(59 days)
No
The description focuses on the mechanical components and function of a catheter-based system for thrombus removal. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
This device is designed for the non-surgical removal of emboli and thrombi from blood vessels and for the treatment of pulmonary embolism, which are direct therapeutic interventions.
No
The device is a system for the non-surgical removal of emboli and thrombi (treatment), not for diagnosing conditions.
No
The device description clearly outlines physical components (catheters, syringe, wireform disks) and procedures involving their manipulation within the body, indicating it is a hardware-based medical device.
Based on the provided information, the FlowTriever Retrieval/Aspiration System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- FlowTriever Function: The FlowTriever system is a medical device used inside the body (in vivo) to physically remove blood clots from blood vessels. It is a surgical/interventional tool, not a diagnostic test performed on a sample.
- 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 therapeutic and procedural actions, not diagnostic testing.
- Device Description: The description details a catheter-based system for minimally invasive treatment, involving physical manipulation within the vasculature.
Therefore, the FlowTriever Retrieval/Aspiration System falls under the category of a therapeutic or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 two main components packaged separately:
Aspiration Guide Catheter FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) 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 FlowTriever Catheter is retracted into the Aspiration Guide Catheter to capture the targeted thrombus. Additional clot may also be removed by aspiration with the provided 60 cc syringe. After the procedure is complete, the Aspiration Guide Catheter and FlowTriever 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 vasculature and for the treatment of pulmonary embolism.
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 substantial equivalence of the modified FlowTriever Retrieval/Aspiration System. This testing demonstrated compliance with relevant product specifications. These tests included:
- Packaging Testing
- Leak Testing
- Vacuum Testing
- Tensile Testing
- Simulated Use Testing
Accelerated 2-year shelf-life testing was conducted for the modification to the 60 cc syringe to support the existing 2-year shelf-life.
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)
Inari FlowTriever Retrieval/Aspiration System (K181694)
Reference Device(s)
Inari FlowTriever Retrieval/Aspiration System (K162970)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2018
Inari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs and Quality Assurance 9272 Jeronimo Rd., Suite 124 Irvine, California 92618
Re: K182233
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: August 16, 2018 Received: August 17, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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, 2018.10.15 08:45:43 Eleni Whatley -04'00' 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) K182233
Device Name FlowTriever Retrieval/Aspiration System
Indications for Use (Describe)
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.
| 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
K182233
PAGE 1 OF 2
510(K) SUMMARY
| Date prepared | August 17, 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 | Inari FlowTriever Retrieval/Aspiration System (K181694) |
| Reference device | Inari FlowTriever Retrieval/Aspiration System (K162970) |
| 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: | |
| Aspiration Guide Catheter FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) 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 FlowTriever Catheter is | |
| retracted into the Aspiration Guide Catheter to capture the targeted thrombus. | |
| Additional clot may also be removed by aspiration with the provided 60 cc | |
| syringe. After the procedure is complete, the Aspiration Guide Catheter and | |
| FlowTriever Catheter are removed from the patient. | |
| Indications for Use | 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. |
4
PAGE 2 OF 2
- The change to the FlowTriever Retrieval/Aspiration System from the version Device modifications cleared under K181694 is to replace the Retraction Aspirator with the manual retraction of the FlowTriever Catheter into the Aspiration Guide Catheter and the aspiration of thrombus using a 60 cc VacLok syringe. The tip of the syringe has been modified to connect to the Aspiration Guide Catheter's side port tubing connector. Alternatively, an Aspiration Adapter is provided that allows a physician to connect an off-the-shelf syringe directly to the side port tubing connector of the Aspiration Guide Catheter for aspiration.
There is no change of intended use or fundamental scientific technology between Summary of substantial equivalence the proposed and predicate devices.
The FlowTriever Retrieval/Aspiration System has the same indication for use as the predicate, K181694.
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:
- Packaging Testing ●
- . Leak Testing
- Vacuum Testing
- Tensile Testing
- . Simulated Use Testing
Accelerated 2-year shelf-life testing was conducted for the modification to the 60 cc syringe to support the existing 2-year shelf-life.
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. With consideration of the results of the testing leveraged from K181694 and K162970, it can be concluded that the proposed FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate devices.