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510(k) Data Aggregation
(106 days)
The B-Laser™ Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).
The B-Laser™ System consists of two sub-units: 1) a single use catheter ("B-Laser™ catheter"); and 2) a laser system. The B-Laser™ catheter is a single use catheter that is made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The B-Laser™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 mJ/mm² to the occluded or narrowed artery. The B-Laser™ System must work over a commercially available 300cm 0.014" guide wire (GW) that crosses the lesion intraluminally. - For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a quidewire at the center of the inner blunt blade. Please note that 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions. These devices should not be used in ISR cases.
The larger B-Laser™ catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "offcenter" feature (2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.
The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
The B-Laser Atherectomy System is intended for the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on safety and effectiveness endpoints rather than defining specific numerical acceptance criteria for each measurement. However, based on the documented "achieved" status of primary endpoints, we can infer the achieved performance.
| Criterion | Reported Device Performance |
|---|---|
| Pivotal Study - Primary Safety Endpoint | Achieved. Only 1 Major Adverse Event (MAE) at 30 days (death, not related to the device) out of 97 subjects (1.03%). |
| Pivotal Study - Primary Effectiveness Endpoint | Achieved. Average reduction of residual stenosis was 33.6% (14.2% SD) out of 95 evaluable subjects (or 107 evaluable lesions). |
| Pilot Study - Lesion Crossing Success | 100% success in crossing the target lesions (52/52 lesions in 49 subjects). |
| Pilot Study - Residual Stenosis Reduction | 35.04% on average (determined by retrospective evaluation by independent Corelab). |
| Pilot Study - Device-related Perioperative Clinically Significant Adverse Events | 0% |
| Pilot Study - Major Adverse Events (MAE) at 30-days and 6-months post procedure | 0% |
| Pilot Study - Major Adverse Events (MAE) at 1-year post procedure | 2 cases (4.3%) amongst 46 subjects that completed 1-year follow-up. (One target lesion revascularization at 384 days, one planned revascularization with surgical by-pass due to recurrent symptoms of chronic ischemia after 1-year follow-up). |
| Pivotal Study - Secondary Safety Endpoint (Dissections, Spasm, Staining) | Only 11 Type A and 5 Type B dissections, 1 case of transient spasm, and 1 case of transient staining after device use. None required intervention. |
| Pivotal Study - Device Related Perioperative Complications | None noted or reported. |
2. Sample Size Used for the Test Set and Data Provenance:
- Pilot Study: 49 subjects (52 lesions). Data provenance is "Europe" (prospective, single-arm, multi-center, open-label, non-randomized clinical study).
- Pivotal Study: 97 subjects (107 evaluable lesions). Data provenance is "US and Europe" (pivotal, prospective, single-arm, multi-center, open-label, non-randomized IDE clinical study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions that "residual stenosis reduction" in the pilot study was "determined by retrospective evaluation by independent Corelab." While it indicates independent analysis, it does not specify the number of experts from the Corelab or their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method:
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the clinical studies. It mentions an "independent Corelab" for stenosis evaluation in the pilot study, implying a standardized review process, but details of how disagreements would be resolved are not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not done. The studies described are single-arm studies evaluating the performance of the B-Laser Atherectomy System itself, not comparing human readers with and without AI assistance. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.
6. Standalone Performance:
The document describes the performance of the "B-Laser Atherectomy System" as a medical device. This is a standalone performance study of the device itself (algorithm only without human-in-the-loop performance is not applicable here as it is a physical device). The "standalone" context for this device refers to its ability to perform the intended atherectomy procedure effectively and safely.
7. Type of Ground Truth Used:
For the clinical studies, the ground truth was established through clinical outcomes data (e.g., successful lesion crossing, reduction in residual stenosis, occurrence of adverse events, MAE rates) as assessed by clinical investigators and an independent Corelab.
8. Sample Size for the Training Set:
The document describes clinical performance testing, meaning these studies were conducted on the finished device to evaluate its safety and effectiveness. It does not mention a "training set" in the context of an AI/algorithm where a separate training dataset would be used. The clinical studies represent validation of the device's performance in human subjects.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" for an algorithm, this question is not applicable to the information provided about the B-Laser Atherectomy System, which is a physical medical device, not an AI or software algorithm requiring a training phase for its core functionality.
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