(30 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) 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.
This document is a 510(k) summary for the Triever Catheters (K210195) and does not contain the detailed information necessary to fully answer your request.
Here's a breakdown of why and what information is missing:
- Acceptance Criteria and Device Performance Table: The document states that "Clinical testing was not required for the determination of substantial equivalence" and that the submission "added a warning... in patients with severe pulmonary hypertension." This implies there were no new performance studies conducted to establish acceptance criteria or report new device performance metrics for the modified device. The original predicate device (K202345) would have had such studies, but their details are not present here.
- Sample size and data provenance for test set: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Number of experts and qualifications for ground truth: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Adjudication method: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- MRMC comparative effectiveness study: Not applicable, as no clinical studies are mentioned.
- Standalone algorithm performance: Not applicable, as this is a medical device (catheter system), not an AI algorithm.
- Type of ground truth used: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Sample size for training set: Not applicable, as this is a medical device (catheter system), not an AI algorithm.
- How ground truth for training set was established: Not applicable, as this is a medical device (catheter system), not an AI algorithm.
Summary of available information:
The document explicitly states:
- Clinical testing was not required for the determination of substantial equivalence for this specific submission (K210195).
- The determination of substantial equivalence was based on the fact that the modification (adding a warning to the Instruction for Use regarding severe pulmonary hypertension) does not raise new or different questions of safety and effectiveness compared to the predicate device (Triever Catheters K202345).
- The device has the same indications for use as the predicate device.
To obtain the information you're looking for regarding acceptance criteria, performance data, and study details, you would need to access the information associated with the predicate device (K202345) or any prior 510(k) submissions for the Triever Catheters where such performance data would have been required for initial clearance.
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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
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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
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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)
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PAGE 1 OF 2
510(K) SUMMARY
| Date prepared | January 22, 2021 |
|---|---|
| Name | Inari Medical, Inc.9 Parker, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Ellen NguyenRegulatory 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-wirecatheter-based system for the minimally invasive treatment of thromboemboli inthe peripheral vasculature and for the treatment of pulmonary embolism. Thesystem 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 advancedto the thrombus. Self-expanding wireform disks are deployed to engage thrombusby retracting the outer delivery catheter. The FlowTriever Catheter is retractedinto the Triever Catheter to capture the targeted thrombus. Additional clot may beremoved by aspiration with the provided 60 cc VacLok Vacuum syringe. After theprocedure is complete, the Triever Catheter and FlowTriever Catheter areremoved 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 severepulmonary hypertension. |
| Summary ofsubstantial equivalence | There is no change of intended use or fundamental scientific technology betweenthe proposed and predicate device. Triever Catheters have the same indication foruse 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.ConclusionThe information provided demonstrates that including a warning for use in patientswith severe pulmonary hypertension in the Instructions for Use does not raise newor different questions of safety and effectiveness. It can be concluded that TrieverCatheters with the modified labeling is substantially equivalent to the predicatedevice. |
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§ 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).