathological findings in treated vessels.
Clinical Testing:
Inari Medical conducted the FlowTriever Pulmonary Embolectomy Clinical ("FLARE") Study, a prospective, single-arm, multicenter study, to evaluate the safety and effectiveness of the FlowTriever System for the treatment of acute pulmonary embolism (PE). A total of 106 subjects were enrolled at 18 investigational sites. The primary safety endpoint was the composite of major adverse events (MAE), defined as device-related death, major bleeding and treatment-related adverse events (clinical deterioration, pulmonary vascular injury, or cardiac injury) measured at 48 hours. The primary effectiveness endpoint was reduction in RV/LV ratio from baseline to 48 hours. The study met the performance goals for the primary study endpoints. Refer to the Instruction for Use for detailed clinical study information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Infusion Aspiration Catheter System (K143563)
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.
EkoSonic Endovascular System (K140151)
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
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May 17, 2018
Inari Medical, Inc. Eben Gordon Vice President, Regulatory Affairs & Quality Assurance 9272 Jeronimo Road Suite 124 Irvine, California 92618
Re: K180466
Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 7, 2018 Received: March 8, 2018
Dear Eben Gordon:
We have reviewed vour 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180466
Device Name
FlowTriever Retrieval/Aspiration System
Indications for Use (Describe)
The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System 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 Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
| 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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3
510(K) SUMMARY
K180466
| Date prepared | February 16, 2018 |
|---|---|
| Name | Inari Medical, Inc. |
| 9272 Jeronimo Road, Suite 124 | |
| Irvine, CA 92618 | |
| 949.600.8433 x114 | |
| Contact person | Eben Gordon |
| Vice President, Regulatory Affairs & Quality Assurance | |
| Trade name | FlowTriever Retrieval/Aspiration System |
| Common name | Embolectomy catheter |
| Regulation Name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | DXE |
| Regulatory class | II |
| Predicate device | Infusion Aspiration Catheter System (K143563) |
| Reference device | EkoSonic Endovascular System (K140151) |
| Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire |
| catheter-based system for the minimally invasive treatment of pulmonary | |
| embolism. The system is comprised of three main components packaged | |
| separately: | |
| ● Aspiration Guide Catheter | |
| ● FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15- | |
| 18 mm) | |
| ● Retraction Aspirator | |
| The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and | |
| advanced to the thrombus. Self-expanding wireform disks are deployed to engage | |
| thrombus by retracting the outer delivery catheter. The hand-lever operated | |
| Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever | |
| Catheter with thrombus into the Aspiration Guide Catheter to capture clot and | |
| restore blood flow. | |
| Indications for Use | The FlowTriever Retrieval/Aspiration System consists of the FlowTriever |
| Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever | |
| Retrieval/Aspiration System 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral | |
| vasculature and for the treatment of pulmonary embolism. | |
| Summary of | |
| substantial equivalence | The purpose of this submission is to expand the indications for use of the |
| FlowTriever/Aspiration System for the treatment of pulmonary embolism and | |
| propose device design changes. |
The FlowTriever Retrieval/Aspiration System and the predicate device have the
same intended use: removal of obstructing material (including emboli and
thrombi) from blood vessels by mechanical means.
The device design changes do not significantly change the underlying
technological characteristics and do not raise different questions of safety and
effectiveness compared to the predicate. |
| Non-Clinical Testing
In alignment with the Design Failure Modes and Effects Analysis, verification and
validation testing was identified in support of the FlowTriever
Retrieval/Aspiration System. These tests included:
Pouch seal visual inspection and dye penetration Pouch peel, seal strength Visual and dimensional inspections Guidewire compatibility Snap fit, Dilator Luer to Guide Catheter hemostasis valve Deployment force of Wireform Catheter from Delivery Catheter Retraction force of Wireform Catheter into Delivery Catheter Retraction force of Wireform Catheter into Guide Catheter Leakage testing of Wireform Catheter with guidewire in place Guide Catheter/Infusion Wireform Catheter kink radius Liquid leakage under pressure Leakage testing, devices with Guide Catheter hemostasis valve Test of conical fittings with 6% Luer taper Air leakage into hub assembly during aspiration Retraction Aspirator retraction testing Tube Set Check Valve and vent plug inspection Tube set, leakage Tube Set check valve cracking pressure Determination of flow rate through catheter | |
4
- Corrosion resistance
- . Tube set tensile strength
5
- Particulate matter evaluation
- Burst pressure and burst testing ●
- Simulated Use Tracking and tensile, Delivery Catheter, Guide Catheter, Dilator, Wireform Catheter
- . Simulated Use tracking and torque
Biocompatibility testing in accordance with ISO 10993-1:
- MEM elution ●
- ISO Guinea Pig Maximization Sensitization
- ISO Intracutaneous Irritation
- Acute systemic toxicity
- Hemolysis, direct contact and extract method ●
- Complement Activation, C3a and SC5b-9 Assay ●
- Unactivated Partial Thromboplastin Time (UPTT) Test
Acute evaluation of the safety and performance of the FlowTriever Retrieval/Aspiration System was successfully performed in swine pulmonary arteries. Specifically the ability to place and deploy the device, the fluoroscopic visibility and the ability to infuse fluid through the catheters was evaluated, and all acceptance criteria were successfully met. In addition, the histological evaluation of the vessel specimens after use of the test devices was performed and demonstrated no significant gross or histopathological findings in treated vessels.
Clinical Testing
Inari Medical conducted the FlowTriever Pulmonary Embolectomy Clinical ("FLARE") Study, a prospective, single-arm, multicenter study, to evaluate the safety and effectiveness of the FlowTriever System for the treatment of acute pulmonary embolism (PE). A total of 106 subjects were enrolled at 18 investigational sites. The primary safety endpoint was the composite of major adverse events (MAE), defined as device-related death, major bleeding and treatment-related adverse events (clinical deterioration, pulmonary vascular injury, or cardiac injury) measured at 48 hours. The primary effectiveness endpoint was reduction in RV/LV ratio from baseline to 48 hours. The study met the performance goals for the primary study endpoints. Refer to the Instruction for Use for detailed clinical study information.
Conclusion
Compared to the predicate device, the expanded indication and device modifications to the FlowTriever Retrieval/Aspiration System do not change the intended use and the technological differences do not raise different questions of safety and effectiveness. Based on the results of pre-clinical testing and the FLARE Clinical Study, the data supports that the FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device.