(217 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.
Triever Catheters are also intended for use in treating clot 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.
The document provided describes a 510(k) premarket notification for the Inari Medical Triever24 and Triever20 devices. The submission focuses on modifications to existing devices and demonstrates substantial equivalence to a predicate device. This is primarily a mechanical/physical device rather than an AI/software-driven diagnostic tool.
Therefore, the information typically requested regarding acceptance criteria and study design for AI/ML medical devices (such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, and training set details) is not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to biocompatibility and non-clinical performance testing to ensure the modified physical device maintains its safety and effectiveness compared to the predicate device.
Here's an interpretation of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."
While a direct table of specific acceptance criteria values and reported performance values is not explicitly presented, the document lists the types of non-clinical tests performed to meet these criteria. Each of these tests would have pre-defined acceptance criteria (e.g., maximum force, minimum flow rate, no leakage). The report confirms that the results of these tests passed these unstated criteria.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Biocompatibility | Devices meet biological safety requirements per ISO 10993-1. | "The passing results demonstrate that the subject devices and accessories meet biological safety requirements per ISO 10993-1." |
| • Cytotoxicity | No cytotoxic effects | Passed |
| • Sensitization | No sensitization | Passed |
| • Intracutaneous Reactivity | No significant irritation/reactivity | Passed |
| • Acute Systemic Toxicity | No acute systemic toxic effects | Passed |
| • Material-Mediated Pyrogenicity | No pyrogenic response | Passed |
| • Hemocompatibility | Acceptable blood compatibility (Hemolysis, Complement Activation, Thromboresistance, Platelet and Leukocyte Count, Partial Thromboplastin Time) | Passed |
| Non-Clinical Performance | Devices conform to relevant product specifications for: | "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications." |
| Visual & Dimensional Insp. | Conformance to design specifications | Met |
| Guidewire & Dilator Comp. | Proper fit and function with guidewires/dilators | Verified |
| 3-Point Bend Test | Acceptable flexibility/stiffness | Met |
| Removal & Insertion Force | Within specified limits | Met |
| Retraction Force | Within specified limits | Met |
| Clot Burden Removal Validation | Effective removal of clot | Validated |
| Air Leakage during Aspiration | No significant air leakage | Met |
| Leak Test | No leaks | Met |
| Vacuum Test | Maintains vacuum | Met |
| Kink Radius Test | Resists kinking at specified radii | Met |
| Flow Rate (Triever24 only) | Satisfactory flow through catheter | Met |
| Stopcock Misuse Leakage Test | No leakage under misuse conditions | Met |
| Simulated Use & Tensile Test | Maintains integrity and function during simulated use | Met |
| Torque Test | Resists twisting, maintains integrity | Met |
| Locking/Unlocking Force/Torque | Within specified limits for secure and easy operation | Met |
| Particulate Matter | Within acceptable limits | Met |
| Pouch Seal Visual Inspection | No visible defects | Met |
| Pouch Peel Seal Strength | Within specified strength range | Met |
| Guidewire & Catheter Comp. | Proper fit and function (previously cleared) | Leveraged from previous clearance |
| Small-Bore Connectors | Conformance to standards | Leveraged from previous clearance |
| Catheter Burst | Withstands specified pressure | Leveraged from previous clearance |
| Corrosion Resistance | No significant corrosion | Leveraged from previous clearance |
| Sheath Compatibility | Proper fit and function with sheaths | Leveraged from previous clearance |
| Push-Button Force Testing | Within specified limits | Leveraged from previous clearance |
2. Sample size used for the test set and the data provenance:
- This is a medical device modification submission, not an AI/ML study.
- The "test set" refers to physical samples of the modified Triever24 and Triever20 devices. The document does not specify the exact number of units tested for each non-clinical test, but it implies standard engineering and laboratory testing protocols were followed for device verification and validation.
- Data provenance: Not applicable in the context of clinical data for AI/ML. The data comes from internal laboratory testing of the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation of medical images/data for ground truth. The "ground truth" here is established by the engineering and manufacturing specifications and established test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, to resolve discrepancies in expert readings. Device performance is determined by objective physical and chemical tests.
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 study was not done. This is a physical medical device, not an AI-assisted diagnostic tool. Clinical testing was explicitly stated as "not required for the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm for standalone performance. The device is a physical catheter system used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for acceptance) for this device is its adherence to established engineering specifications, material properties, biocompatibility standards (e.g., ISO 10993-1), and functional performance requirements as demonstrated through the listed non-clinical tests. This is not derived from medical expert consensus or patient outcomes data in the typical sense of AI/ML validation, but rather from predefined objective test methods.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model that requires a training set. The device is a physical product.
9. How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML model.
§ 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).