(65 days)
The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The ClotTriever Catheter is comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque. Other provided accessories include a pre-dilator, the funnel loading tool and a Large Bore 60 cc syringe
The provided document is a 510(k) premarket notification for the ClotTriever Thrombectomy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data. It does not typically involve extensive clinical studies with human subjects in the same way a PMA (Premarket Approval) submission would, especially for an AI/ML-driven device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this specific document. This document focuses on the mechanical and functional performance of a medical device (a thrombectomy system with a pre-dilator) through non-clinical testing.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of non-clinical testing performed.
| Test Type | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | Device meets specified visual and dimensional requirements. | All acceptance criteria were met. |
| Guidewire Compatibility | Device is compatible with specified guidewire. | All acceptance criteria were met. |
| Leak Testing | Device does not leak beyond acceptable limits. | All acceptance criteria were met. |
| Simulated Use | Device performs as intended during simulated use. | All acceptance criteria were met. |
| Insertion/Kink Radius Testing | Device resists kinking and can be inserted as intended. | All acceptance criteria were met. |
| Tensile Testing | Device meets specified tensile strength requirements. | All acceptance criteria were met. |
| In Vivo Functional Testing/Radiopacity Verification | Device functions as intended in vivo (animal or cadaver model implied) and is radiopaque as specified. | All acceptance criteria were met. |
| Pouch Seal Visual Inspection and Dye Penetration | Pouch seals are intact and prevent dye penetration. | All acceptance criteria were met (leveraged from K163549). |
| Pouch, Peel, Seal Strength | Pouch seals meet specified strength requirements for opening. | All acceptance criteria were met (leveraged from K163549). |
| Sterilization Validation | Device is effectively sterilized. | All acceptance criteria were met (leveraged from K163549). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each type of non-clinical test. The data provenance is internal testing performed by Inari Medical, Inc. The nature of the testing (bench, in-vitro, and potentially in vivo animal/cadaver for functional testing) indicates it's likely prospective data collection for the purpose of this submission. The origin of the data is the manufacturer's testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device submission based on non-clinical engineering and performance testing, not an AI/ML algorithm requiring expert review for ground truth establishment.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML study requiring expert adjudication of outputs. The tests are typically conducted according to standardized protocols with defined acceptance criteria.
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
Not applicable. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm. The testing described is for the mechanical and functional performance of the device itself.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the product specifications and performance standards for the device, and established engineering principles for evaluating medical device safety and effectiveness. For example:
- Visual and Dimensional Inspection: Comparison against engineering drawings and design specifications.
- Leak Testing: Absence of fluid egress under specified pressure.
- Tensile Testing: Measurement against predefined force resistance requirements.
- In Vivo Functional Testing: Successful and safe operation in a relevant biological model (e.g., animal or cadaver model, though the document does not specify which was used or the exact endpoints, only that the test was conducted).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).