(30 days)
Not Found
No
The summary describes a mechanical catheter-based system for thrombus removal and fluid management. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis.
Yes.
The device is intended for the non-surgical removal of emboli and thrombi from blood vessels, which directly treats a medical condition.
No
The device is described as a system for the "non-surgical removal of emboli and thrombi" and "treatment" of thromboemboli, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines a catheter-based system with physical components (catheters, syringe, wireform disks) used for mechanical removal of thrombi, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description and Intended Use: The provided text clearly describes a system of catheters used for the physical removal of emboli and thrombi from blood vessels within the patient's body. It also mentions the injection, infusion, and aspiration of fluids into or from a blood vessel. These are all in vivo procedures, meaning they are performed directly on a living organism.
- Lack of Specimen Examination: There is no mention of the device being used to examine specimens outside of the body.
Therefore, based on the provided information, the Triever Catheters and the FlowTriever Retrieval/Aspiration System are not IVDs. They are interventional medical devices used for therapeutic procedures within the body.
N/A
Intended Use / Indications for Use
Triever Catheters are 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.
Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Triever Catheters are also intended for use in transit in the right atrium but not in conjunction with FlowTriever Catheters.
Product codes (comma separated list FDA assigned to the subject device)
QEW
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 24 Fr) 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 Triever 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 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 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
blood vessels, peripheral vasculature, pulmonary embolism, 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)
Animal testing was not required for the determination of substantial equivalence.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
February 24, 2021
Inari Medical Ms. Ellen Nguyen Regulatory Affairs Associate 9 Parker. Suite 100 Irvine, California 92618
Re: K210195
Trade/Device Name: Triever Catheters Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: January 22, 2021 Received: January 25, 2021
Dear Ms. Nguyen:
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)
K210195
Device Name Triever Catheters
| Indications for Use ( Describe ) |
|---|
| Triever Catheters are 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.
Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Triever Catheters are also intended for use 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)
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
PAGE 1 OF 2
510(K) SUMMARY
| Date prepared | January 22, 2021 |
|---|---|
| Name | Inari Medical, Inc. |
| 9 Parker, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 | |
| Contact person | Ellen Nguyen |
| Regulatory Affairs Associate | |
| Trade name | Triever Catheters |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Regulatory class | II |
| Predicate device | Triever Catheters (K202345) |
| 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 24 Fr) 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 Triever 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 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 FlowTriever Catheter are | |
| removed from the patient. | |
| Indications for Use | Triever Catheters are 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. Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. |
| Triever Catheters are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters. | |
| Device modifications | This submission added a warning to the Instruction for Use in patients with severe |
| pulmonary hypertension. | |
| Summary of | |
| substantial equivalence | There is no change of intended use or fundamental scientific technology between |
| the proposed and predicate device. Triever Catheters have the same indication for | |
| use as the predicate, K202345. |
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
The information provided demonstrates that including a warning for use in patients
with severe pulmonary hypertension in the Instructions for Use does not raise new
or different questions of safety and effectiveness. It can be concluded that Triever
Catheters with the modified labeling is substantially equivalent to the predicate
device. |
4