(57 days)
The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.
The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis.
The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer.
The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.
Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets the acceptance criteria. It's important to note that the provided text is an FDA 510(k) summary, which often provides high-level summaries of acceptance criteria and performance rather than detailed tables for every test.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative for many of the bench tests (e.g., "meets its design specifications"). For the clinical studies, quantitative performance goals are provided.
Bench and Animal Testing Acceptance Criteria & Performance:
| Test Category | Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|---|
| Bench Testing | Meets design output requirements, conforms to user needs/intended uses, safe and effective. | Performance meets design specifications, safe and effective for intended use. |
| Catheter Diameter/Balloon Profile | N/A (implied to meet specs) | N/A (implied to meet specs) |
| Tensile Strength | N/A | N/A |
| Kink Resistance/Flexibility | N/A | N/A |
| Catheter Torsional Strength | N/A | N/A |
| Balloon Inflation/Deflation Time | N/A | N/A |
| Minimum Burst Strength (RBP) | N/A | N/A |
| Balloon Compliance | N/A | N/A |
| Fatigue (multi-inflations) | N/A | N/A |
| Pushability & Trackability | N/A | N/A |
| Fluoroscopic Visibility | N/A | N/A |
| Particulate Evaluation | N/A | N/A |
| Pulsing Cycles & Output | N/A | N/A |
| Console Testing | Meets design specifications. | Performance meets design specifications. |
| Hardware Design Verif. | N/A | N/A |
| Electrical Performance | N/A | N/A |
| Electromagnetic Comp. | N/A | N/A |
| Software V&V | N/A | N/A |
| Life Expectancy | N/A | N/A |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, hemocompatible. | Confirmed to be non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and hemocompatible. |
| Animal Testing | As safe as the control device in a chronic healthy porcine model. | No trends between treatment and control in injury, inflammation, fibrin, endothelialization or neointimal smooth cells. |
Clinical Study (RESTORE ATK & RESTORE BTK) Acceptance Criteria & Performance:
| Endpoint | Acceptance Criteria (Performance Goal) | RESTORE ATK (Above-the-Knee) | RESTORE BTK (Below-the-Knee) |
|---|---|---|---|
| Primary Safety- Freedom from Major Adverse Events (MAE) at 30 days | Lower bound of 95% CI > 91.3% | Lower bound of 95% CI for freedom from MAE (96.8%) was > 91.3% (Actual range: 97.9% - 100%, lower 95% CI 93.5% - 96.9%) | 100% (20/20) - Lower bound of 95% CI for freedom from MAE (0.861) for ITT population. |
| **Primary Effectiveness (RESTORE ATK) - Procedural Success (residual stenosis 89.3% | Lower bound of 95% CI for procedural success (96.9%) was > 89.3% (Actual: 100%). | N/A | |
| Primary Effectiveness (RESTORE BTK) - Acute reduction in percent diameter stenosis | N/A (endpoint is a mean reduction) | N/A | Mean acute reduction in percent diameter stenosis of 47.4% (95% CI: 32.6% to 62.1%) for as-treated subjects. |
| Secondary Effectiveness (RESTORE ATK) - Freedom from MAEs at 6 months | N/A | 97.8% | N/A |
| **Secondary Effectiveness (RESTORE ATK) - Procedural Success (residual stenosis |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).