(28 days)
The Triever20 Curve (21-201) is used coaxially within the Triever24 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 Triever20 Curve (21-201) is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever Catheters.
Triever20 Curve (21-201) is also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters.
The Triever20 Curve (21-201) must be used within the Triever24.
Triever20 Curve, Model 21-201 is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature and the treatment of pulmonary embolism. A Dilator is provided with the Triever20 Curve Catheter to assist in its advancement over a preplaced 0.035" guidewire to the proximal end of the obstruction (thrombus). The Triever24 Catheter is inserted through an introducer sheath (not provided). After Triever24 Catheter placement, the Dilator is removed. The Triever20 Curve Catheter is then inserted through the Triever24 Catheter and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Syringe.
The provided text is a 510(k) summary for the Triever20 Curve (21-201) device, which is an embolectomy catheter. The document focuses on demonstrating substantial equivalence to a predicate device (Inari FlowTriever Retrieval/Aspiration System K213402) and a reference device (Inari Medical, Triever20 Curve K203333), highlighting physical and material modifications.
The vast majority of the "study" described in this document is non-clinical bench testing to verify the device's physical and functional properties. It is not an AI/ML-based device, so the sections on ground truth, MRMC studies, training/test sets, and expert adjudication are not applicable here.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a typical "acceptance criteria vs. performance" table in the context of clinical outcomes or AI model performance. Instead, it lists numerous non-clinical tests and states that "Test results demonstrated that all acceptance criteria were met; the device conforms to established product specifications."
Here are examples of the non-clinical tests mentioned, and what their acceptance criteria would generally imply:
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pouch Seal Visual Inspection | No visible defects, proper seal integrity. | Met acceptance criteria. |
| Bubble Leak Test | No detectable leaks. | Met acceptance criteria. |
| Dye Penetration | No dye penetration, indicating seal integrity. | Met acceptance criteria. |
| Packaging Integrity, Visual Inspection | Intact packaging, no damage. | Met acceptance criteria. |
| Visual and Dimensional | Within specified tolerance for all dimensions and visual attributes. | Met acceptance criteria. |
| Dilator Compatibility | Proper fit and function with the catheter. | Met acceptance criteria. |
| T20 Curve Dilator Insertion and Removal | Smooth insertion and removal without damage or excessive force. | Met acceptance criteria. |
| T20 Curve Insertion and Retraction from T24/Protrieve | Smooth insertion and retraction without damage or excessive force, proper coaxial use. | Met acceptance criteria. |
| T20 Curve Rotation within T24/Protrieve | Smooth rotation, proper targeting of angled tip. | Met acceptance criteria. |
| T20 Curve Recovery Angle | Returns to specified angle after bending. | Met acceptance criteria. |
| Kink Radius | Withstands kinking to a specified radius without permanent deformation or occlusion. | Met acceptance criteria. |
| Torque Testing | Withstands specified torque without failure or excessive deformation. | Met acceptance criteria. |
| Simulated Use Track & Tensile (catheter tested) | Maintains integrity and function during simulated use, withstands tensile forces. | Met acceptance criteria. |
| Simulated Use Track & Torque (catheter tested) | Maintains integrity and function during simulated use, withstands torque. | Met acceptance criteria. |
| Clot Burden Removal Validation | Demonstrates effective aspiration/removal of clot in a simulated environment. | Met acceptance criteria. |
| Vacuum Testing Resistance to collapse under vacuum | Maintains patency under negative pressure. | Met acceptance criteria. |
| Determination of Flowrate Through Catheter & Dilator | Meets specified flow rate for contrast media/fluid aspiration/injection. | Met acceptance criteria. |
| Particulate Matter Determination | Particulate levels below specified limits. | Met acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but it would be physical samples of the device and its components. For bench testing, sample sizes are typically determined by statistical methods or industry standards.
- Data Provenance: The study described is non-clinical (bench testing). There is no patient data involved, therefore no country of origin or retrospective/prospective distinction.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a non-clinical device that does not use AI/ML. The "ground truth" for the tests would be based on engineering specifications, physical measurements, and functional benchmarks. No human experts are establishing "ground truth" in the clinical imaging interpretation sense.
4. Adjudication method for the test set:
Not applicable as this is a non-clinical device. Bench test results are typically recorded and verified by engineers according to test protocols.
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. This is a physical medical device (catheter), not an AI/ML diagnostic tool. Therefore, MRMC studies are not 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" (or more accurately, the reference standard) for this device's performance is based on engineering specifications, physical measurements, and functional performance benchmarks established through design validation testing. For example, a "clot burden removal validation" test would use a standardized clot model and measure the amount of clot removed, with the "ground truth" being the pre-defined effectiveness threshold.
8. The sample size for the training set:
Not applicable. There is no AI/ML component, so no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML component.
§ 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).