(67 days)
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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. 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.
The provided text describes a 510(k) premarket notification for the Inari Medical FlowTriever Retrieval/Aspiration System. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document states that "Test results demonstrated that all acceptance criteria were met," and "This testing FlowTriever demonstrated compliance with relevant product specifications." However, it does not explicitly list the specific quantitative acceptance criteria for each test or the exact performance values achieved. It only lists the types of tests performed.
| Test Category | Specific Test | Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (Not explicitly stated in text) |
|---|---|---|---|
| Material/Component Integrity | Visual and Dimensional Inspections | Implied: Within specified tolerances | Implied: Met specified tolerances |
| Functional Performance (Catheter) | Guidewire Compatibility Verification | Implied: Compatible with designated guidewires | Implied: Demonstrated compatibility |
| Leakage Verification, AGC Hemostasis Valve And Accessory Devices | Implied: No leakage beyond acceptable limits | Implied: No leakage detected | |
| Air Leakage From AGC Hemostasis Valve During Syringe Pullback | Implied: No air leakage beyond acceptable limits | Implied: No air leakage detected | |
| Air Leakage During Syringe Pullback | Implied: No air leakage beyond acceptable limits | Implied: No air leakage detected | |
| Vacuum Testing | Implied: Achieved and maintained specified vacuum levels | Implied: Met specified vacuum requirements | |
| Retraction Force Testing | Implied: Within specified force range | Implied: Within specified force range | |
| Push Button Force | Implied: Within specified force range | Implied: Within specified force range | |
| Retraction Aspirator Device Retraction | Implied: Consistent and effective retraction | Implied: Demonstrated consistent and effective retraction | |
| Simulated Use, Track and Tensile | Implied: Met performance requirements for simulated use, tracking, and tensile strength | Implied: Met performance requirements | |
| Stopcock Torque Testing | Implied: Within specified torque range | Implied: Within specified torque range | |
| Burst Testing of Hemostasis Valve and Stopcock | Implied: Withstood specified burst pressures | Implied: Withstood specified burst pressures |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. The data provenance is non-clinical testing, meaning it involves engineering and bench testing, not patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies do not apply in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the study described is non-clinical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation of outcomes. The "ground truth" here is adherence to engineering specifications and performance standards.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3. The testing involves objective measurements against predefined specifications, not subjective human assessment 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 comparative effectiveness study was not done. The device is a physical medical device (embolectomy catheter), not an AI-driven diagnostic or assistive system that would involve human readers. Clinical testing was explicitly stated as "not required for the determination of substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on established product specifications, engineering standards, and the intended use of the device. The tests were designed to verify that the modified device met these predefined criteria.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this non-clinical engineering and performance testing for a physical medical device. This is not an AI/machine learning study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2018
Inari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs and Quality Assurance 9272 Jeronimo Rd., Suite 124 Irvine, California 92618
Re: K173672
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: January 24, 2018 Received: January 26, 2018
Dear Mr. Gordon:
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. 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 medical devices and radiation-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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173672
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 FlowTriever Retrieval/Aspiration System 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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510(K) SUMMARY
| Date prepared | November 28, 2017 |
|---|---|
| Name | Inari Medical, Inc.9272 Jeronimo Road, Suite 124Irvine, CA 92618949.600.8433 x114 |
| Contact person | Eben GordonVice 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 | Inari FlowTriever Retrieval/Aspiration System (K162970) |
| Reference device | Inari ClotTriever Thrombectomy System (K163549) |
| Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wirecatheter-based system for the minimally invasive treatment of thromboemboli inthe peripheral vasculature. The system is comprised of three main componentspackaged separately:● Aspiration Guide Catheter● FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm)● Retraction AspiratorThe FlowTriever Catheter is inserted through the Aspiration Guide Catheter andadvanced to the thrombus. Self-expanding wireform disks are deployed to engagethrombus by retracting the outer delivery catheter. The hand-lever operatedRetraction Aspirator simultaneously aspirates fluids and retracts the FlowTrieverCatheter with thrombus into the Aspiration Guide Catheter to capture clot andrestore blood flow. |
| Indications for Use | The Flow Triever Retrieval/Aspiration System consists of the FlowTrieverCatheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTrieverRetrieval/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 fluidsinto or from a blood vessel.The FlowTriever Retrieval/Aspiration System is intended for use in the peripheralvasculature. |
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PAGE 2 OF 2
Device modifications The modification to the FlowTriever Retrieval/Aspiration System are primarily intended to streamline the user interaction with the device changes and include the following:
- . Replacement of the hemostasis valve seal with a user actuated hemostasis valve seal in the Aspiration Guide Catheter's proximal hub.
- Addition of a stopcock in the sideport tubing.
- . Elimination of the Valve Dilator, Aspiration Insert, Flush Port Adapter, and tubing clamp components.
Summary of There is no change of intended use or fundamental scientific technology between substantial equivalence the proposed and predicate devices.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing supported the substantial equivalence of the modified Retrieval/Aspiration System. This testing FlowTriever demonstrated compliance with relevant product specifications. These tests included:
- Visual and Dimensional Inspections ●
- Guidewire Compatibility Verification
- Leakage Verification, AGC Hemostasis Valve And Accessory Devices ●
- . Air Leakage From AGC Hemostasis Valve During Syringe Pullback
- Air Leakage During Syringe Pullback ●
- Vacuum Testing ●
- Retraction Force Testing
- Push Button Force
- Retraction Aspirator Device Retraction ●
- Simulated Use, Track and Tensile
- Stopcock Torque Testing ●
- Burst Testing of Hemostasis Valve and Stopcock .
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the modified FlowTriever Retrieval/Aspiration System is substantially equivalent 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).