(29 days)
Not Found
No
The 510(k) summary describes a mechanical system for thrombus removal and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is indicated for the non-surgical removal of emboli and thrombi from blood vessels, which directly treats a medical condition.
No
The device is designed for the treatment of thromboemboli (retrieval/aspiration), and for the injection, infusion, and/or aspiration of fluids, which are interventional/therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components (catheters, aspirator) and a mechanical mechanism for thrombus removal, indicating it is a hardware-based medical device, not software-only.
Based on the provided text, the Flow Triever Retrieval/Aspiration System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. They are used in vitro (outside the body).
- The Flow Triever Retrieval/Aspiration System is a catheter-based system used within the body (in the peripheral vasculature) to physically remove emboli and thrombi. It is an in vivo device.
The description clearly states its purpose is for the "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 circulatory system, not on samples taken from the patient.
N/A
Intended Use / 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.
Product codes
DXE
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 three main components packaged separately:
Aspiration Guide Catheter (AGC) 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, blood vessels
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 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 safety and effectiveness of the modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included:
- Visual & Dimensional Inspections
- Leakage Testing: Guide Catheter Hemostasis Valve and Devices ●
- Air Leakage from Guide Catheter Hemostasis Valve During Syringe ● Pullback
- Retraction Testing: Retraction Aspirator
- Check Valve & Vent Plug Testing: Tube set ●
- Leakage Verification: Tube Set, Clot Reservoir
- Valve Cracking Pressure: Clot Reservoir
- Simulated use Track and Tensile: Guidewire Compatibility
- Simulated use Track and Tensile: Flush Port, Guide Catheter, Tube Set
- . Vacuum Testing: Guide Catheter, Clot Reservoir, Tube Set
- Torque Testing: Clot Reservoir Luer Activated Valve ●
- Clot Burden: Clot Reservoir .
- Valve Dilator Insertion Force: Guide Catheter .
- . Corrosion Resistance: Clot Reservoir
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use.
Clinical testing was not required for the determination of substantial equivalence.
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.
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Inari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs & Quality Assurance 9272 Jeronimo Road, Suite 124 Irvine, CA 92618
Re: K162970
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: October 21, 2016 Received: October 24, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Brian D. Pullin -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) K162970
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) |
|---|
| ------------------------------------------------- |
X 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 13, 2016 |
|---|---|
| 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 devices | Inari Medical Infusion Aspiration Catheter 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 | |
| three main components packaged separately: | |
| Aspiration Guide Catheter (AGC) 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. | |
| Device Modifications | The change to the FlowTriever Retrieval/Aspiration System allows the |
| removal of the FlowTriever Catheter from the patient without the | |
| simultaneous removal of the Aspiration Guide Catheter. The modifications | |
| being implemented are: | |
| Retraction Aspirator Tubing Set |
- The checkvalve in the tubing arm is replaced with the clot reservoir. The
former in-line checkvalve component is now integrated into the clot |
4
reservoir cap.
-
- The connection to the AGC is achieved via a quick-release coupling rather than a Luer connection. Aspiration Guide Catheter
-
- Increasing the side port tubing inner diameter from 0.098" to 0.188".
-
- Replacing the stopcock with an on/off clamp and the larger lumen quickrelease coupling.
-
- Opening the hub's tubing connection lumen diameter from 0.096" to 0.235'' to accommodate the larger inner diameter tubing.
New Aspiration Guide Catheter Components
-
- Flush Port Adapter Luer female connector on one end and a quickrelease coupling on the other for attachment to the AGC.
-
- Hub Valve Insert Inserted into the AGC hub to open the hemostasis valve as the FlowTriever Catheter is drawn through it.
-
- Aspiration Insert Seals on the guidewire and in the hub to allow a vacuum to transport any thrombus (and blood) to the clot reservoir.
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.
There is no change of intended use or fundamental scientific technology Summary of substantial equivalence between the proposed and predicate devices.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the safety and effectiveness of the modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included:
- Visual & Dimensional Inspections
- Leakage Testing: Guide Catheter Hemostasis Valve and Devices ●
- Air Leakage from Guide Catheter Hemostasis Valve During Syringe ● Pullback
- Retraction Testing: Retraction Aspirator
- Check Valve & Vent Plug Testing: Tube set ●
- Leakage Verification: Tube Set, Clot Reservoir
- Valve Cracking Pressure: Clot Reservoir
- Simulated use Track and Tensile: Guidewire Compatibility
- Simulated use Track and Tensile: Flush Port, Guide Catheter, Tube Set
- . Vacuum Testing: Guide Catheter, Clot Reservoir, Tube Set
- Torque Testing: Clot Reservoir Luer Activated Valve ●
5
- Clot Burden: Clot Reservoir .
- Valve Dilator Insertion Force: Guide Catheter .
- . Corrosion Resistance: Clot Reservoir
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 non-clinical testing, it is concluded that the modified FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device.