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The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA Laser System™ is composed of a laser light source and catheter consisting of optically conducting fluid encased in medical grade tubing enclosed by an optical window on either end. The tip and the fluid conduct the ultraviolet laser energy from the laser light source to the distal tip of the catheter. The laser light is generated by a 308nm excimer source. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to a blockage or lesion. Patient contacting parts of the device are the distal tip (titanium), the distal tip window (glass), the glue for the distal tip (epoxy), and the catheter tube (FEP). These parts are limited (

The provided text describes the clinical testing results for the DABRA Laser System but does not contain information typically found in an AI/ML device submission for establishing acceptance criteria and proving performance against them. The device described is a medical laser system, not an AI/ML-based device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or training set ground truth establishment for an AI/ML device.

The document focuses on the DABRA Laser System (a hardware and physical-action device for treating chronic total occlusions) and evaluates it based on:

• Bench Tests: Energy output, fluence, beam divergence, ablation through samples, maneuverability, insertion/retraction force, pull testing, corrosion resistance, perforation testing, kink testing, torque testing, radio-opaque tip testing, fluid leak analysis, package integrity, dimensional testing, particulate investigation, simulated use testing.
• Conformance to Standards: IEC electrical safety, laser product safety, electromagnetic compatibility, electronic product radiation, intravascular catheters, usability engineering.
• Biocompatibility Testing: C3a complement activation, cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, partial thromboplastin time, material-mediated pyrogenicity, SC5b-9 complement activation, acute systemic toxicity, in vivo human thrombus evaluation.
• Sterilization: Gamma radiation sterilization in conformance with ISO 11137.
• Clinical Results (for this laser device):
  • Study Population: 50 patients (66 lesions).
  • Outcomes evaluated: Proper deployment and predictability from packaging, ease of vasculature navigation, predicted manner/time/ease of lesion crossing, predicted procedure outcome, no undesired effects on follow-up, no observed adverse events or safety issues.
  • Conclusion: The device performed equivalently to the predicate and "exceeded the performance goal" based on these unquantified clinical outcomes.

This information is for a physical medical device and its associated clinical effectiveness and safety, not for an AI/ML diagnostic or prognostic software.

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