(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.
§ 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).