(29 days)
The CAPERE® Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels.
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE® Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The provided text describes the 510(k) clearance for the CAPERE Thrombectomy System. This regulatory submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a specific performance acceptance criteria against a medical outcome (like 'improving diagnostic accuracy'). Therefore, many of the requested categories for AI/diagnostic devices (e.g., multireader-multicase studies, expert consensus for ground truth on a training set) are not applicable to this type of device clearance.
The "acceptance criteria" in this context refer to the device meeting engineering and functional performance specifications, and demonstrating that changes from the predicate device do not introduce new safety or effectiveness concerns.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance |
|---|---|
| Compliance with relevant standards (e.g., ISO 10555-1, ISO 594-2) for bond joints affected by increased length. | Demonstrated compliance; maintained predicate characteristics. |
| Simulated clot retrieval without capture basket rupture. | Functioned as intended; simulated clot retrieved without rupture. |
| Simulated clot retrieval without catheter damage. | Functioned as intended; no catheter damage. |
| Simulated clot retrieval without other adverse device effect. | Functioned as intended; no other adverse device effects. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in terms of numerical units (e.g., N devices tested). The document states "functional bench testing was conducted" and "Simulated Use Testing was completed." It refers to "the CAPERE® Thrombectomy System" in the singular, but implies testing was performed sufficiently to make general claims. It does not provide the number of devices or iterations tested.
- Data Provenance: The tests are described as "nonclinical performance testing" and "functional bench testing" / "Simulated Use Testing." This indicates laboratory-based, simulated data, not data from human patients or a specific country of origin. The data is implicitly prospective in the sense that the tests were designed and conducted to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is not a study involving human interpretation of data where expert ground truth is established (e.g., radiology image interpretation). The "ground truth" for these tests is defined by the engineering specifications and the ability of the device to perform its mechanical functions in a simulated environment.
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication method (like 2+1, 3+1) is relevant for this type of mechanical and functional performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a mechanical device, not an AI/diagnostic software. MRMC studies are not relevant for its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a hardware medical device, not an algorithm. Its performance is inherent to its design and function. However, the "Simulated Use Testing" could be considered analogous to "standalone performance" in the sense that it evaluates the device's function without a human patient or a full clinical scenario, but within a simulated environment.
7. The Type of Ground Truth Used
- Engineering Specifications and Functional Performance Benchmarks: The ground truth for this device's testing is primarily based on predefined engineering and functional performance criteria. For example, "without capture basket rupture," "without catheter damage," and "maintained predicate characteristics" are the benchmarks.
8. The Sample Size for the Training Set
- Not Applicable. This device is a mechanical thrombectomy system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design and manufacturing process are informed by engineering principles, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant. The "ground truth" for the device's design (if you were to interpret it broadly as the basis for its creation) would be established through established medical device design principles, biomechanical understanding of fluid dynamics and clot removal, and experience with predicate devices.
§ 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).