(122 days)
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.
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.
The provided document is a 510(k) summary for the Triever Catheters. It describes a device modification to include "clot in transit in the right atrium" in the Indications for Use (IFU) statement. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in a quantitative manner typical of performance studies for AI software.
However, based on the information provided, we can extract the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: No heart damage (perforation, valve damage) related to treatment in the right atrium. | No right atrium treatment related cases in which any heart damage, i.e., perforation, valve damage, etc. was noted. |
| Effectiveness: Sufficient clot removal. | Average clot removal estimated to be almost 90%. |
| Clinician satisfaction with clot removal performance. | Inari Account Managers' assessment of clinician satisfaction based on clot removal performance. |
| No new or different questions of safety and effectiveness raised by the expanded IFU. | 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. |
| (Implicit) General anesthesia for delicate patients should be carefully considered. | One adverse event (patient death) was attributed to the use of general anesthesia in a tenuous patient, not the device itself. |
2. Sample size used for the test set and the data provenance
- Sample Size: Clinical data was collected and evaluated for 47 patients.
- Data Provenance: The nature of the study (evaluating use of Triever Catheters in the right atrium from approximately 7,650 venous thromboembolism procedures performed) suggests this data is retrospective, compiled from existing patient records where the device was used in this specific scenario. The country of origin is not specified, but the submission is to the FDA, suggesting a US context or data relevant to US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. The assessments appear to be based on clinical outcomes and "Inari Account Managers' assessment of clinician satisfaction."
4. Adjudication method for the test set
The document does not describe an adjudication method. The clinical data appears to be a review of outcomes from actual patient cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This study is focused on the safety and effectiveness of a medical device (catheter) for a specific indication, not on the performance of an AI algorithm or human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this document describes a medical device (catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for effectiveness (clot removal) appears to be based on outcomes data from patient treatments and possibly clinical assessment during or after the procedure. For safety, it relies on the absence of reported adverse events like heart damage.
8. The sample size for the training set
This document does not describe the development or training of an algorithm, so there is no mention of a training set sample size.
9. How the ground truth for the training set was established
Not applicable, as no algorithm training set is described.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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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 100Irvine, CA 92618949.600.8433 x114 |
| Contact person | Eben GordonVice 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-wirecatheter-based system for the minimally invasive treatment of thromboemboliin 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-placed0.035" guidewire. After removal of its dilator, thrombus may be removed byaspiration with the provided 60 cc VacLok Vacuum syringe. After theprocedure 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 fluidsinto or from a blood vessel.Triever Catheters are intended for use in the peripheral vasculature and forthe treatment of pulmonary embolism.Triever Catheters are also intended for use in treating clot in transit in the rightatrium but not in conjunction with FlowTriever Catheters. |
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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.
§ 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).