(26 days)
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.
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 2 sizes: 16 Fr and 20 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 also 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) Premarket Notification from the FDA regarding the Inari Medical FlowTriever Retrieval/Aspiration System (K191368). It is a submission for a device modification, specifically, providing a Large Bore 60 cc Syringe in the sterile package of the Triever16 catheter.
Based on the provided text, the device in question is a medical device, not an AI/ML powered device. As such, the typical acceptance criteria and study designs relevant to AI/ML device performance (like sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment by experts, etc.) are not applicable here.
The 510(k) submission states:
- "Clinical testing was not required for the determination of substantial equivalence."
- "No modifications have been made to the previously cleared Triever16 nor the Large Bore 60 cc Syringe. Design verification for inclusion of the Large Bore 60 cc Syringe with the Triever16 was limited to packaging evaluation after simulated shipping."
- "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications."
Therefore, I cannot provide the detailed information requested for an AI/ML driven device based on this document. The acceptance criteria and performance data for this submission are focused on the safety and effectiveness of a physical medical device, specifically related to a change in packaging for an already cleared component, rather than the performance of an AI algorithm.
However, I can extract the general "acceptance criteria" and "device performance" in the context of this specific 510(k) submission, understanding that they relate to a non-AI device modification:
Acceptance Criteria and Study for K191368 (FlowTriever Retrieval/Aspiration System Modification)
Since this is a physical medical device and the submission pertains to a packaging change, the "acceptance criteria" and "device performance" relate to the physical integrity, sterility, and functionality of the device components as a result of that change, rather than diagnostic or analytical performance metrics typically associated with AI/ML.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Packaging Integrity & Product Protection | Maintain sterility and physical integrity of the device (Triever16 and Large Bore 60 cc Syringe) after packaging under simulated shipping conditions. | "Design verification for inclusion of the Large Bore 60 cc Syringe with the Triever16 was limited to packaging evaluation after simulated shipping." "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." |
| Shelf-Life | Support a 2-year shelf-life for the Triever16 with the included syringe. | "Accelerated 2-year shelf-life testing for Triever16 and Triever20 were leveraged to support a 2-year shelf-life for the Triever16." "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." |
| Functionality/Intended Use | (Implicit) The modified device package does not negatively impact the intended use or fundamental scientific technology of the FlowTriever Retrieval/Aspiration System. | "The device modification proposed is providing the Large Bore 60 cc Syringe in the sterile package of the Triever16... The same syringe is already provided in the Triever20... used for the same aspiration purpose." "The proposed device modifications... do not change its intended use nor does it change the principles of operation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated numerically for the packaging evaluation or shelf-life testing. The document mentions "sample size for design verification testing" was determined based on "risk category" and "confidence/reliability percentages," which is standard for medical device testing but the specific number is not provided.
- Data Provenance: The studies were conducted by Inari Medical as part of their design verification and validation process for a 510(k) modification. The nature of the tests (packaging, shelf-life) implies laboratory-based or simulated environment testing, not patient data from a specific country. The studies are prospective in the sense that they were designed and executed to evaluate the specific modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. For a physical device modification focused on packaging and shelf-life, "ground truth" as established by medical experts (like radiologists for AI/ML) is not a relevant concept. The ground truth would be the objective physical properties and performance characteristics determined through engineering and materials testing (e.g., package seal integrity, sterility, burst strength, material degradation over time).
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in human expert assessments, typically in diagnostic or clinical settings. This is not relevant for the type of engineering and physical testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement with AI vs. without AI Assistance
- No. This is a physical medical device, not an AI/ML device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device. There is no algorithm to test standalone.
7. The Type of Ground Truth Used
- For this device modification, the "ground truth" was established through engineering specifications, physical testing standards, and established material science practices. It involves objective measurements and assessments of physical attributes like package integrity, material degradation, and maintenance of sterility, rather than clinical outcomes or expert consensus on a diagnosis.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a physical medical device. There is no "training set" or corresponding ground truth establishment in the context of machine learning.
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June 17, 2019
Inari Medical Eben Gordon Vice President, RA/QA 9272 Jeronimo Rd., Suite 124 Irvine, CA 92618
Re: K191368
Trade/Device Name: FlowTriever Retrieval/Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: May 21, 2019 Received: May 22, 2019
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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) K191368
Device Name
FlowTriever Retrieval/Aspiration System
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.
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 - Special 510(k)
| Date prepared | May 21, 2019 |
|---|---|
| Name | Inari Medical, Inc.9272 Jeronimo Road, Suite 124Irvine, CA 92618949.600.8433 x114 |
| Contact person | Eben GordonVice President, Regulatory Affairs & Quality Assurance |
| Trade name | FlowTriever Retrieval/Aspiration System |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K183198) |
| Reference device | Inari FlowTriever Retrieval/Aspiration System (K182233) |
| 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 2 sizes: 16 Fr and 20 Fr)• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18mm, 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 mayalso be removed by aspiration with the provided 60 cc VacLok Vacuum syringe.After the procedure is complete, the Triever Catheter and FlowTriever Catheterare 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. |
| Device modifications | The device modification proposed is providing the Large Bore 60 cc Syringe in the sterile package of the Triever163. The same syringe is already provided in the Triever20 (cleared under K182233) used for the same aspiration purpose. |
| 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, K183198.Non-Clinical TestingNo modifications have been made to the previously cleared Triever16 nor the Large Bore 60 cc Syringe. Design verification for inclusion of the Large Bore 60 cc Syringe with the Triever16 was limited to packaging evaluation after simulated shipping. The risk category, determined during the risk analysis process, was used to assign confidence/reliability percentages in the determination of sample size for design verification testingAccelerated 2-year shelf-life testing for Triever16 and Triever204 were leveraged to support a 2-year shelf-life for the Triever16.Clinical testing was not required for the determination of substantial equivalence.Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.ConclusionThe proposed device modifications to the FlowTriever Retrieval/Aspiration System do not change its intended use nor does it change the principles of operation. With consideration of the results of the testing leveraged from K183198, it can be concluded that the proposed FlowTriever Retrieval/Aspiration System is substantially equivalent to the predicate device. |
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K191368
3 Formerly "16 Fr Aspiration Guide Catheter"
4 Formerly "20 Fr Aspiration Guide Catheter
§ 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).