(299 days)
The ClearLumen Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.
The ClearLumen Thrombectomy System consists of a thrombectomy catheter, saline drive unit ("SDU") and aspirate collection vacuum bottles. The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter I.D., to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's .014″ wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The catheter's proximal polycarbonate hub connects to the SDU and provides coaxial access to the infusion and aspiration lumens. The ClearLumen Catheter is connected to the battery operated SDU, which includes a pump to generate pressurized saline and conduit/collection of aspirate. The SDU uses a toggle switch to turn the pump on and off and actuate a valve in line to a pre-charged vacuum bottle (aspiration source). The SDU connects via spike to a standard saline bag (saline source).
The provided text describes a 510(k) premarket notification for the ClearLumen Thrombectomy System, establishing its substantial equivalence to predicate devices based on non-clinical and clinical performance data.
Here's the information requested, extracted and organized:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate devices and meeting pre-determined product specifications and external standard requirements. The reported device performance indicates that all testing conducted met these criteria. Specific quantitative acceptance criteria or precise numerical performance targets are not explicitly detailed in the provided summary.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. | All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. |
| Acceptable safety and performance profile (in-vivo). | Achieved in porcine in-vivo study. |
| Study success defined by two primary endpoints: Myocardial Blush Grade (MBG) ≥ 2 and final Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3. | The study reported success based on these endpoints, although specific percentages are not provided in the summary. |
| No Major Adverse Coronary Events (MACE) or device related Significant Adverse Events (SAE) through 30-day follow-up. | No MACE or device related SAEs were reported in the human clinical study. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Human Clinical Study):
- Sample Size: 20 subjects
- Data Provenance: Prospective, single-center human clinical study. The country of origin is not explicitly stated, but clinical trials for FDA submissions are often conducted in the US or in countries with an ethical and regulatory framework comparable to the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications who established the ground truth for the test set (human clinical study). The study endpoints (Myocardial Blush Grade (MBG) and Thrombolysis In Myocardial Infarction (TIMI) flow grade) are typically determined by cardiologists or interventional radiologists reviewing angiographic images.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set's clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, nor any discussion of AI assistance or its effect size on human reader performance. This device is a mechanical thrombectomy system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical instrument (thrombectomy system), not a software algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For In-Vitro Testing: Ground truth was based on pre-determined product specifications and external standard requirements, as well as accepted engineering and biological testing methodology (e.g., ISO standards for biocompatibility and sterilization).
- For In-Vivo (Animal) Study: Ground truth was based on observed safety and performance metrics in the animal model.
- For Human Clinical Study: Ground truth was based on clinical outcomes data, specifically:
- Myocardial Blush Grade (MBG) ≥ 2
- Final Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3
- Absence of Major Adverse Coronary Events (MACE)
- Absence of device-related Significant Adverse Events (SAE)
These are objective clinical endpoints typically assessed by trained medical professionals.
8. The Sample Size for the Training Set
The document describes a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than training a novel algorithm. Therefore, there is no mention of a "training set" in the context of device development or evaluation for this thrombectomy system. The studies described are for verification and validation.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" for this device, this question is not applicable.
§ 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).