(122 days)
No
The summary describes a mechanical catheter-based system for thrombus removal and fluid injection/aspiration. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance metrics are based on physical clot removal and clinician satisfaction, not algorithmic performance.
Yes
The device is indicated for the "non-surgical removal of emboli and thrombi from blood vessels" and for the "treatment of pulmonary embolism", which are therapeutic interventions.
No
Explanation: The device is described as a system for the "non-surgical removal of emboli and thrombi" and "minimally invasive treatment of thromboemboli," which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "catheter-based system" comprised of physical components like "Triever Catheters" and "FlowTriever Catheters," which are hardware.
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.
- Device Function: The description clearly states that the Triever Catheters are 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 is an interventional medical device used directly within the patient's body.
- No Mention of Sample Analysis: There is no mention of the device being used to analyze samples outside of the body.
Therefore, the Triever Catheter system is an interventional device, not an in vitro diagnostic device.
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)
OEW
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) Triever Catheters 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
peripheral vasculature, pulmonary embolism, right atrium, pulmonary arteries, superior vena cava, right ventricle.
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: Animal testing was performed with the Triever Catheter to evaluate usability of aspiration of the Triever24 catheter when used in the right atrium. While there were some limitations of the study, no adverse events were noted.
Clinical Data: Clinical data was collected and evaluated for 47 patients (out of approximately 7,650 venous thromboembolism procedures performed), in which Triever Catheters were used for treatment in the right atrium. Of these 47 patients treated, 32 patients were treated only in the right atrium with another 15 patients being treated in the right atrium plus either the pulmonary arteries, superior vena cava, or right ventricle. The Triever24 was used in 61.7% (29/47) of cases, Triever20, 44.7% (21/47), and Triever16, 2.1% (1/47). One patient with a borderline massive PE with clot in transit, experienced an adverse event resulting in patient death. The patient was given general anesthesia which resulted in progressive deterioration and ultimately death despite successful treatment of the clot-in-transit. There was no right atrium treatment related cases in which any heart damage, i.e., perforation, valve damage, etc. was noted. The one adverse event, patient death, was attributed to the use of general anesthesia in a tenuous patient. Device effectiveness was substantiated by average clot removal estimated to be almost 90% and Inari Account Managers' assessment of clinician satisfaction based on clot removal performance.
Conclusion: The information provided demonstrates that including clot in transit in the right atrium to the indications for use statement does not raise new or different questions of safety and effectiveness. It can be concluded that the modified Triever Catheter is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
average clot removal estimated to be almost 90%
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.
FlowTriever Retrieval/Aspiration System (K191710)
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.
AngioVac Cannula (K190594)
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
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December 18, 2020
Inari Medical Mr. Eben Gordon Vice President, RA/QA 9 Parker, Suite 100 Irvine, California 92618
Re: K202345
Trade/Device Name: Triever Catheters Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW Dated: November 17, 2020 Received: November 19, 2020
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
1
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) 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,
For Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202345
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)
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510(K) SUMMARY
| Date prepared | December 7, 2020 |
|---|---|
| Name | Inari Medical, Inc. |
| 9 Parker, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 x114 | |
| Contact person | Eben Gordon |
| Vice President, Regulatory Affairs & Quality Assurance | |
| 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 | FlowTriever Retrieval/Aspiration System (K191710) |
| Reference device | AngioVac Cannula (K190594) |
| 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) | |
| Triever Catheters 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 | 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. |
4
Device modification This submission proposes including clot in transit in the right atrium to the Indications for Use statement for the Triever Catheters.
The Triever Catheters, predicate and reference devices have the same intended use: removal of thrombus and emboli from vessels.
Non-Clinical Testing
Animal testing was performed with the Triever Catheter to evaluate usability of aspiration of the Triever24 catheter when used in the right atrium. While there were some limitations of the study, no adverse events were noted.
Clinical Data
Summary of
substantial
equivalence
Clinical data was collected and evaluated for 47 patients (out of approximately 7,650 venous thromboembolism procedures performed), in which Triever Catheters were used for treatment in the right atrium. Of these 47 patients treated, 32 patients were treated only in the right atrium with another 15 patients being treated in the right atrium plus either the pulmonary arteries, superior vena cava, or right ventricle.
The Triever24 was used in 61.7% (29/47) of cases, Triever20, 44.7% (21/47), and Triever16, 2.1% (1/47).
One patient with a borderline massive PE with clot in transit, experienced an adverse event resulting in patient death. The patient was given general anesthesia which resulted in progressive deterioration and ultimately death despite successful treatment of the clot-in-transit.
There was no right atrium treatment related cases in which any heart damage, i.e., perforation, valve damage, etc. was noted. The one adverse event, patient death, was attributed to the use of general anesthesia in a tenuous patient. Device effectiveness was substantiated by average clot removal estimated to be almost 90% and Inari Account Managers' assessment of clinician satisfaction based on clot removal performance.
Conclusion
The information provided demonstrates that including clot in transit in the right atrium to the indications for use statement does not raise new or different questions of safety and effectiveness. It can be concluded that the modified Triever Catheter is substantially equivalent to the predicate device.