(178 days)
Not Found
No
The summary describes a mechanical device for thrombus removal and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a 'FlowTriever Retrieval/Aspiration System' intended for the 'non-surgical removal of emboli and thrombi from peripheral blood vessels'. This directly addresses a medical condition (thromboemboli) with a therapeutic action (removal), fitting the definition of a therapeutic device.
No
The device is described as a catheter system for the non-surgical removal of emboli and thrombi from peripheral blood vessels and for injection, infusion, and/or aspiration of fluids. It is a therapeutic device designed to treat a condition by removing physical obstructions (thromboemboli), rather than to diagnose or detect a disease or condition.
No
The device description clearly outlines a physical catheter-based system with mechanical components (catheters, self-expanding disks, syringe) used for the physical removal of thrombi. The performance studies also focus on physical properties and performance of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the non-surgical removal of emboli and thrombi from peripheral blood vessels and injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. This describes a therapeutic and interventional procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a catheter-based system used to physically remove blood clots from within the patient's blood vessels. This is a medical device used for treatment, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is mechanical removal and fluid management within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
Device Description
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 two main components packaged separately:
- Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
- FlowTriever2 Catheter
The FlowTriever2 Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding disk(s) are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever2 Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever2 Catheter are removed from the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral blood vessels, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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 modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included:
Visual & Dimensional Inspection
Guidewire Compatibility Verification
Radial Expansion Force
Deployment Force
Retraction Force
Element Visual Inspection; Post Retraction Cycles
Leak and Vacuum Test; Post Retraction Cycles
Kink Resistance
Clot Analog Burden Removal Validation
Chronic Clot Analog Burden Removal Validation
Simulated Use, Track and Tensile
Liquid Leakage under Pressure
Burst Pressure
Simulated Use, Torque
Corrosion Resistance
Particulate testing
Animal testing met predetermined acceptance criteria. Clinical testing was not required for the determination of substantial equivalence. Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
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.
Inari FlowTriever Retrieval/Aspiration 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.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 4, 2020
Inari Medical Eben Gordon Vice President, RA/QA 9 Parker. Suite 100 Irvine, California 92618
Re: K201541
Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: November 2, 2020 Received: November 3, 2020
Dear Eben 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. 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 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
1
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 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
2
Indications for Use
510(k) Number (if known) K201541
Device Name
FlowTriever Retrieval/Aspiration System
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 FlowTriever2 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 3
510(K) SUMMARY
| Date prepared | December 2, 2020 |
|---|---|
| Name | Inari Medical, Inc. |
| 9 Parker, Suite 100 | |
| Irvine, CA 92618 | |
| 949.418.4095 | |
| 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 | QEW |
| Secondary Product | |
| code | KRA |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K143563) |
| Description | 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 two main components | |
| packaged separately: | |
| • Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr) | |
| • FlowTriever2 Catheter |
The FlowTriever2 Catheter is inserted through the Triever Catheter and advanced
to the thrombus. Self-expanding disk(s) are deployed to engage thrombus by
retracting the outer delivery catheter. The FlowTriever2 Catheter is retracted into
the Triever Catheter to capture the targeted thrombus. Additional clot may be
removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the
procedure is complete, the Triever Catheter and FlowTriever2 Catheter are
removed from the patient. |
| 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. |
| Explanation of differences in indications for use | The indications for use of the FlowTriever2 Catheter is the same as the predicate device, i.e., use in the peripheral vasculature. |
| Device modifications | The reason for this submission is to introduce a FlowTriever Catheter variant with these changes:
Redesign of the FlowTriever Catheter disk geometry Reduction of FlowTriever Catheter disks from 3 to 1 FlowTriever Catheter disk changed from formed nitinol wire to laser cut nitinol FlowTriever Catheter inner shaft material change to Polyimide/braid/Polyimide-PTFE composite FlowTriever Delivery Catheter length increased by 5 cm to 120 cm FlowTriever Delivery Catheter proximal Luer material changed to polycarbonate Non-patient contacting proximal stop feature added to alert user when the device is deployed |
| Technological characteristics comparison | The proposed modifications to the FlowTriever Catheter principally involve the optimizing the disk geometry and reducing the number of disks from 3 to 1. The FlowTriever2's single disk shortens the treatment segment affording less risk of vessel damage while maintaining thrombus removal performance. The remaining incremental changes either improve manufacturability (laser cut nitinol disk, polyimide/braid/Polyimide-PTFE composite inner catheter material, polycarbonate Luer) or improve usability (5 cm longer Delivery Catheter, proximal stop feature). |
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PAGE 2 OF 3
5
| Summary of substantial equivalence | There is no change of intended use or fundamental scientific technology between the proposed and predicate device. The FlowTriever Retrieval/Aspiration System has the same indication for use as the predicate. |
|---|---|
| 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 modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included: | |
| Visual & Dimensional Inspection Guidewire Compatibility Verification Radial Expansion Force Deployment Force Retraction Force Element Visual Inspection; Post Retraction Cycles Leak and Vacuum Test; Post Retraction Cycles Kink Resistance Clot Analog Burden Removal Validation Chronic Clot Analog Burden Removal Validation Simulated Use, Track and Tensile Liquid Leakage under Pressure Burst Pressure Simulated Use, Torque Corrosion Resistance Particulate testing | |
| Animal testing met predetermined acceptance criteria. Clinical testing was not required for the determination of substantial equivalence. | |
| Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. | |
| Conclusion | |
| The proposed device modifications to the FlowTriever Retrieval/Aspiration System do not change its intended use or raise new or different questions of safety and effectiveness. With consideration of the results of the testing, it can be concluded that the proposed FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device. |