(30 days)
No
The 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/ML.
Yes
The device is indicated for "non-surgical removal of emboli and thrombi from blood vessels" and for "treatment of pulmonary embolism," which are therapeutic interventions aimed at treating a medical condition.
No
The device is described as a system for the non-surgical removal of emboli and thrombi from blood vessels and for injection/aspiration of fluids, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components (catheters, aspirator) and a mechanical mechanism of action, indicating it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the FlowTriever Retrieval/Aspiration System is a catheter-based system used for the non-surgical removal of emboli and thrombi from blood vessels and for injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. This involves direct intervention within the body (in vivo), not testing samples outside the body (in vitro).
The device is a therapeutic medical device used for interventional procedures within the vascular system.
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
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 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: The FlowTriever Retrieval/Aspiration System is identical to the version cleared under K173672. Appropriate rationales were provided to support that the testing provided under K173672 may be appropriately leveraged to support clearance of this device for the proposed intended use. Therefore, additional verification testing is not necessary to establish compliance to design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Inari FlowTriever Retrieval/Aspiration System (K180466), Inari FlowTriever Retrieval/Aspiration System (K173672)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 FDA logo is composed 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 Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in blue, followed by "U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
June 17, 2018
Inari Medical, Inc. Eben Gordon Vice President, Regulatory Affairs & Quality Assurance 9272 Jeronimo Rd Suite 124 Irvine, California 92618
Re: K181325
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: May 17, 2018 Received: May 18, 2018
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. 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 (QS) regulation (21 CFR Part 820);
1
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 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.
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
2
Indications for Use
510(k) Number (if known) K181325
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
| Date prepared | June 13, 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 devices | Inari FlowTriever Retrieval/Aspiration System (K180466) (Primary Predicate) |
| Inari FlowTriever Retrieval/Aspiration System (K173672) | |
| 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 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: |
4
- 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.
The Aspiration Guide Catheter and Retraction Aspirator Tubing Set were Device modifications modified from the versions cleared under K180466 to allow the removal of the FlowTriever Catheter from the patient without the simultaneous removal of the Aspiration Guide Catheter. In doing so, if another embolectomy pass is attempted, the step of re-introducing the Aspiration Guide Catheter and crossing the right heart is eliminated. All other components of the FlowTriever Retrieval/Aspiration System are identical to those cleared under K180466. The modifications to the Aspiration Guide Catheter and Retraction Aspirator
included the following:
- . Replacing the hemostasis valve with a user-actuated hemostasis valve in the Aspiration Guide Catheter's proximal hub.
- . Replacing the off-the-shelf stopcock with a large bore stopcock in the side port tubing.
- Increasing the lumen diameters of the tubing and connector in the fluid ● path between the Aspiration Guide Catheter to the collection bag.
- Replacing the checkvalve component in the Tubing Set with a clot reservoir to prevent clot from plugging distal checkvalve as it is transported to the collection bag.
These modifications made the Aspiration Guide Catheter and Retraction Aspirator Tubing Set identical to the Aspiration Guide Catheter and Retraction Aspirator Tubing Set cleared under K173672. As all of the other components of the FlowTriever Retrieval/Aspiration System were already identical to those cleared under K173672, the modifications make the proposed FlowTriever Retrieval/Aspiration System identical to the one cleared under K173672.
Summary of There is no change of intended use or fundamental scientific technology between substantial equivalence the proposed and predicate devices.
The FlowTriever Retrieval/Aspiration System has the same indication for use as the primary predicate, K180466. The indication for use for the additional predicate, K173672, only differs in that it does not include treatment of pulmonary embolism.
The FlowTriever Retrieval/Aspiration System has been modified from the version cleared under K180466 to be identical the version cleared under K173672.
Non-Clinical Testing
The FlowTriever Retrieval/Aspiration System is identical to the version cleared under K173672. Appropriate rationales were provided to support that the testing
5
Image /page/5/Picture/0 description: The image shows two lines of text inside a rectangular box. The first line reads "K181325", and the second line reads "PAGE 3 OF 3". The text is centered within the box.
provided under K173672 may be appropriately leveraged to support clearance of this device for the proposed intended use. Therefore, additional verification testing is not necessary to establish compliance to design specifications.
Conclusion
The proposed device modifications to the FlowTriever Retrieval/Aspiration System do not change its intended use or raise different questions of safety and effectiveness. With consideration of the results of the testing leveraged from K173672, it can be concluded that the proposed FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device.