(28 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 Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).
The FDA document for the Protrieve Sheath (K230331) details acceptance criteria and performance data primarily for non-clinical testing related to a design modification. The submission emphasizes substantial equivalence to a predicate device and an expansion of the Indications for Use.
It's important to note that this document does not describe a study involving AI assistance for human readers, nor does it detail a standalone algorithm performance study. The device in question is a medical sheath, not an AI/ML powered diagnostic device. Therefore, many of the requested points, such as MRMC studies, expert ground truth for imaging, and training set details, are not applicable to this type of medical device submission.
Here's the information gleaned from the provided text regarding acceptance criteria and performance, as applicable to this medical device:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Protrieve Sheath (K230331)
| Acceptance Criteria Category | Specific Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Performance | Simulated Use, Flushing – Protrieve Sheath | Not explicitly stated in terms of specific numeric or qualitative thresholds for flushing. | "Test results demonstrated that all acceptance criteria were met." |
| Functional Performance | Leakage Testing – Protrieve Sheath | Not explicitly stated in terms of specific numeric or qualitative thresholds for leakage. | "Test results demonstrated that all acceptance criteria were met." |
| Mechanical Performance | Tensile Testing – Protrieve Sheath | Not explicitly stated in terms of specific numeric thresholds for tensile strength. | "Test results demonstrated that all acceptance criteria were met." |
Note: The document states that "verification tests were identified and performed only for the attributes impacted by the slide actuator modification to support substantial equivalence." This implies that the acceptance criteria for these tests were established to ensure the modified device performs comparably to the previous version and the predicate device. However, the specific quantitative or detailed qualitative criteria are not explicitly listed in the provided summary. The general statement "Test results demonstrated that all acceptance criteria were met" confirms successful performance against these internal criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of units or test iterations conducted for the "Simulated Use, Flushing," "Leakage Testing," and "Tensile Testing." In non-clinical device testing, sample sizes are typically determined by statistical methods to ensure robustness and often align with recognized standards.
- Data Provenance: This was a non-clinical bench testing study, not a clinical study involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective collection is not applicable. The testing was performed by Inari Medical, Inc. to support regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This submission pertains to a physical medical device (introducer sheath) and its performance in non-clinical bench testing. There is no "ground truth" established by experts in the context of diagnostic outcomes or image interpretation, as would be relevant for an AI/ML-based device. The "ground truth" for these tests are the pre-defined performance specifications of the device.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical bench testing, there is no need for expert adjudication of results. The results are typically quantitative measurements against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation where human readers' performance with and without AI assistance is compared. The Protrieve Sheath is an introducer sheath; therefore, an MRMC study was not performed. The document explicitly states "Clinical testing was not required to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study was not conducted.
7. The Type of Ground Truth Used
- Engineering Specifications and Industry Standards: The "ground truth" for the non-clinical testing (Simulated Use, Flushing, Leakage, Tensile Testing) would be the device's technical specifications and relevant performance requirements derived from engineering design, risk analysis (FMEA), and applicable medical device standards. The statement "all acceptance criteria were met" indicates performance aligned with these pre-defined standards.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no training set for this type of medical 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).