(64 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 9Fr Delivery Catheter and 12Fr Guide 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.
Here's a breakdown of the acceptance criteria and the study information for the CAPERE® Thrombectomy System, based on the provided FDA 510(k) summary:
This device is not an AI/ML device, so some of the requested information (like MRMC studies, training set details, and expert qualifications for ground truth) is not applicable or not provided in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Functional Bench Testing: | Non-Clinical Performance Testing | |
| - Compliance with ISO 10555-1 (Sterile, single-use intravascular catheters) | Demonstrated compliance | Functional Bench Testing |
| - Compliance with ISO 594-2 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment) | Demonstrated compliance | Functional Bench Testing |
| - Compression resistance maintained similar to predicate | Maintained predicate characteristics | Functional Bench Testing |
| - Bond joints integrity maintained similar to predicate | Maintained predicate characteristics | Functional Bench Testing |
| - Force to retract basket into funnel catheter meets requirements (same as predicate) | Determined to meet the same retraction force requirements as the predicate | Functional Bench Testing (Simulated-use test method) |
| - Ability to capture and remove clot completely (same as predicate) | Determined to completely capture and remove the simulated clot and therefore maintains the characteristics of the predicate | Functional Bench Testing (Simulated-use test method) |
| Biocompatibility: | Unchanged from the predicate; predicate characteristics maintained | Based on predicate device's characteristics |
| Sterilization: | Unchanged from the predicate; predicate characteristics maintained | Based on predicate device's characteristics |
| Packaging: | Unchanged from the predicate; predicate characteristics maintained | Based on predicate device's characteristics |
| Overall Performance: | Functioned as intended under previously established test methods | Non-Clinical Performance Testing |
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of number of devices or number of tests for each specific functional bench test. It mentions "functional bench testing was conducted" and describes the types of tests.
- Data Provenance: The studies are non-clinical, in-vitro bench tests conducted to evaluate device performance against established standards and predicate device characteristics. No information on geographical origin is typically relevant or provided for this type of testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a non-clinical, physical device. "Ground truth" in the context of expert review for diagnostic AI/ML is not relevant here. The acceptance criteria are based on engineering standards (ISO) and performance equivalence to a legally marketed predicate device.
-
Adjudication method for the test set:
- Not applicable. The tests are objective measurements against defined standards and predicate performance, rather than subjective interpretations requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This is a physical medical device (thrombectomy system), not a diagnostic AI/ML system that would involve human readers interpreting cases.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not a software algorithm.
-
The type of ground truth used:
- The "ground truth" for the performance evaluation is based on engineering standards (ISO 10555-1, ISO 594-2) and the established performance characteristics of the predicate device. For clot capture, the "ground truth" is complete capture and removal of a simulated clot.
-
The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no training set in the sense of data used to train an algorithm.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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).