(25 days)
No
The description focuses on the mechanical components and function of a catheter-based system for thrombus removal, with no mention of AI or ML capabilities.
Yes
The device is indicated for the non-surgical removal of emboli and thrombi from blood vessels and for the treatment of pulmonary embolism and clot in transit in the right atrium, which are therapeutic interventions.
No
The device is described as a "Retrieval/Aspiration System" and its stated purpose is the "non-surgical removal of emboli and thrombi" and "injection, infusion, and/or aspiration of contrast media and other fluids." These functions are therapeutic or interventional, not diagnostic.
No
The device description clearly outlines physical components (catheters, syringe) and a mechanical function (aspiration), indicating it is a hardware-based medical device.
Based on the provided information, 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, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The FlowTriever Retrieval/Aspiration System is a catheter-based system used inside the body (in vivo) to physically remove blood clots from vessels.
- Intended Use: The intended use is for the non-surgical removal of emboli and thrombi from blood vessels and for the injection/aspiration of fluids within the blood vessels. This is a therapeutic and interventional procedure, not a diagnostic test performed on a sample.
The device is clearly designed for direct intervention within the patient's circulatory system, which is the opposite of an in vitro diagnostic.
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.
Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
Product codes
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 and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20 (and 20 Curved) and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, peripheral vasculature, pulmonary, right atrium
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 No clinical data was required to support the change to the contraindications.
Clinical Testing No clinical data was required to support the change to the contraindications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Inari FlowTriever Retrieval/Aspiration System (K202345)
Reference Device(s)
Inari FlowTriever Retrieval/Aspiration System (K201541)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 30, 2021
Inari Medical, Inc. Larry Boucher Regulatory Affairs Manager 9 Parker. Suite 100 Irvine, California 92618
Re: K211013
Trade/Device Name: FlowTriever Retrieval/Aspiration System. FlowTriever Catheters: Triever 16. Triever 20, Triever 20 Curve, Triever 24 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: April 2, 2021 Received: April 5, 2021
Dear Larry Boucher:
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
1
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) 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 (OS) 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 mediation-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
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Indications for Use
510(k) Number (if known) K211013
Device Name
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters: Triever 20, Triever 20 Curve, Triever 24
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.
Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
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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PAGE 1 OF 2
510(K) SUMMARY
| Date prepared | April 2, 2021 |
|---|---|
| Name | Inari Medical, Inc. |
| 9 Parker, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 | |
| Contact person | Larry Boucher |
| Regulatory Affairs Manager | |
| Trade name | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters: Triever 16, |
| Triever 20, Triever 20 Curve, Triever 24 | |
| 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 (K202345) |
| Reference Device | Inari FlowTriever Retrieval/Aspiration System (K201541) |
| 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 and for the treatment of pulmonary embolism. The | |
| system is comprised of two main components packaged separately: | |
| • Triever Catheters (available in 3 sizes: 16, 20 (and 20 Curved) and 24 Fr) | |
| • FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 | |
| mm, and 19-25 mm) | |
| Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are | |
| inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After | |
| removal of its dilator, thrombus may be removed by aspiration with the provided | |
| 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever | |
| Catheter is 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. | |
| Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are | |
| also intended for use in treating clot in transit in the right atrium but not in | |
| conjunction with FlowTriever Catheters. |
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5
| Device modifications | The contraindication for FlowTriever and Triever Catheter has been changed by deleting "chronic clot" from the examples given "…for removal of fibrous, adherent, or calcified material…". |
|---|---|
| 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, K202345. |
Non-Clinical Testing
Non-clinical testing was not required to support the change to the contraindications.
Clinical Testing
No clinical data was required to support the change to the contraindications.
Conclusion
Removing "chronic clot" from the example "of fibrous, adherent, or calcified material" of a contraindication for the FlowTriever Retrieval/Aspiration System does not raise new or different questions of safety or and effectiveness. Therefore, the FlowTriever Retrieval/Aspiration System with the modified contraindication is substantially equivalent to the predicate device. |